Comparison Matrix ISO 9001:2015 & IATF 16949 vs ISO/TS 16949:2009 Dv!op" an" #rovi"" $%:
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Comparison Matrix ISO 9001:2015 & IATF 16949 vs ISO/TS 16949:2009
ISO 9001:01! " I#$F 01% cl clause
ISO&$S 1%9'9:009 clause
(omments
The text that is bolded is text from IATF 16949. 16949.
The text that is bolded is automotive text from ISO/TS 16949. 16949.
The comments that are bolded relate to the automotive requirements requirements
$he normal te)t is from ISO 9001:01!
$he normal te)t is from ISO 9001:00*
$he comments in normal te)t relate to ISO 9001:01!
Fore!ord This Automotive "ualit# $ana%ement S#stem Standard& herein referred to as 'Automotive "$S Standard' or 'IATF 16949&' alon% !ith a((licable automotive customer)s(ecific requirements& ISO 9**1+,*1requirements& and ISO 9***+,*1defines the fundamental qualit# mana%ement s#stem requirements for automotive (roduction and relevant service (arts or%ani.ations As such& this Automotive "$S Standard cannot be considered a stand)alone "$S Standard but has to be com(rehended as a su((lement to and used in conunction !ith ISO 9**1+,*1- ISO 9**1+,*1- is (ublished as a se(arate ISO Standard
The automotive requirements are no! in a se(arate document& IATF 16949& !hich is This Technic Tec hnical al S(ecification& cou(led cou(le d !ith not an ISO standard IATF 16949 is a((licable customer )s(ecifi c intended to be used !ith ISO9**1+,*1-5 in requirements& fact IATF 16949 refers to ISO 9**1 defines defi nes the fundamen fund amental tal qualit qua lit# # throu%hout the various various clauses IATF mana%eme mana %ement nt s#stem s#ste m requireme requ irements nts for 16949 is also intended to be used !ith the those customer s(ecific requirements subscrib subs cribin% in% to this Technica Tech nical l S(ecification Annex A 0control (lan (lan of IATF 16949 is a normative (art of IATF 16949 and therefore contains requirements that must be met
IATF 16949+,*16 01st edition re(resents an innovative document& %iven the stron% orientation to the customer& !ith inclusion of a number of consolidated (revious customer s(ecific requirements Annex 2 is (rovided (rovided for %uidance to im(lement the IATF 16949 requirements unless other!ise s(ecified b# customer s(ecific requirements
Annex A 03ontrol lan lan is a normative (art of
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this Automotive "$S standard
4 Contxt o t( orani3ation '.1 +nderstandin, the or,ani-ation and its conte)t
4o equialent clause
$he or,ani-ation shall determine e)ternal and internal issues that are releant to its /ur/ose and its strate,ic direction and that affect its ailit to achiee the intended result2s3 of its qualit mana,ement mana,em ent sstem. sstem . $he or,ani-ation shall monitor and reiew information aout these e)ternal and internal issues.
$he issues can relate to:
4O$5 1 Issues can include /ositie and ne,atie factors or conditions conditions for considera consideration. tion.
S#3 ?ar7et " com/etition $echnolo, deelo/ment (ultural " social directions directions 5conomic deelo/ment International $rade
4O$5 +nderstandin, +nderstandin, the e)ternal conte)t can e facilitated considerin, issues arisin, from le,al6 technolo,ical6 com/etitie6 mar7et6 cultural6 social and economic enironments6 whether international6 national6 re,ional or local.
For automotive s(ecificall# le%al issues could relate to 1 assen%er restraints , n%ine air emissions 7 2ra8in% s#stems 4 xterior li%ht illumi illuminat nation ion and others others de(endin% de(endin% on the t#(es of (roducts (roducts and (osition (osition in the su((l# chain
4O$5 8 4O$5 +nder +n dersta stand ndin, in, the int intern ernal al cont conte) e)tt can e facilitated consideri considerin, n, issues related to alues6 alues6 culture6 7nowled,e 7nowled,e and /erformance /erformance of the or,ani-ation.
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enerall or,ani-ations address this deelo/in, a ision statement and a mission statement these are deelo/ed into a lon, term strate,ic direction and a strate,ic /lan. $hese further lead to shorter 8 to ! ear usiness deelo/ment /lans6 which are su//orted annual ,oals and o;ecties. For small to medium si-e or,ani-ations6 these ma e unstated and undocumented and e in the mind of the owner or ma not e)ist at all.
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+nderstandin, the needs and e)/ectations of interested /arties 4.2
o )'iva!nt +!a's
Owner2s3 A indiiduals6 inestment com/anies6 cor/orate ownershi/6 stoc7holders
Due to their effect or /otential effect on the or,ani-ations ailit to consistentl /roide /roducts and serices that meet customer and a//licale statutor and re,ulator requirements6 the or,ani-ation shall determine:
5m/loees Re,ulators (ustomers (om/etitors $rade #ssociations State and local usiness communit Owners Su//liers 4ei,hors
2.a) the interested /arties that are releant to the qualit mana,ement sstem 2.b) the requirements of these interested /arties that are releant to the qualit mana,ement sstem.
For automotive s(ecificall#& interested (arties could include AIA& SA& :OT and A& ISO/TS certification bod#
$he or,ani-ation shall monitor and reiew information aout these interested /arties and their releant requirements.
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Or,ani-ations interested /arties include:
For Tier , and belo!& interested (arties include the O$s that their customers su((l# to
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Determinin, the sco/e of the qualit mana,ement sstem 4.3
4.2.2
$he or,ani-ation shall determine the oundaries and a//licailit of the qualit mana,ement sstem to estalish its sco/e. Bhen determinin, this sco/e6 the or,ani-ation shall consider:
3.a) the e)ternal and internal issues referred to in '.1 3.b) the requirements of releant interested /arties referred to in '. 3.c) the /roducts or,ani-ation.
and
serices
Quality manual
The organization shall establish and maintain a quality manual that includes ..a3 the sco/e of the qualit mana,ement sstem6 includin, details of and ;ustification for an e)clusions 2see 1.36
Sco/e requirements are more e)/licit
,)'ir" Contnt $/es of /roducts " serices #//lication of all requirements from ISO 9001 that are a//licale A if the hae actiities&/rocesses the are to e included Coundaries of the Q?S ustification for an e)clusions
of the
$he or,ani-ation shall a//l all the requirements of this International Standard if the are a//licale within the determined sco/e of its qualit mana,ement sstem.
Sco/e determined considerin, e)ternal " internal issues6 requirements of interested /arties " /roducts " serices
$he sco/e of the or,ani-ations qualit mana,ement sstem shall e aailale and e maintained as documented information. $he sco/e shall state the t/es of /roducts and serices coered6 and /roide ;ustification for an requirement of this International Standard that the or,ani-ation determines is nota//licale to the sco/e of its qualit mana,ement sstem. (onformit to this International Standard ma onl e claimed if the requirements determined as not ein, a//licale do not affect the or,ani-ations ailit or res/onsiilit to ensure the conformit of its /roducts and serices and the enhancement of customer satisfaction. 471 :eterminin% the sco(e of the qualit# mana%ement s#stem ; su((lemental Su((ortin% functions& !hether on)site
Automotive S(ecific+ Sco(e must include su((ortin% functions& 0remote and on)site Onl# (ermitted exclusion is (roduct desi%n and develo(ment and this
4.4 Qualit mana,ement sstem 4.4.1 $he or,ani-ation shall estalish6 im/lement6 maintain and continuall im/roe a qualit mana,ement sstem6 includin, the /rocesses needed and their interactions6 in accordance with the requirements of this International Standard.
$he or,ani-ation shall determine the /rocesses needed for the qualit mana,ement sstem and their a//lication throu,hout the or,ani-ation6 and shall: 4.1.a) determine the in/uts required and the out/uts e)/ected from these /rocesses
4.1.b) determine the sequence and interaction of these /rocesses 4.1.c) determine and a//l the criteria and methods 2includin, monitorin,6 measurements and related /erformance indicators3 needed to ensure the effectie o/eration and control of these /rocesses 4.1.d) determine the resources needed for these /rocesses and ensure their aailailit 4.1.e) assi,n the res/onsiilities and authorities for these /rocesses 4.1.f) address the ris7s and o//ortunities as determined in accordance with the requirements of %.1 4.1.g) ealuate these /rocesses and im/lement an chan,es
41 nra! r)'irmnts $he or,ani-ation shall estalish6 document6 im/lement and maintain a qualit mana,ement sstem and continuall im/roe its effectieness in accordance with the requirements of this International Standard. $he or,ani-ation shall a3determine the /rocesses needed for the qualit mana,ement sstem and their a//lication throu,hout the or,ani-ation 2see 1.36 3determine the sequence and interaction of these /rocesses6 c3 determine criteria and methods needed to ensure that oth the o/eration and control of these /rocesses are effectie6 d3ensure the aailailit of resources and information necessar to su//ort the o/eration and monitorin, of these /rocesses6 e3monitor6 measure where a//licale6 and analse these /rocesses6 and f3 im/lement actions necessar to achiee /lanned results and continual im/roement of these /rocesses. the or,ani-ation in accordance with the requirements of this International Standard. Bhere an or,ani-ation chooses to outsource an /rocess that affects /roduct conformit to requirements6 the or,ani-ation shall ensure control oer such /rocesses. $he t/e and e)tent of control to e a//lied to these outsourced /rocesses shall e defined within the qualit mana,ement sstem. 4O$5 1 =rocesses needed for the qualit mana,ement sstem referred to aoe include
#ro+ss Approa+( a""itions/+(ans #ssi,n res/onsiilities " authorities for the /rocesses #ddress ris7s and o//ortunities with lin7 to %.1
Discussion of outsourced /rocesses moed to a reference in clause *.1 which refers to control descried in clause *.' asicall the /urchasin, requirements
Automotive has added s(ecific !ordin% requirin% the "$S to lead to conformance of the (roduct to requirements includin% customer&
needed to ensure that these /rocesses achiee their intended results
/rocesses for mana,ement actiities6 /roision of resources6 /roduct reali-ation6 measurement6 analsis and im/roement.
4.1.h) im/roe the /rocesses and the qualit mana,ement sstem.
4O$5 #n Eoutsourced /rocess is a /rocess that the or,ani-ation needs for its qualit mana,ement sstem and which the or,ani-ation chooses to hae /erformed an e)ternal /art.
4411 3onformance of (roducts and (rocesses The or%ani.ation shall ensure conformance of all (roducts and (rocesses& includin% service (arts and those that are outsourced& to all a((licable customer& statutor#& and re%ulator# requirements 0see Section <4,,
4O$5 8 5nsurin, control oer outsourced /rocesses does not asole the or,ani-ation of the res/onsiilit of conformit to all customer6 statutor and re,ulator requirements. $he t/e and e)tent of control to e a//lied to the outsourced /rocess can e influenced factors such as the /otential im/act of the outsourced /rocess on the or,ani-ationGs ca/ailit to /roide /roduct that conforms to requirements6 a)
441, roduct safet# The or%ani.ation shall have documented (rocesses for the b) the de,ree to which the control for mana%ement of (roduct)safet# related the /rocess is shared6 (roducts and manufacturin% c) the ca/ailit of achiein, the (rocesses& !hich shall include but not necessar control throu,h the be limited to the follo!in%& !here a//lication of H.'. a((licable+ a3 identification b# the or%ani.ation of statutor# and re%ulator# (roduct)safet# requirements5 411 >"@I>$=TS ; 3 customer notification of =>A? S@?$=TA? requirements in item a5 c3 s(ecial a((rovals for desi%n F$A5 nsurin% control over outsourced of (roduct safet#) (rocesses shall d3 identification not absolve the related characteristics5 or%ani.ation of the res(onsibilit# of e3 identification and controls of safet#) conformit# to all customer requirements related characteristics of (roduct and =OT6 See also 41 and 417 at the (oint of manufacture5 f3 s(ecial a((roval of control (lans and (rocess F$As5 ,3 reaction (lans 0see Section 91115 h3 defined res(onsibilities& definition of escalation (rocess and flo! of information& includin% to( mana%ement& and customer notification5
statutor# and re%ulator# requirements
=o! need a documented (rocess for the mana%ement of (roduct B safet# related (roducts and (rocesses Identification of safet# related requirements and inclusion in F$As& control (lans& controls such as !or8 instructions& flo! do!n to su((liers& trainin% This clause requires more detailed control over safet# related (roducts& (rocesses and characteristics This control includes s(ecial a((rovals for F$As and control (lans and an# chan%es There is a lot more detail relatin% to the control of these safet# related requirements
trainin% identified b# the or%ani.ation or customer for (ersonnel involved in (roduct)safet# related (roducts and associated manufacturin% (rocesses5 chan%es of (roduct or (rocess shall be a((roved (rior to im(lementation& includin% evaluation of (otential effects on (roduct safet# from (rocess and (roduct chan%es 0see ISO 9**1& Section <765 8 transfer of requirements !ith re%ard to (roduct safet# throu%hout the su((l# chain& includin% customer)desi%nated sources 0see Section <4715 I (roduct traceabilit# b# manufactured lot 0at a minimum throu%hout the su((l# chain 0see Section <-,15 m lessons learned for ne! (roduct introduction i3
=OT+ S(ecial a((roval is an additional a((roval b# the function 0t#(icall# the customer that is res(onsible to a((rove such documents !ith safet#)related content
4.4.2
$o the e)tent necessar6 the or,ani-ation shall:
4.2.a) maintain documented information to su//ort the o/eration of its /rocesses 4.2.b) retain documented information to hae confidence that the /rocesses are ein, carried out as /lanned.
5 a"rs(ip 5.1
1.1.a) ta7in, accountailit for the effectieness of the qualit mana,ement sstem 1.1.b) ensurin, that the qualit /olic and qualit o;ecties are estalished for the qualit mana,ement sstem and are com/atile with the conte)t and strate,ic direction of the or,ani-ation 1.1.c) ensurin, the inte,ration of the qualit mana,ement sstem requirements into the or,ani-ations usiness /rocesses
d) /romotin, the use of the /rocess a//roach and ris7 ased thin7in, e) ensurin, that the resources needed for the qualit mana,ement sstem are aailale f) communicatin, the im/ortance of effectie qualit mana,ement and of conformin, to the qualit mana,ement sstem requirements
$o/ ?ana,ement A new&now e)/licit commitments and accountailities: 5/1
Manamnt +ommitmnt
#ccountailit for effectieness of the Q?S $o/ mana,ement shall /roide eidence of its commitment to the deelo/ment and im/lementation of the quali t mana,ement sstem and continuall im/roin, its effectieness communicatin, to the or,ani-ation the im/ortance of meetin, customer as well as statutor and re,ulator requirements6 a)
b) estalishin, the qualit /olic6 c)
ensurin, that qualit o;ecties are estalished6
d) conductin, mana,ement reiews6 and e) ensurin, the aailailit of resources.
5nsurin, Q?S achiees intended results (om/atile with Strate,ic Direction of or,ani-ation Inte,ration with usiness /rocesses 2inter/reted in conte)t of nature of or,ani-ation A for /rofit not for /rofit /riate6 /ulic3
g) ensurin, that the qualit mana,ement sstem achiees its intended results h)
en,a,in,6 directin, and su//ortin, /ersons to contriute to the effectieness of the qualit mana,ement sstem
i)
/romotin, im/roement
) su//ortin, other releant mana,ement roles to demonstrate their leadershi/ as it a//lies to their areas of res/onsiilit.
This clause no! requires three cor(orate res(onsibilit# (olicies+ Anti)briber# (olic# m(lo#ee 3ode of 3onduct DhistleB2lo!in% olic#
4O$5 Reference to Eusiness in this International Standard can e inter/reted roadl to mean those actiities that are core to the /ur/oses of the or,ani-ations e)istence6 whether the or,ani-ation is /ulic6 /riate6 for /rofit or not for /rofit.
-111 3or(orate res(onsibilit# The or%ani.ation shall define and im(lement cor(orate res(onsibilit# (olicies& includin% at a minimum an anti) briber# (olic#& an em(lo#ee code of conduct& and an ethics escalation (olic# 0'!histle)blo!in% (olic#' -11, rocess effectiveness and efficienc# To( mana%ement shall revie! the (roduct reali.ation (rocesses and su((ort (rocesses to evaluate and im(rove their effectiveness and efficienc# The results of the (rocess revie! activities shall be included as in(ut to the mana%ement revie! 0see Section 97,1 -117 rocess o!ners To( mana%ement shall identif# (rocess
The (rocess effectiveness and efficienc# evaluation is no! an in(ut to mana%ement revie! 511 >O3SS FFI3I=3C To( mana%ement shall revie! the (roduct reali.ation (rocesses and the su((ort (rocesses to assure their effectiveness and efficienc#
=o! requires the s(ecific identification and com(etenc# of (rocess o!ners
o!ners !ho are res(onsible for mana%in% the or%ani.ationEs (rocesses and related out(uts rocess o!ners shall understand their roles and be com(etent to (erform those roles 0see ISO 9**1& Section ,
5.1.2 (ustomer Focus
$o/ mana,ement shall demonstrate leadershi/ and commitment with res/ect to customer focus ensurin, that: 1.2.a) customer and a//licale statutor and re,ulator requirements are determined6 understood and consistentl met
1.2.b) the ris7s and o//ortunities that can affect conformit of /roducts and serices and the ailit to enhance customer satisfaction are determined and addressed 1.2.c) the focus on enhancin, customer satisfaction is maintained.
52 C'stomr o+'s $o/ mana,ement shall ensure that customer requirements are determined and are met with the aim of enhancin, customer satisfaction 2see H..1 and *..13.
(ustomer focus tie to re,ulator requirements as well as customer requirements
(ustomer focus tie to ris7 as affectin, /roducts " serices
!. =olic
5.2.1
Dv!opin t( )'a!it% po!i+% $o/ mana,ement shall estalish6 im/lement and maintain a qualit /olic that: a) is a//ro/riate to the /ur/ose and conte)t of the or,ani-ation and su//orts its strate,ic direction
b)/roides a framewor7 for settin, qual it o;ecties c) includes a commitment to satisf a//licale requirements d)includes a commitment to continual im/roement of the qualit mana,ement sstem. 522 Comm'ni+atin t( )'a!it% po!i+% $he qualit /olic shall: a) e aailale and e maintained as documented information
5.3 7'a!it% po!i+% $o/ mana,ement shall ensure that the qualit /olic a) is a//ro/riate to the /ur/ose of the or,ani-ation6
#o!i+% ties to (onte)t of or,ani-ation Strate,ic direction
b) includes a commitment to com/l
with requirements and continuall im/roe the effectieness of the qualit mana,ement sstem6 c) /roides a framewor7 for
estalishin, and reiewin, qualit o;ecties6
Reiew for continuin, suitailit was remoed
d) is communicated and understood within
the or,ani-ation6 and
#ailailit to interested /arties added
e) is reiewed for continuin, suitailit.
b)e communicated6 understood and a//lied within the or,ani-ation c) e aailale to releant interested /arties6 as a//ro/riate. 58 Or,ani-ational roles6 res/onsiilities and authorities $o/ mana,ement shall ensure that the res/onsiilities and authorities for releant roles are assi,ned6 communicated and understood within the or,ani-ation. $o/ mana,ement shall assi,n the res/onsiilit and authorit for: a) ensurin, that the qualit mana,ement sstem conforms to the requirements
551 Res/onsiilit and authorit $o/ mana,ement shall ensure that res/onsiilities and authorities are defined and communicated within the or,ani-ation. ..2 Manamnt rprsntativ $o/ mana,ement shall a//oint a memer of the or,ani-ationGs mana,ement who6 irres/ectie of other res/onsiilities6 shall hae res/onsiilit and authorit that
$here is no lon,er a /osition of Emana,ement re/resentatie $here are now ! res/onsiilities and authorities that need to e assi,ned.
of this International Standard
b)ensurin, that the /rocesses are delierin, their intended out/uts c) re/ortin, on the /erformance of the qualit mana,ement sstem and on o//ortunities for im/roement 2see 10.136 in /articular to to/ mana,ement d)ensurin, the /romotion of customer focus throu,hout the or,ani-ation e) ensurin, that the inte,rit of the qualit mana,ement sstem is maintained when chan,es to thequalit mana,ement sstem are /lanned and im/lemented.
includes
a) ensurin, that /rocesses needed for the qualit mana,ement sstem are estalished6 im/lemented and maintained6 b) re/ortin, to to/ mana,ement on the /erformance of the qualit mana,ement sstem and an need for im/roement6 and c) ensurin, the /romotion of awareness of
customer requirements throu,hout the or,ani-ation. 4O$5 $he res/onsiilit of a mana,ement re/resentatie can include liaison with e)ternal /arties on matters relatin, to the qualit mana,ement sstem.
