Internal Audit of ISO 9001:2015 Quality Management System
Examinaon a!er
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INSTRUCTIONS:
1& 2&
lease ans'er all (uesons in 30 minutes& Mar) your ans'er at t*e a!!ro!riate s!a+e on your ans'er s*eet 'it* 2, !en+il& Only ONE (1)
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ans'er s*all -e mar)ed for ea+* (ueson& /ollo' /ollo ' t*e instru+ instru+ons ons of t*e test test +ontr +ontroller oller and and sto! sto! 'ring '*en '*en you are are told to to do so& est !a!er !a!er along along 'it* 'it* ans'er ans'er s*eet s*eet must must -e return returned ed at t*e t*e end of t*e t*e test& test&
Internal Audit of ISO 9001:2015 Quality Management System raining "ourse osttraining Examinaon
1&
3*i+* of t*e follo'ing -est des+ri-e ISO 9001:20154 I6 II6 III6 I6 a. b. c. d.
2&
Quality management systems re(uirements Intended to -e used in +on7un+on 'it* ISO 1001 en8ironmental management system ISO 9001 is +era-le -y a++redited +er+aon -odies ISO 9001 is only a!!li+a-le to manufa+turers; regardless of si
I = III II = III I = II I; II = I
>"om-inaon of internal and external issues t*at +an *a8e an e?e+t on an organi
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"ontext of t*e organi
>Systema+; inde!endent and do+umented !ro+ess for o-taining o-7e+8e e8iden+e and e8aluang it o-7e+8ely to determine t*e extent to '*i+* t*e audit +riteria are fullled is t*e denion of a. b. c. d.
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Audit Internal ins!e+on Ba-oratory tesng Internal audit !ro+edure
Mandatory do+umented informaon re(uired -y ISO 9001:2015 standard in+ludes I6 II6 III6 I6 a. b. c. d.
5&
S+o!e of t*e (uality management system Quality o-7e+8es %esign and de8elo!ment +*anges Maintenan+e of infrastru+ture
I; II = I I; II = III II; III = I I; II; III = I
In '*at +lause of ISO 9001:2015 standard is t*e re(uirement for +ondu+ng internal audit s!e+ied4 a. b. c. d.
age 2 of 7
"lause "ontext of t*e organi
Internal Audit of ISO 9001:2015 Quality Management System raining "ourse osttraining Examinaon
D&
Audit is a systema+; inde!endent and do+umented !ro+ess for o-taining o-7e+8e e8iden+e and e8aluang it o-7e+8ely to determine t*e extent to '*i+* t*e audit +riteria are f ullled& 3*i+* are t*e follo'ing +an -e used as o-7e+8e e8iden+e4 I6 II6 III6 I6 a. b. c. d.
F&
I = II I = I II = I All of t*e a-o8e
Audit +riteria in+lude I6 II6 III6 I6 a. b. c. d.
C&
ISO 9001:2015 standard "ustomer +ontra+t re(uirements Quality manual O!erang !ro+edures
I; II = III I; II = I II; III = I I; II; III = I
audit s*all -e !erformed at !lanned inter8als -y internal auditors of t*e organi
9&
raining aendan+e re+ords Su!!lier e8aluaon re+ords "ustomer sasfa+on sur8ey re!orts Quality o-7e+8e re!orts
Site Annual Internal Su!!lier
ur!ose of +ondu+ng internal audits in+ludes t*e follo'ing EXCEPT a. b. c. d.
o +*e+) +om!lian+e of t*e (uality management system against ISO 9001:2015 re(uirements o +*e+) im!ro8ement needs o raise non+onforman+e re!ort for areas not +om!lied to t*e ISO 9001:2015 standard o +*e+) e?e+8eness of t*e (uality management system
10& Extent and -oundaries of an audit are dened as a. b. c. d.
age 3 of 7
Audit s+o!e Audit +riteria Audit E8iden+e Audit s+*edule
Internal Audit of ISO 9001:2015 Quality Management System raining "ourse osttraining Examinaon
11& 3*i+* of t*e follo'ing are t*e !rin+i!les of auding4 I6 II6 III6 a. b. c. d.
Et*i+al +ondu+t E8iden+e -ased a!!roa+* %ue !rofessional +are
I = II II = III I; II = III I = III
12& As long as a !ie+e of +ri+al monitoring e(ui!ment is !eriodi+ally examined -y t*e o!erators '*o )no' and use it; a formali
rue /alse
1.& In !re!aring for an audit; one of t*e )ey !oints in an audit team sele+on is: a. b. c. d.
Sele+ng all (ualied lead auditors Ensuring one of t*e auditors is in a senior management !osion Sele+ng auditors '*o are inde!endent of t*e area to -e audited a8ing t*e team leaders +*oose t*e !eo!le t*ey li)e to 'or) 'it*
1& ISO 9001:2015 Quality management !rin+i!les in+ludes I6 II6 III6 I6 a. b. c. d.
Beaders*i! ro+ess a!!roa+* System a!!roa+* "ustomer fo+us
I; II = III II; III = I I; II = I I; III = I
15& 3*i+* of t*e follo'ing su!!liers re(uire +ontrols to ensure (uality re(uirements *a8e -een met4 I6 OJ+e staonery !rodu+ts II6 ,ul) materials III6 rans!orter I6 *ird !arty 'are*ouse a. b. c. d.
age 4 of 7
I; II = III II; III = I I; III = I I; II = I
Internal Audit of ISO 9001:2015 Quality Management System raining "ourse osttraining Examinaon
1D& Q" ins!e+on !rograms s*all -e esta-lis*ed to monitor and measure +onformity of !rodu+ts& 3*i+* of t*e follo'ing s*all -e ins!e+ted during internal audit4 I6 II6 III6 I6 a. b. c. d.
