2. 3. 11. 1. -Panduan-Mutu.doc

PANDUAN MUTU UNTUK

LABORATORIUM PENGUJIAN BALAI PENGAWAS PENGAWAS OBAT DAN MAKANAN M AKANAN DI SIMPANG SI MPANG ULIM

NOMOR

: 01/PM/BPOM/09

TERBITAN / REVISI

: 5/4

Nomor Sa!"a"

: 5

P#m#$a"$

: Ma Ma"a%#r T#&"!' S#&'! P#"$(%!a" M!&ro)!oo$!

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:

T#r&#"+a! T!+a& *#r&#"+a!

BALAI PENGAWAS OBAT DAN MAKANAN DI PALU

PANDUAN PANDUAN MUTU "#MBAR P#N$#%A&AN

No. Bagian Terbit rbitan an// Tgl Tgl

:i : 5/ 5/ 05 05 - 01 – 200 2009 9

Revii/ Tgl : !/ 05 - 01 – 2009 &ala'an : 1 (ari 1 Diet)*)i : Mana*er M)t)

PANDUAN MUTU UNTUK

LABORATORIUM PENGUJIAN BALAI PENGAWAS PENGAWAS OBAT DAN MAKANAN M AKANAN DI SIMPANG SI MPANG ULIM

Pa"+(a" M(*( !"! +!'a,&a" o#,:

+r- DEWI DE WISU SUR.ATI R.ATIMa"a%#r P("a&

BALAI PENGAWAS OBAT DAN MAKANAN DI SIMPANG ULIM

PANDUAN PANDUAN MUTU P#RUBA&AN


: ii : 5/ 5/ 05 05 - 01 – 200 2009 9


Proe()r Pengiian Per)ba+an Pan()an M)t): 1. T)li li eti etia, a, ,er) ,er)ba ba+a +an n (ala (ala' ' olo olo' ' ang ang (i (ie( e(ia iaa an n 2. el)aran (o)'en ang la'a . Ma)an (o)'en ang bar) !. "a)an ,ara ra ang 'engii ,e ,er)b r)ba+an PERUBAAN

MENABUT

MEMASUKKAN

PARA2

No

Tanggal Tanggal

1

0-0!-0

2

21-0-0



04-04-05

!

04-04-05

No Bagian %el)r)+ bagian %el)r)+ bagian R)ang ling), o'eti 5.

Revii/ Terbitan 0/1

5

0!-02-04

5.

6

4

20-0!-04

2/



2-05-04

%el)r)+ bagian !.10

0/1

%el)r)+ +ala'an %el)r)+ +ala'an %el)r)+ +ala'an 1 (ari 1



2-05-04

5.

6

9

2-05-04

5.

10

05-01-09

11

05-01-09

%el)r)+ bagian 5.

12

05-01-09

5.

1

05-01-09

-

3 2/

2/

&ala'an %el)r)+ +ala'an %el)r)+ +ala'an 12 (ari 51

No Bagian %el)r)+ bagian %el)r)+ bagian R)ang ling), o'eti 5.

Revii/ Terbitan 1/2 2/ /!

%el)r)+ +ala'an %el)r)+ +ala'an 12 (ari 51

5.

!/5

%el)r)+ bagian !.10

/! 1/2

%el)r)+ +ala'an %el)r)+ +ala'an %el)r)+ +ala'an 1 (ari 1

1 (ari 1

5.

!/5

1 (ari 1

5/4

1 (ari 1

5.

4/

1 (ari 1

6


!/5

!/5


5/4

%el)r)+ +ala'an 1 (ari 1

4/

5.

5.

/

1 (ari 1

-

2.0

0/1

1 (ari 1

-


/!

&ala'an


: iii : 5/ 5/ 05 05 - 01 – 200 2009 9

PANDUAN PANDUAN MUTU

D7%TR7BU%7

%alinan No. 1 2 (an ali 

Terbitan 5 5 5

!

5


Pe'egang Mana*er P)n8a Mana*er M)t) Mana*er Teni %ei Peng)*ian Pro() Tera,eti Narotia bat Tra(iional o'etia (an Pro() o',le'en Mana*er Te Teni %e % ei Pe P eng)*ian Pa P angan (a ( an Ba Ba+an

5 4 

5 5 5

Berba+aa Mana*er Teni %ei Peng)*ian Mirobiologi Mana*er A('initrai o'ite Are(itai Naional


PANDUAN PANDUAN MUTU DA;TAR DA;TAR 7%7 7 %7

BAGIAN


: iv : 5/ 5/ 05 05 - 01 – 200 2009 9


JUDUL

JUMLA ALAMAN

LEMBAR JUDUL

1 aama"

!

LEMBAR PENGESAAN

1 aama"

!!

PERUBAAN

1 aama"

!!!

DISTRIBUSI

1 aama"

!3

DA2TAR ISI

 aama"

1-0

PENDAULUAN

1 aama"

-0

AUAN NORMATI2

1 aama"

-1

KEBIJAKAN MUTU

1 aama"

-0 4-0

ISTILA DAN DE2INISI PERS.ARATAN MANAJEMEN

5 aama"

4-1

ORGANISASI

4 aama"

4-

SISTEM MANAJEMEN

 aama"

4- 4-4

PENGENDALIAN DOKUMEN KAJI ULANG PERMINTAAN TENDER DAN KONTRAK

 aama" 1 aama"

4-5

SUB KONTRAK PENGUJIAN

1 aama"

4-6

PEMBELIAN JASA DAN PERBEKALAN

1 aama"

4-7

PELA.ANAN KEPADA PELANGGAN

1 aama"

4-8 4-9

PENGADUAN PENGENDALIAN PE PEKERJAAN PE PENGUJIAN .ANG TIDAK SESUAI

1 aama" 1 aama"

4-10

PENINGKATAN

1 aama"

4-11

TINDAKAN PERBAIKAN

1 aama"

4-1

TINDAKAN PENEGAAN

1 aama"

4-1

PENGENDALIAN REKAMAN

1 aama"


PANDUAN PANDUAN MUTU

: iv : 5/ 5/ 05 05 - 01 – 200 2009 9


DA;TAR DA;TAR 7%7 7 %7

BAGIAN


JUDUL

JUMLA ALAMAN

4-14

AUDIT INTERNAL

1 aama"

4-15

KAJI ULANG MANAJEMEN

1 aama"

5-0

PERS.ARATAN TEKNIS

5-1

UMUM

1 aama"

5- 5-

PERSONIL KONDISI AKOMODASI DAN LINGKUNGAN METODA PENGUJIAN DA DAN VA VALIDASI METODE

 aama" 1 aama"

5-5

PERALATAN

 aama"

5-6

KETERTELUSURAN PENGUKURAN

1 aama"

5-7

PENGAMBILAN ONTO

1 aama"

5-8

PENANGANAN ONTO .ANG DIUJI

1 aama"

5-9

JAMINAN MUTU ASIL PENGUJIAN

1 aama"

5-10

PELAPORAN ASIL

 aama"

5-4

Lam!ra" 1 Lam!r Lam!ra" a"  Lam!r Lam!ra" a" 

R(a"$ L!"$&( P#"$(%!a" S*r(&* S*r (&*(r (r Or$a"! Or$a"!'a' 'a'!! Baa! Baa! POM +! Pa( Pa( )#r+a'ar&a" )#r+a'ar&a" SK Ka Ba+a" POM S*r(&* S*r (&*(r (r Or$a"! Or$a"!'a' 'a'!! S!'*#m S!'*#m Ma"a% Ma"a%#m# #m#" "

 aama"

6 aama" 1 aama" 1 aama aama" "