5511 >SO=SI2I?ITC FO> "@A?ITC -71 Or%ani.ational roles& res(onsibilities& $ana%ers !ith res(onsibilit# and authorit# and authorities ; su((lemental To( mana%ement shall assi%n for corrective action shall be (rom(tl# (ersonnel !ith the res(onsibilit# and informed of (roducts or (rocesses !hich authorit# to ensure that customer do not conform to requirements requirements are met These ersonnel res(onsible for conformit# to assi%nments shall be documented (roduct requirements shall have the This includes but is not limited to the authorit# to sto( (roduction to correct selection of s(ecial characteristics& qualit# (roblems settin% qualit# obectives and related roduction o(erations across all shifts shall trainin%& corrective and (reventive be staffed !ith (ersonnel in char%e of& or actions& (roduct desi%n and dele%ated res(onsibilit# for& ensurin% develo(ment& ca(acit# anal#sis& conformit# to (roduct requirements lo%istics information& customer scorecards& and customer (ortals -7, >es(onsibilit# and authorit# for (roduct requirements and corrective actions To( mana%ement shall ensure that+ a3 (ersonnel res(onsible for conformit# to (roduct requirements have the authorit# to sto( shi(ment and sto( (roduction to !.!..1 3@STO$> >>S=TATI
These are the res(onsibilities of the customer re(resentative in ISO/TS 16949 and have been ex(anded a bit All these res(onsibilities should be documented some!here for exam(le ob descri(tions or qualit# manual or (rocedures
correct qualit# (roblems5 To( mana%ement shall desi%nate =OT :ue to the (rocess desi%n in some (ersonnel !ith res(onsibilit# and authorit# industries& it mi%ht not al!a#s be to ensure that customer requirements are (ossible to sto( (roduction immediatel# addressed This includes selection of In this case& the affected batch must be s(ecial characteristics& settin% qualit# contained and shi(ment to the customer obectives and related trainin%& corrective (revented and (reventive actions& (roduct desi%n and 3 (ersonnel !ith authorit# and develo(ment res(onsibilit# for corrective action are (rom(tl# informed of (roducts or (rocesses that do not conform to requirements to ensure that nonconformin% (roduct is not shi((ed to the customer and that all (otential nonconformin% (roduct is identified and contained5 c3 (roduction o(erations across all shifts are staffed !ith (ersonnel in char%e of& or dele%ated res(onsibilit# for& ensurin% conformit# to (roduct requirements
6 #!annin
6.1
A+tions to a""rss ris9s an" opport'nitis 542 Qualit mana,ement sstem 611 Bhen /lannin, for the qualit /lannin, mana,ement sstem6 the or,ani-ation shall $o/ mana,ement shall ensure that consider the issues referred to in '.1 and the 4.2.a) the /lannin, of the qualit requirements referred to in '. and determine mana,ement sstem is carried out in the ris7s and o//ortunities that need to e order to meet the requirements ,ien addressed to: in '.16 as well as the qualit a) ,ie assurance that the qualit o;ecties6 and mana,ement sstem can achiee its intended result2s3 4.2.b) the inte,rit of the qualit mana,ement sstem is maintained b)enhance desirale effects when chan,es to the qualit c) /reent6 or reduce6 undesired effects mana,ement sstem are /lanned and im/lemented. d)achiee im/roement. $he or,ani-ation shall /lan: 6/1/2 a) actions to address these ris7s and o//ortunities
b)how to: 1)
inte,rate and im/lement the actions into its qualit mana,ement sstem /rocesses 2see '.'3
2)
ealuate the effectieness of these actions. #ctions ta7en to address ris7s and o//ortunities shall e /ro/ortionate to the /otential im/act on the conformit of /roducts and serices. 4O$5 1 O/tions to address ris7s can include aoidin, ris76 ta7in, ris7 in order to /ursue an o//ortunit6 eliminatin, the ris7 source6 chan,in, the li7elihood or consequences6 sharin, the ris76 or retainin, ris7 informed decision. 4O$5 O//ortunities can lead to the ado/tion of new /ractices6 launchin, new /roducts6 o/enin, new mar7ets6 addressin, new clients6 uildin, /artnershi/s6 usin, new
$here is not a com/arale clause in 00* ersion onl the er ,eneral that /lannin, of the Q?S should meet the /rocess a//roach requirements and qualit o;ecties $his reision e)/ects that the Q?S addresses identified ris7s arisin, from the consideration of the conte)t of the or,ani-ation and the requirements of interested /arties $he conte)t of the or,ani-ation mi,ht lead to ris7s such as: =roduct ris7s A FD#6 DO$6 5=# 2e)am/les ,as milea,e requirements on ehicles /roduct shi//in, ris7sha-ardous materials ehicle li,htin, requirements food and dru, ris7s3 $he requirements of interested /arties ma lead to ris7s identified durin, contract reiew such as short delier times or difficult /roduct requirements or su//liers ailit to /roide raw materials or com/onents
?ost of our clients will identif ris7s durin, contract reiew and ta7e actions such as ne,otiatin, delier dates or ta7in, e)ce/tion to /roduct requirements or ealuatin, ris7s durin, desi,n actiities 2es/eciall desi,n reiews6 erification and alidation3 or identifin, ris7s when selectin, and ealuatin, su//liers
technolo, and other desirale and iale /ossiilities to address the or,ani-ations or its customers needs
61,1 >is8 anal#sis The or%ani.ation shall include in its ris8 anal#sis& at a minimum& lessons learned from (roduct recalls& (roduct audits& field returns and re(airs& com(laints& scra(& and re!or8 The or%ani.ation shall retain documented information as evidence of the results of ris8 anal#sis 61,, reventive action The or%ani.ation shall determine and im(lement action0s to eliminate the causes of (otential nonconformities in order to (revent their occurrence reventive actions shall be a((ro(riate to the severit# of the (otential issues The or%ani.ation shall establish a (rocess to lessen the im(act of ne%ative effects of ris8 includin% the follo!in%+ a3 determinin% (otential nonconformities and their causes5 3 evaluatin% the need for action to (revent occurrence of nonconformities5 c3 determinin% and im(lementin% action needed5 d3 documented information of action ta8en5 e3 revie!in% the effectiveness of the (reventive action ta8en5 f3 utili.in% lessons learned to (revent recurrence in similar (rocesses 0see ISO 9**1& Section 16 682 3O=TI==3C ?A=S The or%ani.ation shall (re(are 61,7 3ontin%enc# (lans contin%enc# (lans to satisf# customer The or%ani.ation shall+ requirements in the event of an f.a3 identif# and evaluate internal and emer%enc# such as utilit# interru(tions& external ris8s to all manufacturin% labour shorta%es& 8e# equi(ment failure (rocesses and infrastructure equi(ment and field returns essential to maintain (roduction out(ut and to ensure that customer requirements are met5 f.3 define contin%enc# (lans accordin% to
IATF 16949 ex(ects that (erformance data/indicators such recalls& audit results& returns G re(airs& com(laints& scra( G re!or8 to be tied into the ris8 anal#sis Similar to the ex(ectation that returns& scra( and com(laints !ere ex(ected to be tied to the F$As in ISO/TS 16949& but this is broader and ties to all of the ris8 anal#ses mechanisms used b# the or%ani.ation
This clause adds in the (revious (reventive action requirements but in the context of requirin% s(ecific actions to address ris8s
This clause includes the ISO/TS 16949 contin%enc# (lan requirements !hich is no! tied to and based on the ris8 anal#sis There should be consistenc# bet!een the ris8 anal#sis and the contin%enc# (lans These requirements no! include+ 1. A (rocess to notif# customers of an# incidents 0extent G duration affectin%
f.c3
f.d3
f.e3
f.f3
f.,3
ris8 and im(act to the customer5 (re(are contin%enc# (lans for continuit# of su((l# in the event of an# of the follo!in%+ 8e# equi(ment failures 0also see Section <-6115 interru(tion from externall# (rovided (roducts& (rocesses& and services5 recurrin% natural disasters5 fire5 utilit# interru(tions5 labour shorta%es5 or infrastructure disru(tions5 include& as a su((lement to the contin%enc# (lans& a notification (rocess to the customer and other interested (arties for the extent and duration of an# situation im(actin% customer o(erations5 (eriodicall# test the contin%enc# (lans for effectiveness 0e%& simulations& as a((ro(riate5 conduct contin%enc# (lan revie!s 0at a minimum annuall# usin% a multidisci(linar# team includin% to( mana%ement& and u(date as required5 document the contin%enc# (lans and retain documented information describin% an# revision0s& includin% the (erson0s !ho authori.ed the chan%e0s
The contin%enc# (lans shall include (rovisions to validate that the manufactured (roduct continues to meet customer s(ecifications after the re)start of (roduction follo!in% an emer%enc# in !hich (roduction !as sto((ed and if the re%ular shutdo!n (rocesses !ere not follo!ed
o(erations that is continuit# of su((l# , Included s(ecificall# are 8e# equi(ment failure& su((l# chain 0externall# (rovided (roduct G services& natural disasters5 fire5 utilit# interru(tion5 labor shorta%es or infrastructure disru(tion 7 eriodicall# testin% the (lans for effectiveness 4 >evie! of the (lans annuall#
The contin%enc# (lan needs to include the validation of (roduct follo!in% an emer%enc# and if the re%ular shutdo!n (rocess !as not follo!ed
%. Qualit o;ecties and /lannin, to achiee them $he or,ani-ation shall estalish 6/2/1 qualit o;ecties at releant functions6 leels and /rocesses needed for the qualit mana,ement sstem. $he qualit o;ecties shall: a) e consistent with the qualit /olic
b)
e measurale
c)
ta7e into account a//licale requirements
54 #!annin 541
7'a!it% o$+tivs
$o/ mana,ement shall ensure that qualit o;ecties6 includ in, those needed to meet requirements for /roduct Jsee H.1 a3K6 are estalished at releant functions and leels within the or,ani-ation. $he qualit o;ecties shall e measurale and consistent with the qualit /olic.
Some additional requirements for e)am/le releance to /roduct conformit and customer satisfaction
d) e releant to conformit of /roducts and serices and to enhancement of customer satisfaction e)
e monitored
f)
e communicated
g) e u/dated as a//ro/riate. $he or,ani-ation shall maintain documented information on the qualit o;ecties. 622 Bhen /lannin, how to achiee its qualit o;ecties6 the or,ani-ation shall determine: a) what will e done b) what resources will e required c)
who will e res/onsile
d) when it will e com/leted e) how the results will e ealuated.
#n action /lan is now e)/ected for the qualit o;ecties
6,,1 "ualit# obectives and (lannin% to achieve them ; su((lemental To( mana%ement shall ensure that qualit# obectives to meet customer requirements are defined& established& and maintained for relevant functions& (rocesses& and levels throu%hout the or%ani.ation
-411 "ualit# obectives ; Su((lemental To( mana%ement shall define qualit# obectives and measurements that shall be included in the business (lan and used to de(lo# the qualit# (olic# =OT6
"ualit# obectives should address customer ex(ectations and be achievable The results of the or%ani.ationEs revie! re%ardin% interested (arties and their relevant !ithin a defined time (eriod requirements shall be considered !hen the or%ani.ation establishes its annual 0at a minimum qualit# obectives and related (erformance tar%ets 0internal and external
I#$F 1%9'9 requires annual o;ecties I#$F 1%9'9 also ties the estalishment of o;ecties to the interested /arties and their requirements6 which ties o;ecties to O5?s for tier su//liers and elow.
%.8 =lannin, of chan,es Bhen the or,ani-ation determines the need for chan,es to the qualit mana,ement sstem6 the chan,es shall e carried out in a /lanned manner 2see '.'3. $he or,ani-ation shall consider: 3.a) the /ur/ose of the chan,es and their /otential consequences
3.b) the inte,rit of the qualit mana,ement sstem
542 Qualit mana,ement sstem /lannin, $o/ mana,ement shall ensure that 4.2.a) the /lannin, of the qualit mana,ement sstem is carried out in order to meet the requirements ,ien in '.16 as well as the qualit o;ecties6 and the inte,rit of the qualit mana,ement sstem is maintained when chan,es to the qualit mana,ement sstem are /lanned and im/lemented.
4.2.b)
3.c) the aailailit of resources 3.d) the allocation or reallocation of res/onsiilities and authorities.
; S'pport H.1 Resources H.1.1 eneral $he or,ani-ation shall determine and /roide the resources needed for the estalishment6 im/lementation6 maintenance and continual im/roement of the qualit mana,ement sstem. $he or,ani-ation shall consider:
a) the ca/ailities of6 and constraints on6 e)istin, internal resources b)what needs to e otained from e)ternal /roiders.
#op! ;/1/2 $he or,ani-ation shall determine and /roide the /ersons necessar for the effectie im/lementation of its qualit mana,ement sstem and for the o/eration and control of its /rocesses.
Q?S chan,e control more detailed
61
=roision of resources $he or,ani-ation shall determine and /roide the resources needed 1.a) to im/lement and maintain the qualit mana,ement sstem and continuall im/roe its effectieness6 and to enhance customer satisfaction meetin, customer requirements. 1.b)
4o essential chan,es some e)/lanation wordin, added
;18 Inrastr'+t'r $he or,ani-ation shall determine6 /roide and maintain the infrastructure necessar for the o/eration of its /rocesses and to achiee conformit of /roducts and serices. 4O$5
Infrastructure can include:
a) uildin,s and associated utilities b) equi/ment6 includin, hardware and software c) trans/ortation resources d) information and communication technolo, .
Infrastructure $he or,ani-ation shall determine6 /roide and maintain the infrastructure needed to achiee conformit to /roduct requirements. Infrastructure includes6 as a//licale6
4o essential chan,es some word smithin,
uildin,s6 wor7s/ace and associated utilities6 3.a)
/rocess equi/ment 2oth hardware and software36 and 3.b)
3.c) su//ortin, serices 2such as trans/ort6
communication or information sstems3.
171 lant& facilit#& and equi(ment (lannin% The relationshi( of (lant& facilit# and The or%ani.ation shall use a 681 ?A=T& FA3I?ITC A=: "@I$=T equi(ment to ris8 identification and multidisci(linar# a((roach includin% ris8 miti%ation !as added ?A==I= identification and ris8 miti%ation methods The or%ani.ation shall use a for develo(in% and im(rovin% (lant& multidisci(linar# a((roach 0see 711 for facilit#& and equi(ment (lans In desi%nin% develo(in% (lant& facilit# and equi(ment (lant la#outs& the or%ani.ation shall+ (lans lant la#outs shall o(timi.e material a3 o(timi.e material flo!& material travel& handlin% and value)added use of handlin%& and value)added use of floor floor s(ace includin% control of s(ace& and shall facilitate s#nchronous nonconformin% (roduct& and flo! $ethods shall be develo(ed 3 facilitate s#nchronous material flo!& material and im(lemented to evaluate and monitor as a((licable The connection bet!een ne! (roduct and the effectiveness of existin% o(erations $ethods shall be develo(ed and =OT These requirements should focus ne! o(erations/chan%es to o(erations and im(lemented to evaluate manufacturin% on lean manufacturin% (rinci(les and the manufacturin% feasibilit# and ca(acit# feasibilit# for ne! (roduct or ne! lin8 to the effectiveness of the qualit# (lannin% !ere added o(erations $anufacturin% feasibilit# mana%ement s#stem assessments shall include ca(acit# (lannin% These methods shall also be a((licable for evaluatin% (ro(osed chan%es to existin% o(erations The or%ani.ation shall maintain (rocess effectiveness& includin% (eriodic re) evaluation relative to ris8& to incor(orate
The connection bet!een (rocess effectiveness and ris8s !as added
an# chan%es made durin% (rocess a((roval& control (lan maintenance 0see Section <-11& and verification of ob set)u(s 0see Section <-17
The assessments of manufacturin% feasibilit# and ca(acit# (lannin% are no! in(uts to mana%ement revie!
Assessments of manufacturin% feasibilit# and evaluation of ca(acit# (lannin% shall be in(uts to mana%ement revie!s 0see ISO 9**1& Section 97 =OT 1 These requirements should include the a((lication of lean manufacturin% (rinci(les =OT , These requirements should a((l# to on)site su((lier activities& as a((licable ;14 5nironment for the o/eration of /rocesses $he or,ani-ation shall determine6 /roide and maintain the enironment necessar for the o/eration of its /rocesses and to achiee conformit of /roducts and serices. 4O$5 # suitale enironment can e a comination of human and /hsical factors6 such as: a) social 2e.,. non discriminator6 calm6 non confrontational3
Bor7 enironment as it a//lies to o/eration of the /rocesses as well as the /roduct
Bor7 enironment 64 $he or,ani-ation shall determine and mana,e the wor7 enironment needed to achiee conformit to /roduct requirements. 4O$5 $he term Ewor7 enironment relates to those conditions under which wor7 is /erformed includin, /hsical6 enironmental and other factors 2such as noise6 tem/erature6 humidit6 li,htin, or weather3.
This !as added to the ISO 9**1+,*1!ordin%
b) /scholo,ical 2e.,. stressreducin,6
urnout /reention6 emotionall /rotectie3 c) /hsical 2e.,. tem/erature6 heat6
humidit6 li,ht6 airflow6 h,iene6 noise3. $hese factors can differ sustantiall de/endin, on the /roducts and serices /roided.
641
>SO==? SAFTC TO A3HI 3O=FO>$ITC TO >O:@3T >"@I>$=TS roduct safet# and means to minimi.e (otential ris8s to em(lo#ees shall be addressed b# the or%ani.ation& es(eciall# in the desi%n and develo(ment (rocess and in manufacturin% (rocess activities
=OT Dhere third)(art# certification to ISO 4-**1 0or equivalent is reco%ni.ed& it ma# be used to demonstrate the or%ani.ationEs conformit# to the 642 3?A=?I=SS OF >$ISS (ersonnel safet# as(ects of this
=o chan%es
requirement
141 nvironment for the o(eration of (rocesses ; su((lemental The or%ani.ation shall maintain its (remises in a state of order& cleanliness& and re(air that is consistent !ith the (roduct and manufacturin% (rocess needs
The or%ani.ation shall maintain its (remises in a state of order& cleanliness and re(air consistent !ith the (roduct and manufacturin% (rocess needs
;15 Monitorin an" mas'rin rso'r+s nra! ;/1/5/1 $he or,ani-ation shall determine and /roide the resources needed to ensure alid and reliale results when monitorin, or measurin, is used to erif the conformit of /roducts and serices to requirements. $he or,ani-ation shall ensure that the resources /roided: 4.a) are suitale for the s/ecific t/e of monitorin, and measurement actiities ein, underta7en b) are maintained to ensure their continuin, fitness for their /ur/ose. $he or,ani-ation shall retain a//ro/riate documented information as eidence of fitness for /ur/ose of the monitorin, and measurement resources.
1511 Mas'rmnt s%stms ana!%sis Statisti+a! st'"is s(a!! $ +on"'+t" to ana!%s t( variation prsnt in t( rs'!ts o a+( t%p o insp+tion* mas'rmnt* an" tst )'ipmnt s%stm i"ntii" in t( +ontro! p!an T( ana!%ti+a! mt(o"s an" a++ptan+ +ritria 's" s(a!! +onorm to t(os in rrn+ man'a!s on mas'rmnt s%stms ana!%sis Ot(r ana!%ti+a! mt(o"s an" a++ptan+ +ritria ma% $ 's" i approv" $% t( +'stomr ,+or"s o +'stomr a++ptan+ o a!trnativ mt(o"s s(a!! $ rtain" a!on it( rs'!ts rom a!trnativ mas'rmnt s%stms ana!%sis #rioriti3ation o MSA st'"is s(o'!" o+'s on +riti+a! or sp+ia! pro"'+t or pro+ss +(ara+tristi+s
;6 Contro! o monitorin an" mas'rin )'ipmnt $he or,ani-ation shall determine the monitorin, and measurement to e underta7en and the monitorin, and measurin, equi/ment needed to /roide eidence of conformit of /roduct to determined requirements.
(aliration moed under resources clause It at first a//ears6 that software is not coered an more ut the wordin, was chan,ed from Eequi/ment to Eresources so it still is coered
$he or,ani-ation shall estalish /rocesses to ensure that monitorin, and measurement can e carried out and are carried out in a manner that is consistent with the monitorin, and measurement requirements. Bhere necessar to ensure alid results6 measurin, equi/ment shall e calirated or erified6 or oth6 at s/ecified interals6 or /rior to use6 a,ainst measurement standards traceale to international or national measurement standards where no such standards e)ist6 the asis used for caliration or erification shall e recorded 2see '..'3 a)
b) e ad;usted or read;usted as necessar
hae identification in order to determine its caliration status c)
e safe,uarded from ad;ustments that would inalidate the measurement result d)
e /rotected from dama,e and deterioration durin, handlin,6 maintenance and stora,e. e)
The measurement s#stems anal#sis requirements are the same5 there is an added note about (rioriti.ation of $SA studies to focus on critical/s(ecial characteristics
;61 $AS@>$=T SCST$ A=A?CSIS Statistical studies shall be conducted to Mas'rmnt tra+a$i!it% ;/1/5/2 anal#se the variation (resent in the results Bhen measurement traceailit is a of each t#(e of measurin% and test requirement6 or is considered the equi(ment s#stem This requirement shall or,ani-ation to e an essential /art of a((l# to measurement s#stems referenced /roidin, confidence in the alidit of in the control (lan The anal#tical measurement results6 measurin, equi/ment methods and acce(tance criteria used shall conform to those in customer shall e: reference manuals on measurement a) calirated or erified6 or oth6 at s/ecified s#stems anal#sis Other anal#tical methods interals6 or /rior to use6 a,ainst and acce(tance criteria ma# be used if measurement standards traceale to a((roved b# the customer international or national measurement standards when no such standards e)ist6 the asis used for caliration or erification shall e retained as documented information b)identified in order to determine their status
c) safe ,uarded from ad;ustments6 dama,e or deterioration that would inalidate the caliration status and susequent measurement results. $he or,ani-ation shall determine if the alidit of /reious measurement results has een adersel affected when measurin, equi/ment is found to e unfit f or its intended /ur/ose6 and shall ta7e a//ro/riate action as necessar. =OT A number or another identifier traceable to the device calibration record meets the intent of the requirements in ISO 9**1+,*1-
In addition6 the or,ani-ation shall assess and record the alidit of the /reious measurin, results when the equi/ment is found not to conform to requirements. $he or,ani-ation shall ta7e a//ro/riate action on the equi/ment and an /roduct affected. Records of the results of caliration and erification shall e maintained 2see '..'3. Bhen used in the monitorin, and measurement of s/ecified requirements6 the ailit of com/uter software to satisf the intended a//lication shall e confirmed. $his shall e underta7en /rior to initial use and reconfirmed as necessar.
4O$5 (onfirmation of the ailit of com/uter software to satisf the intended a//lication would t/icall 1-,1 3alibration/verification records include its erification and confi,uration The or%ani.ation shall have a documented mana,ement to maintain its suitailit for (rocess for mana%in% calibration/verification use. records >ecords of the calibration/verification
A documented (rocess is required for mana%in% calibration/verification records This clause on calibration/verification records is ex(anded to cover out of
activit# for all %au%es and measurin% and tolerance %a%e conditions5 s(ecificall# =OT6 A number or other identifier test equi(ment 0includin% em(lo#ee)o!ned covers soft!are5 includes en%ineerin% traceable to the device calibration equi(ment relevant for measurin%& chan%es affectin% measurement s#stems record meets the intent of requirement customer)o!ned equi(ment& or on)site c above su((lier)o!ned equi(ment needed to (rovide evidence of conformit# to internal ;62 3A?I2>ATIO=/>IFI3ATIO= >3O>:S requirements& le%islative and re%ulator# >ecords of the calibration/verification requirements& and customer)defined activit# for all %au%es& measurin% and test requirements shall be retained equi(ment& needed to (rovide evidence of conformit# of (roduct to determined The or%ani.ation shall ensure that requirements& includin% em(lo#ee) and calibration/verification activities and customer)o!ned equi(ment& shall include records shall include the follo!in% details+ equi(ment identificati on& includin% the .a3 revisions follo!in% en%ineerin% chan%es measurement standard a%ainst !hich that im(act measurement s#stems5 the equi(ment is calibrated& .3 an# out)of)s(ecification readin%s as revisions follo!in% en%ineerin% received for calibration/verification5 chan%es& .c3 an assessment of the ris8 of the an# out)of)s(ecification readin%s as intended use of the (roduct caused b# received for calibration/verification& the out)of)s(ecification condition5 an assessment of the im(act of out)of) .d3 !hen a (iece of ins(ection s(ecification condition& measurement and test equi(ment is statements of conformit# to found to be out of calibration or s(ecification after defective durin% its (lanned verification calibration/verification& and or calibration or durin% its use& notification to the customer if sus(ect documented information on the validit# (roduct or material has been shi((ed of (revious measurement results obtained !ith this (iece of ins(ection measurement and test equi(ment shall be retained& includin% the associated standardEs last calibration date and the next due date on the calibration re(ort5 .e3 notification to the customer if sus(ect (roduct or material has been shi((ed5 .f3 statements of conformit# to s(ecification after calibration/verification5 .,3 verification that the soft!are version used for (roduct and (rocess control is as s(ecified5 .h3 records of the calibration and maintenance activities for all %au%in% 0includin% em(lo#ee)o!ned equi(ment& customer)o!ned equi(ment& or on)site
.i3
su((lier)o!ned equi(ment5 (roduction)related soft!are verification used for (roduct and (rocess control 0includin% soft!are installed on em(lo#ee)o!ned equi(ment& customer) o!ned equi(ment& or on)site su((lier) o!ned equi(ment
;1-7 ?aborator# >equirements The internal laboratory requirements are 1-71 Internal laborator# An or%ani.ationEs internal laborator# facilit# essentially unchanged shall have a defined sco(e that includes its ca(abilit# to (erform the required ins(ection& test& or calibration services This laborator# sco(e shall be included in the qualit# mana%ement s#stem documentation ;68 ?A2O>ATO>C >"@I>$=TS The laborator# shall s(ecif# and im(lement& ;681 I=T>=A? ?A2O>ATO>C as a minimum& requirements for+ An or%ani.ationEs internal laborator# .i.a3 adequac# of the laborator# technical facilit# shall have a defined sco(e that (rocedures5 includes its ca(abilit# to (erform the .i.3 com(etenc# of the laborator# required ins(ection& test or calibration (ersonnel5 services This laborator# sco(e shall be .i.c3 testin% of the (roduct5 included in the qualit# mana%ement .i.d3 ca(abilit# to (erform these services s#stem documentatio n The laborator# correctl#& traceable to the relevant shall s(ecif# and im(lement& as a (rocess standard 0such as AST$& =& minimum& technical requirements for etc5 !hen no national or international adequac# of the laborator# (rocedures& standard0s is available& the or%ani.ation shall define and im(lement com(etenc# of the laborator# (ersonnel& a methodolo%# to verif# measurement testin% of the (roduct& ca(abilit# to (erform these services s#stem ca(abilit#5 correctl#& traceable to the relevant .i.e3 customer requirements& if an#5 (rocess standard 0such as AST$& .i.f3 revie! of the related records =& etc& and =OT Third)(art# accreditation to revie! of the related records ISO/I3 1*,- 0or equivalent ma# be Accreditation to ISO/I3 1*,=OT6 used to demonstrate the or%ani.ationEs ma# be used to demonstrate the in)house laborator# conformit# to this or%ani.ationEs in)house laborator# requirement The external laboratory requirements are conformit# to this requirement but is not essentially unchanged 1-7, xternal laborator# mandator# xternal/commercial/inde(endent laborator# facilities used for ins(ection& test& or calibration services b# the or%ani.ation shall have a defined laborator# sco(e that
includes the ca(abilit# to (erform the ;682 T>=A? ?A2O>ATO>C required ins(ection& test& or calibration& and xternal/commercial/inde(endent either+ laborator# facilities used for ins(ection& test or calibration services b# the L the laborator# shall be accredited to ISO/I3 1*,- or national equivalent or%ani.ation shall have a defined and include the relevant ins(ection& laborator# sco(e that includes the test& or calibration service in the ca(abilit# to (erform the required sco(e of the accreditation ins(ection& test or calibration& and either 0certificate5 the certificate of there shall be evidence that the external calibration or test re(ort shall laborator# is acce(table to the include the mar8 of a national customer& or accreditation bod#5 or the laborator# shall be accredited to L there shall be evidence that the ISO/I3 1*,- or national equivalent external laborator# is acce(table to the customer =OT 1 Such evidence ma# be =OT Such evidence ma# be demonstrated demonstrated b# customer assessment& b# customer assessment& for exam(le& or b# for exam(le& or b# customer)a((roved customer) a((roved second)(art# second) (art# assessment that the assessment that the laborator# meets the laborator# meets the intent of ISO/I3 intent of ISO/I3 1*,- or national 1*,- or national equivalent equivalent The second)(art# assessment =OT , Dhen a qualified laborator# is ma# be (erformed b# the or%ani.ation not available for a %iven (iece of assessin% the laborator# usin% a customer) equi(ment& calibration services ma# be a((roved method of assessment (erformed b# the equi(ment manufacturer 3alibration services ma# be (erformed b# In such cases& the or%ani.ation should the equi(ment manufacturer !hen a qualified ensure that the requirements listed in laborator# is not available for a %iven (iece 671 have been met of equi(ment In such cases& the or%ani.ation shall ensure that the requirements listed in Section 1-71 have been met @se of calibration services& other than b# qualified 0or customer acce(ted laboratories& ma# be subect to %overnment re%ulator# confirmation& if required
Orani3ationa! no!" ;/1/6 $he or,ani-ation shall determine the 7nowled,e necessar for the o/eration of its /rocesses and to achiee conformit of /roducts and serices. $his 7nowled,e shall e maintained and e made aailale to the e)tent necessar. Bhen addressin, chan,in, needs and trends6 the or,ani-ation shall consider its current 7nowled,e and determine how to acquire or access an necessar additional 7nowled,e and required u/dates. 4O$5 1 Or,ani-ational 7nowled,e is 7nowled,e s/ecific to the or,ani-ation it is ,ained e)/erience. It is information that is used and shared to achiee the or,ani-ations o;ecties. 4O$5 Or,ani-ational 7nowled,e can e ased on: a) internal sources 2e.,. intellectual /ro/ert 7nowled,e ,ained from e)/erience lessons learned from failures and successful /ro;ects ca/turin, and sharin, undocumented 7nowled,e and e)/erience the results of im/roements in /rocesses6 /roducts and serices3 b) e)ternal sources 2e.,. standards academia conferences ,atherin, 7nowled,e from customers or e)ternal /roiders3. H. (om/etence $he or,ani-ation shall: a) determine the necessar com/etence of /erson2s3 doin, wor7 under its control that affects the /erformance and effectieness of the qualit mana,ement sstem
$here is no equialent clause in ISO9001:00*.
