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7/25/2019 ABC QualityManual
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ABC Quality Manual
QMG
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