)#r+a'ar&a" SK Ka Baa! POM +! Pa(


PANDUAN MUTU P#NDA&U"UAN

No. Bagian Terbitan/ Tgl

: 1.0 : 5/ 05 - 01 – 2009


1.1 %aaran Pan()an M)t) a(ala+ 1.1.1 Me'berian inor'ai tentang organiai (an ativita laboratori)' Balai PM (i Pal) ter)ta'a (ala' 'e'berian ,elaanan ,eng)*ian. 1.1.2 Dig)naan ebagai ba+an a8)an (ala' 'engelola e')a ativita ang beraitan (engan %ite' Mana*e'en (i "aboratori)' Peng)*ian Balai PM (i Pal). 1.1.. %ebagai (aar 'elaanaan a)(it )nt) 'e'atian ba+
1. o(e eti (ala' 'elaanaan t)ga Balai PM (i Pal) 'eng)ta'aan (i(i,lin (e(iai (an e*)*)ran erta ,roeionalita er*a (engan 'enera,an ,rini, in(e,en(ent ebagai beri)t: 1..1 Meng)ta'aan e*)*)ran (a,at (i,er8aa (an 'e'egang e')a ra+aia egiatan ,eng)*ian ang (ila)an. 1..2 Melaanaan t)ga (engan ,en)+ raa tangg)ng *a

PANDUAN MUTU

A>UAN NRMAT7;


: 2.0 : 1/ 05 - 01 – 2009

Revii/ Tgl : 0/ 05 - 01 – 2009 &ala'an : 1 (ari 1 Diet)*)i : Mana*er M)t)

Pan()an ')t) ini (i))n (an (iterbitan ber(aaran 7%/7#> 1025 :2005 beriian eteta,an ang 'en*a(i a8)an (ala' (ala' ,enelenggaraan "aboratori)' ,eng)*ian. Do)'en ')t) ang berla) ebel)'na a'an(e'en beri)t ata) revii (ari (o)'en ')t) erta (o)'en ,en)n*ang lainna ti(a berla) *ia tela+ (iterbitan (o)'en ,er)ba+an. Unt) (o)'en ang ti(a bertanggal 'aa a8)an ang berla) a(ala+ (o)'en ang (iterbitan ,aling a+ir. Pan()an ')t) ini berii e')a ,eraratan ang +ar) (i,en)+i ole+ laboratori)' ,eng)*ian Balai PM (i %i',ang Uli' (ala' 'elaanaan ,eng)*ian ter+a(a, ')t) (an ea'anan ,ro() tera,eti narotia ,iotro,ia obat tra(iional o'eti ,angan (an ba+an berba+aa (engan 'enga8) ,a(a Perat)ran Menteri ee+atan R7 e,)t)an Menteri ee+atan R7 e,)t)an e,ala Ba(an Penga
No. Bagian

: 2.1

DI SMPANG ULIM

PANDUAN MUTU #B7=AAN MUTU

Terbitan/ Tgl

: 5/ 05 - 01 – 2009


Mana*e'en "aboratori)' Peng)*ian Balai Penga 1025:2005 g)na 'e'berian *a'inan oniteni (an o',eteni teni ,eng)*ian (ala' ling), egiatanna. %ite' Mana*e'en M)t) "aboratori)' Balai PM (it)angan (ala' ,an()an ')t) ,roe()r ')t) (an intr)i er*a ang (i(o)'entaian (i'engerti (an (ilaanaan ole+ e')a ,eronil e8ara ,roeional.

+r- DEWISUR.ATIMa"a%#r P("a&


PANDUAN MUTU


: .0 : 5/ 05 - 01 – 2009

Revii/ Tgl

: !/ 05 - 01 - 2009

7%T7"A& DAN D#;7N7%7

&ala'an : 1 (ari 5 Diet)*)i : Mana*er M)t)

.1 "aboratori)' "aboratori)' a(ala+ intani/le'baga ang 'elaanaan ,eng)*ian. .2 "aboratori)' Peng)*i "aboratori)' ang (iare(itai a(ala+ laboratori)' ang tela+ 'e',erole+ are(itai (ari o'ite Are(itai Naional ber(aaran ))l (ari o'ite Are(itai Teni e)ai (engan ,e(o'an 7%/7#> 1025:2005. . "aboratori)' Peng)*ian bat (an Narotia "aboratori)' Peng)*ian bat (an Narotia a(ala+ laboratori)' ang 'eng)*i ')t) obat (an narotia. .! "aboratori)' Peng)*ian bat Tra(iional "aboratori)' Peng)*ian bat Tra(iional a(ala+ laboratori)' ,eng)*ian ang 'eng)*i ')t) ,ro() obat tra(iional. .5 "aboratori)' Peng)*ian o'etia "aboratori)' Peng)*ian o'etia a(ala+ laboratori)' ,eng)*ian ang 'eng)*i ')t) ,ro() o'eti alat ee+atan (an ,erbealan ee+atan r)'a+ tangga. .4 "aboratori)' Peng)*ian Pangan (an Ba+an Berba+aa "aboratori)' Peng)*ian Pangan (an Ba+an Berba+aa a(ala+ laboratori)' ,eng)*ian ang 'eng)*i ')t) ,ro() 'aanan 'in)'an (an ba+an berba+aa. . "aboratori)' Mirobiologi "aboratori)' Mirobiologi a(ala+ laboratori)' ,eng)*ian ang 'ela)an ,eng)*ian ,oteni antibioti terilita ,ro() tera,eti ,iotro,ia narotia (an ,ro() alat ee+atan tertent) erta 'eng)*i *)'la+ (an *eni 8e'aran 'iroorgani'e ang teran()ng (ala' ,ro() ,angan o'etia (an obat tra(iional. . Peng)*ian Peng)*ian a(ala+ egiatan teni ang ter(iri ata ,eneta,an ,enent)an at) ata) lebi+ iat ata) arateriti (ari )at) ,ro() ba+an ,eralatan organi'e eno'ena ii ,roe ata) *aa e)ai (engan ,roe()r ang tela+ (iteta,an.


PANDUAN MUTU


: .0 : 5/ 05 - 01 – 2009

Revii/ Tgl

: !/ 05 - 01 - 2009

7%T7"A& DAN D#;7N7%7

.9


%ite' Mana*e'en %ite' Mana*e'en a(ala+ tr)t)r organiai tangg)ng *a
.10 Pan()an M)t) Pan()an M)t) a(ala+ (o)'en (aar %ite' Mana*e'en ang (i'ilii ole+ laboratori)' ,eng)*ian Balai Penga 1025:2005. .11 %tan(ar A8)an %tan(ar A8)an a(ala+ alat ang (ig)naan ebagai a8)an (ala' 'elaanaan ,eng)*ian. .12 Ba+an A8)an Berertiiat Ba+an A8)an Berertiiat a(ala+ )at) ba+an a8)an ang at) ata) lebi+ iatna (iberi ertiiat (engan ,roe()r terait ang tela+ ba) (iertai (engan ata) (a,at (itel))ri e )at) ertiiat ata) (o)'en lain ang (iterbitan ole+ ba(an ertiiai. .1 U*i Proiieni U*i Proeieni a(ala+ ala+ at) 8ara )nt) 'engeta+)i )n*) er*a laboratori)' (engan 8ara ,erban(ingan antar laboratori)'. .1! Peraratan Peraratan a(ala+ )',)lan ,eiiai ang 'aing-'aing (a,at (i))r ata) (i)rai ,eiiai (ari iat at) eat)an agar (a,at (irealiaian (an (i)*i


PANDUAN MUTU


: .0 : 5/ 05 - 01 – 2009

Revii/ Tgl

: !/ 05 - 01 - 2009

7%T7"A& DAN D#;7N7%7

&ala'an :  (ari 5 Diet)*)i : Mana*er M)t)