?ost clients do not hae an /rocess for ca/turin, this 7nowled,e other than e)ternal standards and s/ecifications. Bill hae to consider estalishin, a lessons learned dataase to ca/ture trial 7nowled,e
(lients should consider how the or,ani-ation ca/tures the 7nowled,e ,ained when someone is sent to e)ternal trainin, or e)ternal trainin, is done internall
6/2
?'man rso'r+s
621 General
Personnel performing work affecting conformity to product requirements shall be competent on the basis of appropriate education, training, skills and experience.
#wareness moed to ne)t clause H.8
b)ensure that these /ersons are com/etent on the asis of a//ro/riate education6 trainin,6 or e)/erience c) where a//licale6 ta7e actions to acquire the necessar com/etence6 and ealuate the effectieness of the actions ta7en d) retain a//ro/riate documented information as eidence of com/etence. 4O$5 #//licale actions can include6 for e)am/le6 the /roision of trainin, to6 the mentorin, of6 or the re assi,nment of currentl em/loed /ersons or the hirin, or contractin, of com/etent /ersons.
,1 3om(etence ; su((lemental The or%ani.ation shall establish and maintain a documented (rocess0es for identif#in% trainin% needs includin% a!areness 0see Section 71 and achievin% com(etence of all (ersonnel (erformin% activities affectin% conformit# to (roduct and (rocess requirements ersonnel (erformin% s(ecific assi%ned tas8s shall be qualified& as required& !ith (articular attention to the satisfaction of customer requirements ,, 3om(etence ; on)the)ob trainin% The or%ani.ation shall (rovide on)the)ob trainin% 0!hich shall include customer requirements trainin% for (ersonnel in an# ne! or modified res(onsibilities affectin% conformit# to qualit# requirements& internal requirements& re%ulator# or le%islative requirements5 this shall include contract or a%enc# (ersonnel The level of detail required for on)the)ob trainin% shall be
4O$5 (onformit to /roduct requirements can e affected directl or indirectl /ersonnel /erformin, an tas7 within the qualit mana,ement sstem.
Comptn+* trainin an" aarnss $he or,ani-ation shall a3 determine the necessar com/etence for /ersonnel /erformin, wor7 affectin, conformit to /roduct requirements6 b) where a//licale6 /roide trainin, or ta7e other actions to achiee the necessar com/etence6 6/2/2
c)
ealuate the effectieness of the actions ta7en6
d) ensure that its /ersonnel are aware
of the releance and im/ortance of their actiities and how the contriute to the achieement of the qualit o;ecties6 and e) maintain a//ro/riate records of
education6 trainin,6 s7ills and e)/erience 2see '..'3. 6,,1 T>AI=I= The clause on Jroduct :esi%n S8illsK !as The or%ani.ation shall establish and moved to clause <7,, maintain documented (rocedures for identif#in% trainin% needs and achievin% com(etence of all (ersonnel (erformin% activities affectin% conformit# to (roduct requirements ersonnel (erformin% s(ecific assi%ned tas8s shall be qualified& Additional details in the on the ob trainin% as required& !ith (articular attention to the clause but no bi% chan%es satisfaction of customer requirements =OT 1 This a((lies to all em(lo#ees havin% an effect on qualit# at all levels of the or%ani.ation =OT , An exam(le of the customer) s(ecific requ irements is the a((licati on of
commensurate !ith the level of education the (ersonnel (ossess and the com(lexit# of the tas80s the# are required to (erform for their dail# !or8 ersons !hose !or8 can affect qualit# shall be informed about the consequences of nonconformit# to customer requirements
di%iti.ed mathematicall# based data %... T>AI=I= O= TH LO2 The or%ani.ation shall (rovide on)the)ob trainin% for (ersonnel in an# ne! or modified ob affectin% conformit# to (roduct requirements& includin% contract or a%enc# (ersonnel ersonnel !hose !or8 can affect qualit# shall be informed about the consequences to the customer of nonconformit# to qualit# requirements
,7 Internal auditor com(etenc# The or%ani.ation shall have a documented (rocess0es to verif# that internal auditors are com(etent& ta8in% into account an# customer)s(ecific requirements For additional %uidance on auditor com(etencies& refer to ISO 19*11 The or%ani.ation shall maintain a list of qualified internal auditors "ualit# mana%ement s#stem auditors& manufacturin% (rocess auditors& and (roduct auditors shall all be able to demonstrate the follo!in% minimum com(etencies+ a3 understandin% of the automotive (rocess a((roach for auditin%& includin% ris8)based thin8in%5 3 understandin% of a((licable customer) s(ecific requirements5 c3 understandin% of a((licable ISO 9**1 and IATF 16949 requirements related to the sco(e of the audit5 d3 understandin% of a((licable core tool requirements related to the sco(e of the audit5 e3 understandin% ho! to (lan& conduct& re(ort& and close out audit findin%s Additionall#& manufacturin% (rocess auditors shall demonstrate technical understandin% of the relevant manufacturin% (rocess0es to be audited& includin% (rocess ris8 anal#sis 0such as F$A and control (lan roduct auditors shall demonstrate com(etence in understandin% (roduct requirements and use of relevant measurin% and test
=e! detailed requirements for internal auditor com(etenc# includin% demonstration of com(etenc#
equi(ment to verif# (roduct conformit# Dhere trainin% is (rovided to achieve com(etenc#& documented information shall be retained to demonstrate the trainerEs com(etenc# !ith the above requirements $aintenance of and im(rovement in internal auditor com(etence shall be demonstrated throu%h+ f3 executin% a minimum number of audits (er #ear& as defined b# the or%ani.ation5 and ,3 maintainin% 8no!led%e of relevant requirements based on internal chan%es 0e%& (rocess technolo%#& (roduct technolo%# and external chan%es 0e%& ISO 9**1& IATF 16949& core tools& and customer s(ecific requirements ,4 Second)(art# auditor com(etenc# The or%ani.ation shall demonstrate the com(etence of the auditors underta8in% the second)(art# audits Second)(art# auditors shall meet customer s(ecific requirements for auditor qualification and demonstrate the minimum follo!in% core com(etencies& includin% understandin% of+ a3 the automotive (rocess a((roach to auditin%& includin% ris8 based thin8in%5 3 a((licable customer and or%ani.ation s(ecific requirements5 c3 a((licable ISO 9**1 and IATF 16949 requirements related to the sco(e of the audit5 d3 a((licable manufacturin% (rocess0es to be audited& includin% F$A and control (lan5 e3 a((licable core tool requirements related to the sco(e of the audit5 f3 ho! to (lan& conduct& (re(are audit
:emonstration of the maintenance of auditor com(etenc#
=e! detailed requirements for second (art# auditor com(etenc# includin% demonstration of com(etenc#
re(orts& and close out audit findin%s
;8 #wareness $he or,ani-ation shall ensure that /ersons doin, wor7 under the or,ani-ations control are aware of: a) the qualit /olic b)releant qualit o;ecties
c) their contriution to the effectieness of the qualit mana,ement sstem6 includin, the enefits of im/roed /erformance d) the im/lications of not conformin, with the qualit mana,ement sstem requirements.
58 " Qualit /olic 552 +
$hese awareness requirements were dis/ersed in seeral clauses /reiousl
622 " Our clients should consider includin, questions related to these requirement in their internal audits to hel/ ,a,e the awareness of their /ersonnel
%...8 $?OC $OTIATIO= A=: 71 A!areness ; su((lemental $OD>$=T The or%ani.ation shall maintain The or%ani.ation shall have a (rocess to documented information that motivate em(lo#ees to achieve qualit# demonstrates that all em(lo#ees are obectives& to ma8e continual a!are of their im(act on (roduct qualit# im(rovements& and to create an and the im(ortance of their activities in environment to (romote innovation The achievin%& maintainin%& and im(rovin% (rocess shall include the (romotion of qualit#& includin% customer requirements qualit# and technolo%ical a!areness and the ris8s involved for the customer throu%hout the !hole or%ani.ation !ith nonconformin% (roduct 7, m(lo#ee motivation and em(o!erment The or%ani.ation shall have a The or%ani.ation shall maintain a (rocess to measure the extent to documented (rocess0es to motivate !hich its (ersonnel are a!are of em(lo#ees to achieve qualit# obectives& the relevance and im(ortance of to ma8e continual im(rovements& and to their activities and ho! the# create an environment that (romotes contribute to the achievement of innovation The (rocess shall include the the qualit# obectives Msee 6,, dN (romotion of qualit# and technolo%ical a!areness throu%hout the !hole or%ani.ation
;4 (ommunication
The organization shall determine the internal and external communications relevant to the quality management system, including on what it will communicate b)when to communicate! c) with whom to communicate!
d)how to communicate! e) who communicates.
5.5.3 Internal communication Top management shall ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the quality management system.
The clause requirin% a (rocess to measure the extent to !hich (ersonnel are a!are of J has been re!orded to Jmaintain documented information that demonstrates that K The clause on em(lo#ee motivation has been re!orded5 not si%nificant chan%es
#dditional detail6 ut no real chan,es
;5 Documented information ;51 nra!
$he or,ani-ations qualit mana,ement sstem shall include: a) documented information required this International Standard
b)documented information determined the or,ani-ation as ein, necessar for the effectieness of the qualit mana,ement sstem. 4O$5 $he e)tent of document ed information for a qualit mana,ement sstem can differ from one or,ani-ation to another due to: " the si-e of or,ani-ation and its t/e of actiities6 /rocesses6 /roducts and serices
nra! 4/2/1 $he qualit mana,ement sstem documentation shall include a) documented statements of a qualit /olic and qualit o;ecties6 b)
a qualit manual6
documented /rocedures and records required this International Standard6 and
$here is no lon,er a requirement for s/ecific /rocedures
documents6 includin, records6 determined the or,ani-ation to e necessar to ensure the effectie /lannin,6 o/eration and control of its /rocesses.
For e)am/le:
c)
d)
4O$5 1 Bhere the term Edocumented /rocedure a//ears within this International Standard6 this means that the /rocedure is estalished6 " the com/le)it of /rocesses and their documented6 im/lemented and maintained. # interactions sin,le document ma address the requirements " the com/etence of /ersons. for one or more /rocedures. # requirement for a documented /rocedure ma e coered more than one document. 4O$5 $he e)tent of the qualit mana,ement -11 "ualit# mana%ement s#stem sstem documentation can differ from one documentation or,ani-ation to another due to
The or%ani.ationEs qualit# mana%ement s#stem shall be documented and include a qualit# manual& !hich can be a series of documents 0electronic or hard co(# The format and structure of the qualit# manual is at the discretion of the or%ani.ation and !ill de(end on the or%ani.ationEs si.e& culture& and com(lexit# If a series of documents is used& then a list shall be retained of the documents that com(rise the qualit# manual for the or%ani.ation
$he term Edocumented information is used to coer documents such as /rocedures and records.
Instead of an internal audit /rocedure an or,ani-ation could /resent an internal audit schedule and audit forms&records that demonstrate audit criteria6 audit sco/e6 audit /lannin, audit re/ortin, and correctie action on 4(Rs
(ontrols still required ut ma e a little more s/ecific or descri/tie
a)
the si-e of or,ani-ation and t/e of actiities6 b) the com/le)it of /rocesses and their interactions6 and c) the com/etence of /ersonnel. 4O$5 8 $he documentation can e in an form or t/e of medium.
422 Qualit manual The qualit# manual shall include& at a $he or,ani-ation shall estalish and maintain minimum& the follo!in%+ a qualit manual that includes the sco(e of the qualit# mana%ement a3 2.2.b) the sco/e of the qualit s#stem& includin% details of and mana,ement sstem6 includin, ustification for an# exclusions5 details of and ;ustification for an
IATF 16949 adds bac8 in the requirement for a qualit# manual !ith some required content includin% (revious content !hich !as required
documented (rocesses established
3
for
c3
d3
the qualit# mana%ement s#stem& or reference to them5 the or%ani.ationEs (rocesses and their sequence and interactions 0in(uts and out(uts& includin% t#(e and extent of control of an# outsourced (rocesses5 a document 0ie& matrix indicatin% !here !ithin the or%ani.ationEs qualit# mana%ement s#stem their customer)s(ecific requirements are addressed
e)clusions 2see 1.36 the documented /rocedures estalished for the qualit mana,ement sstem6 or reference to them6 and 2.2.c)
a descri/tion of the interaction etween the /rocesses of the qualit mana,ement sstem. 2.2.d)
=OT A matrix of ho! the requirements of this Automotive "$S standard are addressed b# the or%ani.ationEs (rocesses ma# be used to assist !ith lin8a%es of the or%ani.ationEs (rocesses and this Automotive "$S Cratin an" 'p"atin ;/5/2 Bhen creatin, and u/datin, documented information6 the or,ani-ation shall ensure a//ro/riate: a) identification and descri/tion 2e.,. a title6 date6 author6 or reference numer3 b)format 2e.,. lan,ua,e6 software ersion6 ,ra/hics3 and media 2e.,. /a/er6 electronic3
c) reiew and a//roal for suitailit and adequac.
(ontrol of documented Information 7..!.1 Documented information required the qualit mana,ement sstem and this International Standard shall e controlled to ensure:
5.3.1.a)
it is aailale and suitale for
Contro! o "o+'mnts 4.2.! Documents required the qualit mana,ement sstem shall e controlled. Records are a s/ecial t/e of document and shall e controlled accordin, to the requirements ,ien in '..'.
use6 where and when it is needed
5.3.1.b) it is adequatel /rotected 2e.,. from loss of confidentialit6 im/ro/er use6 or loss of inte,rit3. ;582 For the control of documented information6 the or,ani-ation shall address the followin, actiities6 as a//licale: a) distriution6 access6 retrieal and use
b)stora,e and /reseration6 /reseration of le,iilit
includin,
c) control of chan,es 2e.,. ersion control3 d) retention and dis/osition. Documented information of e)ternal ori,in determined the or,ani-ation to e necessar for the /lannin, and o/eration of the qualit mana,ement sstem shall e identified as a//ro/riate6 and e controlled. Documented information retained as eidence of conformit shall e /rotected from unintended alterations. 4O$5 #ccess can im/l a decision re,ardin, the /ermission to iew the documented information onl6 or the /ermission and authorit to iew and chan,e the documented information.
-7,1 >ecord retention The or%ani.ation shall define& document& and im(lement a record retention (olic# The control of records shall satisf# statutor#& re%ulator#& or%ani.ational& and customer requirements roduction (art a((rovals& toolin% records 0includin% maintenance and o!nershi(& (roduct and (rocess desi%n records& (urchase orders 0if a((licable& or
# documented /rocedure shall e estalished to define the controls needed a) to a//roe documents for adequac /rior to issue6 b) to reiew and u/date as necessar and re a//roe documents6
to ensure that chan,es and c) the current reision status of documents are identified6 d) to ensure that releant ersions of a//licale documents are aailale at /oints of use6 e) to ensure that documents remain le,ile and readil identifiale6 f) to ensure that documents of e)ternal ori,in determined the or,ani-ation to e necessar for the /lannin, and o/eration of the qualit mana,ement sstem are identified and their distriution controlled6 and ,3 to /reent the unintended use of osolete documents6 and to a//l suitale identification to them if the are retained for IATF requires a documented record retention policy and defines retention for certain an /ur/ose. records for example PPAP records. Contro! o r+or"s 4/2/4 Records estalished to /roide eidence of conformit to requirements and of the effectie o/eration of the qualit mana,ement sstem shall e controlled. $he or,ani-ation shall estalish a documented /rocedure to define the controls needed for the identification6 stora,e6 /rotection6 retrieal6 retention and dis/osition of records. Records shall remain le,ile6
contracts and amendments shall be retained for the len%th of time that the (roduct is active for (roduction and service requirements& (lus one calendar #ear& unless other!ise s(ecified b# the customer or re%ulator# a%enc# =OT roduction (art a((roval documented information ma# include a((roved (roduct& a((licable test equi(ment records& or a((roved test data
readil identifiale and retrieale. =OT 1 J:is(ositionK includes dis(osal =OT , J>ecordsK also include customer) s(ecified records 4,41 >3O>:S >T=TIO= The control of records shall satisf# statutor#& re%ulator# and customer requirements
4,71 =I=>I= S3IFI3ATIO=S The or%ani.ation shall have a (rocess to T( orani3ation s(a!! (av a "o+'mnt" assure the timel# revie!& distribution pro+ss "s+ri$in t( rvi* and "istri$'tion* an" imp!mntation o a!! im(lementation of all customer +'stomr ninrin en%ineerin% standards/s(ecifications and stan"ar"s/sp+ii+ations an" r!at" chan%es based on customer)required rvisions $as" on +'stomr s+("'!s* schedule Timel# revie! should be as as r)'ir" soon (n an ninrin as (ossible& and shall not exceed t!o stan"ar"/sp+ii+ation +(an rs'!ts in a !or8in% !ee8s pro"'+t "sin +(an* rr to t( The or%ani.ation shall maintain a record r)'irmnts in ISO 9001* S+tion -86 of the date on !hich each chan%e is (n an ninrin stan"ar"/sp+ii+ation +(an rs'!ts in a im(lemented in (roduction pro"'+t ra!i3ation pro+ss +(an* rr Im(lementatio n shall include u(dated to t( r)'irmnts in S+tion -561 T( documents orani3ation s(a!! rtain a r+or" o t( =OT A chan%e in these "at on (i+( a+( +(an is standards/s(ecifications requires an imp!mnt" in pro"'+tion u(dated record of customer (roduction Imp!mntation s(a!! in+!'" 'p"at" (art a((roval !hen these s(ecifications "o+'mnts are referenced on the desi%n record or if ,vi s(o'!" $ +omp!t" it(in 10 the# affect documents of (roduction (art orin "a%s o r+ipt o notii+ation o a((roval (rocess& such as control (lan& ninrin stan"ar"s/sp+ii+ations F$As& etc +(ans OT> A +(an in t(s stan"ar"s/sp+ii+ations ma% r)'ir an 'p"at" r+or" o +'stomr pro"'+tion part approva! (n t(s sp+ii+ations ar rrn+" on t( "sin r+or" or i t(% a+t "o+'mnts o t( pro"'+tion part approva! pro+ss* s'+( as +ontro! p!an* ris
;5822 >ninrin sp+ii+ations
IATF requires a documented (rocess for controllin% en%ineerin% s(ecifications includin% quite a fe! detailed controls
ana!%sis As=* t+
- Opration *.1 O/erational /lannin, and control $he or,ani-ation shall /lan6 im/lement and control the /rocesses 2see '.'3 needed to meet the requirements for the /roision of /roducts and serices6 and to im/lement the actions determined in (lause %6 : a) determinin, the requirements for the /roducts and serices
b)estalishin, criteria for: 1)
the /rocesses
;1 #!annin o pro"'+t ra!i3ation $he or,ani-ation shall /lan and deelo/ the /rocesses needed for /roduct reali-ation. =lannin, of /roduct reali-ation shall e consistent with the requirements of the other /rocesses of the qualit mana,ement sstem 2see '.13. In /lannin, /roduct reali-ation6 the or,ani-ation shall determine the followin,6 as a//ro/riate: a) qualit o;ecties and requirements for the /roduct
2)
the acce/tance of /roducts and serices c) determinin, the resources needed to achiee conformit to the /roduct and serice requirements d)im/lementin, control of the /rocesses in accordance with the criteria
e) determinin, and 7ee/in, documented information to the e)tent necessar: 1) to hae confidence that the /rocesses hae een carried out as /lanned 2) to demonstrate the conformit of /roducts and serices to their requirements. 4O$5 EMee/in, im/lies oth the m aintainin, and the retainin, of documented information.
b) the need to estalish /rocesses and
documents6 and to /roide resources s/ecific to the /roduct required erification6 alidation6 monitorin,6 measurement6 ins/ection and test actiities s/ecific to the /roduct and the criteria for /roduct acce/tance d3 records needed to /roide eidence that the reali-ation /rocesses and resultin, /roduct meet requirements 2see '..'3. $he out/ut of this /lannin, shall e in a form suitale for the or,ani-ationGs method of o/erations. c)
4O$5 1 # document s/ecifin, the /rocesses of the qualit mana,ement sstem 2includin, the /roduct reali-ation /rocesses3 and the resources to e a//lied to a s/ecific /roduct6 /ro;ect or contract can e referred to as a qualit /lan. 4O$5 $he or,ani-ation ma also a//l the requirements ,ien in H.8 to the deelo/ment of /roduct reali-ation /rocesses
$he out/ut of this /lannin, shall e suitale for the or,ani-ations o/erations. $he or,ani-ation shall control /lanned chan,es and reiew the consequences of =OT Some unintended chan,es6ta7in, action to miti,ate mana%ement an aderse effects6 as necessar. (lannin% as $he or,ani-ation shall ensure that outsourced reali.ation /rocesses are controlled 2see *.'3.
customers refer to (roect or advanced (roduct qualit# a means to achieve (roduct Advanced (roduct qualit#
$his /lannin, clause now includes a chan,e control requirement and a reference to clause *.' for control of outsourced /rocesses
(lannin% embodies the conce(ts of error (revention and continual im(rovement as contrasted !ith error detection& and is based on a multidisci(linar# a((roach ;11 ?A==I= OF >O:@3T >A?IPATIO= ; S@?$=TA? 3ustomer requirements and references to its technical s(ecifications shall be included in the (lannin% of (roduct <11 O(erational (lannin% and control ; reali.ation as a com(onent of the qualit# su((lemental (lan Dhen (lannin% for (roduct reali.ation& the ;12 A33TA=3 3>IT>IA follo!in% to(ics shall be included+ Acce(tance criteria shall be defined a3 customer (roduct requirements and b# the or%ani.ation and& !here technical s(ecifications5 required& a((roved b# the customer 3 lo%istics requirements5 For attribute data sam(lin%& the c3 manufacturin% feasibilit#5 acce(tance level shall be .ero d3 (roect (lannin% 0refer to ISO 9**1& defects Section <7,5 0see <,71 e3 acce(tance criteria The resources identified in ISO 9**1& Section <1 c& refer to the required verification& validation& monitorin%& 17 3O=FI:=TIA?ITC measurement& ins(ection& and test The or%ani.ation shall ensure the activities s(ecific to the (roduct and the confidentialit# of customer)contracted criteria for (roduct acce(tance (roducts and (roects under <1, 3onfidentialit# develo(ment& and related (roduct The or%ani.ation shall ensure the information confidentialit# of customer)contracted (roducts and (roects under develo(ment& includin% related (roduct information
There are a fe! additions 0lo%istics& (roect (lannin% ?ess detail !ith res(ect to acce(tance criteria
The chan%e control clause 14 !as moved under the desi%n and develo(ment chan%e clause see <761 belo!
