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ISO 9000

What ?

Why ?

How ?
ISO 9000 - WHAT ?
1946
- Standardization Movement
- Formation o Internationa! Or"ani#ation or
Standardization - $ I%O%S% &&& ISO'
- ()r*o#e i# to deve!o* )niorm ")ide!ine# on
+)a!ity mana"ement #y#tem

19,-
- Formation o ISO Te.hni.a! /ommittee $T/ 106'
at 12
- ()r*o#e i# to de#i"n Standard# 3 4)ide!ine#
ISO 9000 - WHAT ?
19,0- Standard# 5orn
- ISO 9000 - F)ndamenta!#
- ISO 9001 - 6e#i"n
- ISO 900- - Man)a.t)rin"
- ISO 9007 - Servi.e
- ISO 9004 - 4)ide!ine#
19948 -000 3 -00, - Standard# revi#ed
ISO 90019-00,

- Result orientation [ System > System + Results]


- Quality Policy [No Structure > Structure ]
- Quality Objectives [ No Structure > SMART ones]
- ocumentation [ !ar"e > Meanin"#ul]
- $m%rovement #ocus [ &ontinuous > &ontinual]
- A%%roac' [ No Mo(el > No) Process Mo(el ]

S$MP!* TO +S* -
A ,OO TOO! -OR
OR,AN$SAT$ON *.*!OPM*NT
ISO 9001 STANDARD
Specifies Requirements
Quality Management System
S.o*e o ISO 90019-00,
The ISO 9001:2008 standad s!e"i#ies e$uiements The ISO 9001:2008 standad s!e"i#ies e$uiements
#% a QMS &hee an %ganisati%n: #% a QMS &hee an %ganisati%n:
1' needs t% dem%nstate its a(ility t% "%nsistently
!%)ide !%du"t * se)i"e that meets "ust%me
and a!!li"a(le egulat%y e$uiements+ and
2' aims t% enhan"e "ust%me satis#a"ti%n th%ugh
e##e"ti)e a!!li"ati%n %# the system+ in"luding
!%"esses #% "%ntinual im!%)ement %# the
system and the assuan"e %# "%n#%mity t%
"ust%me and a!!li"a(le egulat%y e$uiements'
S T R + & T + R * O - $ S O / 0 0 0
S * R $ * S O - S T A N A R S
The ISO 9000 series of standard contains
4 core standards:
a) ISO 9000:2005
QMS: Fundamentals and Vocabulary
b) ISO 9001:2008
QMS : Requirements
c) ISO 9004:2000
QMS : Guidelines for performance improvements
d) ISO 19011:2002
Guidelines for quality and environmental auditing
Quality Management ,in"i!les

*i"'t 1uality mana"ement %rinci%les 'ave been


i(enti#ie( t'at can be use( by to% mana"ement in
or(er to lea( t'e or"anisation to)ar(s im%rove(
%er#ormance2
&ustomer -ocus
!ea(ers'i%
$nvolvement o# %eo%le
Process A%%roac'
System a%%roac' to Mana"ement
&ontinual $m%rovement
-actual a%%roac' to (ecision ma3in"
Mutually bene#icial su%%lier relations'i%s
(:O/;SS

An %ganisati%n #un"ti%ns th%ugh a seies


%# a"ti)ities lin-ed t% ea"h %the t% deli)e
a se)i"e'

.a"h a"ti)ity % a set %# a"ti)ities ta-es


"etain in!uts and "%n)ets them int%
%ut!uts'

Su"h a"ti)ity % a set %# a"ti)ities &hi"h


tans#%m in!uts int% %ut!uts is "alled
,%"ess'
Mea#)re

Why mea#)re9
/hat "ann%t (e measued "ann%t (e
m%nit%ed'

Mea#)re what9
Th%se !aametes &hi"h in#luen"e
e##i"ien"y 0 e##e"ti)eness %# the !%"ess'
Quality Management System Requirements
:e+)irement S.o*e

Quality Management System - 1eneal e$uiements and D%"umentati%n


e$uiements'