.15 Peronil a. Mana*er P)n8a a(ala+ e,ala Balai PM (i Pal) b. Mana*er M)t) a(ala+ a(ala+ ,eronil ang (it)n*) 8. Mana*er Teni a(ala+ e,ala %ei Peng)*ian (. Mana*er A('initrai a(ala+ e,ala %)b Bagian Tata Ua+a e. De,)ti Mana*er M)t) a(ala+ ,eronil ang (it)n*). . Penelia a(ala+ ta ang (it)n*) 'e'a+a'i tentang ,roe()r (an 'eto(e ,eng)*ian t)*)an ,eng)*ian erta (a,at 'enga*i (an 'eni',)lan +ail+ailna. g. elo',o =a'inan M)t) a(ala+ ta ang (it)n*) ber(aaran %)rat e,)t)an e,ala Balai PM (i Pal). .14 Pro() Tera,eti Pro() Tera,eti a(ala+ e(iaan ata) ,a()an ba+an-ba+an ang (ig)naan )nt) 'engeta+)i ata) 'eneli(ii ite' ilooi ata) ea(aan ,atologi (ala' ranga ,eneta,an (iagnoa ,en8ega+an ,ene'b)+an ,e')li+an ,eningatan ee+atan (an ontrae,i. .1 Pangan ?ter'a) Ba+an Ta'ba+an Pangan@ Pangan ?ter'a) Ba+an Ta'ba+an Pangan@ a(ala+ etia, barang ang (i,ro()i ata) (iola+ (ie(aran ata) (inataan ebagai 'aanan ata) 'in)'an )nt) on)'i 'an)ia erta e')a ba+an ang (ig)naan (ala' ,ro()i ata) ,engola+an 'aanan (an 'in)'an. .1 o'eti o'eti a(ala+ e(iaan ata) ,a()an ba+an ang ia, )nt) (ig)naan ,a(a bagian l)ar .19 Perbealan ee+atan R)'a+ Tangga Perbealan ee+atan R)'a+ Tangga a(ala+ alat ba+an ata) 8a',)ran )nt) ,e'eli+araan (an ,era
BALAI PENGAWAS OBAT DAN MAKANAN

No. Bagian

: .0

DI SIMPANG ULIM

Terbitan/ Tgl

: 5/ 05 - 01 – 2009

PANDUAN MUTU

7%T7"A& DAN D#;7N7%7

Revii/ Tgl : !/ 05 - 01 - 2009 &ala'an : ! (ari 5 Diet)*)i : Mana*er M)t)

. .20 bat Tra(iional bat Tra(iional a(ala+ ba+an ata) ra')an ba+an ang ber),a ba+an t)'b)+an ba+an +e

PANDUAN MUTU R$AN7%A%7


: !.1 : 5/ 05 - 01 – 2009

Revii/ Tgl : !/ 05 - 01 - 2009 &ala'an : 1 (ari 5 Diet)*)i : Mana*er M)t)

A8)an 7%/7#> 1025:2005 % e,ala Ba(an PM No. 0501/%/BPM Ta+)n 2001 "atar Belaang Balai PM (i Pal) 'er),aan Unit Pelaana Teni (i bi(ang ,e'eriaan e8ara laboratori)' ,eng)*ian (an ,enilaian ')t) obat 'aanan (an 'in)'an o'eti (an alat ee+atan obat tra(iional narotia (an ba+an berba+aa

e)ai ,er)n(ang-)n(angan ang berla) ang bera(a (iba 1025:2005 (i,erl)an ,engelolaan ang bai (an oniteni )nt) 'en*alanan ativita egiatan e8ara ter) 'ener). %tr)t)r rganiai %tr)t)r rganiai Balai PM ber(aaran % e,ala Ba(an PM No. 0501/%/BPM tanggal 1 Mei 2001. %tr)t)r rganiai e,erti ,a(a "a',iran 2. Unt) 'enera,an %ite' Mana*e'en e)ai 7%/7#> 1025:2005 e,ala PM (i Pal) 'eneta,an %tr)t)r rganiai e,erti ,a(a "a',iran . T)ga Tangg)ng =a

: !.1 : 5/ 05 - 01 – 2009

PANDUAN MUTU

R$AN7%A%7


2. T)ga Tangg)ng =a
e.

Men*a'in ,elaanaan %ite' Mana*e'en M)t) (i laboratori)' ber*alan (engan bai . Bertangg)ng*a


*.


: !.1 : 5/ 05 - 01 – 2009

Revii/ Tgl : !/ 05 - 01 - 2009 &ala'an :  (ari 5 Diet)*)i : Mana*er M)t)

Mengat)r ,ene',atan (an ,eneri'aan ,eronel laborator)' e)ai )aliiai ang (ib)t)+an . Mengea+an )raian t)ga Penelia l. Meren8anaan (an 'elaanaan ,rogra' ,elati+an ang (ib)t)+an (ala' ranga ,eningatan %DM

'. n. o. ,. C.

Meneri'a %)rat Per'intaan U*i (an 'e'b)at %)rat Perinta+ er*a e,a(a Penelia Me'eri'a "a,oran &ail U*i ang tela+ (ie(er+anaan (ala' >atatan Peng)*ian (ari Penelia Ati 'ela)an oor(inai (engan Mana*er Teni %ei lainna Me'b)at %)rat Per'intaan U*i e ei ,eng)*ian/laboratori)' lain )nt) 'ela)an )*i ang ti(a bia (ier*aan (i eina Menan(atangani la,oran ,eng)*ian.

!. T)ga Tangg)ng =a


: !.1 : 5/ 05 - 01 – 2009

PANDUAN MUTU

R$AN7%A%7

Revii/ Tgl : !/ 05 - 01 - 2009 &ala'an : ! (ari 5 Diet)*)i : Mana*er M)t)

g. +. i. *.

Bertangg)ng*a
4. Tangg)ng =aP/">P e')(ian 'engeval)ai (an 'enan(atangani la,oran tereb)t e. Mela,oran &ail U*i e,a(a Mana*er Teni . Me'berian ))l (an aran (ala' ranga elan8aran egiatan teni ,eng)*ian. A,abila eorang 'ana*er ber+alangan 'aa t)ga tangg)ng *a



: !.1 : 5/ 05 - 01 – 2009


Uraian T)ga Mana*er P)n8a Mana*er M)t) Mana*er Teni (an Mana*er A('initrai De,)ti Mana*er M)t) (itan(atangani (an (ia+an ole+ Mana*er P)n8a. Uraian t)ga Penelia (itan(atangani (an (ia+an ole+ Mana*er Teni. Uraian t)ga ,eronel ,eng)*i (itan(atangani (an (ia+an ole+ Penelia erta Uraian t)ga ,eronel a('initrai (itan(atangani (an (ia+an ole+ Mana*er A('initrai. Mana*er P)n8a Mana*er M)t) Mana*er A('initrai Mana*er Teni De,)ti Mana*er M)t) Penelia (an elo',o =a'inan M)t) (iteta,an ber(aaran % e,ala Balai PM (i Pal) e)ai (engan PT=M. 5.2-1/BPM/09. Dala' ranga 'elaanaan t)ga laboratori)' 'e'atian a(ana: 1. %etia, ,eronel beba (ari etia, ,engar)+ ti(a bai e)ai (engan PT=M/!.1-0.1/BPM/09. 2. Perlin()ngan era+aiaan inor'ai (an +a e,e'ilian ,elanggan e)ai (engan PT=M/!.1-0.2/BPM/09.


PANDUAN MUTU

%7%T#M MANA=#M#N


: !.2 : 5/ 05 - 01 – 2009


!.2.1

A8)an : 7%/7#> 1025:2005

!.2.2

ebi*aan M)t) Pan()an M)t) 'er),aan (o)'en (aar ite' ang (i'ilii ole+ laboratori)' ,eng)*ian Balai PM (i Pal) )nt) 'e'en)+i ,eraratan Pe(o'an 7%/7#> 1025:2005. "aboratori)' Peng)*ian Balai PM (i Pal) 'e',)nai %ite' Mana*e'en ang 'en8a), tr)t)r organiai e 1025:2005.

!.2.

T)*)an %ite' Mana*e'en %ite' Mana*e'en "aboratori)' Peng)*ian Balai PM (i Pal) bert)*)an )nt) 'en*a'in e')a egiatan ,eng)*ian e8ara oniten ,roeional (an 'a',) 'elaanaan ,eng)*ian e)ai tan(ar ang berla).

!.2.!

Pan()an M)t) 1. Pan()an M)t) (i))n (an (ie'bangan ebagai a8)an er*a laboratori)' ,eng)*ian Balai PM (i Pal) beriian ,ernataan ebi*aan (an t)*)an %ite' Mana*e'en ang (iterbitan (iba
2.