<, >equirements for (roducts and services -21 C'stomr +omm'ni+ation (ommunication with customers shall include: a) /roidin, information relatin, to /roducts and serices
b)handlin, enquiries6 contracts or orders6 includin, chan,es c) otainin, customer feedac7 relatin, to /roducts and serices6 includin, customer com/laints
7.2.! C'stomr +omm'ni+ation $he or,ani-ation shall determine and im/lement effectie arran,ements for communicatin, with customers in relation to 2.3.a) /roduct information6
enquiries6 contracts or order handlin,6 includin, amendments6 and
2.3.b)
d)handlin, or controllin, customer /ro/ert e) estalishin, s/ecific requirements for contin,enc actions6 when releant.
<,11 3ustomer communication su((lemental Dritten or verbal communication shall be in the lan%ua%e a%reed !ith the customer The or%ani.ation shall have the abilit# to communicate necessar# information& includin% data in a customer)s(ecified com(uter lan%ua%e and format 0e%& com(uter)aided desi%n data& electronic data interchan%e
1)
an a//licale statutor and
(ustomer communication added a cou/le of communication to/ics Some reor,ani-ation requirements
"
rewordin,
4ote on /ost delier actiities remoed
2.3.c) customer feedac76 includin,
customer com/laints. $ore ex(licit callout concernin% the communication of data
;
-22 Dtrminin t( r)'irmnts r!at" to pro"'+ts an" srvi+s Bhen determinin, the requirements for the /roducts and serices to e offered to customers6 the or,ani-ation shall ensure that: a) the requirements for the /roducts and serices are defined6 includin,:
Rearran,ed order of suclauses
;281 3@STO$> 3O$$@=I3ATIO= ; S@?$=TA? The or%ani.ation shall have the abilit# to communicate necessar# information& includin% data& in a customer) s(ecified lan%ua%e and format 0e% com(uter)aided desi%n data& electronic data exchan%e
;/2/1
Dtrmination o& r)'irmnts r!at" to t( pro"'+t $he or,ani-ation shall determine a) requirements s/ecified the customer6 includin, the requirements for delier and /ostdelier actiities6 b) requirements not stated the customer
ut necessar for s/ecified or intended
of
use6 where 7nown6
re,ulator requirements
2)
those considered necessar the or,ani-ation
b)the or,ani-ation can meet the claims for the /roducts and serices it offers.
c)
statutor and re,ulator requirements a//licale to the /roduct6 and
d) an additional requirements considered
necessar the or,ani-ation. =otes , and 7 are no! included in clause <,,1
<,,1 :eterminin% the requirements for 4O$5 =ostdelier actiities include6 for (roducts and services ; su((lemental e)am/le6 actions under warrant /roisions6 These requirements shall include contractual oli,ations such as rec#clin%& environmental im(act& and maintenance serices6 and su//lementar characteristics identified as a result of serices such as recclin, or final dis/osal. the or%ani.ationEs 8no!led%e of the (roduct and manufacturin% (rocesses =OT 1 ost)deliver# activities include 3om(liance to ISO 9**1& Section <,, item a an# after)sales (roduct service (rovided 1& shall include but not be limited to the as (art of the customer contract or follo!in%+ (urchase order all a((licable %overnment& safet#& and environmental re%ulations related to =OT , This requirement includes acquisition& stora%e& handlin%& rec#clin%& rec#clin%& environmental im(act and elimination& or dis(osal of material characteristics identified as a result of the or%ani.ationEs 8no!led%e of the (roduct and manufacturin% (rocesses 0see 7,7 =OT 7 3om(liance to item c includes all a((licable %overnment& safet# and environmental re%ulations& a((lied to acquisition& stora%e& handlin%& rec#clin%& elimination or dis(osal of materials
-28 ,vi o r)'irmnts r!at" to pro"'+ts an" srvi+s *..8.1 $he or,ani-ation shall ensure that it has the ailit to meet the requirements for /roducts and serices to e offered to customers. $he or,ani-ation shall conduct a reiew efore committin, to su//l /roducts and serices to a customer6 to include: a) requirements s/ecified the customer6 includin, the requirements for delier and /ost delier actiities b)requirements not stated the customer6 ut necessar for the s/ecified or intended use6 when 7nown
c) requirements or,ani-ation
s/ecified
the
d)statutor and re,ulator requirements a//licale to the /roducts and serices e) contract or order requirements differin, from those /reiousl e)/ressed. $he or,ani-ation shall ensure that contract or order requirements differin, from those /reiousl defined are resoled. $he customers requirements shall e confirmed the or,ani-ation efore acce/tance6 when the customer does not /roide a documented statement of their requirements. 4O$5 In some situations6 such as internet sales6 a formal reiew is im/ractical for each order. Instead6 the reiew can coer releant /roduct information6 such as catalo,ues or adertisin, material.
Reiew of requirements related to the /roduct $he or,ani-ation shall reiew the requirements related to the /roduct. $his reiew shall e conducted /rior to the or,ani-ationGs commitment to su//l a /roduct to the customer 2e.,. sumission of tenders6 acce/tance of contracts or orders6 acce/tance of chan,es to contracts or orders3 and shall ensure that /roduct requirements are 2.2.a) defined6 contract or order requirements differin, from those /reiousl e)/ressed are resoled6 and
2.2.b)
the or,ani-ation has the ailit to meet the defined requirements. Records of the results of the reiew and actions arisin, from the reiew shall e maintained 2see '..'3. Bhere the customer /roides no documented statement of requirement6 the customer requirements shall e confirmed the or,ani-ation efore acce/tance. 2.2.c)
Now specifically requires a record of the ,,1 >ID OF >"@I>$=TS waiver >?AT: TO TH >O:@3T ; <,711 >evie! of the requirements for S@?$=TA? (roducts and services ; su((lemental Daivin% the requirement stated in ,, for a The or%ani.ation shall retain documented formal revie! 0see note shall require evidence of a customer)authori.ed !aiver customer authori.ation for the requirements stated in ISO 9**1&
-8 Desi,n and deelo/ment of /roducts and serices -81 nra! $he or,ani-ation shall estalish6 im/lement and maintain a desi,n and deelo/ment /rocess that is a//ro/riate to ensure the susequent /roision of /roducts and serices.
;8 Dsin an" "v!opmnt =OT6
(lause introduction a//ears to require a desi,n /rocess
;81Dsin an" "v!opmnt p!annin
Suclauses for desi,n reiew6 desi,n erification and desi,n alidation were comined into a desi,n control suclause
The requir ements of 7 include (roduct and manufacturin% (rocess desi%n and develo(ment& and focus on error (revention rather than detection
$he or,ani-ation shall /lan and control the desi,n and deelo/ment of /roduct. Durin, -811 :esi%n and develo(ment of (roducts the desi,n and deelo/ment /lannin,6 the and services ; su((lemental or,ani-ation shall determine The requirements of ISO 9**1& Section <71& shall a((l# to (roduct and a) the desi,n and deelo/ment sta,es6 manufacturin% (rocess desi%n and develo(ment and shall focus on error b) the reiew6 erification and alidation (revention rather than detection that are a//ro/riate to each desi,n and deelo/ment sta,e6 and The or%ani.ation shall document the desi%n and develo(ment (rocess c) the res/onsiilities and authorities Dsin an" "v!opmnt p!annin In determinin, the sta,es and controls for desi,n and deelo/ment6 the or,ani-ation shall consider: ".!.2
a) the nature6 duration and com/le)it of the desi,n and deelo/ment actiities b)
the required /rocess sta,es6 includin, a//licale desi,n and deelo/ment reiews
c)
the required desi,n and deelo/ment erification and alidation actiities
d)
the res/onsiilities and authorities inoled in the desi,n and deelo/ment /rocess
e) the internal and e)ternal resource needs for the desi,n and deelo/ment of /roducts and
for desi,n and deelo/ment. $he or,ani-ation shall mana,e the interfaces etween different ,rou/s inoled in desi,n and deelo/ment to ensure effectie communication and clear assi,nment of res/onsiilit.
=lannin, out/ut shall e u/dated6 as a//ro/riate6 as the desi,n and deelo/ment /ro,resses.
4O$5 Desi,n and deelo/ment reiew6 erification and alidation hae distinct /ur/oses. $he can e conducted and recorded se/aratel or in an comination6 as suitale for the /roduct and the or,ani-ation .
4ew e)/licit requirement to consider /otential consequences of failure due to the nature of the /roducts " serices an as/ect of ris7 identification in the desi,n /rocess IATF 16949 requires a documented desi%n and develo(ment (rocess
serices
f) the need to control interfaces etween /ersons inoled in the desi,n and deelo/ment /rocess g)
the need for inolement of customers and users in the desi,n and deelo/ment /rocess
h)
the requirements for susequent /roision of /roducts and serices
i)
the leel of control e)/ected for the desi,n and deelo/ment /rocess customers and other releant interested /arties the documented information needed to demonstrate that desi,n and deelo/ment requirements hae een met.
Additional detail added to desi%n and ;811 $@?TI:IS3I?I=A>C A>OA3H develo(ment (lannin%& for exam(le The or%ani.ation shall use a (roect mana%ement5 and su((l# chain multidisci(linar# a((roach to (re(are for (roduct reali.ation& includin% develo(ment/finali.ation and monitorin% of s(ecial characteristics& <7,1 :esi%n and develo(ment (lannin% ; develo(ment and revie! of F$As& su((lemental includin% actions to reduce (otential The or%ani.ation shall ensure that desi%n ris8s& and and develo(ment (lannin% includes all develo(ment and revie! of control affected sta8eholders !ithin the (lans or%ani.ation and& as a((ro(riate& its su((l# chain xam(les of areas for usin% such a multidisci(linar# a((roach include A multidisci(linar# a((roach t#(icall# =OT6 but are not limited to the follo!in%+ incl udes the or%ani.ationEs desi%n& a3 (roect mana%ement 0for exam(le& manufacturin%& en%ineerin%& qualit#& (roduction and other a((ro(riate (ersonnel A" or :A)>A5 3 (roduct and manufacturin% (rocess desi%n activities 0for exam(le& :F$ and :FA& such as consideration of the use of alternative desi%ns and manufacturin% (rocesses5 c3 develo(ment and revie! of (roduct desi%n ris8 anal#sis 0F$As& includin% actions to reduce (otential ris8s5 d3 develo(ment and revie! of manufacturin% (rocess ris8 anal#sis
)
0for exam(le& F$As& (rocess flo!s& control (lans& and standard !or8 instructions =OT A multidisci(linar# a((roach t#(icall# includes the or%ani.ationEs desi%n& manufacturin%& en%ineerin%& qualit#& (roduction& (urchasin%& su((lier& maintenance& and other a((ro(riate functions
<7,, roduct desi%n s8ills The or%ani.ation shall ensure that (ersonnel !ith (roduct desi%n res(onsibilit# are com(etent to achieve desi%n requirements and are s8illed in a((licable (roduct desi%n tools and techniques A((licable tools and techniques shall be identified b# the or%ani.ation
%...1 >O:@3T :SI= SQI??S The or%ani.ation shall ensure that (ersonnel !ith (roduct desi%n res(onsibilit# are com(etent to achieve desi%n requirements and are s8illed in a((licable tools and techniques A((licable tools and techniques shall be identified b# the or%ani.ation
=OT An exam(le of (roduct desi%n s8ills is the a((lication of di%iti.ed mathematicall# based data
<7,7 :evelo(ment of (roducts !ith embedded soft!are The or%ani.ation shall use a (rocess for qualit# assurance for their (roducts !ith internall# develo(ed embedded soft!are A soft!are develo(ment assessment methodolo%# shall be utili.ed to assess the or%ani.ationEs soft!are develo(ment (rocess @sin% (rioriti.ation based on ris8 and (otential im(act to the customer& the or%ani.ation shall retain documented information of a soft!are develo(ment ca(abilit# self)assessment The or%ani.ation shall include soft!are develo(ment !ithin the sco(e of their internal audit (ro%ramme 0see Section 9,,1
A ne! clause addressin% soft!are develo(ment for embedded soft!are and qualit# assurance for embedded soft!are
Dsin an" "v!opmnt Inp'ts $he or,ani-ation shall determine the requirements essential for the s/ecific t/es of /roducts and serices to e desi,ned and deelo/ed. $he or,ani-ation shall consider: ".!.!
3.3.a) functional and /erformance requirements 3.3.b) information deried from /reious similar desi,n and deelo/ment actiities 3.3.c) statutor and re,ulator requirements 3.3.d) standards or codes of /ractice that the or,ani-ation has committed to im/lement 3.3.e) /otential consequences of failure due to the nature of the /roducts and serices. In/uts shall e adequate for desi,n and deelo/ment /ur/oses6 com/lete and unami,uous. (onflictin, desi,n and deelo/ment in/uts shall e resoled. $he or,ani-ation shall retain documented information on desi,n and deelo/ment in/uts.
<771 roduct desi%n in(ut The or%ani.ation shall identif#& document& and revie! (roduct desi%n in(ut requirements as a result of contract revie! roduct desi%n in(ut requirements include but are not limited to the follo!in%+
;82 Dsin an" "v!opmnt inp'ts In/uts relatin, to /roduct requirements shall e determined and records maintained 2see '..'3. $hese in/uts shall include a)functional and /erformance requirements6 b) a//licale statutor and re,ulator requirements6 c)
where a//licale6 information deried from /reious similar desi,ns6 and
d) other requirements essential for
desi,n and deelo/ment. $he in/uts shall e reiewed for adequac. Requirements shall e com/lete6 unami,uous and not in conflict with each other. =OT6 S(ecial characteristics 0see ,11 are included in this requirement
H.8..1 >O:@3T :SI= I=@T The or%ani.ation shall identif#& document and revie! the (roduct desi%n in(ut requirements& includin% the follo!in%+ customer requirements 0contract revie! such as s(ecial character istics 0see 7,7& identification& traceabilit# and (ac8a%in%5 use of information+ the or%ani.ation shall have a (rocess to de(lo# information %ained from (revious desi%n (roects& com(etitor anal#sis& su((lier
The desi%n in(ut clause no! includes a tie to the feasibilit# anal#sis and requires a (rocess for de(lo#in% information from (revious (roects5 benchmar8in%5 su((lier feedbac8
(roduct s(ecifications includin% but not limited to s(ecial characteristics 0see Section <7775 boundar# and interface requirements+ 3 c3 identification& traceabilit#& and (ac8a%in%+ d3 consideration of desi%n alternatives5 assessment of ris8s !ith the in(ut e3 requirements and the or%ani.ationEs abilit# to miti%ate/mana%e the ris8s& includin% from the feasibilit# anal#sis5 f3 tar%ets for conformit# to (roduct requirements includin% (reservation& reliabilit#& durabilit#& serviceabilit#& health& safet#& environmental& develo(ment timin%& and cost5 a((licable statutor# and re%ulator# ,3 requirements of the customer) identified countr# of destination& if (rovided5 h3 embedded soft!are requirements a3
The or%ani.ation shall have a (rocess to de(lo# information %ained from (revious desi%n (roects& com(etitive (roduct anal#sis 0benchmar8in%& su((lier feedbac8& internal in(ut& field data& and other relevant sources for current and future (roects of a similar nature
feedbac8& internal in(ut& field data& and other relevant sources& for current and future (roects of a similar nature5 tar%ets for conformit# to (roduct requirements& life& reliabilit#& durabilit#& maintainabilit#& timin% and cost
rror)(roofin% no! out of the note and (art of the clause
H.8.. $A=@FA3T@>I= >O3SS
=OT One a((roach for considerin% desi%n :SI = I=@T alternatives is the use of trade)off curves The or%ani.ation shall identif#& document and revie! the manufacturin% (rocess desi%n in(ut requirements& includin% <77, $anufacturin% (rocess desi%n in(ut (roduct desi%n out(ut data& The or%ani.ation shall identif#& tar%ets for (roductivit#& (rocess document& and revie! manufacturin% ca(abilit# and cost& (rocess desi%n in(ut requirements customers requirements& if an#& and includin% but not limited to the ex(erience from (revious follo!in%+ develo(ments a3 (roduct desi%n out(ut data includin% s(ecial characteristics5 3 tar%ets for (roductivit#&
(rocess
=OT6
The manufact urin% (rocess desi%n
A fe! ne! in(uts listed includin% technolo%ical alternatives& ne! materials5 (roduct handlin% and er%onomics
inclu in clu des the use of err or) (roof (r oofin in% % met hods hod s to ca(abilit#& timin%& and cost5 de% ree a((r o(r iat e to the ma%nit ma% nit ude of the manufacturin% technolo%# a de%ree (roblems and commensurate commensurate !ith the ris8s alternatives5 encountered customer requirements& if an#5 d3 e3 ex(erience from (revious develo(ments5 f3 ne! materials5 (roduct handlin% and er%onomic ,3 requirements5 and desi%n for manufacturin% and desi%n h3 for assembl# The manufacturin% (rocess desi%n shall include the use of error)(roofin% methods to a H.8..8 S3IA? 3HA>A3T 3HA>A3T>ISTI3 >ISTI3S S de%ree a((ro(riate to the The or%ani.ati or%an i.ation on shall identif# ident if# s(ecial s(eci al ma%nitude of the (roblem0s and characte char acterist ristics ics Msee 77 dN and commensurate !ith the ris8s incl ude all s(ecial charac cha racter terist istics ics in the include encountered control (lan& (lan& com(l# com( l# !ith custome cus tomer)s r)s(eci (ecified fied definiti defi nitions ons and s#mbols& s#mb ols& and <777 S(ecial characteristics iden tif# (rocess (roc ess control contr ol documen do cuments ts identif# The or%ani.ation shall use a includin% incl udin% dra!in%s& dra! in%s& F$As& control multidisci(linar# a((roach to establish& document& and im(lement its (rocess0es (lans& and o(erat o(e rator or instru ins tructi ctions ons to identif# s(ecial characteristics& !ith !it h the custo cus tomer merEs Es s(ecia s(e cial l includin% those determined b# the characterist ic s#mbol or or the customer and the ris8 anal#sis (erformed or%ani.ati or%an i.ationRs onRs equivalent equiv alent s#mbol s#mbo l or or b# the or%ani.ation& and shall include the notat not ation ion to inclu inc lude de those tho se (rocess (rocess follo!in%+ ste(s ste (s that tha t affec aff ectt s(ecia s(e cial l h.a3 documentation of all s(ecial characteristics charac character terist istics ics in the dra!in dra!in%s %s 0as required& ris8 anal#sis 0such as F$A& control (lans& and standard !or8/o !or8/o(er (erato atorr instru instructi ctions ons55 s(ecia s(ecial l =OT6 charact cha ract eristi eri stics cs can incl ude =OT6 S(ecial characteristics and (rocess (arameters (rocess (arameters char charac acte teri rist stic ics s are are iden identi tifi fied ed !ith !ith (roduct characteristics s(ecif s(ecific ic mar8in mar8in%s %s and are cascad cascaded ed throu%h each of these documents5 h.3 develo(ment of control and monitorin% strate%ies for s(ecial characteristics of (roducts and (roduction (rocesses5 (rocesses5 h.c3 custom customer) er)s(e s(ecif cified ied a((rov a((rovals als&& !hen !hen required5 h.d3 com(lianc com(liance e !ith customer)s customer)s(ecif (ecified ied defin efinit itio ions ns and and s#mbo #mbols ls or the the c3
Identification of s(ecial characteristics no! tied to ris8 anal#sis
$his clause now contains desi,n reiews6 desi,n erification and desi,n alidation
or%ani.ati or%ani.ationEs onEs equivalen equivalentt s#mbols s#mbols or nota notati tion ons& s& as defi define ned d in a s#mb s#mbol ol conversion table The s#mbol Desi,n and deelo/ment reiew sstematic reiews reiews of conversion table shall be submitted to #t suitale sta,es6 sstematic desi,n and deelo/ment shall e /erformed the customer& if required in accordance with /lanned arran,ements 2see H.8.13 3.4.a) to ealuate the ailit of the Dsin an" "v!opmnt ".!.4 results of desi,n and deelo/ment to +ontro!s $he or,ani-ation shall meet requirements6 and a//l controls to the desi,n and deelo/ment /rocess to ensure that:
a) the results to e achieed are defined b)reiews are conducted to ealuate the ailit of the results of desi,n and deelo/ment to meet requirements c) erificati erification on actiities are conducted to ensure that the desi,n and deelo/ment out/uts meet the in/ut requirements d)alidation actiities are conducted to ensure that the resultin, /roducts and serices meet therequirements for the s/ecified a//lication or intended use e) an necessar actions are ta7en on /rolems determined durin, the reiews66 or erification andalidation reiews actiities f) documented information of these actiities is retained. 4O$5 Desi,n and deelo/ment reiews6 erification and alidation alidation hae distinct /ur/oses. $he can e conducted se/aratel or in an comination6 as is suitale for the /roducts /roduct s and serices of the or,ani-ation.
<74 <741 1 $onito $onitorin rin% % $easurements at s(ecified sta%es durin% the
controls
to identif an /rolems and /ro/ose necessar actions.
3.4.b)
=artici/ants in such reiews shall include re/resentaties of functions concerned with the desi,n and deelo/ment sta,e2s3 ein, reiewed. Records of the results of the reiews and an necessar actions shall e maintained 2see '..'3.
=OT6 =O T6 These The se revie! rev ie!s s are ar e nor mall# mal l# coord coo rdin inate ated d !ith !it h the th e desi% des i%n n (hases and include incl ude manufact manu facturi urin% n% (rocess (rocess desi%n and develo(ment
;841 MOITO,I $easur $ea sureme ements nts at s(ecif s(e cified ied sta%es sta %es of desi%n des i%n and develo dev elo(me (ment nt shall sha ll be defined& defi ned& anal#s ana l#sed ed and re(ort re( orted ed !ith !it h sum s umma mar# r# result res ults s as an in(ut in (ut to mana% man a%eme ement nt revie! rev ie! These measurem meas urement ents s include incl ude =OT6 =O T6 qualit# ris8s& costs& lead)times& critical (aths (aths and others& othe rs& as a((ro(r a(( ro(r iate iate
7.!.
Dsin an"
=o! includes activit# re(ortin% to the customer as required
desi%n and develo(ment of (roducts and (rocesses shall be be defined& anal#sed& and re(orted !ith summar# results as an in(ut to mana%ement revie! 0see Section 97,1
"v!opmnt "v!opmnt vrii+ation Nerification shall e /erformed in accordance with /lanned arran,ements 2see H.8.13 to ensure th that th the desi,n and deelo/ment out/uts hae met the desi,n and deelo/ment in/ut requirements. Records of the results of the erification and an necessar actions shall e maintained 2see '..'3.
