abc qualitymanual

7/25/2019 ABC QualityManual

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ABC Quality Manual

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Document Info

DOC ID ABC-QualityManual

DOC NAME Quality Manual of ABC CompanyFILE NAME ABC-QualityManual.doc

CONTROLLER QMG

ER!ION ".#

RELEA!E DATE (Date baselined after approval)

A$T%ORED B&

REIE'ED B&

A((ROED B&

History

ER!ION DATE A$T%ORED)REI!ED B&

REIE'EDB&

A((ROEDB&

REA!ON FORAMENDMENT

*.# Quality

o+,cti/ madma/u0a+l

".#

Version 2.0 Confidential Page 1 of 46


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QUALITY MANUAL

Quality Manual App0oal/

Name Position Signature Date

(0oducd +y QMG

App0od +y Mana1mntRp0/ntati

2MR3

Aut4o0i5d +y CEO



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REVISIN HISTRY

Re!ision

No"

Date of

Re!ision

Re!ise# $y Reason for U%#ate

*.* QMG Includd nam of MR

*."

*.6



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Ta&'e of (ontents

M//a1 f0om t4 (0/idnt.............................................................................................................6

*. Int0oduction............................................................................................................................6*.*. !cop..................................................................................................................................6*.". Application) Inclu/ion) E7clu/ion......................................................................................6

*.6. Dfinition/8 A++0iation/ and Ac0onym/.........................................................................6

". Company (0ofil....................................................................................................................6".*. Contact Info0mation............................................................................................................6

6. Quality (olicy and Quality O+,cti/..................................................................................6

6.*. Quality (olicy.....................................................................................................................66.". Quality O+,cti/..............................................................................................................6

9. Quality !y/tm.......................................................................................................................6

9.*. Quality !y/tm Modl........................................................................................................6:. Mana1mnt R/pon/i+ility..................................................................................................6

:.*. Mana1mnt Commitmnt.................................................................................................6

:.". Cu/tom0 Focu/..................................................................................................................6

:.6. Quality (olicy.....................................................................................................................6:.9. Quality (lannin1.................................................................................................................6

:.:. R/pon/i+ility8 Aut4o0ity and Communication..................................................................6

:.;. Mana1mnt Ri.6. D/i1n and Dlopmnt...................................................................................................6

>.9. (u0c4a/in1..........................................................................................................................6>.:. (0oduction and !0ic.......................................................................................................6

?. Ma/u0mnt8 Analy/i/ and Imp0omnt............................................................................6

?.*. Gn0al...............................................................................................................................6?.". Monito0in1 and Ma/u0mnt............................................................................................6

?.6. Cont0ol of nonconfo0min1 p0oduct.....................................................................................6

?.9. Analy/i/ of Data.................................................................................................................6?.:. Imp0omnt.......................................................................................................................6

@. Appndic/............................................................................................................................6



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Message from t)e Presi#ent

In o0d0 fo0 ABC to maintain it/ po/ition a/ a p0oid0 of 1lo+al uality /oft


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*" Intro#uction

T4i/ documnt d/c0i+/ t4 o0all uality /y/tm at ABC and i/ a mandato0y

0ui0mnt of t4 /y/tm. It includ/ all 0ui0mnt/ of I!O @##* "###. It al/o includ/

additional 0ui0mnt/ nc//a0y fo0 ABC to + a


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cu/tom0 ltt0 of accptanc3 o0 any ot40

l1al commitmnt nt0d into +y ABC todli0 a p0oduct o0 /0ic.

App0oin1 Official ABC p0/on aut4o0i5d to app0o a Cu/tom0A10mnt.

O+,cti Eidnc Info0mation


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!QA !oft


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."*" Qua'ity Po'icy

QUALITY PLI(Y

$%tate company&s quality policy here!'

ABC Mana1mnt n/u0/ t4at t4 company/ uality policy

I/ app0op0iat fo0 t4 pu0po/ of ABC actiiti/

Includ/ commitmnt/ to comply


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."+" Qua'ity &0ecti!es

QUALITY $1E(TIVES

$%tate company&s quality obectives here!'