Doo'en %ite' Mana*e'en ter'a) Pan()an M)t) Proe()r Pelaanaan 7ntr)i er*a (an or'at-or'at erta (o)'en ,en())ng (ie'bangan (an (ien(alian ole+ elo',o =a'inan M)t) e)ai (engan PT=M.!.-0/BPM/09.

.

&irari (o)'en %ite' Mana*e'en laboratori)' Balai PM (i Pal) ter(iri (ari: "evel 1 : Pan()an M)t) Do)'en %ite' Mana*e'en ang 'eng)raian gari bear ebi*aan %ite' Mana*e'en laboratori)' ang (itera,an ,eng)*ian Balai PM (i Pal). Do)'en ini (ia+an ole+ Mana*er P)n8a. "evel 2

: Proe()r Teta, =a'inan M)t) ?PT=M@ Do)'en %ite' Mana*e'en )nt) 'engen(alian egiatan er*a ang (itera,an ,a(a 'aing-'aing laboratori)'.


PANDUAN MUTU %7%T#M MANA=#M#N

"evel 


: !.2 : 5/ 05 - 01 – 2009

Revii/ Tgl

: !/ 05 - 01 - 2009


: 7ntr)i er*a ?7@ Do)'en %ite' Mana*e'en ang berii ta+a,-ta+a, ,elaanaan egiatan antara lain Meto(e Analia Pengo,eraian Alat ata) egiatan ,eii lainna ang (i,erl)an (ibe(aan ata: a. 7ntr)i er*a 'eto(e ,eng)*ian ?7-"ab@ b. 7ntr)i er*a Pengg)naan Alat 8. 7ntr)i er*a Pe'eli+araan Alat (. 7ntr)i er*a A('initrai Do)'en (ia+an ole+ Mana*er M)t) ata) Mana*er Teni ata) Mana*er A('initrai.

"evel !

: Do)'en ,en)n*ang ang ter(iri ata or'at-or'at %tan(ar A8)an Man)al Alat Rea'an M)t) (an ebagaina. BALAI PENGAWAS OBAT DAN MAKANAN No. Bagian : !. DI SIMPANG ULIM Terbitan/ Tgl : 5/ 05 - 01 – 2009

PANDUAN MUTU

Revii/ Tgl &ala'an

: !/ 05 - 01 - 2009 : 1 (ari 2

P#N$#NDA"7AN DUM#N

Diet)*)i : Mana*er M)t)

!..1

A8)an : 7%/7#> 1025:2005

!..2

Do)'entai elo',o =a'inan M)t) ber
!..

Do)'en %ite' Mana*e'en +ar) (io')niaian e,a(a (i'engerti ole+ tere(ia bagi (an (ite',atan ole+ ,eronel terait (i laboratori)' ang e)ai. Do)'en ang berla) elal) tere(ia (i e')a loai egiatan laboratori)' e)ai (engan PT=M.!.-0/BPM/09.

!..!

%e')a Do)'en %ite' Mana*e'en ang (iterbitan )nt) ,eronel (i laboratori)' +ar) (ia*i )lang (an (ia+an ole+ ,eronel ang ber
!..5

Pan()an M)t) (an Do)'en %ite' Mana*e'en lainna (ia*i )lang e8ara berala (engan 'engi(entiiai 'enganalii (an 'en8ari ,e'e8a+an 'aala+ ang ti'b)l (an (o)'en enantiaa (i')ta+iran ole+ elo',o =a'inan M)t) e)ai (engan PT=M.!.-0/BPM/09.

!..4

Do)'en e(al)ara (itari (ari e')a te',at ,engg)naan (an (iberi tan(a ang e)ai. Penan(aan ber(aaran: a. Teren(ali : i. berla) ii. ti(a berla) - (itari (an (ii',an ?)nt) )aa ,engeta+)an@ - (itari (an (i')na+an b. Ti(a teren(ali %e')a (o)'en ite' ')t) laboratori)' tela+ (iberi i(entita +))

!..

Per)ba+an Pan()an M)t) (ia+an ole+ Mana*er P)n8a Per)ba+an (o)'en elain Pan()an M)t) (ia+an ole+ Mana*er M)t) ata) Mana*er Teni ata) Mana*er A('initrai. Per)ba+an (o)'en (irea' (ala' 8atatan ,er)ba+an/a'an(e'en e)ai (engan PT=M.!.-0/BPM/09.




: !. : 5/ 05 - 01 – 2009

Revii/ Tgl


: !/ 05 - 01 - 2009


!..

Per)ba+an Do)'en %ite' Mana*e'en Per)ba+an Do)'en %ite' Mana*e'en (ala' ,erangat o',)ter (ila)an (engan ,roe()r e)ai (engan PT=M.!.-0/BPM/09.

!..9

Do)'en %ite' Mana*e'en ang (ib)at ole+ laboratori)' +ar) (ii(entiiai e8ara +)). 7(entiiai tereb)t +ar) 'en8a), tanggal ,enerbitan (an/ata) i(entiiai revii ,eno'oran +ala'an (an *)'la+ +ala'an e)ai (engan PT=M.!.-0/BPM/09.


PANDUAN MUTU A=7 U"AN$ P#RM7NTAAN T#ND#R DAN NTRA


: !.! : 5/ 05 - 01 – 2009


!.!.1

A8)an : 7%/7#> 1025:2005

!.!.2

ebi*aan a*i )lang ,er'intaan ten(er (an ontra (ilaanaan )nt) 'e'atian ba+
!.!.

a*i )lang ,er'intaan ten(er (an ontra (ilaanaan e)ai (engan PT=M.!.-0!/BPM/09.

!.!.!

Peni',angan a,a,)n (ari ontra elal) (iinor'aian e,a(a ,elanggan.

!.!.5

Rea'an a*i Ulang Per'intaan Ten(er (an ontra (i(o)'entaian (engan bai e)ai (engan PT=M.!.1-12/BPM/09.

!.!.4


PANDUAN MUTU %UB NTRA P#N$U=7AN


: !.5 : 5/ 05 - 01 – 2009


!.5.1

A8)an : 7%/7#> 1025:2005

!.5.2

ebi*aan %)b ontra Peng)*ian (ila)an arena ea(aan ta ter()ga e,erti er)aan intr)'ent / alat )*i ba+an ,e'ban(ing/,ereai +abi ata) beban er*a ang terlal) berlebi+an.

!.5.

%)b ontra Peng)*ian %)b ontra Peng)*ian (iberian e,a(a laboratori)' ang terare(itai 'e'en)+i 7%/7#> 1025:2005 (an (ila)an e)ai (engan PT=M.!.505/BPM/09.

!.5.!

Pela,oran "aboratori)' ,eng)*ian Balai PM (i Pal) 'e'b)at la,oran +ail ,eng)*ian ber(aaran la,oran ,eng)*ian (ari laboratori)' ,eneri'a %)b ontra e)ai (engan PT=M.!.5-05/BPM/09.

!.5.5

"aboratori)' 'e'eli+ara (atar )b ontrator ang (ig)naan )nt) ,eng)*ian (an rea'an (ari b)tina e)ai (engan PT=M.!.5-05/BPM/09.


PANDUAN MUTU P#MB#"7AN =A%A DAN P#RB#A"AN


: !.4 : 5/ 05 - 01 – 2009


!.4.1

A8)an : 7%/7#> 1025:2005

!.4.2

ebi*aan "aboratori)' Peng)*ian Balai PM (i Pal) 'engg)naan *aa (an ,erbealan (ari l)ar (engan ')t) ang 'e'a(ai )nt) 'e',erta+anan e,er8aaan ata ,eng)*ian ang (ila)an.

!.4.

"aboratori)' aan 'ela)an veriiai lebi+ (a+)l) ter+a(a, *aa ata) ,erbealan ang (i,ao )nt) ee)aian ,eiiai ang (itent)an e)ai (engan PT=M/!.4-04/BPM/09.

!.4.!

"aboratori)' 'elal)i Mana*er A('intrai Mana*er M)t) (an Mana*et Teni 'ela)an eval)ai ter+a(a, ,e'ao *aa (an ,erbealan 'ini'al 1 ?at)@ ali (ala' eta+)n e)ai (engan PT=M/!.4-04/BPM/09.