Management Res!%nsi(ility - Management "%mmitment+ 2ust%me #%"us+



Quality !%li"y+ Quality %(3e"ti)es+ ,lanning+
Res!%nsi(ility+ auth%ity 0 "%mmuni"ati%n+
and Management e)ie&'

Res%u"e Management - ,%)isi%n %# es%u"es+ 4uman es%u"es+


In#astu"tue and /%- en)i%nment'

,%du"t Reali5ati%n - ,lanning+ 2ust%me e$uiements+ Design 0


de)el%!ment+ ,u"hasing+ ,%du"ti%n 0
se)i"e !%)isi%n and 2%nt%l %# m%nit%ing 0
measuing e$ui!ments'

Measuement+ Analysis and - M%nit%ing and measuement+ 2%nt%l %#


Im!%)ement n%n - "%n#%ming !%du"t+ Analysis %# data
0 2%ntinual im!%)ement'
6o.)ment# and :e.ord#
Documents Records
What it gives? Document gives guidance on what,
how, when, where to do?
Record gives historical evidence
how an activity was performed and
what results were achieved?
Possibility of
change
Documents keep changing with time
as everyone tries to find better
direction and better working methods.
Records, being history can not be
changed.
Eample !uality Policy
Responsibility
"rganisation #hart
!uality $anual
Procedure
Work %nstructions
&lank Record 'ormats
Drawings ( )pecifications
Price *ist
$aintenance )chedule
Production Plan etc.
%nspection and +est Records
#alibration Records
$anagement Review Records
%nternal !uality ,udit Reports
+raining Records
Design -erification Records
Design Review Records etc.
#ontrol defined in #lause ../.0. of %)" 12234/225 #lause ../... of %)" 12234/225
Re"%ds ae s!e"ial ty!e %# d%"uments and ae esta(lished and maintained t% !%)ide e)iden"e %# "%n#%mity t% e$uiements and %# e##e"ti)e
%!eati%ns %# the $uality management system'
The list %# mandat%y e"%ds as !e standad is:
Results %# management e)ie&s'
Re"%ds %# edu"ati%n+ e6!eien"e+ taining and $uali#i"ati%ns'
Re"%ds t% !%)ide e)iden"e that eali5ati%n !%"ess and esulting !%du"t meet e$uiement'
Results %# "ust%me e$uiement e)ie&s and a"ti%ns aising #%m e)ie&s'
Design and de)el%!ment in!ut elating t% !%du"t e$uiement'
Re"%ds %# design and de)el%!ment e)ie&s'
Results %# design and de)el%!ment )ei#i"ati%n and any ne"essay a"ti%ns'
Results %# the e)ie& %# design and de)el%!ment "hanges and any ne"essay a"ti%ns'
Results %# e)aluati%n %# su!!lies and any ne"essay a"ti%ns aising #%m the e)aluati%n'
.)iden"e %# )alidated !%"esses'
Ta"ea(ility 7&hee it is e$uiement8'
Re"%ds %# "ust%me !%!ety l%ss* damage * %the&ise #%und unsuita(le'
Results %# "ali(ati%n and )ei#i"ati%n'
Re"%ds %# intenal audit'
Re"%ds %# !%du"t "%n#%mity &ith a""e!tan"e "iteia indi"ating auth%ity es!%nsi(le #% elease %#
!%du"t'
Re"%ds %# the natue %# n%n"%n#%mities and any su(se$uent a"ti%ns ta-en+ in"luding "%n"essi%ns
%(tained'
Re"%ds %# esults %# "%e"ti)e a"ti%ns ta-en'
Re"%ds %# esults %# !e)enti)e a"ti%ns ta-en'
Mandatory :e.ord# :e+)ired 5y Standard
2lause N%' 9 :
Q'M'S ;Quality Management System<

9'1 : 1eneal Re$uiements

9'2 : D%"umentati%n Re$uiements


9'2'1 : 1eneal
9'2'2 : Quality manual
9'2'= : 2%nt%l %# d%"uments
9'2'9 : 2%nt%l %# e"%ds
2lause N%' > :
Management Res!%nsi(ility