2" Qua'ity System

To ac4i ou0 uality 1oal/8 it i/ nc//a0y t4at 0y+ody in ABC u/ t4 /am

p0oc///8 p0ocdu0/ and p0actic/ and 4a/ t4 /am und0/tandin1 of 7cutin1 a p0o,ct. T4i/

i/ po//i+l only if all t4 p0ocdu0/ and p0actic/ a0 a/ily aaila+l in on plac. T4i/ i/ac4id +y maintainin1 t4 Quality !y/tm.

Quality !y/tm i/ a documntd n1in0in1 p0oc// t4at idntifi/ t4 /tp/ follo


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! t4 fi1u0 a+o. T4/ p0oc/// and actiiti/ a0 10oupd a/

!oft


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2"*"*" Qua'ity System Management Process

ABC 4a/ /ta+li/4d and documntd a Quality !y/tm and maintain/ it a/ a man/ ofn/u0in1 t4at ou0 p0oduct/ and /0ic/ confo0m to /pcifid 0ui0mnt/.

T4 0ui0mnt/ of t4i/ Quality !y/tm a0 dfind in t4 follo


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2"*"." Qua'ity System Documents 6 Data (ontro'

ABC 4a/ /ta+li/4d a documntd p0ocdu0 to cont0ol t4 c4an1/ to all t4 uality

documnt/ 2li= t4 Quality Manual8 (0ocdu0/8 Guidlin/8 Tmplat/8 C4c=li/t/8 !tanda0d/

and Fo0m/3 and data to n/u0 t4at t4 mo/t 0cnt 0i/ion of t4/ documnt/8


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Fo0mat of Quality Documnt/

All uality documnt/ fo0 t4 Tc4nical Dpa0tmnt a0 fo0mattd in a unifo0m tmplat.Eac4 uality documnt


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p0otction8 0t0ial8 0tntion tim and di/po/ition of 0co0d/. ABC 0ui0/ t4at Quality

Rco0d/ mu/t +

Idntifid8 collctd8 fild8 /to0d8 maintaind8 and di/po/itiond acco0din1 to

documntd p0ocdu0/8

Rtaind fo0 /ta+li/4d 0tntion tim/8

L1i+l8

!to0d in an app0op0iat ni0onmnt to p0nt dt0io0ation8

Radily 0t0ia+l8 and

Aaila+l to cu/tom0/


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Ri


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T4 p0oduct


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!oft


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All t4 0u/t/ f0om t4 cu/tom0


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T0ac=in1 and 0i


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T4/ a0 don on t4 documnt/ to n/u0 t4at t4y a0 a/ p0 t4 0ui0mnt/.

QA Audit/

T4/ a0 t4 in/pction/ conductd on t4 ot40 itm/ li= Cod8 $/0 Int0fac8

(0ototyp/8 T/t R/ult/ and Final (0oduct to + dli0d to n/u0 t4 confo0mity

of t4 itm. E.1. Cod Ri


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T4i/ al/o includ/ t4 uniu idntification of ac4 dli0d p0oduct and all t4 0latd

/oft


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Re'ate# Proce#ures

Confi1u0ation Mana1mnt (0ocdu0 2rocedure Id3

2"*"


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!cu0ity Op0ation/

T40 a0 /t0ict /cu0ity p0ocdu0/ to + follo


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Timf0am fo0 maintainin1 any pa0ticula0 uality 0co0d


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;"." Qua'ity Po'icy

! 6.*.

;"2" Qua'ity P'anning

ABC n/u0/ t4at uality i/ an int10al pa0t of t4 d/i1n and dlopmnt of it/ p0oduct/

and /0ic/. It mp4a/i5/ t4 u/ of p0o+lm p0ntion and p0o+lm co00ction in o0d0 to

/upply uality p0oduct/ and /0ic/ to it/ cu/tom0/. T4 actiiti/ 1o0nd +y t4 Quality!y/tm a0 idntifid and documntd. T4/ documntd p0ocdu0/ a0 cont0olld and

ffctily implmntd to n/u0 t4at ABC p0oduct/ mt cu/tom0 0ui0mnt/. Quality

plannin1 i/ m+ddd in t4 p0ocdu0/ a/


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2Appndi7 A3. T4 dpa0tmnt 4ad/ a0 0/pon/i+l fo0 updatin1 t4i0 dpa0tmnt

0/pon/i+iliti/8 a/ t4 o01ani5ational /t0uctu0 of t4 company c4an1/.