!.4.5

Rea'an Pe'ao "aboratori)' 'erea' 'eni',an (an 'e'eli+ara (o)'en ari, ,e'ao (an (o)'en eval)ai ter+a(a, ,e'ao ang 'e'berian *aa (an ,erbealan. Peni',anan rea'an (ila)an ole+ bagian a('initrai e)ai (engan PT=M/!.4-04/BPM/09.


PANDUAN MUTU P#"AANAN #PADA P#"AN$$AN


: !. : 5/ 05 - 01 – 2009


!..1

A8)an : 7%/7#> 1025:2005

!..2

"aboratori)' Peng)*ian Balai PM (i Pal) elal) 'eng),aaan er*a a'a ang bai (engan ,elanggan )nt) lariiai ,er'intaan (an )nt) 'e'anta) iner*a laboratori)' (engan teta, 'en*aga era+aiaan ,elanggan lain e)ai PT=M/!.-0/BPM/09.

!..

Bila (iangga, ,erl) laboratori)' (a,at 'e'berian ee',atan e,a(a ,elanggan )nt) 'enaian ,eng)*ian ang (ila)an )nt) ,elanggan ang berang)tan e)ai PT=M/!.-0/BPM/09.

!..!

Bila (iangga, ,erl) laboratori)' (a,at 'e'berian inor'ai (an lariiai ,er'intaan ,eng)*ian e,a(a ,elanggan.


PANDUAN MUTU P#N$ADUAN


: !. : 5/ 05 - 01 – 2009


!..1

A8)an : 7%/7#> 1025:2005

!..2

"aboratori)' 'enangani ,enga()an bai lian 'a),)n tert)li (ari ,elanggan ata) ,i+a lain tentang ,elaanan laboratori)' e8ara benar (an te,at.

!..

Penanganan Penga()an %etia, ,enga()an ang (ia',aian ,elanggan (itangani ole+ Mana*er A('initrai e)ai (engan PT=M/!.-0/BPM/09.

!..!

Rea'an %e')a ,enga()an (ari ,elanggan ata) ,i+a lain (an langa+-langa+ ang (ia'bil ebagai tin(aan ole+ laboratori)' (i8atat (an (irea' e)ai (engan PT=M/!.-0/BPM/09.


PANDUAN MUTU P#N$#NDA"7AN P##R=AAN P#N$U=7AN AN$ T7DA %#%UA7


: !.9 : 5/ 05 - 01 – 2009


!.9.1

A8)an : 7%/7#> 1025:2005

!.9.2

"aboratori)' Peng)*ian Balai PM (i Pal) bertangg)ng *a
!.9.

"aboratori)' aan 'engeval)ai (an 'enga'bil tin(aan ,erbaian erta 'enginor'aian e,a(a ,elanggan ?a,abila (i,erl)an@ egera etela+ (ieta+)i a(ana ,eni',angan ata) eti(ae)aian ,eer*aan e)ai (engan PT=M/!.09-09/BPM/09. ang bertangg)ng *a

PANDUAN MUTU P#N7N$ATAN


: !.10 : 5/ 05 - 01 – 2009


!.10.1 A8)an : 7%/7#> 1025:2005 !.10.2 Unt) 'eningatan ')t) laboratori)' Mana*er M)t) 'e',rogra'an ,en(i(ian teni. !.10. "aboratori)' enantiaa 'ela)an analii (ata ang terait laboratori)' ter'a) (ata +ail a)(it internal 'a),)n eternal.

(engan

!.10.! Melaanaan tin(aan ,erbaian tin(aan ,en8ega+an erta a*i )lang 'ana*e'en )nt) ,eningatan eetiita ite' 'ana*e'en e8ara berelan*)tan.


PANDUAN MUTU T7NDAAN P#RBA7AN


: !.11 : 5/ 05 - 01 – 2009


!.11.1 A8)an : 7%/7#> 1025:2005 !.11.2 "aboratori)' Peng)*ian Balai PM (i Pal) aan elal) 'eng),aaan tin(aan ,erbaian ata eti(ae)aian ,eer*aan ata) ,eni',angan (ari ebi*aan (an ,roe()r 'elal)i ,eronel ang o',eten. !.11. Tin(aan ,erbaian (i')lai (ari ,eneli(ian (ari laboratori)' ang o',eten )nt) 'enent)an ,enebab ,er'aala+an e)ai (engan PT=M/!.1110/BPM/09. !.11.! %el)r)+ +ail i(entiiai ,er'aala+an ang ,otenial erta tin(aan ,erbaian ang (ila)an (i,anta) (an (i(o)'entaian (engan bai e)ai (engan PT=M/!.11-10/BPM/09. !.11.5 A)(it Ta'ba+an Dia',ing ,rogra' a)(it ang (iren8anaan elo',o =a'inan M)t) 'ela)an a)(it ta'ba+an a,abila i(entiiai eti(ae)aian %ite' Mana*e'en 'eni'b)lan erag)an ,a(a ee)aian laboratori)' (engan ebi*aan (an/ata) ,roe()r ,i+a lain/,elanggan )nt) 'enent)an ,enebab ,er'aala+an e)ai (engan PT=M/!.11-10/BPM/09. 1. Maala+ (ii(entiiai (ari egiatan: Pengen(alian ,eer*aan ang ti(a e)ai • a*i Ulang %ite' Mana*e'en • U',an bali (ari ,elanggan • Analii ,enebab • - Peraratan ,elanggan - %a',el (an ,eiiaina - Meto(e (an ,roe()r - Peronel - Peralatan (an ba+an - alibrai Pe'ili+an alternati • 2. Pelaanaan tin(aan Tin(aan ,enia(aan 'aala+ • A)(it )lang ,a(a titi ber'aala+ •

. Pe'anta)an +ail tin(aan ,erbaian ?a,aa+ tela+ eeti@.


PANDUAN MUTU T7NDAAN P#N>#$A&AN


: !.12 : 5/ 05 - 01 – 2009


!.12.1 A8)an : 7%/7#> 1025:2005 !.12.2 Dala' ranga Tin(aan Pen8ega+an laboratori)' enantiaa 'ela)an i(entiiai ,e'anta)an (an (o)'entai ter+a(a, ,enebab eti(ae)aian ang ,otenial erta 'a',) 'enga'bil 'anaat )nt) 'ela)an ,eningatan iner*a %ite' Mana*e'en laboratori)' e)ai (engan PT=M/!.1211/BPM/09. !.12. Unt) 'en*a'in eetina tin(aan ,en8ega+an (ilaanaan (ari ta+a, a

PANDUAN MUTU P#N$#NDA"7AN R#AMAN


: !.1 : 5/ 05 - 01 – 2009


!.1.1 A8)an : 7%/7#> 1025:2005 !.1.2 ebi*aan "aboratori)' 'eneta,an (an 'e'eli+ara ,roe()r )nt) i(entiiai ,eng)',)lan ,e'berian in(e ,engaean ,engari,an ,eni',anan ,e'eli+araan (an ,e')na+an rea'an ')t) (an rea'an teni.