>'1 : Management 2%mmitment

>'2 : 2ust%me ?%"us

>'= : Quality ,%li"y

>'9 : ,lanning

>'9'1 : Quality O(3e"ti)es
>'9'2 : QMS ,lanning

>'> : Res!%nsi(ility+ Auth%ity 0 2%mmuni"ati%n


>'>'1 : Res!%nsi(ility 0 Auth%ity
>'>'2 : Management Re!esentati)e
>'>'= : Intenal 2%mmuni"ati%n

>'@ : Management Re)ie&



>'@'1 : 1eneal
>'@'2 - Re)ie& In!ut
>'@'= : Re)ie& Out!ut


2lause N%' @ :
Res%u"e Management

@'1 : ,%)isi%n %# es%u"es

@'2 : 4uman Res%u"es


@'2'1 : 1eneal
@'2'2 - 2%m!eten"e+ Taining 0 A&aeness

@'= : In#astu"tue

@'9 : /%- .n)i%nment


2lause N%' A
,%du"t Reali5ati%n
A'1 : ,lanning %# !%du"t eali5ati%n
A'2 : 2ust%me elated !%"esses
A'2'1 : Deteminati%n %# e$uiements elated t% the !%du"t
A'2'2 : Re)ie& %# e$uiements elated t% the !%du"t
A'2'= : 2ust%me 2%mmuni"ati%n
A'= : Design 0 De)el%!ment
A'='1 : D 0 D !lanning
A'='2 : D 0 D in!uts
A'='= : D 0 D %ut!uts
A'='9 : D 0 D e)ie&
A'='> : D 0 D )ei#i"ati%n
A'='@ : D 0 D )alidati%n
A'='A : 2%nt%l %# D 0 D 2hanges
A'9 : ,u"hasing
A'9'1 : ,u"hasing !%"ess
A'9'2 - ,u"hasing in#%mati%n
A'9'= : Bei#i"ati%n %# !u"hased !%du"t
A'> : ,%du"ti%n and Se)i"e !%)isi%n
A'>'1 - 2%nt%l %# !%du"ti%n 0 se)i"e !%)isi%n
A'>'2 - Balidati%n %# !%"esses #% !%du"ti%n and se)i"e !%)isi%n
A'>'= - Identi#i"ati%n 0 ta"ea(ility
A'>'9 - 2ust%me !%!ety
A'>'> - ,ese)ati%n %# !%du"t
A'@ : 2%nt%l %# m%nit%ing and measuing e$ui!ment
2lause N%' 8 :
Measuement+ Analysis 0 Im!%)ement

8'1 : 1eneal

8'2 : M%nit%ing 0 Measuement


8'2'1 : 2ust%me Satis#a"ti%n
8'2'2 : Intenal Audit
8'2'= : M%nit%ing 0 Measuement %# ,%"esses
8'2'9 : M%nit%ing 0 Measuement %# ,%du"ts

8'= : 2%nt%l %# N%n : 2%n#%ming ,%du"t

8'9 : Analysis %# data

8'> : Im!%)ement
8'>'1 : 2%ntinual Im!%)ement
8'>'2 : 2%e"ti)e A"ti%n
8'>'= : ,e)enti)e A"ti%n
ISO 9000 - HOW ?

BISION+ MISSION+ QCADITE ,ODI2E 0


OFG.2TIB.S

DO2CM.NTATION
- QCADITE MANCAD
4%& d% &e "%m!ly t% QMS e$uiements H
- ,RO2.SS MANCAD
4%& d% %u !%"esses !e#%m H 4%& d% &e !e#%m %u %!eati%ns H

TRAININ1 - A/AR.N.SS I SEST.M I ACDIT

IM,D.M.NTATION

INT.RNAD QCADITE ACDIT I M1MT' MT1'

,R.-ACDIT I 2.RTI?I2ATION ACDIT I


,.RIODI2 * SCRB.IDDAN2. ACDIT
ISO 90019-00, - WH< ?