;";"*" Presi#ent

T4 (0/idnt of ABC 4a/ ultimat 0/pon/i+ility to /ta+li/4 uality policy8 and


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Opn action itm/ f0om p0iou/ Mana1mnt Ri< mtin1/

Co00cti and p0nti action/

Int0nal audit /c4dul and p0o10//

Int0nal and E7t0nal audit 0/ult/

Mt0ic/ containd in t4 /y/tm ll and dpa0tmntal ll p0ocdu0/ Di/cu//ion on t4 /uita+ility and ffctin// of t4 Quality Mana1mnt !y/tm in

mtin1 t4 ABC Quality (olicy and o+,cti/

T4 MR n/u0/ t4at minut/ of t4 Mana1mnt Ri< mtin1/ a0 p0pa0d anddi/t0i+utd8 and t4at t4 /tatu/ of a//i1nd action itm/ i/ t0ac=d. Mana1mnt Ri< mtin1

minut/ a0 to + cont0olld in acco0danc


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T4 !E(G 0i


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T4 !E(G 4a/ /ta+li/4d and maintain/ a /t of /oft


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p0ocdu0/ a0 +in1 follo


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o01ani5ation.

En/u0 t4at t4 Quality !y/tm i/ /ta+li/4d8

documntd8 implmntd and maintaind.

R1ula0ly 0i< t4 /uita+ility and ffctin// of t4

Quality !y/tm Coo0dinat imp0omnt/ to t4 Quality !y/tm.

Liai/on


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n4ancmnt/ 0ui0d +y t4 cu/tom08 o0 if t4 dlay i/ cau/d +y t4 cu/tom0 in p0oidin1

info0mation o0 dlayin1 accptanc t/tin1. I//u/ connctd


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T0ainin1 Rco0d/

Rco0d/ of t0ainin1 a0 maintaind a/ Quality Rco0d/. '4n t4 mploy/ complt at0ainin1 p0o10amm8 t4 %R Dpa0tmnt


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Rui0d 0ification8 alidation8 monito0in18 in/pction and t/t actiiti/ /pcific to

t4 p0oduct and t4 c0it0ia fo0 p0oduct accptanc and

Rco0d/ ndd to p0oid idnc t4at t4 0ali5ation p0oc/// and 0/ultin1

p0oduct fulfill 0ui0mnt/.

T4 R/pon/i+l Mana10 /4all n/u0 t4at app0op0iat d/i1n and confi1u0ation

mana1mnt plan a0 dlopd8 implmntd and =pt up to dat in acco0danc


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ABC 4a/ /ta+li/4d and maintain/ a documntd p0ocdu0 to n/u0 t4at all pu0c4a/d

1ood/) /oft


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Cla0ly /tipulatd p0oduct c0it0ia8 /uc4 a/


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=";"2" (ustomer Pro%erty

Cu/tom0-/upplid p0oduct/ a0 0ifid to n/u0 t4at it do/ not comp0omi/ t4 ualitya/pct/ of ou0 p0oduct o0 /0ic/. T4 /to0a1 and maintnanc of t4/ p0oduct/ a0 cont0olld

/o t4at any lo//8 dama1 o0 un/uita+ility fo0 u/ of /uc4 p0oduct/


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T4 R/pon/i+l Mana10 /4all idntify and documnt /pcial p0ocdu0/ fo0 4andlin18

/to0a18 pac=a1in18 p0/0ation and dli0y if 0ui0d.

Re'ate# Proce#ures

(0ocdu0 fo0 !oft


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@##* "### 0ui0mnt/. Mana1mnt 0/pon/i+l fo0 t4 function/ +in1 auditd /4all 0i