!.1. %ite' Rea'an %ite' Rea'an 'eli,)ti rea'an ')t) (an rea'an teni +ar) (a,at (iba8a (i,eli+ara (an (ii',an (engan bai a'an erta (i*aga era+aiaanna e)ai (engan PT=M/!.-0/BPM/09 (an PT=M/!.1-12/BPM/09. Rea'an ')t) antara lain: "a,oran A)(it 7nternal a*i Ulang Mana*e'en Tin(aan Perbaian Tin(aan Pen8ega+an (an &ail U*i Proiieni. Rea'an teni antara lain Rea'an Penga'atan &ail Data/inor'ai )nt) a)(it Rea'an %ta %alinan %ertiiat Peng)*ian "e'baran er*a B)) er*a "e'bar Peria >atatan er*a %ertiiat alibrai (an Rea'an alibrai. !.1.! Per)ba+an ter+a(a, Rea'an %etia, eala+an (ala' rea'an +ar) (i8oret teta,i 'ai+ +ar) bia (iba8a. Perbaian (it)li e'bali (an (iberi ,ara. Bagi rea'an ang (ii',an e8ara eletroni tin(aan ang e,a(an +ar) (ila)an )nt) 'en8ega+ +ilang ata) ber)ba+na (ata ali e)ai (engan PT=M/!.-0/BPM/09 (an PT=M/!.112/BPM/09. !.1.5 =anga

PANDUAN MUTU AUD7T 7NT#RNA"


: !.1! : 5/ 05 - 01 – 2009


!.1!.1 A8)an : 7%/7#> 1025:2005 !.1!.2 ebi*aan A)(it internal (ilaanaan e8ara ter,rogra' 'ini'al eta+)n eali ole+ Mana*er M)t) (an +ail a)(it (i(o)'entaian. %etia, a(ana ,eni',angan (ia',aian e,a(a Mana*er Teni )nt) (ila)an ,erbaian ,a(a

PANDUAN MUTU A=7 U"AN$ MANA=#M#N


: !.15 : 5/ 05 - 01 – 2009


!.15.1 A8)an : 7%/7#> 1025:2005 !.15.2 a*i Ulang Mana*e'en Mana*er P)n8a 'elaanaan a*i )lang 'ini'al at) ali (ala' eta+)n )nt) 'engeta+)i eina'b)ngan e8o8oan (an eetiita %ite' Mana*e'en (an egiatan ang (ila)an e)ai (engan PT=M/!.15-1!/BPM/09. a*i )lang (ila)an (engan 'e',er+it)ngan: 1. e8o8oan ebi*aan (engan ,roe()r 2. "a,oran (ari ,eronel enior . &ail a)(it internal ang tera+ir !. Tin(aan ,en8ega+an (an ,erbaian 5. Ae'en ole+ Ba(an #ternal 4. &ail )*i ban(ing antar laboratori)' ?U*i Proiieni@ . Per)ba+an vol)'e (an *eni ,eng)*ian . U',an bali (ari ,elanggan 9. Penga()an 10. ;ator-ator e,erti Pengen(alian M)t) 7nternal a*i Ulang Do)'en %ite' Mana*e'en %)'ber Daa Man)ia (an Pelati+an Peronel. !.15. Te')an a*i )lang 'ana*e'en (an ren8ana tin(aan ang (ila)an +ar) (irea' (an 'ana*e'en 'e'atian tin(aan (ila)an (ala'

PANDUAN MUTU P#R%ARATAN T#N7% UMUM


: 5.1 : 5/ 05 - 01 – 2009


5.1.1

A8)an : 7%/7#> 1025:2005

5.1.2

ebenaran (an e+an(alan ,eng)*ian ang (ila)an (i laboratori)' ,eng)*ian Balai PM (i Pal) angat (itent)an ole+ berbagai ator ang 'eli,)ti: 1. ;ator 'an)ia 2. on(ii ao'o(ai (an ling)ngan . Meto(e ,eng)*ian !. Peralatan 5. etertel))ran ,eng))ran 4. Penga'bilan 8onto+ . Penanganan 8onto+ ang (i )*i

5.1.

ontrib)i 'aing-'aing ator ter+a(a, eti(a,atian ,eng))ran total berbe(a ,a(a ,eng)*ian ang at) (an lainna. "aboratori)' ,eng)*ian Balai PM (i Pal) +ar) 'e',er+it)ngan ator-ator tereb)t (ala' 'enge'bangan 'eto(e ,roe()r ,eng)*ian (ala' ,elati+an (an )aliiai ,eronel erta ,e'ili+an ,eralatan.


PANDUAN MUTU P#R%N7"


: 5.2 : 5/ 05 - 01 – 2009


5.2.1

A8)an : 7%/7#> 1025:2005

5.2.2

ebi*aan "aboratori)' ,eng)*ian Balai PM (i Pal) 'e'ilii ,eronel (ala' *)'la+ 8)), (engan ,engeta+)an e'a',)an (an ,engala'an teni ang 'e'a(ai e+ingga elan8aran ,eng)*ian (an ebenaran +ail (a,at (i*a'in. %etia, ,eronel 'e'a+a'i t)*)an %ite' Mana*e'en ang tert)ang (ala' Pan()an M)t) erta (o)'en ,en)n*angna.

5.2.

A,abila laboratori)' A,abila laboratori)' 'e'ilii ,eronel ang (iaraan ata) (iontra ter'a) ,eronel teni erta ,eronel ,en())ng inti ta'ba+an )nt) 'elaanaan egiatan tertent) 'aa laboratori)' +ar) 'e'atian ba+
5.2.!

)aliiai 1. Peronil %enior laboratori)' +ar) 'e'ilii latar belaang ,en(i(ian teni 'ini'al etara (engan %ar*ana ?%1@ (a,at 'engelola laboratori)' e8ara eeti erta 'e'ilii ,engeta+)an (an etera',ilan teni (ala' 'en)n*ang t)gana. 2. Peronil ,eng)*i +ar) 'e'ilii latar belaang ,en(i(ian teni ata) ,elati+an teni (an tela+ ber,engala'an (i bi(ang ,eng)*ian tertent) ang 'en)n*ang t)gana. . Peronil A('initrai 'e'ilii latar belaang ,en(i(ian 'ini'al etara %eola+ Menenga+ U')' ?%MU@ 'engeta+)i (an 'a'a+a'i egiatan laboratori)' e8ara )')' )nt) 'en)n*ang t)gana. !. Peneri'aan ,ega
5.2.5

T)ga (an tangg)ng *a

PANDUAN MUTU P#R%N7"


: 5.2 : 5/ 05 - 01 – 2009


5.2.4

Uraian t)ga 1. %etia, ,eronel 'e'ilii Uraian T)ga ang (ii',an 'aing-'aing laboratori)' (i bagian a('initrai (an elo',o =a'inan M)t). 2. Uraian T)ga berii e()()an +)b)ngan ,eronel tangg)ng *a
5.2.

Rea'an ,eronil "aboratori)' +ar) 'e'eli+ara (an 'eni',an rea'an ang relevan (ari (ata el)r)+ ,eronel teni ter'a) ,eronel ang (iontra ata) (iaraan e)ai (engan PT=M/5.2-1/BPM/09. 1. Rea'an ,eronel (ii',an ,a(a elo',o =a'inan M)t) e(angan tin(aan Rea'an Peronil (ii',an (i 'aing-'aing laboratori)' (an bagian a('initrai. 2. Rea'an Peronel berii ri
5.2.

Pelati+an (an ,eningatan %DM Unt) 'eningatan ,engeta+)an e'a',)an (an etera',ilan ,eronel erta

PANDUAN MUTU ND7%7 AMDA%7 DAN "7N$UN$AN


: 5. : 5/ 05 - 01 – 2009


5..1

A8)an : 7%/7#> 1025:2005

5..2

ebi*aan Balai PM (i Pal) 'e'ilii bang)nan (an ling)ngan laboratori)' ,eng)*i e)ai (engan ,eraratan. Pengg)naan r)angan ang 'e',engar)+i ')t) (a,at (ien(alian.