Main Objective 9

/ 1 S T O M ; :
/ O = F I 6 ; = / ;

ISO 90019-00, - WH< ?
4ene#its )'ic' or"anisation &AN TA5*

(>A==I=4

(;:FO:MA=/;

(:OA/TI?;=;SS

(OW;: FO: (:OFITS

To /)#tomer#

,%du"t "%n#%ming t% the


e$uiements

De!enda(le and elia(le !%du"t


Im!%)ed su!!ly

Dess n%n"%m!lian"e

2%m!etiti)e !i"ing

?a)%ua(le es!%nse t% "hanges

To Or"ani#ation

Redu"ed e3e"ti%n ate

Im!%)ed %!eati%nal esults

2%nsisten"y in %ut!ut

Im!%)ed "ust%me satis#a"ti%n

In"eased ma-et shae

In"eased etun %n in)estment

To ;m*!oyee#

De#ined %les and


es!%nsi(ilities

In"eased 3%( satis#a"ti%n

Im!%)ed m%ale

Fette &%-ing "%nditi%ns

In)%l)ement

,ide

To S)**!ier# and (artner#

Sta(ility

1%&th

,atneshi! and mutual


undestanding

To So.iety

?ul#illment %# legal and


egulat%y e$uiements

Im!%)ed health and sa#ety

Redu"ed en)i%nmental im!a"t


@1A>IT< MA=A4;M;=T S<ST;M

4%1% 4enera! re+)irement#%

The %gani5ati%n shall esta(lish+ d%"ument+
im!lement and maintain a $uality
management system and "%ntinually
im!%)e its e##e"ti)eness in a""%dan"e &ith
the e$uiements %# ISO 9001:2008
standad'
The or"anization #ha!!

a8 detemine the !%"esses needed #% the $uality management system
and thei a!!li"ati%n th%ugh%ut the %gani5ati%n 7see 1'2 %# ISO
9001:2008 standad8+
(8 detemine the se$uen"e and intea"ti%n %# these !%"esses'
"8 detemine "iteia and meth%ds needed t% ensue that (%th the
%!eati%n and "%nt%l %# these !%"esses ae e##e"ti)e'
d8 ensue the a)aila(ility %# es%u"es and in#%mati%n ne"essay t%
su!!%t the %!eati%n and m%nit%ing %# these !%"esses'
e8 m%nit%+ measue &hee a!!li"a(le+ and analy5e these !%"esses+
and
#8 im!lement a"ti%ns ne"essay t% a"hie)e !lanned esults and
"%ntinual im!%)ement %# the !%"esses'
These processes shall be managed by the organization
in accordance with the requirements of ISO 9001:00!
standard"

#here an organization chooses to outsource any process
that affects product conformity with to requirements$ the
organization shall ensure control o%er such processes"
The type and e&tent of control to be applied to these
outsourced processes shall be defined within the quality
management system"

=ote 19 ,%"esses needed #% the $uality management
system e#eed t% a(%)e in"lude !%"esses #% management
a"ti)ities+ !%)isi%n %# es%u"es+ !%du"t eali5ati%n+ and
measuement+ analysis and im!%)ement'
=ote -9 An J%uts%u"ed !%"essK is a !%"ess that the
%gani5ati%n needs #% its $uality management system and
&hi"h the %gani5ati%n "h%%ses t% ha)e !e#%med (y an
e6tenal !aty'
=ote 79 .nsuing "%nt%l %)e %uts%u"ed !%"esses d%es n%t
a(s%l)e the %gani5ati%n %# the es!%nsi(ility %# "%n#%mity t%
all "ust%me+ statut%y and egulat%y e$uiements' The ty!e
and e6tent %# "%nt%l t% (e a!!lied t% the %uts%u"ed !%"ess
"an (e in#luen"ed (y #a"t%s su"h as:
a8 the !%tential im!a"t %# the %uts%u"ed !%"ess %n the
%gani5ati%nLs "a!a(ility t% !%)ide !%du"t that "%n#%ms
t% e$uiements+
(8 the degee t% &hi"h the "%nt%l #% the !%"ess is shaed+
"8 the "a!a(ility %# a"hie)ing the ne"essay "%nt%l th%ugh
the a!!li"ati%n %# A'9'

4%-% 6o.)mentation re+)irement#
4%-%1 4enera!