$ame of t*e Q" ins!e+tor Ins!e+on met*ods and fre(uen+y Ins!e+on re+ords Bo+aon of Q" la-oratory
I; II = III I; II = I I; III = I II; III = I
1F& %uring site audit on !ro!er storage of ra' materials; '*i+* of t*e follo'ing storage +ondions +om!lies 'it* t*e ISO 9001:2015 re(uirements4 a. b. c. d.
Areas near to t*e !rodu+on ma+*ines Storage areas 'it* !ro!er iden+aon of ra' materials Outside t*e fa+tory In t*e oJ+e
1C& 3*i+* of t*e follo'ing -est dene >"orre+8e A+on4 a. b. c. d.
A+on to eliminate a dete+ted non+onformity A+on to eliminate t*e +ause of a non+onformity and to !re8ent re+urren+e In8esgate root +ause of a dete+ted non+onformity Segregate non+onforming item to re7e+t area
19& A t*ird !arty audit is a. b. c. d.
An internal audit An audit -y +ustomer or +lient An audit -y an inde!endent organi
20& lease arrange t*e follo'ing a++ording to t*e +orre+t internal audit ste!s I6 II6 III6 I6 a. b. c. d.
age 5 of 7
"arry out internal audit a++ording to audit s+*edule re!are audit s+*edule and sele+t internal auditors a)e +orre+8e a+on on non+onforman+e raised during audit "ondu+t +losing meeng to summari
II; I; I; II II; I; I; III I; II; I; III III; I; II; I
Internal Audit of ISO 9001:2015 Quality Management System raining "ourse osttraining Examinaon
21& Auditor s*all not audit t*eir o'n 'or)s or areas of res!onsi-ilies; GHE or /ABSE4 a. b.
rue /alse
22& 3*i+* of t*e follo'ing +an -e used to +*e+) (uality +om!lian+e of ra' materials4 I6 II6 III6 I6 a. b. c. d.
est re!ortsK +er+ate of analysis !ro8ided -y su!!lier for ea+* -at+* of materials su!!lied ISO 9001 +er+ates from su!!lier !ro8ing t*e su!!lier +om!lian+e 'it* ISO 9001 standards In+oming material ins!e+on re+ords Material deli8ery order
I = II II = III II = I I = III
2.& E8iden+e t*at +an -e audited to 8erify t*e im!lementaon and e?e+8eness of trainings +ondu+ted in+ludes: I6 II6 III6 I6 a. b. c. d.
raining aendan+e re+ords raining e?e+8eness e8aluaon re+ords "er+ates of aendan+e raining !lan
I = II I = III II = III I; II; III = I
2& "orre+8e a+on s*all -e +arried out '*ene8er a +om!laint from +ustomer is re+ei8ed& As an internal auditor; *o' do you +*e+) if !ro!er a+on *as -een ta)en to sol8e t*e +om!laint issues4 a.
b. c. d.
,y +*e+)ing t*e +ustomer +om!laint re+ord indi+ang root +ause of +om!laint; +orre+8e a+on ta)en and 8eri+aon of a+on ta)en ,y inter8ie'ing t*e sales !ersonnel on +ustomer feed-a+) !ertaining to t*e +om!laint issues "onta+t t*e +ustomer to 8erify if t*e +om!laint issue *as -een sol8ed ,y +*e+)ing t*e management re8ie' meeng minutes to +onrm t*e +om!laint *as -een dis+ussed and sol8ed
25& 3*i+* of t*e follo'ing %OES $O +om!ly 'it* t*e good storage re(uirements4 a. b. c. d.
age 6 of 7
Store on !allet or ra+)ing Mix ra' material and nis*ed !rodu+t as long as all items are !a+)ed !ro!erly Ba-el ra' material Store room is +lean and 'ell 8enlated
Internal Audit of ISO 9001:2015 Quality Management System raining "ourse osttraining Examinaon
2D& Internal audit s*all -e +ondu+ted4 a. b. c. d.
At !lanned inter8als On+e a year 3*ene8er +*anges to t*e (uality management system o++ur rior to t*e sur8eillan+e audit -y +er+aon -ody
2F& ISO 9001:2015 re(uirements in+lude a. b. c. d.
ealt* and safety re(uirements O!eraonal !lanning and +ontrol Quality +osng All of t*e a-o8e
2C& 3*i+* of t*e follo'ing are re(uired to ena-le tra+ea-ility of nis*ed !rodu+t4 I6 II6 III6 I6 a. b. c. d.
Ba-el ra' materials 'it* re+ei8ing date and -at+* num-er Ge+ord !rodu+on a+8ies in+luding materials used in 7o- s*eets "ondu+t mo+) re+all on a yearly -asis Maintain nis*ed !rodu+t deli8ery re+ords
I; II = III I; III = I I; II = I II; III = I
29& 3*at informaon is -eing soug*t during a t*ird !arty audit of a (uality management system4 a. b. c. d.
A list of non+onformies to ISO 9001:2015 O-7e+8e e8iden+e of +onformity 'it* ISO 9001:2015 A management +ommitment to (uality assuran+e All of t*e a-o8e
.0& o a+t as an internal auditor of a (uality management system a !erson *as to I6 II6 III6 I6 a. b. c. d.
age 7 of 7
,e registered as a +er+ated auditor a8e undergone a formal ISO 9001:2015 internal audit training ,e inde!endent from t*e areas to -e audited a8e -een a (uality system manager
I = II II = III I; II = III II; III = I