Dhen required b# the customer& measurements of the (roduct and (rocess develo(me develo(ment nt activit# activit# shall be re(orted re(orted to the customer at sta%es s(ecified& or a%reed to& b# the customer =OT Dhen a((ro(riate& these measurements ma# include qualit# ris8s& costs& lead times& critical (aths& and other measurements
Dsin an" "v!opmnt va!i"ation Desi,n and deelo/ment alidation shall e /erformed in accordance with /lanned arran,ements arran,ements 2see 2see H.8.13 H.8.13 to ensure that the resultin, /roduct is ca/ale of meetin, the <74, <74, :esi%n :esi%n and develo(ment develo(ment validation validation requirements for the s/ecified a//lication or :esi%n and develo(ment validation shall be intended use6 where 7nown. Bhereer (erformed in accordance accordance !ith customer requirements& includin% an# a((licable /racticale6 alidation shall e com/leted industr# and %overnmental a%enc#)issued /rior to the the delier delier or im/lementation of re%ulator# standards The timin% of desi%n the /roduct. Records of the results of and develo(ment validation shall be (lanned alidation alidation and an necessar necessar actions shall in ali%nment !ith customer)s(ecified timin%& e maint ained 2see '..'3. as a((licable =OT 1 The validatio valid ation n (rocess (roc ess normall# norm all# Dhere contractuall# a%reed !ith the includes incl udes an anal#sis anal# sis of field fiel d re(orts re(o rts for customer& this shall include evaluation of the similar simi lar (roducts (roducts interaction of the or%ani.ationEs (roduct& includin% embedded soft!are& !ithin the =OT , The requirements of 7- and 76 s#stem of the final customerEs (roduct above abo ve a((l# a(( l# to both bo th (rod (r oduct uct and 7.!.#
manufacturin% (rocesses ;861 D>SI AD D>@>O#M>T
@AIDATIO SB##>M>TA :esi%n :esi% n and develo(m deve lo(ment ent validati vali dation on shall shal l be (erformed be (erformed in accordance !ith customer requirements& includ in cludin% in% (ro%ramme timin%
;862 ;86 2 #,O #,OTOT TOT#> #> #,O #,O,A ,AMM> MM>
Added a((licable a((licable re%ulator# requirements& coordination !ith customer timin%& and the interaction of the (roduct !ith the customerRs (roduct to the validation clause
<747 rotot#(e (ro%ramme Dhen required b# the customer& the or%ani.ation shall have a (rotot#(e (ro%ramme and control (lan The or%ani.ation shall use& !henever (ossible& the same su((liers& toolin%& and manufacturin% (rocesses as !ill be used in (roduction
Dhen required b# the customer& the or%ani.ation shall have a (rotot#(e (ro%ramme and control (lan The or%ani.ation shall use& !herever (ossible& the same su((liers& toolin% and manufacturin% (rocesses as !ill be used in (roduction All (erformance)testin% activities shall be monitored for timel# com(letion and conformit# to requirements Dhile services ma# be outsourced& the or%ani.ation shall be res(onsible for the outsourced services& includin% technical leadershi(
All (erformance)testin% activities shall be monitored for timel# com(letion and conformit# to requirements Dhen services are outsourced& the or%ani.ation shall include the t#(e and extent of control in the sco(e of its qualit# mana%ement s#stem to ensure that outsour ced services conform to requirements 0see ISO 9**1& Section <4
<744 roduct a((roval (rocess The or%ani.ation shall establish& im(lement& and maintain a (roduct and manufacturin% a((roval (rocess conformin% to requirements defined b# the customer0s The or%ani.ation shall a((rove externall# (rovided (roducts and services (er ISO 9**1& Section <47& (rior to submission of their (art a((roval to the customer The or%ani.ation shall obtain documented (roduct a((roval (rior to shi(ment& if required b# the customer >ecords of such a((roval shall be retained
The a((lication of (roduct a((roval to su((liers is moved out of the note and into >O:@3T A>OA? the clause requirements
;868 >O3SS Have to have documented a((roval The or%ani.ation shall conform to a (roduct and manufacturin% (rocess a((roval (rocedure reco%ni.ed b# the customer =OT roduct a((roval should be subsequent to the verification of the manufacturin% (rocess This (roduct and manufacturin% (rocess a((roval (rocedure shall also be a((lied to su((liers
=OT roduct a((roval should subsequent to the verification of manufacturin% (rocess
be the
-85 Dsin an" "v!opmnt o'tp'ts $he or,ani-ation shall ensure that desi,n and deelo/ment out/uts:
a) meet the in/ut requirements b)are adequate for the susequent /rocesses for the /roision of /roducts and serices c) include or reference monitorin, and measurin, requirements6 as a//ro/riate6 and acce/tance criteria
;88 Dsin an" "v!opmnt o'tp'ts $he out/uts of desi,n and deelo/ment shall e in a form suitale for erification a,ainst the desi,n and deelo/ment in/ut and shall e a//roed /rior to release. Desi,n and deelo/ment out/uts shall meet the in/ut requirements for desi,n and deelo/ment6
a)
b) /roide a//ro/riate information for
/urchasin,6 /roduction and serice /roision6 d)s/ecif the characteristics of the /roducts and serices that are c) contain or reference /roduct acce/tance essential for their intended criteria6 and /ur/oseand their safe and /ro/er /roision. d) s/ecif the characteristics of the /roduct $he or,ani-ation shall retain documented that are essential for its safe and /ro/er information on desi,n and deelo/ment use. out/uts. <7-1 :esi%n and develo(ment out(uts ; 4O$5 Information for /roduction and serice su((lemental /roision can include details for the The list of (roduct desi%n out(uts is The (roduct desi%n out(ut shall be /reseration of /roduct. ex(ressed in terms that can be verified and no! more extensive validated a%ainst (roduct desi%n in(ut requirements The (roduct desi%n out(ut ;881 >O:@3T :SI= O@T@TS ; shall include but is not limited to the follo!in%& as a((licable+ S@?$=TA? a3 desi%n ris8 anal#sis 0F$A5 The (roduct desi%n out(ut shall be 3 reliabilit# stud# results5 ex(ressed in terms that can be verified c3 (roduct s(ecial characteristics5 and validated a%ainst (roduct desi%n d3 results of (roduct desi%n error) in(ut requirements The (roduct desi%n (roofin%& such as :FSS& :F$A& and FTA5 out(ut shall include e3 (roduct definition includin% 7: models& desi%n F$A& reliabilit# results& technical data (ac8a%es& (roduct (roduct s(ecial characteristics and manufacturin% information& and s(ecifications& %eometric dimensionin% G tolerancin% (roduct error)(roofin%& as a((ro(riate& 0:GT5 f3 ,: dra!in%s& (roduct manufacturin% (roduct definition includin% dra!in%s or information& and %eometric mathematicall# based data&
dimensionin% G tolerancin% 0:GT5 results& and (roduct desi%n revie!s results& (roduct desi%n revie! results5 results5 dia% nostic ic %uidelines& !here a((licable dia%nost h3 servic service e dia%no dia%nosti stic c %uidel %uideline ines s and re(air and serviceabilit# instructions5 i3 service (art requirements5 (ac8a%in% and labelin% requirements for shi((in% =OT Interim desi%n out(uts should include an# en%ineerin% (roblems bein% resolved throu%h a tradeoff (rocess ,3
The list of (rocess desi%n out(uts is no! more extensive <7-, <7-, $anufactur $anufacturin% in% (rocess (rocess desi%n out(ut The or%ani.ation shall document the manufacturin% (rocess desi%n out(ut in a manner that enables verification a%ainst the manufacturin% (rocess desi%n in(uts The $A=@FA3T@>I= T@>I= >O3SS ;882 $A=@FA3 or%ani.ation shall verif# the out(uts a%ainst :SI= :SI = O@T O@T@T @T manufacturin% (rocess desi%n in(ut The manufac turin% turi n% (rocess desi%n out(ut requirements The manufacturin% (rocess shall be ex(r ex (res esse sed d in term te rms s that th at can ca n be desi%n out(ut shall include but is not limited verified veri fied a%ainst a%ai nst manufact man ufacturin urin% % (rocess to the follo!in%+ desi%n desi% n in(ut in(u t requirem requ irements ents and validated valid ated s(ecifications and dra!in%s5 a3 The manufac turin% turi n% (rocess desi%n out(ut 3 s(ecial characteristics for (roduct shall include and manufacturin% (rocess5 s(ec ificatio ations ns and dra!in%s& dra!i n%s& c3 identi identific ficati ation on of (roces (rocess s in(ut in(ut s(ecific manufact manu facturin urin% % (rocess flo! variables that im(act characteristics5 d3 toolin% and equi(ment for (roduction chart/la#out& and control& includin% ca(abilit# manu facturin urin% % (rocess F$As& F$As& manufact studies of equi(ment and (lan 0see -11& -11& control (lan (rocess0es5 !or8 instructio ns& e3 manu manufa fact ctur urin in% % (roc (roces ess s flo! flo! a((roval acce(tance criteria& charts/la#out& includin% lin8a%e of (roduct& (rocess a((roval data dat a for qualit qua lit#& #& reliabilit#& (rocess& and toolin%5 maintainabil it# and measurabilit# & f3 ca(acit# anal#sis5 ,3 manufacturin% (rocess F$A5 resu lts of error)(r erro r)(roofi oofin% n% activitie activ ities& s& as results h3 maintenance (lans and a((ro(riate& and instructions5 meth me thod ods s of ra(i ra (id d dete de tect ctio ion n and an d i3 control (lan 0see Annex A5 feed fe edba bac8 c8 of (roduct/manufacturin% (roduct/manufacturin% standard !or8 and !or8 !or8 instructions5 (rocess nonconformities nonconformities 8 (rocess a((roval acce(tance criteria5 I data for qualit#& reliabilit#& maintainabilit#& and measurabilit#5 m results results of error)(roof error)(roofin% in% identifica identification tion and verification& as a((ro(riate5
n methods of ra(id detection& feedbac8& and correction of (roduct/manufacturin% (rocess nonconformities nonconformities
Dsin an" "v!opmnt +(ans -/8/6 $he or,ani-ation shall identif6 reiew and control chan,es made durin,6 or susequent to6 the desi,n and deelo/ment of /roducts and serices6 to the e)tent necessar to ensure that there is no aderse im/act on conformit to requirements. $he or,ani-ation shall retain documented information on:
a) desi,n and deelo/ment chan,es b)the results of reiew reiews s c) the authori-ation of the chan,es d)the actions ta7en to /reent aderse im/acts.
<761 :esi%n and develo(ment chan%es ; su((lemental The or%ani.ation shall evaluate all desi%n chan%es after initial (roduct a((roval& includin% those (ro(osed b# the or%ani.ation or its su((liers& for (otential im(act on fit& form& function& (erformance& and/or durabilit# These chan%es shall be validated a%ainst customer requirements and a((roved internall#& (rior to (roduction im(lementation im(lementation If required b# the customer& the or%ani.ation shall obtain documented a((roval& or a documented !aiver& from the customer (rior to (roduction im(lementation For (roducts !ith embedded soft!are& the
;8; Contro! o "sin an" "v!opmnt +(ans Desi,n and deelo/ment chan,es shall e identified and records maintained. $he chan,es shall e reiewed6 erified and alidated6 as a//ro/riate6 and a//roed efore im/lementation. $he reiew of desi,n and deelo/ment chan,es shall include ealuation of the effect of the chan,es on constituent /arts and /roduct /roduct alread deliered. Records of the results of the reiew of chan,es and an necessar actions shall e maintained 2see '..'3. :esi%n :es i%n and an d develo dev elo(me (ment nt chan% cha n%es es =OT6 =O T6 include incl ude all chan%es durin% duri n% the (roduct (ro duct (ro%ramme life 0see 0see 14 ;14 3HA= 3O=T>O 3O=T>O? ? The or%ani.ati or%an i.ation on shall shal l ha have a (rocess to control and reac re actt to chan ch an%e %es s that th at im(a im (act ct (roduct reali.ation The effec eff ects ts of an# chan%e& includ inc ludin% in% those tho se chan%e cha n%es s caused cau sed b# an# su((lier su(( lier& & shall be assessed asse ssed& & and verifica veri fication tion and valid ation atio n activiti acti vities es shall be defined& defi ned& to ensure ensu re com(lia com (liance nce !ith customer requirements 3han%es 3han %es shall shal l be validated before im(lementati on For Fo r (ro(rietar# desi%ns& im(ac im (actt on form fo rm&& fit and functi fun ction on 0incl 0in cludi udin% n% (erformance and/or and/o r durabilit dura bilit# # shall shal l be rev r evie ie!e !ed d !ith !i th the th e cust cu stom omer er so that th at all al l effe ef fect cts s can ca n be (ro(erl# evaluated evaluated Dhen Dh en requir req uired ed b# the custo cu stomer mer& & additional verification /identificat ion requirements & such su ch as thos th ose e requ re quir ired ed for fo r ne! n e! (roduct (roduct introduction& shall be met me t =OT =OT 1 An# (roduct reali.ation chan%e affecti affe ctin% n% custome cust omerr require requ irement ments s requires requ ires notificat noti ficat ion to& and a%reemen a%re ementt from& fro m& the customer
or%ani.ation shall document the revision level of soft!are and hard!are as (art of the chan%e record
-4 Contro! o xtrna! provision o oo"s an" srvi+s *.'.1 eneral $he or,ani-ation shall ensure that e)ternall /roided /rocesses6 /roducts and serices conform to requirements. $he or,ani-ation shall determine the controls to e a//lied to e)ternall /roided /rocesses6 /roducts and serices when: a) /roducts and serices from e)ternal /roiders are intended for incor/oration into the or,ani-ations own /roducts and serices b)/roducts and serices are /roided directl to the customer2s3 e)ternal /roiders on ehalf of the or,ani-ation c) a /rocess6 or /art of a /rocess6 is /roided an e)ternal /roider as a
=OT , The above requirement a((lies to (roduct and manufacturin% (rocess chan%es
;4 #'r+(asin ;/4/1
#'r+(asin pro+ss
$he or,ani-ation shall ensure that /urchased /roduct conforms to s/ecified /urchase requirements. $he t/e and e)tent of control a//lied to the su//lier and the /urchased /roduct shall e de/endent u/on the effect of the /urchased /roduct on susequent /roduct reali-ation or the final /roduct. $he or,ani-ation shall ealuate and select su//liers ased on their ailit to su//l /roduct in accordance with the or,ani-ationGs requirements. (riteria for selection6 ealuation and reealuation shall e estalishe d. Records of the results of ealuations and an necessar actions arisin, from the ealuation shall
(lause roadened to s/ecificall coer e)ternall /roided /rocesses6 /roduct and serices A more clearl coers outsourced /rocesses
?ore clearl a//lies to /roduct related /roducts6 /rocesses and serices
result of a decision the or,ani-ation. $he or,ani-ation shall determine and a//l criteria for the ealuation6 selection6 monitorin, of /erformance6 and re ealuation of e)ternal /roiders6 ased on their ailit to /roide /rocesses or /roducts and serices in accordance with requirements. $he or,ani-ation shall retain documented information of these actiities and an necessar actions arisin, from the ealuations.
<411 eneral ; su((lemental The or%ani.ation shall include all (roducts and services that affect customer requirements such as subassembl#& sequencin%& sortin%& re!or8& and calibration services in the sco(e of their definition of externall# (rovided (roducts& (rocesses& and services
<41, Su((lier selection (rocess The or%ani.ation shall have a documented su((lier selection (rocess The selection (rocess shall include+ a3 an assessment of the selected su((lierEs ris8 to (roduct conformit# and uninterru(ted su((l# of the or%ani.ationEs (roduct to their customers5 3 relevant qualit# and deliver# (erformance5 an evaluation of the su((lierEs qualit# c3 mana%ement s#stem5 multidisci(linar# decision ma8in%5 d3 and an assessment of soft!are e3 develo(ment ca(abilities& if a((licable Other su((lier selection criteria that should
e maintained 2see '..'3.
=OT 1 urchased (roducts above include all (roducts and services that affect customer requirements such as sub) assembl#& sequencin%& sortin%& re!or8 and calibration services =OT , Dhen there are mer%ers& acquisitions or affiliations associated !ith su((liers& the or%ani.ation should verif# the continuit# of the su((lierEs qualit# mana%ement s#stem and its effectiveness
=ote 1 is no! in the su((lemental requirements clause <411
=ote , is no! in the su((lemental requirements clause <41,
>equires a documented su((lier selection (rocess includin% more details concernin% to(ics considered
be considered include the follo!in%+ volume of automotive business L 0absolute and as a (ercenta%e of total business5 L financial stabilit#5 (urchased (roduct& material& or L service com(lexit#5 required technolo%# 0(roduct or L (rocess5 adequac# of available resources 0e%& L (eo(le& infrastructure5 desi%n and develo(ment ca(abilities L 0includin% (roect mana%ement5 manufacturin% ca(abilit#5 L L chan%e mana%ement (rocess5 business continuit# (lannin% 0e%& L disaster (re(aredness& contin%enc# (lannin%5 L lo%istics (rocess5 L customer service
H.'.1.8 3@STO$>)A>O: SO@>3S -418 3ustomer)directed sources 8no!n as ':irected)2u#' Dhen s(ecified b# the customer& the or%ani.ation shall (urchase (roducts& materials& or services from customer) directed sources
0also
All requirements of Section <4 0exce(t the requirements in IATF 16949& Section <41, are a((licable to the or%ani.ationEs control of customer)directed sources unless s(ecific a%reements are other!ise defined b# the contract bet!een the or%ani.ation and the customer
Dhe re s(ecified b# the contract 0e% customer en%ineerin% dra!in%& s(ecification& the or%ani.ation shall (urchase (roducts& materials or services from a((roved sources The use of customer)desi%nated sources& includin% tool/%au%e su((liers& does not relieve the or%ani.ation of the res(onsibilit# for ensurin% the qualit# of (urchased (roducts
=ote that the requirements in <41, !ith res(ect to su((lier selection do not a((l# to directed bu# sources
T%p an" xtnt o +ontro! -/4/2 $he or,ani-ation shall ensure that e)ternall /roided /rocesses6 /roducts and serices do not adersel affect the or,ani-ations ailit to consistentl delier conformin, /roducts and serices to its customers. $he or,ani-ation shall: a) ensure that e)ternall /roided /rocesses remain within the control of its qualit mana,ement sstem
b)define oth the controls that it intends to a//l to an e)ternal /roider and those it intends to a//lto the resultin, out/ut
@rii+ation o p'r+(as" ;/4/8 pro"'+t $he or,ani-ation shall estalish and im/lement the ins/ection or other actiities necessar for ensurin, that /urchased /roduct meets s/ecified /urchase requirements. Bhere the or,ani-ation or its customer intends to /erform erification at the su//lierGs /remises6 the or,ani-ation shall state the intended erification arran,ements and method of /roduct release in the /urchasin, information.
$/e " e)tent of control se/arated into new clause and erification of /urchased /roduct incor/orated into this clause
4ew requirements Eto ensure that e)ternall /roided /rocesses remain within the control of its Q?S A we "o not intrprt this to mean that an or,ani-ation hain, an outsource Process cannot drop ship to the c!stomer
c) ta7e into consideration: 1)
the /otential im/act of the e)ternall /roided /rocesses6 /roducts and serices on the or,ani-ations ailit to consistentl meet customer and a//licale statutor and re,ulator requirements
2)
the effectieness of the controls a//lied the e)ternal /roider
d)determine the erification6 or other actiities6 necessar to ensure that the e)ternall /roided /rocesses6 /roducts and serices meet requirements
<4,1 T#(e and extent of control ; su((lemental The or%ani.ation shall have a documented (rocess to identif# outsourced (rocesses and to select the t#(es and extent of controls used to
=eed a documented (rocess to select and control outsourced (rocesses
verif# conformit# of externall# (rovided (roducts& (rocesses& and services to internal 0or%ani.ational and external customer requirements The (rocess shall include the criteria and actions to escalate or reduce the t#(es and extent of controls and develo(ment activities based on su((lier (erformance and assessment of (roduct& material& or service ris8s
;411 STATBTO, AD ,>BATO, COFO,MIT All (urchased (roducts or materials used in (roduct shall conform to <4,, Statutor# and re%ulator# a((licable statutor# and re%ulator# requirements requirements The or%ani.ation shall document their (rocess to ensure that (urchased (roducts& (rocesses& and services conform to the current a((licable statutor# and re%ulator# requirements in the countr# of recei(t& the countr# of shi(ment& and the customer) identified countr# of destination& if (rovided If the customer defines s(ecial controls for certain (roducts !ith statutor# and re%ulator# requirements& the or%ani.ation shall ensure the# are im(lemented and maintained as defined& includin% at su((liers
x(anded su((lemental clause requirin% a documented (rocess for ensurin% re%ulator# com(liance and associated customer com(liance b# the su((l# chain
The su((lier "$S develo(ment has been clarified5 no! includes second (art# H.'.1. SB##I>, 7BAIT MAA>M>T audits5 ISO9**1 certification b# SST>M D>@>O#M>T accredited 325 the (rocess sequence The or%ani.ation shall (erform su((lier leads to certification to IATF 16949 qualit# mana%ement s#stem develo( ment of su((lier conformit# !ith <4,7 Su((lier qualit# mana%ement s#stem !ith the %oal this Technical S(ecification 3onformit# develo(ment The or%ani.ation shall require their !ith ISO 9**1+,**< is the first ste( in su((liers of automotive (roducts and achievin% this %oal services to develo(& im(lement& and =OT6 The (rioriti.ation of su((liers for im(rove a qualit# mana%ement s#stem develo(ment de(ends u(on& for exam(le& certified to ISO 9**1& unless other!ise authori.ed b# the customer Me%& item a the su((lierEs qualit# (erformance and belo!N& !ith the ultimate obective of the im(ortance of the (roduct su((lied becomin% certified to this Automotive "$S Standard @nless other!ise s(ecified b# the customer& the follo!in% sequence should be @nless other !ise s(ecified b# the customer& su((liers to the or%ani.ation a((lied to achieve this requirement+
a3 3
c3
d3
e3
com(liance to ISO 9**1 throu%h shall be third (art#& re%istered to ISO second)(art# audits5 9**1+,**< b# an accredited third)(art# certification to ISO 9**1 throu%h third) certification bod# (art# audits5 unless other!ise s(ecified b# the customer& su((liers to the or%ani.ation shall demonstrate conformit# to ISO 9**1 b# maintainin% a third) (art# certification issued b# a certification bod# bearin% the accreditation mar8 of a reco%ni.ed IAF $?A 0International Accreditation Forum $ultilateral >eco%nition Arran%ement member and !here the accreditation bod#Es main sco(e includes mana%ement s#stem certification to ISO/I3 1*,15 certification to ISO 9**1 !ith com(liance to other customer)defined "$S requirements 0such as $inimum Automotive "ualit# $ana%ement S#stem >equirements for Sub)Tier Su((liers M$A"$S>N or equivalent throu%h second)(art# audits5 certification to ISO9**1 !ith com(liance to IATF 16949 throu%h second)(art# audits5 certification to 16949 throu%h third) (art# audits 0valid third)(art# certification of the su((lier to IATF 16949 b# an lATF)reco%ni.ed certification bod#
-4281 Automotive (roduct)related soft!are or automotive (roducts !ith embedded soft!are The or%ani.ation shall require their su((liers of automotive (roduct)related soft!are& or automotive (roducts !ith embedded soft!are& to im(lement and maintain a (rocess for soft!are qualit# assurance for their (roducts A soft!are develo(ment assessment methodolo%# shall be utili.ed to assess
=e! clause requirin% su((liers of (roduct !ith embedded soft!are to have a soft!are "A (ro%ram for their (roducts and to use a soft!are develo(ment assessment methodolo%# in assess their s#stem
the su((lierEs soft!are develo(ment (rocess @sin% (rioriti.ation based on ris8 and (otential im(act to the customer& the or%ani.ation shall require the su((lier to retain documented information of a soft!are develo(ment ca(abilit# self) assessment
-424 Su((lier monitorin% The or%ani.ation shall have a documented (rocess and criteria to evaluate su((lier (erformance in order to ensure conformit# of externall# (rovided (roducts& (rocesses& and services to internal and external customer requirements At a minimum& the follo!in% su((lier (erformance indicators shall be monitored+ delivered (roduct conformit# to e.a3 requirements5 customer disru(tions at the receivin% e.3 (lant& includin% #ard holds and sto( shi(s5 deliver# schedule (erformance5 e.c3 e.d3 number of occurrences of (remium frei%ht If (rovided b# the customer& the or%ani.ation shall also include the follo!in%& as a((ro(riate& in their su((lier (erformance monitorin%+ e.e3 s(ecial status customer notifications related to qualit# or deliver# issues5 e.f3 dealer returns& !arrant#& field actions& and recalls -4241 Second)(art# audits The or%ani.ation shall include a second) (art# audit (rocess in their su((lier mana%ement a((roach Second)(art# audits ma# be used for the follo!in%+ e.f.a3 su((lier ris8 assessment5 su((lier monitorin%5 e.f.3 e.f.c3 su((lier "$S develo(ment5
H.'.8. SB##I>, MOITO,I Su((lier (erformance shall be monitored throu%h the follo!in% indicators+ delivered (roduct conformit# to requirements5 customer disru(tions& includin% field returns5 deliver# schedule (erformance 0includin% incidents of (remium frei%ht5 status customer notifications s(ecial related to qualit# or deliver# issues The or%ani.ation shall (romote su((lier monitorin% of the (erformance of their manufactur in% (rocesses
This ne! clause requires a second (art# audit (rocess of su((liers
(roduct audits5 (rocess audits 2ased on a ris8 anal#sis& includin% (roduct safet#/re%ulator# requirements& (erformance of the su((lier& and "$S certification level& at a minimum& the or%ani.ation shall document the criteria for determinin% the need& t#(e& frequenc#& and sco(e of second)(art# audits The or%ani.ation shall retain records of the second)(art# audit re(orts If the sco(e of the second)(art# audit is to assess the su((lierEs qualit# mana%ement s#stem& then the a((roach shall be consistent !ith the automotive (rocess a((roach =OT uidance ma# be found in the IATF Auditor uide and ISO 19*11 e.f.d3 e.f.e3
-425 Su((lier develo(ment The or%ani.ation shall determine the (riorit#& t#(e& extent& and timin% of required su((lier develo(ment actions for its active su((liers :etermination in(uts shall include but are not limited to the follo!in%+ e.f.e.a3 (erformance issues identified throu%h su((lier monitorin% 0see Section <4,45 e.f.e.3 second)(art# audit findin%s 0see Section <4,415 e.f.e.c3 third)(art# qualit# mana%ement s#stem certification status5 e.f.e.d3 ris8 anal#sis The or%ani.ation shall im(lement actions necessar# to resolve o(en 0unsatisfactor# (erformance issues and (ursue o((ortunities for continual im(rovement
Su((lier develo(ment has to include (erformance monitorin%& second (art# audits and ris8 anal#sis !ith issues identified and follo!ed to effective com(letion
. -48 Inormation or xtrna! provi"rs $he or,ani-ation shall ensure the adequac of requirements /rior to their communication to the e)ternal /roider. $he or,ani-ation shall communicate to e)ternal /roiders its requirements for:
a) the /rocesses6 /roducts and serices to e /roided
;/4/2 #'r+(asin in&ormation =urchasin, information shall descrie the /roduct to e /urchased6 includin,6 where a//ro/riate6 a)
b) requirements for qualification of
/ersonnel6 and
b)the a//roal of: 1)
/roducts and serices
2)
methods6 /rocesses and equi/ment
3)
the release of /roducts and serices
c) com/etence6 includin, an required qualification of /ersons
requirements for a//roal of /roduct6 /rocedures6 /rocesses and equi/ment6
c)
qualit mana,ement sstem requirements.