5..

on(ii ao'o(ai (an ling)ngan (a,at (i,anta) e)ai (engan PT=M/5.14/BPM/09. 1. "aboratori)' 'e'anta) 'engen(alian (an 'erea' on(ii ling)ngan ang (i,eraratan ole+ ,eiiai 'eto(e (an ,roe()r ang relevan ata) bila on(ii 'e',engar)+i ')t) +ail. 2. Bagi ,eng)*ian ang 'e'erl)an r)angan (engan on(ii +)) (ilenga,i (engan (in(ing ,e'ia+ ang eeti (an (engan ,eralatan ang e)ai. . Rea'an on(ii ling)ngan (ii',an ole+ ,et)ga ang (it)n*) ,int) r)angan (i*aga elal) tert)t), g)na 'en*aga on(ii r)angan *alan 'a) (an ,engg)naan r)angan ang 'e',engar)+i ')t) ,eng)*ian (iteta,an (an (ia
5..!

eberi+an (an ea'anan "ing)ngan %e')a ,eronel bertangg)ng *a

PANDUAN MUTU M#TD# P#N$U=7AN DAN EA"7DA%7 M#TD#


: 5.! : 5/ 05 - 01 – 2009

Revii/ Tgl

: !/ 05 - 01 - 2009


A8)an : 7%/7#> 1025:2005 ebi*aan Meto(e (an ,roe()r ,eng)*ian 'enga8) ,a(a %tan(ar Naional e,erti %N7 140201-1995 ?;7 7E@ regional internaional 'eto(e ang (ie'bangan en(iri ole+ PPMN. Bila (i,erl)an (a,at 'e',erg)naan 'eto(e lain ang tela+ (ivali(ai (an (iet)*)i ,elanggan. Pe'ili+an Meto(e (ila)an e)ai (engan PT=M/5.!-15/BPM/09. 1. Dala' ,elaanaan ,eng)*ian laboratori)' 'engg)naan 'eto(e ba) ang )(a+ (i,)bliaian (ala' tan(ar internaional regional naional ata) (i,erole+ (ari organiai teni ang 'e',)nai re,)tai ?PPMN@. %el)r)+ 'eto(e ba) ang (ig)naan (iveriiai terlebi+ (a+)l) ole+ Mana*er Teni ebel)' (ig)naan. 2. Meto(e ba) ti(a ba) (an ang (ie'bangan en(iri ebel)' (ig)naan )(a+ (ivali(ai. . Pelanggan +ar) (iberi inor'ai tentang 'eto(e ang (i,ili+ )nt) ,eng)*ian. Meto(e ang (ie'bangan laboratori)' Penge'bangan 'eto(e )nt) e,erl)an en(iri beerta vali(ai 'en*a(i tangg)ng *a

PANDUAN MUTU M#TD# P#N$U=7AN DAN EA"7DA%7 M#TD#


: 5.! : 5/ 05 - 01 – 2009


Pengen(alian (ata 1. Per+it)ngan (an ,e'in(a+an (ata 'elal)i ,enge8ean ang e)ai 'en)r)t 8ara ite'ati. 2. Pengen(alian (ata 'elal)i o',)ter (i,eli+ara )nt) 'e'atian elaaan )ngina (an (ilenga,i (engan on(ii ling)ngan (an ,roe()r ,engo,eraian agar e)t)+an (an era+aiaan (ata ,eng)*ian (a,at ter*a'in e)ai (engan PT=M/5.!-0/BPM/09.


PANDUAN MUTU P#RA"ATAN


: 5.5 : 5/ 05 - 01 – 2009


5.5.1

A8)an : 7%/7#> 1025:2005

5.5.2

ebi*aan Peralatan (i laboratori)' ,eng)*ian 'e'en)+i ,eiiai (itent)an (ala' tan(ar erta elal) bera(a (ala' ea(aan 'e'en)+i arat ,eng)*ian. Dala' ea(aan tertent) a,abila laboratori)' +ar) 'eng)naan ,eralatan (il)ar ,enga 1025:2005.

5.5.

Progra' alibrai Progra' alibrai ang (iteta,an )nt) bearan ata) nilai )ta'a (ari ,eralatan ang ber,engar)+ ter+a(a, ')t) +ail )*i. Pera
5.5.!

Peralatan (io,eraian ole+ ,eronel e8ara bertangg)ng *a
5.5.5

Peralatan (an ,iranti l)na Peralatan (an ,iranti l)na ang (ig)naan )nt) ,eng)*ian +ar) 'a',) 'eng+ailan a)rai ang (i,erl)an (an +ar) e)ai (engan ,eiiai ang relevan (engan ,eng)*ian ang (i'a)(. Progra' alibrai +ar) (iteta,an )nt) bearan ata) nilai )ta'a (ari ,eralatan ang iat-iatna 'e',)nai ,engar)+ ang igniian ,a(a +ail. %ebel)' (ig)naan ,eralatan +ar) (ialibrai (an (i8e )nt) 'eneta,an ,eralatan tereb)t 'e'en)+i ,erartan ,eiiai laboratori)' (an e)ai (engan ,eiiai tan(ar relevan e)ai (engan PT=M/5.4-19/BPM/09.

5.5.4

Rea'an Ri
5.5.

"aboratori)' 'e'ilii ,roe()r ,enanganan ,eralatan 1. %etia, ,eralatan (ite',atan ,a(a loai ang e)ai (ilenga,i (engan intr)i ,engg)naanna e)ai (engan PT=M/5.5-19/BPM/09. 2. %etia, ,e'in(a+an ata) ,e'in*a'an intern ,eralatan (ilaanaan ei*in Penelia (engan e,engeta+)an Mana*er Teni.

. "aboratori)' 'e'ilii ,roe()r )nt) 'e'atian ,eralatan (i')ta+iran a,abila ter(a,at ator orei etela+ (ialibrai e)ai (engan PT=M/5.419/BPM/09. BALAI PENGAWAS OBAT DAN MAKANAN DI PALU

PANDUAN MUTU P#RA"ATAN


: 5.5 : 5/ 05 - 01 – 2009


5.5.

%etia, ,eralatan (an ba+an ba) ,e'ban(ing ang 'en)n*)an ,eni',angan (iberi i(entita ang *ela.

5.5.9

Peralatan laboratori)' ang tela+ (ialibrai (iberian label o(e/i(entita lain )nt) i(entiiai tat) alibrai.

5.5.10 "aboratori)' 'en*a'in ea'anan 'engaibatan eti(aaba+an +ail )*i.

,eralatan

(ari

,enetelan

ang


PANDUAN MUTU #T#RT#"U%URAN P#N$UURAN


: 5.4 : 5/ 05 - 01 – 2009


5.4.1

A8)an : 7%/7#> 1025:2005

5.4.2

ebi*aan Peng)*ian ang (ila)an (i laboratori)' ,eng)*i Balai PM (i Pal) 'e'ilii etertel))ran e tan(ar naional/regional/internaional )nt) at)an ))rna.

5.4.

"aboratori)' ,eng)*ian Balai PM (i Pal) 'e'ilii ,rogra' alibrai )nt) ,eralatan )ta'a )nt) 'en*aga etertel))ran e tan(ar naional e)ai (engan PT=M/5.4-19/BPM/09.

5.4.!

"aboratori)' 'ela)an ,enge8ean alat )nt) 'e'eli+ara tat) alibrai (ari tan(ar e)ai (engan PT=M/5.4-19/BPM/09.


PANDUAN MUTU P#N$AMB7"AN >NT&


: 5. : 4 05 - 01 – 2009

Revii/ Tgl : 5/ 05 - 01 - 2009 &ala'an : 1 (ari 1 Diet)*)i : Mana*er M)t)

5..1

ebi*aan "aboratori)' ,eng)*ian Balai PM (i Pal) ti(a 'ela)an ,enga'bilan 8onto+. >onto+ (iteri'a (ari ,elanggan internal (an ,elanggan eternal.

5..2

Pelanggan 7nternal a(ala+ %ei Pe'eriaan (an Peni(ian Balai PM (i Pal).

5..

Pelanggan #ternal a(ala+ ,elanggan (i l)ar intani Balai PM (i Pal).


PANDUAN MUTU P#NAN$ANAN >NT& AN$ D7U=7


: 5. : / 05 - 01 – 2009

Revii/ Tgl : / 05 - 01 - 2009 &ala'an : 1 (ari 1 Diet)*)i : Mana*er M)t)

5..1

A8)an : 7%/7#> 1025:2005

5..2

ebi*aan >onto+ ang (i)*i (ii(entiiai (engan *ela (an (i,erta+anan on(iina +ingga aat ,e')na+an.

5..

Peneri'aan (an ,enangan 8onto+ )*i Peneri'aan 8onto+ (an ,enanganan 8onto+ U*i laboratori)' ,eng)*ian Balai PM (i Pal) 'engi)ti ,roe()r ang tela+ (itent)an e)ai (engan PT=M/5.-20/BPM/09.

5..!