The $uality management system d%"umentati%n shall in"lude
a8 d%"umented statements %# a $uality !%li"y and $uality
%(3e"ti)es+
(8 a $uality manual+
"8 d%"umented !%"edues and e"%ds e$uied (y this
Intenati%nal Standad+
d8 d%"uments+ in"luding e"%ds detemined (y the %gani5ati%n
t% (e ne"essay t% ensue the e##e"ti)e !lanning+ %!eati%n
and "%nt%l %# its !%"esses'
=ote 19 /hee the tem Jd%"umented !%"edueK a!!eas
&ithin this Intenati%nal Standad+ this means that the
!%"edue is esta(lished+ d%"umented+ im!lemented and
maintained' A single d%"ument may addess the
e$uiements #% %ne % m%e !%"edues' A e$uiement #%
a d%"umented !%"edue may (e "%)eed (y m%e than
%ne d%"ument'
=ote - 9 The e6tent %# the $uality management system
d%"umentati%n "an di##e #%m %ne %gani5ati%n due t%:
a8 the si5e %# %gani5ati%n and ty!e %#
a"ti)ities+
(8 the "%m!le6ity %# !%"esses and thei
intea"ti%ns+ and
"8 the "%m!eten"e %# !es%nnel'

N%te = : The d%"umentati%n "an (e in
any #%m % ty!e %# medium'


4%-%- @)a!ity Man)a!

The %gani5ati%n shall esta(lish and maintain a $uality manual that
in"ludes:

a8 the s"%!e %# the $uality management system+ in"luding details %#
and 3usti#i"ati%n #% any e6"lusi%ns ;see1'2<
(8 the d%"umented !%"edues esta(lished #% the $uality
management system+ % e#een"e t% them+ and
"8 a des"i!ti%n %# the intea"ti%n (et&een the !%"esses %# the $uality
management system'

4%-%7 /ontro! o do.)ment#

D%"uments e$uied (y the $uality management
system shall (e "%nt%lled' Re"%ds ae a s!e"ial
ty!e %# d%"uments and shall (e "%nt%lled a""%ding
t% the e$uiements gi)en 9'2'9'

A d%"umented !%"edue shall (e esta(lished t%
de#ine the "%nt%ls needed:


a8 t% a!!%)e d%"uments #% ade$ua"y !i% t% issue+
(8 t% e)ie& and u!date as ne"essay and e-a!!%)e d%"uments+
"8 t% ensue that "hanges and the "uent e)isi%n status %# d%"uments
ae identi#ied+
d8 t% ensue that ele)ant )esi%ns %# a!!li"a(le d%"uments ae a)aila(le
at !%ints %# use+
e8 t% ensue that d%"uments emain legi(le and eadily identi#ia(le+
#8 t% ensue that d%"uments %# e6tenal %igin detemined (y the
%gani5ati%n t% (e ne"essay #% the !lanning and %!eati%n %# the
$uality management system ae identi#ied and thei disti(uti%n
"%nt%lled and
g8 t% !e)ent the unintended use %# %(s%lete d%"uments+ and t% a!!ly
suita(le identi#i"ati%n t% them i# they ae etained #% any !u!%se'

4%-%4 /ontro! o re.ord#

Re"%ds shall (e esta(lished and maintained t%
!%)ide e)iden"e %# "%n#%mity t% e$uiements and %#
the e##e"ti)e %!eati%n %# the $uality management
system shall (e "%nt%lled'
The %gani5ati%n shall esta(lish a d%"umented
!%"edue t% de#ine the "%nt%ls needed #% the
identi#i"ati%n+ st%age+ !%te"ti%n+ etie)al+ etenti%n
and dis!%siti%n %# e"%ds'
Re"%ds shall emain legi(le+ eadily identi#ia(le and
etie)a(le'