$he or,ani-ation shall ensure the adequac of s/ecified /urchase requirements /rior to their communication to the su//lier.
Bordin, chan,e: ISO 9001:00* required that /urchasin, information 2=Os3 descrie requirements Ewhere a//ro/riate $hose word are not in the reised standard howeer the words are now Ecommunicate to e)ternal /roiders its requirements So if the do not hae such requirements there is nothin, to communicate. Our inter/retation is that there was no essential chan,e
d)the e)ternal /roiders interactions with the or,ani-ation e) control and monitorin, of the e)ternal /roiders /erformance to e a//lied the or,ani-ation f) erification or alidation actiities that the or,ani-ation6 or its customer6 intends to /erform at thee)ternal /roiders /remises.
-481 Information for external (roviders ; su((lemental The or%ani.ation shall (ass do!n all a((licable statutor# and re%ulator# requirements and s(ecial (roduct and
3lause requirin% flo!do!n of re%ulator# and s(ecial characteristics to su((liers and to su((l# chain
(rocess characteristics to their su((liers and require the su((liers to cascade all a((licable requirements do!n the su((l# chain to the (oint of manufacture
-5 #ro"'+tion an" srvi+ provision Contro! o pro"'+tion an" srvi+ provision $he or,ani-ation shall im/lement /roduction and serice /roision under controlled conditions. (ontrolled conditions shall include6 as a//licale: a) the aailailit of documented information that defines: -/5/1
;51 Contro! o pro"'+tion an" srvi+ provision $he or,ani-ation shall /lan and carr out /roduction and serice /roision under controlled conditions. (ontrolled conditions shall include6 as a//licale6 a)
1)
the characteristics of the /roducts to e /roduced6 the serices to e /roided6 or the actiities to e / erformed 2) the results to e achieed
b)the aailailit and use of suitale monitorin, and measurin, resources c) the im/lementation of monitorin, and measurement actiities at a//ro/riate sta,es to erif that criteria for control of /rocesses or out/uts6 and acce/tance criteria for /roducts and serices6 hae een met d)the use of suitale infrastructure and enironment for the o/eration of /rocesses e) the a//ointment of com/etent /ersons6 includin, an required qualification f) the alidation6 and /eriodic realidation6 of the ailit to achiee /lanned results of the /rocesses for /roduction and serice /roision6 where the resultin, out/ut cannot e erified susequent monitorin, or measurement g) the im/lementation of actions to /reent
the aailailit of information that descries the characteristics of the /roduct6
b) the aailailit of wor7 instructions6
as necessar6 c)
$he Es/ecial /rocess requirements are not in a se/arate clause the /rocess alidation requirements are now a ullet in the list
#dded requirements #//ointment of com/etent /ersons A if clients do not hae a /rocess&actiit com/etence determination and matri) the need one
the use of suitale equi/ment6
d) the aailailit and use of monitorin,
and measurin, equi/ment6 e)
the im/lementation of monitorin, and measurement6 and
f)
the im/lementation of /roduct release6 delier and /ostdelier actiities.
Im/lementation of actions to /reent human error A nonconformin, /roduct customer com/laints should lead to at least consideration of mista7e/roofin, the /rocess
$he /rocess alidation requirements are now included in the main clause ;52 @a!i"ation or o& pro+sss pro"'+tion an" srvi+ provision $he or,ani-ation shall alidate an /rocesses for /roduction and serice /roision where the resultin, out/ut cannot e erified susequent monitorin, or measurement and6 as a consequence6 deficiencies ecome a//arent onl after the /roduct is in use or the serice has een deliered. Nalidation shall demonstrate the ailit of these /rocesses to achiee /lanned
human error
h)the im/lementation of release6 delier and /ostdelier actiities.
=OT Suitable infrastructure includes a((ro(riate manufacturin% equi(ment required to ensure (roduct com(liance $onitorin% and measurin% resources include a((ro(riate monitorin% and measurin% equi(ment required to ensure effective control of manufacturin% (rocesses
results. $he or,ani-ation shall estalish arran,ements for these /rocesses includin,6 as a//licale6 a) defined criteria for reiew and a//roal of the /rocesses6 b) a//roal of equi/ment and qualification
The se(arate clause requirin% validation of all (roduction G service (rovision use of s/ecific methods and /rocedures6 (rocesses is no lon%er in the standard of /ersonnel6
c)
d) requirements for records 2see '..'36 and
e3 realidation.
The requirements no! s(ecificall# reco%ni.e that famil# control (lans are OQ
-,1 A?I:ATIO= OF >O3SSS FO> -511 3ontrol (lan The or%ani.ation shall develo( control (lans 0in accordance !ith Annex A at the s#stem& subs#stem& com(onent& and/or material level for the relevant manufacturin% site and all (roduct ;511 su((lied& includin% those for (rocesses (roducin% bul8 materials as !ell as (arts Famil# control (lans are acce(table for bul8 material and similar (arts usin% a common manufacturin% (rocess The or%ani.ation shall have a control (lan for (re)launch and (roduction that sho!s lin8a%e and incor(orates information from the desi%n ris8 anal#sis 0if (rovided b# the customer& (rocess flo! dia%ram& and manufacturin% (rocess ris8 anal#sis out(uts 0such as F$A
>O:@3TIO= A=: S>I3 >OISIO= ; S@?$=TA? The requirements of -, shall a((l# to all (rocesses for (roduction and service (rovision 3O=T>O? ?A= The or%ani.ation shall develo( control (lans 0see Annex A at the s#stem& subs#stem& com(onent and/or material level for the (roduct su((lied& includin% those for (rocesses (roducin% bul8 materials as !ell as (arts& and have a control (lan for (re)launch and (roduction that ta8es into account the desi%n F$A and manufacturin% (rocess F$A out(uts
The The or%ani.ation shall& if required b# the customer& (rovide measurement and conformit# data collected durin% execution of either the (re)launch or (roduction control (lans The or%ani.ation shall include in the control (lan+ controls used for the e.f.e.d.a3 manufacturin% (rocess control& includin%
The requirements no! s(ecificall# include verification of ob set) u(s and 1st (iece ins(ections
control (lan shall list the controls used for the manufacturin% (rocess control& include methods for monitorin% of control exercised over s(ecial character istics 0see 7,7 defined b# both the customer and the or%ani.ation& include the customer)required
verification of ob set)u(s5 information& if an#& and first)off/last)off (art validation& initiate the s(ecified reaction (lan e.f.e.d.3 as a((licable5 0see <,71 !hen the (rocess methods for monitorin% of e.f.e.d.c3 becomes unstable or not control statisticall # ca(able exercised over s(ecial characteristics 0see 3ontrol (lans shall be revie!ed and Annex A defined b# both the customer and u(dated !hen an# chan%e occurs the or%ani.ation5 affectin% (roduct& manufacturin% (rocess& e.f.e.d.d3 the customer)required measurement& lo%istics& su((l# sources or information& if an#5 The revie! and u(date of control (lans is F$A 0see 14 e.f.e.d.e3 s(ecified reaction (lan 0see no! s(ecificall# required in conunction Annex A5 !hen nonconformin% (roduct =OT 3ustomer a((roval ma# be !ith nonconformin% (roduct and customer is detected& the (rocess becomes required after revie! or u(date of the com(laints statisticall# unstable or not statisticall# control (lan ca(able The or%ani.ation shall revie! control (lans& and u(date as required& for an# of the follo!in%+ e.f.e.d.f3 the or%ani.ation determines it has shi((ed nonconformin% (roduct to the customer5 e.f.e.d.,3 !hen an# chan%e occurs affectin% (roduct& manufacturin% (rocess& measurement& lo%istics& su((l# sources& (roduction volume chan%es& or ris8 anal#sis 0F$A 0see Annex A5 e.f.e.d.h3 after a customer com(laint and im(lementation of the associated Dor8 instructions no! also should include corrective action& !hen a((licable5 rules for o(erator safet# e.f.e.d.i3 at a set frequenc# based on a ris8 anal#sis If required b# the customer& the or%ani.ation ;512 DO>Q I=ST>@3TIO=S shall obtain customer a((roval after revie! The or%ani.ation shall (re(are documented or revision of the control (lan !or8 instructions for all em(lo#ees havin% -512 Standardised !or8 ; o(erator res(onsibilities for the o(eration of instructions and visual standards (rocesses that im(act conformit# to The or%ani.ation shall ensure that (roduct requirements These instructions standardised !or8 documents are+ be accessible for use at the !or8 e.f.e.d.i.a3 communicated to and shall understood b# the em(lo#ees !ho are station res(onsible for (erformin% the !or85
le%ible5 (resented in the lan%ua%e0s understood b# the (ersonnel res(onsible to follo! them5 e.f.e.d.i.d3 accessible for use at the desi%nated !or8 area0s The standardised !or8 documents shall also include rules for o(erator safet# e.f.e.d.i.3 e.f.e.d.i.c3
These instructions shall be derived from sources such as the qualit# (lan& the control (lan and the (roduct reali.ation
erification of ob set)u(s no! s(ecificall# references 1st (iece ins(ections and requires records
(rocess ;518 >IFI3ATIO= OF LO2 ST)@S Lob set)u(s shall be verified !henever
(erformed& such as an initial run of a ob& -518 erification of ob set)u(s material chan%eover or ob chan%e The or%ani.ation shall+ e.f.e.d.i.d.a3 verif# ob set)u(s !hen (erformed& such as an initial run of a Dor8 instructions shall be available for ob& material chan%eover& or ob chan%e set)u( (ersonnel The or%ani.ation shall that requires a ne! set)u(5 use statistical methods of verification& e.f.e.d.i.d.3 maintain documented !here a((licable information for set)u( (ersonnel5 e.f.e.d.i.d.c3 use statistical methods of =OT ?ast)off)(art com(arisons are verification& !here a((licable5 recommended e.f.e.d.i.d.d3 (erform first)off/last)off (art validation& as a((licable5 !here a((ro(riate& first)off (arts should be retained for com(arison !ith the last)off erification after shutdo!n is a ne! sub) (arts5 !here a((ro(riate& last)off)(arts clause should be retained for com(arison !ith first)off (arts in subsequent runs5 e.f.e.d.i.d.e3 retain records of (rocess and (roduct a((roval follo!in% set)u( and first)off/last)off (art validations .
<-14 erification after shutdo!n The or%ani.ation shall define and im(lement the necessar# actions to ensure (roduct com(liance !ith requirements after a (lanned or un(lanned (roduction shutdo!n (eriod ;514 >=TI A=: >:I3TI $AI=T=A=3 <-1- Total (roductive maintenance The or%ani.ation shall identif# 8e# (rocess The or%ani.ation shall develo(& im(lement& equi(ment and (rovide resources for and maintain a documented total (roductive machine/equi(ment maintenance and maintenance s#stem an effective (lanned total At a minimum& the s#stem shall include the develo(
follo!in%+ (reventive maintenance s#stem As a a3 identification of (rocess equi(ment minimum& this s#stem shall include the $aintenance obectives are no! an in(ut to necessar# to (roduce conformin% follo!in%+ mana%ement revie! (roduct at the required volume5 (lanned maintenance activities5 3 availabilit# of re(lacement (arts for the and (reservation of (ac8a%in% equi(ment identified in item a5 equi(ment& toolin% and %au%in%5 c3 (rovision of resource for machine& availabilit# of re(lacement (arts for 8e# equi(ment& and facilit# maintenance5 manufacturin % equi(ment5 d3 (ac8a%in% and (reservation of documentin%& evaluatin% and im(rovin% equi(ment& toolin%& and %au%in%5 maintenance obectives e3 a((licable customer)s(ecific >evie! of the maintenance (lan and requirements5 The or%ani.ation shall utili.e (redictive obectives no! s(ecificall# required f3 documented maintenance obectives& maintenance methods to continuall# for exam(le+ O 0Overall qui(ment im(rove the effectiveness and the ffectiveness& $T2F 0$ean Time efficienc# of (roduction equi(ment 2et!een Failure& and $TT> 0$ean Time To >e(air& and reventive $aintenance com(liance metrics erformance to the maintenance obectives shall form an in(ut into mana%ement revie! 0see ISO 9**1& Section 975 ,3 re%ular revie! of maintenance (lan and obectives and a documented action (lan to address corrective actions !here obectives are not achieved5 h3 use of (reventive maintenance methods5 i3 use of (redictive maintenance methods& as a((licable5 ;3 (eriodic overhaul ;515 $A=A$=T OF >O:@3TIO= TOO?I= <-16 $ana%ement of (roduction The or%ani.ation shall (rovide toolin% and manufacturin%& test& resources for tool and %au%e desi%n& ins(ection toolin% and equi(ment fabrication and verification activities The or%ani.ation shall (rovide resources The or%ani.ation shall establish and for tool and %au%e desi%n& fabrication& and im(lement a s#stem for (roduction verification activities for (roduction and toolin% mana%ement includ in%+ service materials and for bul8 materials& as maintenance and re(air facilities and a((licable (ersonnel5 The or%ani.ation shall establish and stora%e and recover#5 im(lement a s#stem for (roduction set)u(5 toolin% mana%ement& !hether o!ned tool)chan%e (ro%rammes for (erishable b# the or%ani.ation or the customer&
includin%5 tools5 maintenance and re(air facilities and tool a3 desi%n modification documentation& (ersonnel5 includin% en%ineerin% chan%e level5 stora%e and recover#5 3 tool modification and revision to c3 set)u(5 documentation5 tool)chan%e (ro%rammes for d3 tool identification& definin% the status& (erishable tools5 such as (roduction& re(air or dis(osal tool desi%n modification e3 The or%ani.ation shall im(lement a s#stem documentation& includin% en%ineerin% to monitor these activities if an# !or8 is chan%e level of the (roduct5 outsourced f3 tool modification and revision to documentation5 =OT This requirement also a((lies to ,3 tool identification& such as serial or the availabilit# of tools for vehicle service asset number5 the status& such as (arts (roduction& re(air or dis(osal5 o!nershi(5 and location ;541 CBSTOM>,.O>D #,ODBCTIO The or%ani.ation shall verif# that TOOI customer)o!ned tools& manufacturin% C'stomr.on" too!s* man'a+t'rin* tst* equi(ment& and test/ins(ection insp+tion too!in an" )'ipmnt s(a!! $ equi(ment are (ermanentl# mar8ed in prmannt!% mar" so t(at t( onrs(ip a visible location so that the o!nershi( and a((lication of each item can be o a+( itm is visi$!* an" +an $ determined "trmin" The or%ani.ation shall im(lement a s#stem to monitor these activities if an# !or8 is outsourced ;516 >O:@3TIO= S3H:@?I= roduction shall be scheduled in order to <-1 roduction schedulin% meet customer requirements& such as The or%ani.ation shall ensure that ust) (roduction is scheduled in order to meet in)time su((orted b# an information customer orders/demands such as Lust)In) s#stem Time 0LIT and is su((orted b# an that (ermits access to (roduction information s#stem that (ermits access to information at 8e# sta%es of the (rocess (roduction information at 8e# sta%es of the and is order driven (rocess and is order driven The or%ani.ation shall include relevant (lannin% information durin% (roduction schedulin%& e%& customer orders& su((lier on)time deliver# (erformance& ca(acit#& shared loadin% 0multi)(art station& lead time& inventor# level& (reventive maintenance& and calibration
-52 Identification and traceailit $he or,ani-ation shall use suitale means to identif out/uts when it is necessar to ensure the conformit of /roducts and serices. $he or,ani-ation shall identif the status of out/uts with res/ect to monitorin, and measurement requirements throu,hout /roduction and serice /roision. $he or,ani-ation shall control the unique identification of the out/uts when traceailit is a requirement6 and shall retain the documented information necessar to enale traceailit.
I"ntii+ation an" tra+a$i!it% Bhere a//ro/riate6 the or,ani-ation shall identif the /roduct suitale means throu,hout /roduct reali-ation. $he or,ani-ation shall identif the /roduct status with res/ect to monitorin, and measurement requirements throu,hout /roduct reali-ation. Bhere traceailit is a requirement6 the or,ani-ation shall control the unique identification of the /roduct and maintain records 2see '..'3. 4O$5 In some industr sectors6 confi,uration mana,ement is a means which identification and traceailit are maintained. 7..!
$he note in reference to confi,uration mana,ement has een remoed
=OT Ins(ection and test status is not The revised requirements ex(ect the indicated b# the location of (roduct in the traceabilit# of (roduct so that (roduction flo! unless inherentl# obvious& nonconformin% (roduct can be clearl# such as material in an automated traced to allo! customer to contain (roduction transfer (rocess Alternatives nonconformin% (roduct esca(es are (ermitted if the status is clearl# -71 I:=TIFI3ATIO= A=: identified& documented& and achieves the T>A3A2I?ITC ; desi%nated (ur(ose S@?$=TA? -521 Identification and traceabilit# ; su((lemental The requirements ex(ect a stud# of The !ords JDhere a((ro(riateK in -7 shall customer and re%ulator# traceabilit# The (ur(ose of traceabilit# is to su((ort not a((l# identification of clear start and sto( (oints requirements and the definition of for (roduct received b# the customer or in a((ro(riate s#stems the field that ma# contain qualit# and/or safet#)related nonconformities Therefore& the or%ani.ation shall im(lement identification and traceabilit# (rocesses as described belo! The or%ani.ation shall conduct an anal#sis of internal& customer& and re%ulator# traceabilit# requirements for all automotive (roducts& includin% develo(in% and documentin% traceabilit# (lans& based on the levels of ris8 or failure severit# for em(lo#ees& customers& and consumers These (lans shall define the
a((ro(riate traceabilit# s#stems& (rocesses& and methods b# (roduct& (rocess& and manufacturin% location that+ a3 enable the or%ani.ation to identif# nonconformin% and/or sus(ect (roduct5 3 enable the or%ani.ation to se%re%ate nonconformin% and/or sus(ect (roduct5 c3 ensure the abilit# to meet the customer and/or re%ulator# res(onse time requirements5 d3 ensure documented information is retained in the format 0electronic& hardco(#& archive that enables the or%ani.ation to meet the res(onse time requirements5 e3 ensure seriali.ed identification of individual (roducts& if s(ecified b# the customer or re%ulator# standards5 f3 ensure the identification and traceabilit# requirements are extended to externall# (rovided (roducts !ith safet#/re%ulator# characteristics #roprt% $!onin to +'stomrs or xtrna! provi"rs $he or,ani-ation shall e)ercise care with /ro/ert elon,in, to customers or e)ternal /roiders while it is under the or,ani-ations control or ein, used the or,ani-ation. $he or,ani-ation shall identif6 erif6 /rotect and safe,uard customers or e)ternal /roiders /ro/ert /roided for use or incor/oration into the /roducts and serices. Bhen the /ro/ert of a customer or e)ternal /roider is lost6 dama,ed or otherwise found to e unsuitale for use6 the or,ani-ation shall re/ort this to the customer or e)ternal /roider and retain documented information on what has occurred. "..!
4O$5 # customers or e)ternal /roiders /ro/ert can include material6 com/onents6 tools and equi/ment6 /remises6 intellectual /ro/ert and
;54 (ustomer /ro/ert $he or,ani-ation shall e)ercise care with customer /ro/ert while it is under the or,ani-ationGs control or ein, used the or,ani-ation. $he or,ani-ation shall identif6 erif6 /rotect and safe,uard customer /ro/ert /roided for use or incor/oration into the /roduct. If an customer /ro/ert is lost6 dama,ed or otherwise found to e unsuitale for use6 the or,ani-ation shall re/ort this to the customer and maintain records 2see '..'3. (ustomer /ro/ert can include 4O$5 intellectual /ro/ert and /ersonal data.
=ote broadens the descri(tion of the a((licabilit# of customer o!ned (ro(ert#
/ersonal data.
-54 #rsrvation $he or,ani-ation shall /resere the out/uts durin, /roduction and serice /roision6 to the e)tentnecessar to ensure conformit to requirements. 4O$5 =reseration can include identification6 handlin,6 contamination control6 /ac7a,in,6 stora,e6 transmission or trans/ortation6 and /rotection.
-541 reservation ; su((lemental reservation shall include identification& handlin%& contamination control& (ac8a%in%& stora%e& transmission or trans(ortation& and (rotection reservation shall a((l# to materials and com(onents from external and/or internal (roviders from recei(t throu%h (rocessin%& includin% shi(ment and until deliver# to/acce(tance b# the customer In order to detect deterioration& the or%ani.ation shall assess at a((ro(riate (lanned intervals the condition of (roduct in stoc8& the (lace/t#(e of stora%e container& and the stora%e environment The or%ani.ation shall use an inventor# mana%ement s#stem to o(timi.e inventor# turns over time and ensure stoc8 rotation& such as 'first)in)first)out' 0FIFO The or%ani.ation shall ensure that obsolete (roduct is controlled in a manner similar to that of nonconformin% (roduct Or%ani.ations shall com(l# !ith (reservation& (ac8a%in%& shi((in%& and labelin% requirements as (rovided b# their customers
H.!.! =reseration of /roduct $he or,ani-ation shall /resere the /roduct durin, internal /rocessin, and delier to
$he e)am/les of /reseration were moed to a note.
the intended destination in order to maintain conformit to requirements. #s a//licale6 /reseration shall include identification6 handlin,6 /ac7a,in,6 stora,e and /rotection. =reseration shall also a//l to the constituent /arts of a /roduct.
--1 STO>A A=: I==TO>C The clause no! includes a definition of In order to detect deterioration& the (reservation condition of (roduct in stoc8 shall be assessed at a((ro(riate (lanned intervals The or%ani.ation shall use an inventor# mana%ement s#stem to o(timi.e inventor# turns over time and assure stoc8 rotation& such as Jfirst)in)first)outK 0FIFO Obsolete (roduct shall be controlled in a similar manner to nonconformin% (roduct
#ost."!ivr% a+tivitis $he or,ani-ation shall meet requirements for /ostdelier actiities associated with the /roducts and serices.