Abnor'aliai ata) ,eni',angan (ari on(ii nor'al 8onto+ )*i +ar) (irea'. Unt) 'en8ega+ er)aan ')t) 8onto+ )*i ,erl) (ii',an ,a(a on(ii ling)ngan ang (i,eraratan ari, 8onto+ )*i (ii',an (i )b bagian Tata Ua+a e8)ali (inataan lain ari, 8onto+ )*i ang 'e'en)+i arat (ii',an ela'a  ?tiga@ b)lan (an ang ti(a 'e'en)+ arat (ii',an ela'a 1 ?at)@ ta+)n e)ai (engan PT=M/5.-20/BPM/09.

5..5

Al)r (itrib)i 8onto+ 1. >onto+ ang beraal (ari ,elanggan beerta %)rat Per'intaan U*i (iera+an e ,et)ga ,eneri'a 8onto+ (i %)b Bagian Tata Ua+a (an (i8atat. 2. >onto+ beerta %)rat Per'intaan U*i ang tela+ (i (i,oii ole+ Mana*er A('initrai (iera+an e Mana*er Teni. . >onto+ beerta %)rat Perinta+ er*a ang (ib)at ole+ Mana*er Teni (iera+an e,a(a Penelia. !. >onto+ beerta %)rat Perinta+ Peng)*ian (ari Penelia (iera+an e,a(a ta ,eng)*i.


PANDUAN MUTU =AM7NAN MUTU &A%7" P#N$U=7AN


: 5.9 : 5/ 05 - 01 – 2009


5.9.1

A8)an : 7%/7#> 1025:2005

5.9.2

Unt) 'en*a'in eaba+an +ail ,eng)*ian laboratori)' ,eng)*ian Balai PM (i Pal) enantiaa 'ela)an Progra' Pengen(alian M)t) e)ai (engan PT=M/5.9-21/BPM/09.

5.9.

Agar egala e8en(er)ngan ata) eti(ae)aian (a,at (i(etei lebi+ a
5.9.!

%elain a)(it ')t) e8ara berala laboratori)' 'en*a'in ')t) +ail ,eng)*ian antara lain ebagai beri)t: 1. eterat)ran ,engg)naan Ba+an A8)an Berertiiat ata) Pengen(alian M)t) 7nternal 'engg)naan ba+an a8)an e)n(er. 2. U*i ban(ing antar laboratori)' ata) Progra' U*i Proeieni. . Peng)*ian )lang ,a(a 8onto+ )*i ang 'ai+ a(a.


PANDUAN MUTU P#"APRAN &A%7"


: 5.10 : 5/ 05 - 01 – 2009


5.10.1 A8)an : 7%/7#> 1025:2005 5.10.2 ebi*aan &ail etia, ,eng)*ian ata) erangaian ,eng)*ian ang (ila)an laboratori)' (ila,oran e8ara a)rat *ela ti(a 'erag)an (an ob*eti (ala' bent) la,oran ata) ertiiat ,eng)*ian (engan 'engg)naan or'at ang )(a+ (itent)an )nt) ,elanggan eternal. Unt) ,elanggan internal +ail )*i (ila,oran (ala' bent) rea,it)lai (ala' )r)n

PANDUAN MUTU P#"APRAN &A%7"


: 5.10 : 5/ 05 - 01 – 2009


5.10.5 eaba+an "a,oran Peng)*ian 1. %e')a "a,oran Peng)*ian +ar) *ela ti(a 'enebaban erag)an ,e'ba8a ata) ,engiri' 8onto+ ?,elanggan@ 2. %etia, +ail ang aan (i8ant)'an (ala' "a,oran Peng)*ian )nt) (iterbitan +ar) (i,eria ole+ ang ber
"a',iran 2

STRUKTUR ORGANISASI BALAI PENGAWAS OBAT DAN MAKANAN DI PALU BERDASARKAN KEPUTUSAN KEPALA BADAN PENGAWAS OBAT DAN MAKANAN

No- 05108/SK/KBPOM Ta"$$a 17 M#! 001

KEPALA

SUB BAGIAN TATA USAHA

SEKSI SERTIFIKASI DAN LIK

SEKSI PENGUJIAN PANGAN DAN BB

SEKSI PENGUJIAN MIKROBIOLOG I

SEKSI PENGUJIAN TERANOKOKO

KELOMPOK JABATAN FUNGSIONAL

SEKSI PEMERIKSAAN DAN PENYIDIKAN

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PANDUAN MUTU #B7=AAN MUTU


: 2.1 : 5/ 05 - 01 – 2009


Mana*e'en "aboratori)' Peng)*ian Balai Penga
Mana*e'en Balai PM tangga, (an 8e,at bertin(a 'engatai 'aala+ ,roeional (an 8er'at (ala' 'elaanaan t)ga 'e'ilii integrita (an re(ibilita ang (ia)i 'aaraat erta enantiaa 'eng)ta'an 'ana*e'en ti'. Unt) egiatan ,eng)*ian (ilaanaan ber(aaran %ite' Mana*e'en M)t) ang e)ai (engan 7%/7#> 1025:2005 g)na 'e'berian *a'inan oniteni (an o',eteni teni ,eng)*ian (ala' ling), egiatanna. %ite' Mana*e'en M)t) "aboratori)' Balai PM (it)angan (ala' ,an()an ')t) ,roe()r ')t) (an intr)i er*a ang (i(o)'entaian (i'engerti (an (ilaanaan ole+ e')a ,eronil e8ara ,roeional. %aaran M)t) : 'ena'ba+ *)'la+ r)ang ling), are(itai 'ena'ba+ *)'la+ intr)i er*a'eto(e analii ang (iveriiai (an Reare(itai laboratori)' balai PM (i Pal) (a,at terlaana

Ma"a%#r P("a&

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:4.2

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4.2.-

A1/an ISO!EI -3$2#*2$$# 4.2.2 Kebi0aan

Pan/an ,// ,er/5aan o/,en a)ar )i)e, ,ana0e,en ,// 6ang i,i"ii o"e7 Ba"ai Be)ar POM )ebagai )/a/ "aboraori/, 5eng/0ian ,// /n/ ,e,en/7i 5er)6araan Peo,an ISO!EI -3$2#%2$$#. Ba"ai Be)ar POM ,e,5/n6ai )i)e, ,ana0e,en ,// 6ang ,en1a/5 )r//r organi)a)i8 e9a0iban8 5rogra,8 5ro)e/r8 in)an)i )era )/,ber a6a 6ang )e)/ai engan egiaan Ba"ai Be)ar POM an ,e,en/7i ISO!EI -3$2#%2$$#. 4.2. T/0/an Si)e, Mana0e,en M// Meningaan o,5een)i an 5e"a6anan "aboraori/, 5eng/0ian 6ang ,er/5aan bagian ari organi)a)i 6ang "ebi7 be)ar 6ang a5a io5era)ian engan )i)e, ,ana0e,en ,// 6ang 0e"a) e)e)/aiann6a engan ISO!EI -3$2#*2$$#. 4.2.4 Sa)aran M//

1. Mena,ba7 0/,"a7 r/ang "ing/5 areia)i 2. Mena,ba7 0/,"a7 In)r/)i Ker0a Meoe Ana"i)a 6ang i(eri;ia)i . Rereia)i Laboraori/, Ba"ai Be)ar POM i Poniana a5a er"a)ana

4.2.# Pan/an M// -. Pan/an ,// i)/)/n an ie,bangan )ebagai a1/an er0a Ba"ai Be)ar POM /n/ ,en1a5ai )a)aran ,// 6ang iinginan. 2. Do/,en ,// 6ang "ain8 5ro)e/r o5era)iona"8 in)r/)i er0a an ;or,a%;or,a )era o/,en 5en//ng ie,bangan an iena"ian o"e7 Ke"o,5o Ja,inan M// )e)/ai engan POB Pengena"ian Do/,en. 4.2.& +irari o/,en ,// Ba"ai Be)ar POM eriri ari : Le(e" - Pan/an M// Meng/raian gari) be)ar ebi0aan )i)e, ,ana0e,en ,// "aboraori/, 6ang iera5an i Ba"ai Be)ar POM. Do/,en ini i)a7an o"e7 Mana0er P/n1a.

2. 3. 11. 1. -Panduan-Mutu.doc

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