In ISO 9001:00* /ostdelier actiities were er riefl mentioned in Econtract reiew and E/roduction " serice /roision $his has een e)/anded to this suclause
In determinin, the e)tent of /ostdelier actiities that are required6 the or,ani-ation shall consider: a) statutor and re,ulator requirements
For most of our clients this suclause will not a//l A the /roal need to hae a discussion that will lead to e)clusion. If the do hae /ost delier actiities6 other than customer re;ected /roduct which is coered under nonconformin, /roduct and customer com/laints then the need to address this suclause
"..
b)the /otential undesired consequences associated with its /roducts and serices c) the nature6 use and intended lifetime of its /roducts and serices d)customer requirements e) customer feedac7. 4O$5 =ostdelier actiities can include actions under warrant /roisions6 contractual oli,ations such as maintenance serices6 and su//lementar serices such as r ecclin, or final dis/osal.
<--1 Feedbac8 of information from service The or%ani.ation shall ensure that a (rocess for communication of information on service concerns to manufacturin%& material handlin%& lo%istics& en%ineerin%& and desi%n activities is established& im(lemented& and maintained =OT 1 The intent of the addition of 'service concerns' to this sub)clause is to ensure that the or%ani.ation is a!are of nonconformin% (roduct0s and material0s that ma# be identified at the
;51; F:2A3Q OF I=FO>$ATIO= F>O$ S>I3 A (rocess for communication of information on service concerns to manufacturin%& en%ineerin% and desi%n activities shall be established and maintained The intent of the addition of Jservice concernsK to this subclause is to ensure that the or%ani.ation is a!are of nonconformities that occur outside of its or%ani.ation . =OT6
customer location or in the field =OT , 'Service concerns' should include the results of field failure test anal#sis 0see Section 1*,6 !here a((licable
<--, Service a%reement !ith customer ;51- S>I3 A>$=T DITH Dhen there is a service a%reement !ith the 3@STO$> customer& the or%ani.ation shall+ Dhen there is a service a%reement !ith the a3 verif# that the relevant service centres customer& the or%ani.ation shall verif# the com(l# !ith a((licable requirements5 effectiveness of 3 verif# the effectiveness of an# s(ecial an# or%ani.ation service centres& (ur(ose tools or measurement equi(ment5 an# s(ecial)(ur(ose tools or c3 ensure that all service (ersonnel are measurement equi(ment& and trained in a((licable requirements the trainin% of service (ersonnel
-/5/6
Contro! o +(ans
$he or,ani-ation shall reiew and control chan,es for /roduction or serice /roision6
#nother chan,e control suclause6 which oerla/s with chan,e requirements in clause *.1. #SR would hae e)/ected this chan,e control under ISO 9001:00*
to the e)tentnecessar to ensure continuin, conformit with requirements. $he or,ani-ation shall retain documented information descriin, the results of the reiew of chan,es6the /erson2s3 authori-in, the chan,e6 and an necessar actions arisin, from the reiew. -561 3ontrol of chan%es ; su((lemental The or%ani.ation shall have a documented (rocess to control and react to chan%es that im(act (roduct reali.ation The effects of an# chan%e& includin% those chan%es caused b# the or%ani.ation& the customer& or an# su((lier& shall be assessed The or%ani.ation shall+ c.a3 define verification
and
validation
A (roduct reali.ation chan%e (rocess that requires defined verification and validation5 (roduction trial run5 ris8 anal#sis5 records The requirements include a((lication to su((liers
activities to ensure com(liance !ith customer requirements5 c.3 validate chan%es before im(lementation5 c.c3 document the evidence of related ris8 anal#sis5 c.d3 retain records of verification and validation 3han%es& includin% those made at su((liers& should require a (roduction trial run for verification of chan%es 0such as chan%es to (art desi%n& manufacturin% location& or manufacturin% (rocess to validate the im(act of an# chan%es on the manufacturin% (rocess Dhen required b# the customer& the or%ani.ation shall+ c.e3 notif# the customer of an# (lanned (roduct reali.ation chan%es after the most recent (roduct a((roval5 obtain documented a((roval& (rior to c.f3 im(lementation of the chan%e5 c.,3 com(lete additional verification or identification requirements& such as (roduction trial run and ne! (roduct validation -5611 Tem(orar# chan%e of (rocess controls The or%ani.ation shall identif#& document& and maintain a list of the (rocess controls& includin% ins(ection& measurin%& test& and error)(roofin% devices& that includes the (rimar# (rocess control and the a((roved bac8)u( or alternate methods The or%ani.ation shall document the (rocess that mana%es the use of alternate control methods The or%ani.ation shall include in this (rocess& based on ris8 anal#sis 0such as F$A& severit#& and the internal a((rovals to be obtained (rior to (roduction im(lementation of the alternate control method
This clause requires a documented (rocess to control tem(orar# chan%es includin% the alternate control methods5 a ris8 anal#sis and customer a((rovals
2efore shi((in% (roduct that !as ins(ected or tested usin% the alternate method& if required& the or%ani.ation shall obtain a((roval from the customer0s The or%ani.ation shall maintain and (eriodicall# revie! a list of a((roved alternate (rocess control methods that are referenced in the control (lan Standard !or8 instructions shall be available for each alternate (rocess control method The or%ani.ation shall revie! the o(eration of alternate (rocess controls on a dail# basis& at a minimum& to verif# im(lementation of standard !or8 !ith the %oal to return to the standard (rocess as defined b# the control (lan as soon as (ossible xam(le methods include but are not limited to the follo!in%+ c.,.a3 dail# qualit# focused audits 0e%& la#ered (rocess audits& as a((licable5 c.,.3 dail# leadershi( meetin%s >estart verification is documented for a defined (eriod based on severit# and confirmation that all features of the error) (roofin% device or (rocess are effectivel# reinstated The or%ani.ation shall im(lement traceabilit# of all (roduct (roduced !hile an# alternate (rocess control devices or (rocesses are bein% used 0e%& verification and retention of first (iece and last (iece from ever# shift
DIs are required for the alternate control methods A dail# revie! of the alternate (rocess controls is required
>equired traceabilit# of the (roduct (roduced !hile the alternate (rocess is used
-6 ,!as o pro"'+ts an" srvi+s $he or,ani-ation shall im/lement /lanned arran,ements6 at a//ro/riate sta,es6 to erif that the /roduct and serice requirements hae een met. $he release of /roducts and serices to the customer shall not /roceed until the /lanned arran,ements hae een satisfactoril com/leted6 unless otherwise a//roed a releant authorit and6 as a//licale6 the customer. $he or,ani-ation shall retain documented information on the release of /roducts and serices. $he documented information shall include: a) eidence of conformit with the acce/tance criteria b)traceailit to the /erson2s3 authori-in, the release.
-24 Monitorin an" mas'rmnt o pro"'+t $he or,ani-ation shall monitor and measure the characteristics of the /roduct to erif that /roduct requirements hae een met. $his shall e carried out at a//ro/riate sta,es of the /roduct reali-ation /rocess in accordance with the /lanned arran,ements 2see H.13. 5idence of conformit with the acce/tance criteria shall e maintained. Records shall indicate the /erson2s3 authori-in, release of /roduct for delier to the customer 2see '..'3.
$he release of /roduct and delier of serice to the customer shall not /roceed until the /lanned arran,ements 2see H.13 hae een satisfactoril com/leted6 unless otherwise a//roed a releant authorit and6 where a//licale6 the -61 >elease of (roducts and services ; customer. su((lemental The or%ani.ation shall ensure that the (lanned arran%ements to verif# that the (roduct and service requirements have been met encom(ass the control (lan and are documented as s(ecified in the control (lan 0see Annex A The or%ani.ation shall ensure that the (lanned arran%ements for initial release of (roducts and services encom(ass (roduct or service a((roval The or%ani.ation shall ensure that (roduct or service a((roval is accom(lished after chan%es follo!in% initial release&
>elease of (roducts no! s(ecificall# tied to the control (lan Dhen selectin% (roduct =OT6 (arameters to monitor com(liance to s(ecified internal and external requirements& the or%ani.ation determines the t#(es of (roduct characteristics& leadin% to the t#(es of measurement& suitable measurement means& and the ca(abilit# and s8ills required
accordin% to ISO 9**1& Section <-6
-62 ?a#out testin%
ins(ection
and
functional -241 ?ACO@T I=S3TIO= A=: F@=3TIO=A? TSTI= A la#out ins(ection and a functional =o chan%es to the la#out A la#out ins(ection and a functional verification to a((licable customer ins(ection/functional testin% verification to a((licable customer en%ineerin% material and (erformance en%ineerin% material and (erformance standards shall be (erformed for each standards shall be (erformed for each (roduct as s(ecified in the control (lans (roduct as s(ecified in the control (lans >esults shall be available for customer >esults shall be available for customer revie! revie! =OT 1 ?a#out ins(ection is the com(lete measurement of all (roduct dimensions sho!n on the desi%n record0s
=OT ?a#out ins(ection is the com(lete measurement of all (roduct dimensions sho!n on the desi%n records
=OT , The frequenc# of la#out ins(ection is determined b# the customer
-242 AA>A=3 IT$S For or%ani.ations manufacturin% (arts =o chan%es to the a((earance items For or%ani.ations manufacturin% (arts desi%nated b# the customer as clause desi%nated b# the customer as Ja((earance itemsK& the or%ani.ation 'a((earance items&' the or%ani.ation shall shall (rovide (rovide the follo!in%+ a((ro(riate resources& includin% a3 a((ro(riate resources& includin% li%htin%& for evaluation& li%htin%& for evaluation5 masters for colour& %rain& %loss& metallic 3 masters for colour& %rain& %loss& metallic brilliance& texture& brilliance& texture& distinctness of ima%e distinctness of ima%e 0:OI& and 0:OI& as a((ro(riate& ha(tic technolo%#& as a((ro(riate5 maintenance and control of a((earance c3 maintenance and control of masters and evaluation equi(ment& and a((earance masters and evaluation verification that (ersonnel ma8in% equi(ment5 a((earance evaluations are com(etent verification that (ersonnel ma8in% d3 and qualified to do so a((earance evaluations are com(etent and -68 A((earance items
qualified to do so
H.'.8.1 ICOMI #,ODBCT COFO,MIT -64 erification and acce(tance of TO ,>7BI,>M>TS =o chan%es to the verification of externall# conformit# of externall# (rovided (roducts The or%ani.ation shall have a (rocess to (rovided (roducts and services clause and services assure the qualit# of (urchased (roduct
The or%ani.ation shall have a (rocess to 0see 47 utili.in% one or more of the ensure the qualit# of externall# (rovided follo!in% methods+ (rocesses& (roducts& and services utili.in% recei(t of& and evaluation of& statistical one or more of the follo!in% methods+ data b# the or%ani.ation5 a3 recei(t and evaluation of statistical receivin% ins(ection and/or testin%& data (rovided b# the su((lier to the such as sam(lin% based on or%ani.ation5 (erformance5 3 receivin% ins(ection and/or testin%& second) or third)(art# assessments such as sam(lin% based on (erformance5 or audits of su((lier sites& !hen c3 second)(art# or third)(art# cou(led !ith records of acce(table assessments or audits of su((lier delivered (roduct conformit# to sites !hen cou(led !ith records of requirements5 acce(table delivered (roduct (art evaluation b# a desi%nated conformance to requirements5 laborator#5 d3 (art evaluation b# a desi%nated another method a%reed !ith the laborator#5 customer e3 another method a%reed !ith the customer -65 Statutor# and re%ulator# conformit# rior to release of externall# (rovided (roducts into its (roduction flo!& the or%ani.ation shall confirm and be able to (rovide evidence that externall# (rovided (rocesses& (roducts& and services conform to the latest a((licable statutor#& re%ulator#& and other requirements in the countries !here the# are manufactured and in the customer)identified countries of destination& if (rovided -66 Acce(tance criteria Acce(tance criteria shall be defined b# the or%ani.ation and& !here a((ro(riate or required& a((roved b# the customer For attribute data sam(lin%& the acce(tance level shall be .ero defects 0see Section 9111
This is a ne! clause to verif# re%ulator# conformit# of externall# (rovided (roducts !ith evidence
H.1. A33TA=3 3>IT>IA Acce(tance criteria shall be defined b# the or%ani.ation and& !here required& a((roved b# the customer For attribute data sam(lin%& the acce(tance level shall be .ero defects 0see <,71
=o chan%e to the acce(tance criteria clause
-; Contro! o non+onormin o'tp'ts *.H.1 $he or,ani-ation shall ensure that out/uts that do not conform to their requirements are identified and controlled to /reent their unintended use or delier.
$he or,ani-ation shall ta7e a//ro/riate action ased on the nature of the nonconformit and its effect on the conformit of /roducts and serices. $his shall also a//l to nonconformin, /roducts and serices detected after delier of /roducts6 durin, or after the /roision of serices. $he or,ani-ation shall deal with nonconformin, out/uts in one or more of the followin, was:
a3correction b)se,re,ation6 containment6 return or sus/ension of /roision of /roducts and serices
Bhere a//licale6 the or,ani-ation shall deal with nonconformin, /roduct one or more of the followin, was: ta7in, action to eliminate the detected nonconformit a)
authori-in, its use6 release or acce/tance under concession a releant authorit and6 where a//licale6 the customer b)
ta7in, action to /reclude its ori,inal intended use or a//lication c)
c) informin, the customer d)otainin, authori-ation for acce/tance under concession. (onformit to the requirements shall e erified when nonconformin, out/uts are corrected.
<11 3ustomer author i.ation concession The or%ani.ation shall obtain a customer concession or deviation (ermit (rior to further (rocessin% !henever the (roduct or manufacturin% (rocess is different from that !hich is currentl# a((roved
-8 Contro! o non+onormin pro"'+t $he or,ani-ation shall ensure that /roduct which does not conform to /roduct requirements is identified and controlled to /reent its unintended use or delier. # documented /rocedure shall e estalished to define the controls and related res/onsiilities and authorities for dealin, with nonconformin, /roduct.
ta7in, action a//ro/riate to the effects6 or /otential effects6 of the nonconformit when nonconformin, /roduct is detected after delier or use has started. d)
Bhen nonconformin, /roduct is corrected for it shall e su;ect to reerification to demonstrate conformit to the requirements. Records of the nature of nonconformities and an susequent actions ta7en6 includin, concessions otained6 shall e
#SR inter/retation A correction includes not onl correctin, the nonconformin, /roduct ut also includes re,radin, or a//roin, the /roduct for an alternate use
Informin, the customer 2ullet c3 a//lies to nonconformin, /roduct that has alread shi//ed
The or%ani.ation shall obtain customer authori.ation (rior to further (rocessin% for 'use as is' and re!or8 dis(ositions of nonconformin% (roduct If sub) com(onents are reused in the manufacturin% (rocess& that sub) com(onent reuse shall be clearl# communicated to the customer in the concession or deviation (ermit The or%ani.ation shall maintain a record of the ex(iration date or quantit# authori.ed under concession The or%ani.ation shall also ensure com(liance !ith the ori%inal or su(ersedin% s(ecifications and requirements !hen the authori.ation ex(ires $aterial shi((ed under concession shall be (ro(erl# identified on each shi((in% container 0this a((lies equall# to (urchased (roduct The or%ani.ation shall a((rove an# requests from su((liers before submission to the customer
maintained 2see '..'3.
-81 COT,O OF OCOFO,MI #,ODBCT SB##>M>TA roduct !ith unidentified or sus(ect status shall be classified as nonconformin% (roduct 0see -7 -82 COT,O OF ,>O,>D #,ODBCT Instructions for re!or8& includin% re) ins(ection requirements& shall be accessible to and utili.ed b# the a((ro(riate (ersonnel -88 CBSTOM>, IFO,MATIO 3ustomers shall be informed (rom(tl# in the event that nonconformin% (roduct has been shi((ed
<1, 3ontrol of nonconformin% (roduct ; -84 CBSTOM>, AI@>, The or%ani.ation shall obtain a customer customer)s(ecified (rocess The or%ani.ation shall com(l# !ith concession or deviation (ermit (rior to a((licable customer)s(ecified controls for further (rocessin% !henever the (roduct nonconformin% (roduct0s or manufacturin% (rocess is different from that !hich is currentl# a((roved The or%ani.ation shall maintain a record of <17 3ontrol of sus(ect (roduct the ex(iration date or quantit# authori.ed The or%ani.ation shall ensure that (roduct The or%ani.ation shall also ensure !ith unidentified or sus(ect status is com(liance !ith the ori%inal or classified and controlled as su(ersedin% nonconformin% (roduct The or%ani.ation s(ecifications and requirements !hen the shall ensure that all a((ro(riate authori.ation ex(ires $aterial shi((ed on manufacturin% (ersonnel receive trainin% an authori.ation shall be (ro(erl# for containment of sus(ect and identified nonconformin% (roduct on each shi((in% container This a((lies equall# to (urchased (roduct The or%ani.ation shall a((rove an# <14 3ontrol of re!or8ed (roduct
The or%ani.ation shall utili.e ris8 anal#sis 0such as F$A methodolo%# to assess ris8s in the re!or8 (rocess (rior to a decision to re!or8 the (roduct If required b# the customer& the or%ani.ation shall obtain a((roval from the customer (rior to commencin% re!or8 of the (roduct
requests from su((liers before submission to the customer
=e! requirement to use ris8 anal#sis 0F$A to assess ris8s in the re!or8 (rocess
The or%ani.ation shall have a documented (rocess for re!or8 confirmation in accordance !ith the control (lan or other relevant documented information to verif# com(liance to ori%inal s(ecifications Instructions for disassembl# or re!or8& includin% re)ins(ection and traceabilit# requirements& shall be accessible to and utili.ed b# the a((ro(riate (ersonnel The or%ani.ation shall retain documented information on the dis(osition of re!or8ed (roduct includin% quantit#& dis(osition& dis(osition date& and a((licable traceabilit# information <1- 3ontrol of re(aired (roduct The or%ani.ation shall utili.e ris8 anal#sis 0such as F$A methodolo%# to assess ris8s in the re(air (rocess (rior to a decision to re(air the (roduct The or%ani.ation shall obtain a((roval from the customer before commencin% re(air of the (roduct The or%ani.ation shall have a documented (rocess for re(air confirmation in accordance !ith the control (lan or other relevant documented information Instructions for disassembl# or re(air& includin% re)ins(ection and traceabilit# requirements& shall be accessible to and utili.ed b# the a((ro(riate
=e! clause on re(air of (roduct >e!or8 is defined 0ISO 9*** definition as action to ensure the (roduct meets requirements >e(air is defined 0ISO 9*** definition as action to ensure the (roduct meets intended use
:ocumented re(air (rocess and re(air instructions :ocumented customer authori.ation for concession
(ersonnel The or%ani.ation shall obtain a documented customer authori.ation for concession for the (roduct to be re(aired The or%ani.ation shall retain documented information on the dis(osition of re(aired (roduct includin% quantit#& dis(osition& dis(osition date& and a((licable traceabilit# information
<16 3ustomer notification The or%ani.ation shall immediatel# notif# the customer0s in the event that nonconformin% (roduct has been shi((ed Initial communication shall be follo!ed !ith detailed documentation of the event
<1 =onconformin% (roduct dis(osition The or%ani.ation shall have a documented (rocess for dis(osition of nonconformin% (roduct not subect to re!or8 or re(air For (roduct not meetin% requirements& the or%ani.ation shall verif# that the (roduct to be scra((ed is rendered unusable (rior to dis(osal The or%ani.ation shall not divert nonconformin% (roduct to service or other use !ithout (rior customer a((roval *.H.
$he or,ani-ation shall documented information that: a) descries the nonconformit
retain
b)descries the actions ta7en c) descries an concessions otained d)identifies the authorit decidin, the action
=e! requirements to render scra( unusable and controls on divertin% nonconformin% (roduct to other uses
in res/ect of the nonconformit.
9 #rorman+ va!'ation 9.1 ?onitorin,6 measurement6 analsis and ealuation 9.1.1 eneral $he or,ani-ation shall determine: what needs to e a) and measured monitored
b)
c)
- Mas'rmnt* ana!%sis an" improvmnt -1 nra!
$he or,ani-ation shall /lan and im/lement the monitorin,6 measurement6 analsis and im/roement /rocesses needed to demonstrate conformit to /roduct the methods for monitorin,6 measurement6 requirements6 analsis and ealuation needed to ensure b) to ensure conformit of the qualit mana,ement alid results sstem6 and to continuall im/roe the effectieness of the when the monitorin, and measurin, shall qualit mana,ement sstem. e /erformed $his shall include determination of a//licale d) when the results from methods6 includin, statistical techniques6 and monitorin, and measurement the e)tent of their use. shall e analsed and ealuated.
$he or,ani-ation shall ealuate the /erformance and the effectieness of the qualit mana,ement sstem. $he or,ani-ation shall retain a//ro/riate documented information as eidence of the
-28 Monitorin an" mas'rmnt o pro+sss $he or,ani-ation shall a//l suitale methods for monitorin, and6 where a//licale6 measurement of the qualit mana,ement sstem /rocesses. $hese methods shall demonstrate the ailit of the /rocesses to achiee /lanned results. Bhen /lanned results are not achieed6 correction and correctie action shall e ta7en6 as a//ro/riate. 4O$5 Bhen determinin, suitale methods6 it is adisale that the or,ani-ation consider the t/e and e)tent of monitorin, or measurement a//ro/riate to each of its /rocesses in relation to their im/act on the conformit to /roduct requirements and on the effectieness of the qualit mana,ement sstem. 9111 $onitorin% and measurement manufacturin% (rocesses The or%ani.ation shall (erform (rocess studies on all ne! manufacturin% 0includin% assembl# or sequencin% (rocesses to verif# (rocess ca(abilit# and to (rovide additional in(ut for (rocess control& includin% those for s(ecial characteristics =OT For some manufacturin% (rocesses& it ma# not be (ossible to demonstrate (roduct com(liance throu%h (rocess ca(abilit# For those (rocesses& alternate methods such as batch conformance to s(ecification ma# be used The or%ani.ation shall maintain manufacturin% (rocess ca(abilit# or (erformance results as s(ecified b# the customerEs (art a((roval (rocess
of -281 $O=ITO>I= A=: $AS@>$=T OF $A=@FA3T@>I= >O3SSS The or%ani.ation shall (erform (rocess studies on all ne! manufacturin% 0includin% assembl# or sequencin% (rocesses to verif# (rocess ca(abilit# and to (rovide additional in(ut for (rocess control The results of (rocess studies shall be documented !ith s(ecifications& !here a((licable& for means of (roduction& measurement and test& and maintenance instruction s These documents shall include obectives for manufacturin% (rocess ca(abilit#& reliabilit#& maintainabilit# and availabilit#& as !ell as acce(tance criteria
requirements The or%ani.ation shall The or%ani.ation shall maintain verif# that the (rocess flo! dia%ram& manufacturin% F$A& and control (lan are (rocess ca(abilit# or (erformance as im(lemented& includin% adherence to the s(ecified follo!in%+ b# the customer (art a((roval (rocess a3 measurement techniques5 requirements The or%ani.ation shall 3 sam(lin% (lans5 ensure acce(tance criteria5 c3 that the control (lan and (rocess flo! d3 records of actual measurement are im(lemented& includin% values and/or test results for variable dia%ram adherence data5 (lans and escalation to the s(ecified e3 reaction (rocess !hen acce(tance criteria are not measurement techniques& met sam(lin% (lans& Si%nificant (rocess events& such as acce(tance criteria& and tool chan%e or machine re(air& shall be reaction (lans !hen acce(tance criteria recorded and retained as documented are not met information Si%nificant (rocess events& such as tool chan%e or The or%ani.ation shall initiate a reaction machine re(air& shall be recorded (lan indicated on the control (lan and evaluated for im(act on com(liance to The or%ani.ation shall initiate a reaction s(ecifications for characteristics that are (lan from the control (lan for either not statisticall# ca(able or are characteristics that are either not unstable These reaction (lans shall include containment of (roduct and 1** statisticall# ca(able or are unstable (ercent ins(ection& as a((ro(riate A These reaction (lans shall include corrective action (lan shall be develo(ed containment of (roduct and 1** and im(lemented b# the or%ani.ation ins(ection& as a((ro(riate A corrective indicatin% s(ecific actions& timin%& and action (lan shall then be com(leted b# assi%ned res(onsibilities to ensure that the (rocess becomes stable and the or%ani.ation& indicatin% s(ecifi c statisticall# ca(able The (lans shall be timin% and assi%ned res(onsibilities to revie!ed !ith and a((roved b# the assure that the (rocess becomes stable customer& !hen required and ca(able The (lans shall be revie!ed The or%ani.ation shall maintain records of !ith and a((roved b# the customer !hen effective dates of (rocess chan%es so required The or%ani.ation shall maintain records of effective dates of (rocess chan%es
9112 Identification of statistical tools The or%ani.ation shall determine the a((ro(riate use of statistical tools The or%ani.ation shall verif# that a((ro(riate statistical tools are included as (art of the advanced (roduct qualit# (lannin% 0or equivalent (rocess and included in the desi%n ris8 anal#sis 0such as :F$A 0!here a((licable& the (rocess ris8 anal#sis 0such as F$A& and the control (lan
9118 A((lication of statistical conce(ts Statistical conce(ts& such as variation& control 0stabilit#& (rocess ca(abilit#& and the consequences of over) adustment& shall be understood and used b# em(lo#ees involved in the collection& anal#sis& and mana%ement of statistical data
-11 I:=TIFI3ATIO= OF STATISTI3A? TOO?S A((ro(riate statistical tools for each (rocess shall be determined durin% advance qualit# (lannin% and included in the control (lan
-12 Q=OD?: OF 2ASI3 STATISTI3A? 3O=3TS 2asic statistical conce(ts& such as variation& control 0stabilit#& (rocess ca(abilit# and over)adustment shall be understood and utili.ed throu%hout the or%ani.ation
-/2/1
C'stomr satisa+tion
$he or,ani-ation shall monitor customers /erce/tions of the de,ree to which their needs and e)/ectations hae een fulfilled. $he or,ani-ation shall determine the methods for otainin,6 monitorin, and reiewin, this information.
#s one of the measurements of the /erformance of the qualit mana,ement sstem6 the or,ani-ation shall monitor information relatin, to customer /erce/tion as to whether the or,ani-ation has met customer requirements. $he methods for otainin, and usin, this information shall e determined.
4O$5 5)am/les of monitorin, customer /erce/tions can include customer sures6 customer feedac7 ondeliered /roducts and serices6 meetin,s with customers6 mar7et share analsis6 com/liments6 warrant claims
4O$5 ?onitorin, customer /erce/tion can include otainin, in/ut from sources such as customer satisfaction sures6 customer data
$.1.2
(ustomer satisfaction
The use of statistical tools is no! tied to the ris8 anal#sis and F$As
and dealer re/orts.
on deliered /roduct qualit6 user o/inion sures6 lost usiness analsis6 com/liments6 warrant claims and dealer re/orts.
3onsideration should be %iven to =OT6 both internal and external customers -211
CBSTOM>, SATISFACTIO SB##>M>TA 9121 3ustomer satisfaction ; 3ustomer satisfaction !ith the or%ani.ation su((lemental shall be monitored throu%h continual 3ustomer satisfaction !ith the evaluation of (erformance of the or%ani.ation shall be monitored throu%h reali.ation (rocesses erformance continual evaluation of internal and indicators shall be based on obective external (erformance indicators to ensure data and include& but not be limited to+ com(liance to the (roduct and (rocess delivered (art qualit# (erformance& s(ecifications and other customer requirements customer disru(tions& includin% field returns& erformance indicators shall be based deliver# schedule (erformance on obective evidence and include but 0includin% incidents of (remium frei%ht& not be limited to the follo!in%+ and e.a3 delivered (art qualit# (erformance5 customer notifications related to qualit# e.3 customer disru(tions5 e.c3 field returns& recalls& and !arrant# or deliver# issues 0!here a((licable5 The or%ani.ation shall monitor the e.d3 deliver# schedule (erformance (erformance of manufacturin% (rocesses 0includin% incidents of (remium frei%ht5 to demonstrate com(liance !ith e.e3 customer notifications related to customer requirements for (roduct qualit# or deliver# issues& includin% qualit# and efficienc# of the (rocess s(ecial status 3ustomer satisfaction no! includes a The or%ani.ation shall monitor the s(ecific reference to online customer (erformance of manufacturin% (rocesses to scorecards and customer (ortals demonstrate com(liance !ith customer requirements for (roduct qualit# and (rocess *.' Ana!%sis o "ata efficienc# The monitorin% shall include the revie! of customer (erformance data $he or,ani-ation shall determine6 collect includin% online customer (ortals and and analse a//ro/riate data to customer scorecards& !here (rovided demonstrate the suitailit and effectieness of the qualit mana,ement sstem and to ealuate where continual $.1.! #nalsis and ealuation of data im/roement of the eff ectieness of the
$he or,ani-ation shall analse and ealuate a//ro/riate data and information arisin, from monitorin, and measurement. $he results of analsis shall e used to ealuate:
a) conformit of /roducts and serices b)the de,ree of customer satisfaction
qualit mana,ement sstem can e made. $his shall include data ,enerated as a result of monitorin, and measurement and from other releant sources.
$he analsis of data shall /roide information relatin, to a) customer satisfaction 2see *..136
c) the /erformance and effectieness of the qualit mana,ement sstem
b)conformit to /roduct requirements 2see
d)if /lannin, has een im/lemented effectiel
c) characteristics and trends of
e) the effectieness of actions ta7en to address ris7s and o//ortunities f) the /erformance of e)ternal /roiders
*..'36
/rocesses and /roducts6 includin, o//ortunities for /reentie action 2see *..8 and *..'36 and su//liers 2see H.'3.
g) the need for im/roements to the qualit mana,ement sstem. ?ethods to analse data can 4O$5 include statistical techniques.
9181 rioriti.ation Trends in qualit# and o(erational (erformance shall be com(ared !ith (ro%ress to!ard obectives and lead to action to su((ort (rioriti.ation of actions for im(rovin% customer satisfaction
-41 AASIS AD BS> OF DATA Trends in qualit# and o(erational (erformance shall be com(ared !ith (ro%ress to!ard obectives and lead to action to su((ort the follo!in%+ develo(ment of (riorities for (rom(t solutions to customer)related (roblems5 determination of 8e# customer) related trends and correlation for status revie!& decision)ma8in% and lon%er term (lannin%5 an information s#stem for the timel# re(ortin% of (roduct information arisin% from usa%e :ata should be com(ared !ith those of com(etito rs and/or a((ro (riate benchmar8s =OT6
9.2 Internal #udit 9.2.1
$he or,ani-ation shall conduct internal audits at /lanned interals to /roide information on whether the qualit mana,ement sstem: a) conforms to:
1)
the or,ani-ations own requirements for its qualit mana,ement sstem
2)
the requirements of this International Standard 3 is effectiel im/lemented and maintained.
$he or,ani-ation shall: 9.2.2 a) /lan6 estalish6 im/lement and maintain an audit /ro,ramme2s3 includin, the frequenc6 methods6 res/onsiilities6 /lannin, requirements and re/ortin,6 which shall ta7e into consideration the im/ortance of the /rocesses concerned6 chan,es affectin, the or,ani-ation6 and
*.. Internal audit $he or,ani-ation shall conduct internal audits at /lanned interals to determine whether the qualit mana,e ment sstem a)
conforms to the /lanned arran,ements 2see H.136 to the requirements of this International Standard and to the qualit mana,ement sstem requirements estalished the or,ani-ation6 and
b) is effectiel im/lemented and
maintained. #n audit /ro,ramme shall e /lanned6 ta7in, into consideration the status and im/ortance of the /rocesses and areas to e audited6 as well as the results of /reious audits. $he audit criteria6 sco/e6 frequenc and methods shall e defined. $he selection of auditors and conduct of audits shall ensure o;ectiit and im/artialit of the audit /rocess. #uditors shall not audit their own wor7.
# documented /rocedure shall e
# /rocedure is no lon,er required6 ut ou do need to hae documented eidence of the im/lementation of the internal audit /ro,ramme 2for e)am/le: schedule audit sco/es6 audit criteria6 chec7lists3 and of the audit results
the results of /reious audits b)define the audit criteria and sco/e for each audit
c) select auditors and conduct audits to ensure o;ectiit and the im/artialit of the audit /rocess d)ensure that the results of the audits are re/orted to releant mana,ement e) ta7e a//ro/riate correction and correctie actions without undue dela f) retain documented information as eidence of the im/lementation of the audit /ro,ramme and the audit results. 4O$5
See ISO 19011 for ,uidance.
estalished to define the res/onsiilities and requirements for /lannin, and conductin, audits6 estalishin, records and re/ortin, results.
Records of the audits and their results shall e maintained 2see '..'3. $he mana,ement res/onsile for the area ein, audited shall ensure that an necessar corrections and correctie actions are ta7en without undue dela to eliminate detected nonconformities and their causes. Followu/ actiities shall include the erification of the actions ta7en and the re/ortin, of erification results 2see *.!.3.
9221 Internal audit (ro%ramme 4O$5 See ISO 19011 for ,uidance. The or%ani.ation shall have a documented internal audit (rocess The (rocess shall include the develo(ment and im(lementation of an internal audit (ro%ramme that covers -221 "@A?ITC $A=A$=T SCST$ A@:IT the entire qualit# mana%ement s#stem The or%ani.ation shall audit its qualit# includin% qualit# mana%ement s#stem audits& mana%ement s#stem to verif# manufacturin% (rocess audits& and (roduct com(liance !ith this Technical audits S(ecification and an# additional qualit# The audit (ro%ramme shall be (rioriti.ed based u(on ris8& internal and external (erformance trends& and criticalit# of the (rocess0es Dhere the or%ani.ation is res(onsible for soft!are develo(ment& the or%ani.ation shall include soft!are develo(ment ca(abilit# assessments in their internal audit (ro%ramme
mana%ement s#stem requirements
IATF requires a documented (rocess
Formall# requires basin% the (ro%ramme on (riorities from ris8 anal#sis
Includes soft!are develo(ment if -222 $A=@FA3T@>I= >O3SS A@:IT or%ani.ation is res(onsible for soft!are develo(ment The or%ani.ation shall audit each manufacturin% (rocess to determine its effectiveness
-228 >O:@3T A@:IT The or%ani.ation shall audit (roducts at
The frequenc# of audits shall be revie!ed and& !here a((ro(riate& adusted based on occurrence of (rocess chan%es& internal and external nonconformities& and/or customer com(laints The effectiveness of the audit (ro%ramme shall be revie!ed as a (art of mana%ement revie! 9,,, "ualit# mana%ement s#stem audit The or%ani.ation shall audit all qualit# mana%ement s#stem (rocesses over each three)#ear calendar (eriod& accordin% to an annual (ro%ramme& usin% the (rocess a((roach to verif# com(liance !ith this Automotive "$S Standard Inte%rated !ith these audits& the or%ani.ation shall sam(le customer)s(ecific qualit# mana%ement s#stem requirements for effective im(lementation 9,,7 $anufacturin% (rocess audit The or%ani.ation shall audit all manufacturin% (rocesses over each three)#ear calendar (eriod to determine their effectiveness and efficienc# usin% customer)s(ecific required a((roaches for (rocess audits Dhere not defined b# the customer& the or%ani.ation shall determine the a((roach to be used
a((ro(riate sta%es of (roduction and deliver# to verif# conformit# to all s(ecified requirements& such as (roduct dimensions& functionalit #& (ac8a%in% an d labellin%& at "$S audits s(ecifies an annual (r%ramme a and so that all "$S (rocesses are audited defined frequenc# over a three #ear calendar (eriod Also requires sam(lin% of customer s(ecific -224 I=T>=A? A@:IT ?A=S "$S requirements for effectiveness Internal audits shall cover all qualit# mana%ement related (rocesses& activities and shifts& and shall be scheduled accordin% to an annual (lan Dhen internal/external nonconformities or customer com(laints occur& the audit $anufacturin% (rocess audits B audit all of frequenc# shall be a((ro(riatel# them over the three #ear (eriod5 determine increased effectiveness and efficienc# usin% =OT S(ecific chec8lists should be used customer s(ecified a((roaches for each audit Include audit of the (rocess ris8 anal#sis F$A and 3ontrol lan -225 I=T>=A? A@:ITO> "@A?IFI3ATIO= The or%ani.ation shall have internal auditors !ho are qualified to audit the requirements of this Technical S(ecificatio n0 see 6,,,
Dithin each individual audit (lan& each manufacturin% (rocess shall be audited on all shifts !here it occurs& includin% the a((ro(riate sam(lin% of the shift handover The manufacturin% (rocess audit shall include an audit of the effective im(lementation of the (rocess ris8 anal#sis 0such as F$A& control (lan& and associated documents 9,,4 roduct audit The or%ani.ation shall audit (roducts usin% customer)s(ecific required
roduct audits usin% customer s(ecific a((roaches
a((roaches at a((ro(riate sta%es of (roduction and deliver# to verif# conformit# to s(ecified requirements Dhere not defined b# the customer& the or%ani.ation shall define the a((roach to be used
9.3 ?ana,ement reiew
?ana,ement reiew 981 eneral $o/ mana,ement shall reiew the 561 nra! or,ani-ations qualit mana,ement sstem6 $o/ mana,ement shall reiew the at /lanned interals6 to ensure its continuin, or,ani-ationGs qualit mana,ement sstem6 at suitailit6 adequac6 effectieness and /lanned interals6 to ensure its continuin, ali,nment with the strate,ic direction of the suitailit6 adequac and effectieness. $his or,ani-ation. reiew shall include assessin, o//ortunities 9811 $ana%ement revie! ; su((lemental for im/roement and the need for chan,es to $ana%ement revie! shall be conducted the qualit mana,ement sstem6 includin, the at least annuall# The frequenc# of qualit /olic and qualit o;ecties. mana%ement revie!0s shall be increased based on ris8 to com(liance !ith Records from mana,ement reiews shall e customer requirements resultin% from maintained 2see '..'3. internal or external chan%es im(actin% the qualit# mana%ement s#stem and (erformance)related issues $.!.2 ?ana,ement Reiew In/uts 5611 "@A?ITC $A=A$=T SCST$ $he mana,ement reiew shall e /lanned and >FO>$A=3 carried out ta7in, into consideration: These revie!s shall include all a) the status of actions from /reious requirements of the qualit# mana%ement s#stem and its (erformance trends as an
?ana,ement reiew now needs to ali,n with the strate,ic direction of the or,ani-ation
?ana,ement reiew in/uts now include su//lier /erformance effectieness of actions to address ris7s adequac of resources chan,es in internal and e)ternal issues
Annual mana%ement revie!s required !ith frequenc# increased based on ris8 to com(liance to customer requirements resultin% from chan%es and (erformance issues
mana,ement reiews
b)chan,es in e)ternal and internal issues that are releant to the qualit mana,ement sstem c) information on the /erformance and effectieness of the qualit mana,ement sstem6 includin, trends in: 1)
customer satisfaction and feedac7 from releant interested /arties
2)
the e)tent to which qualit o;ecties hae een met
3)
/rocess /erformance and conformit of /roducts and serices
4)
nonconformities and correctie actions
5)
monitorin, and measurement results
")
audit results
7)
the /erformance of e)ternal /roiders
d)the adequac of resources e) the effectieness of actions ta7en to address ris7s and o//ortunities 2see %.13 f) o//ortunities for im/roement.
essential (art of the continual im(rovement (rocess art of the mana%ement revie! shall be the monitorin% of qualit# obectives& and the re%ular re(ortin% and evaluation of the cost of (oor qualit# 0see <41 and <-1 These results shall be recorded to (rovide& as a minimum& evidence of the achievement of the qualit# obectives s(ecified in the business (lan& and customer satisfaction !ith (roduct su((lied
,vi inp't .#.2 $he in/ut to mana,ement reiew shall include information on a) results of audits6 b) customer feedac76 c) /rocess
/erformance conformit6
and
/roduct
d) status of /reentie and correctie actions6 e) followIu/
actions from mana,ement reiews6
/reious
f) chan,es that could affect the qualit
mana,ement sstem6 and 9821 $ana%ement revie! in(uts ; g) recommendations for im/roement. su((lemental In(ut to mana%ement revie! shall include+ !.%..1 >ID I=@T ; S@?$=TA? There is no! a list of additional a3 cost of (oor qualit# 0cost of internal In(ut to mana%ement revie! shall include an mana%ement revie! in(uts and external nonconformance5 anal#sis of actual and (otential field)failures 3 measures of (rocess effectiveness5 and their im(act on qualit#& safet# or the c3 measures of (rocess efficienc#5 environment d3 (roduct conformance5 e3 assessments of manufacturin% feasibilit# made for chan%es to existin% o(erations and for ne! facilities or ne! (roduct 0see Section 1715 f3 customer satisfaction 0see ISO 9**1& Section 91,5 ,3 revie! of (erformance a%ainst maintenance obectives5 h3 !arrant# (erformance 0!here a((licable5 i3 revie! of customer scorecards 0!here a((licable5 identification of (otential field failures identified throu%h ris8 anal#sis 0such as F$A5 8 actual field failures and their im(act on safet# or the environment 9.8.8 ?ana,ement Reiew Out/uts $he out/uts of the mana,ement reiew shall ,vi o'tp't $he out/ut from the mana,ement reiew shall include decisions and actions related to: include an decisions and actions related to a) o//ortunities for im/roement ".3.a) im/roement of the b)an need for chan,es to the qualit effectieness of the qualit mana,ement sstem and its
mana,ement sstem
c) resource needs. $he or,ani-ation shall retain documented information as eidence of the results of mana,ement reiews.
/rocesses6 im/roement of /roduct related customer requirements6 and
".3.b)
".3.c)
resource needs. An action (lan is required as a mana%ement revie! out(ut !hen customer (erformance tar%ets are not met
9771 $ana%ement revie! out(uts ; su((lemental To( mana%ement shall document and im(lement an action (lan !hen customer (erformance tar%ets are not met 10 Im/roement 10.1 eneral
* Im/roement *.!.1 (ontinual im/roement
$he or,ani-ation shall determine and select o//ortunities for im/roement and im/lement an necessar actions to meet customer requirements and enhance customer satisfaction.
$he or,ani-ation shall continuall im/roe the effectieness of the qualit mana,ement sstem throu,h the use of the qualit /olic6 qualit o;ecties6 audit results6 analsis of data6 correctie and /reentie actions and mana,ement reiew.
$hese shall include: a) im/roin, /roducts and serices to meet requirements as well as to address future needs and e)/ectations -511
b)correctin,6 /reentin, or reducin, undesired effects c) im/roin, the /erformance and effectieness of the qua lit mana,ement sstem. 4O$5 5)am/les of im/roement can include correction6 correctie action6 continual im/roement6 rea7throu,h chan,e6 innoation and re or,ani-ation.
to
3O=TI=@A? I$>O$=T OF TH O>A=IPATIO= The or%ani.ation shall define a (rocess for continual im(rovement
4ow need to select s/ecific o//ortunities for im/roement and ta7e actions
10. 4onconformit and correctie action 1021 Bhen a nonconformit occurs6 includin, an arisin, from com/laints6 the or,ani-ation shall:
a) react to the nonconformit and6 as a//licale: 1)
ta7e action to control and correct it
2)
deal with the consequences
b)ealuate the need for action to eliminate the cause2s3 of the nonconformit6 in order that it does not recur or occur elsewhere6 :
-52 Corr+tiv a+tion $he or,ani-ation shall ta7e action to eliminate the causes of nonconformities in order to /reent recurrence. (orrectie actions shall e a//ro/riate to the effects of the nonconformities encountered.
# documented /rocedure shall e estalished to define requirements for a)
reiewin, nonconformities customer com/laints36
reiewin, and anal-in, the nonconformit
b) determinin, the causes of
2)
determinin, the causes of the nonconformit
c)
3)
determinin, if similar nonconformities e)ist6 or could /otentiall occur
d) determinin,and
1)
c) im/lement an action needed d)reiew the effectieness of an correctie action ta7en e) u/date ris7s and o//ortunities determined durin, f) /lannin,6 if necessar g) ma7e chan,es to the qualit mana,ement sstem6 if necessar .
2includin,
nonconformities6 ealuatin, the need for action to ensure that nonconformities do not recur6 im/lementin,
action
needed6 e)
records of the results of action ta7en 2see '..'36 and
f)
reiewin, the effectieness of the correctie action ta7en.
# /rocedure is no lon,er required do need documented eidence
10/2/2 $he or,ani-ation shall retain documented information as eidence of: a) the nature of the nonconformities and an susequent actions ta7en
b)the results of an correctie action. -521 >O2?$ SO?I= 1*,7 roblem solvin% The or%ani.ation shall have a defined The or%ani.ation shall have a documented (rocess for (roblem solvin% leadin% to (rocess0es for (roblem solvin% includin%+ root cause identification and elimination a3 defined a((roaches for various t#(es If a customer)(rescribed (roblem)solvin% and scale of (roblems 0e%& ne! format exists& the or%ani.ation shall use the (roduct develo(ment& current (rescribed format manufacturin% issues& field failures& audit findin%s5 3 containment& interim actions& and <-,, >>O>)>OOFI= related activities necessar# for The or%ani.ation shall use error)(roofin% control of nonconformin% out(uts methods in their corrective action (rocess 0see ISO 9**1& Section <5 c3 root cause anal#sis& methodolo%# 3orrective action im(act is no! included used& anal#sis& and results5 -528 3O>>3TI A3TIO= I$A3T in the roblem Solvin% clause d3 im(lementation of s#stemic The or%ani.ation shall a((l# to other corrective actions& includin% similar (rocesses and (roducts the consideration of the im(act on corrective action& and controls similar (rocesses and (roducts5 im(lemented& in order to eliminate the e3 verification of the effectiveness of cause im(lemented corrective actions5 of a nonconformit# f3 revie!in% and& !here necessar#& u(datin% the a((ro(riate documented information 0e%& F$A& control (lan Dhere the customer has s(ecific (rescribed (rocesses& tools& or s#stems for (roblem solvin%& the or%ani.ation shall use those (rocesses& tools& or s#stems unless other!ise a((roved b# the customer 1*,4 rror)(roofin% The or%ani.ation shall have a documented (rocess to determine the use of a((ro(riate error)(roofin% methodolo%ies :etails of the method used shall be documented in the (rocess
rror)roofin% is in the clause belo! 01*,4 A documented (rocess is required $ethodolo%ies to be documented in the F$A The testin% of error)(roofin% devices is required and records of the testin% are required
ris8 anal#sis 0such as F$A and test frequencies shall be documented in the control (lan The (rocess shall include the testin% of error)(roofin% devices for failure or simulated failure >ecords shall be maintained 3hallen%e (arts& !hen used& shall be identified& controlled& verified& and calibrated !here feasible rror)(roofin% device failures shall have a reaction (lan This !arrant# mana%ement s#stem is a ne! clause and a((lies !hen the or%ani.ation is required to (rovide !arrant# for their (roducts
1*,- Darrant# mana%ement s#stems Dhen the or%ani.ation is required to (rovide !arrant# for their (roduct0s& the or%ani.ation shall im(lement a !arrant# mana%ement (rocess The or%ani.ation shall include in the (rocess a method for !arrant# (art anal#sis& includin% =TF 0no trouble found Dhen s(ecified b# the customer& the or%ani.ation shall im(lement the required !arrant# mana%ement (rocess
1*,6 3ustomer com(laints and field failure test anal#sis The or%ani.ation shall (erform anal#sis on customer com(laints and field failures& includin% an# returned (arts& and shall initiate (roblem solvin% and corrective action to (revent recurrence Dhere requested b# the customer& this shall include anal#sis of the interaction of embedded soft!are of the or%ani.ationEs (roduct !ithin the s#stem of the final customerEs (roduct The or%ani.ation shall communicate the results of testin%/anal#sis to the customer and also !ithin the or%ani.ation
-524 >L3T: >O:@3T TST/A=A?CSIS The c#cle time requirement has been The or%ani.ation shall anal#se (arts removed reected b# the customerEs manufacturin% (lants& en%ineerin% facilities and The revised clause includes anal#sis of the dealershi(s The or%ani.ation shall interaction of embedded soft!are minimi.e the c#cle time of this (rocess >ecords of these anal#ses shall be 8e(t and made available u(on request The or%ani.ation shall (erform anal#sis and initiate corrective action to (revent recurrence 3#cle time related to reected =OT6 (roduct anal#sis should be consistent !ith the determination of root cause& corrective action and monit orin% the