A' Mana"ement :e#*on#i5i!ity%

A%1% Mana"ement /ommitment

T%! management shall !%)ide e)iden"e %# its
"%mmitment t% the de)el%!ment and
im!lementati%n %# the $uality management
system and "%ntinually im!%)ing its
e##e"ti)eness (y:

a8 "%mmuni"ating t% the %gani5ati%n the
im!%tan"e %# meeting "ust%me as &ell as
statut%y and egulat%y e$uiements+
(8 esta(lishing the $uality !%li"y+
"8 ensuing that $uality %(3e"ti)es ae esta(lished+
d8 "%ndu"ting management e)ie&s+ and
e8 ensuing the a)aila(ility %# es%u"es'

A%-% /)#tomer Fo.)#

T%! management shall ensue that "ust%me
e$uiements ae detemined and ae met
&ith the aim %# enhan"ing "ust%me
satis#a"ti%n 7see A'2'1 and 8'2'18

A%7 @)a!ity *o!i.y
T%! management shall ensue that the $uality !%li"y

a8 is a!!%!iate t% the !u!%se %# the %gani5ati%n+
(8 in"ludes a "%mmitment t% "%m!ly &ith e$uiement and "%ntinually
im!%)e the e##e"ti)eness %# the $uality management system+
"8 !%)ides a #ame&%- #% esta(lishing and e)ie&ing $uality %(3e"ti)es+
d8 is "%mmuni"ated and undest%%d &ithin the %gani5ati%n+ and
e8 is e)ie&ed #% "%ntinuing suita(ility'



A%4 (!annin"

A%4%1 @)a!ity o5Be.tive#
T%! management shall ensue that $uality %(3e"ti)es+
in"luding th%se needed t% meet e$uiements #%
!%du"t 7see A'1 a8 ae esta(lished at ele)ant
#un"ti%ns and le)els &ithin the %gani5ati%n' The
$uality %(3e"ti)es shall (e measua(le and "%nsistent
&ith the $uality !%li"y'
>'9'2 Quality Management system
!lanning
T%! management shall ensue that:

a< the !lanning %# $uality management


system is "aied %ut in %de t% meet the
e$uiements gi)en in 9'1+ as &ell as the
$uality %(3e"ti)es+ and

(< the integity %# the $uality management


system is maintained &hen "hanges t% the
$uality management system ae !lanned and
im!lemented'

A%A :e#*on#i5i!ity8 a)thority
and .omm)ni.ation

A%A%1 :e#*on#i5i!ity and a)thority

T%! management shall ensue that
es!%nsi(ilities and auth%ities ae de#ined
and "%mmuni"ated &ithin the %gani5ati%n'

A%A%- Mana"ement :e*re#entative

To* mana"ement #ha!! a**oint a mem5er o the or"anizationC#
mana"ement who8 irre#*e.tive o other re#*on#i5i!itie#8 #ha!! have
re#*on#i5i!ity and a)thority that in.!)de#9
a' en#)rin" that *ro.e## needed or the +)a!ity mana"ement #y#tem are
e#ta5!i#hed8 im*!emented and maintained8
5' re*ortin" to to* mana"ement on the *erorman.e o the +)a!ity
mana"ement #y#tem and need or im*rovement8 and
.' en#)rin" the *romotion o awarene## o .)#tomer re+)irement
thro)"ho)t the or"anization%

=ote9 The re#*on#i5i!ity o mana"ement re*re#entative .an in.!)de
!iai#on with eDterna! *artie# on matter re!atin" to +)a!ity mana"ement
#y#tem%

A%A%7 Interna! .omm)ni.ation
T%! management shall ensue that a!!%!iate
"%mmuni"ati%n !%"esses ae esta(lished &ithin
the %gani5ati%n and that "%mmuni"ati%n ta-es
!la"e egading the e##e"ti)eness %# the $uality
management system'

A%6 Mana"ement review
A%6%1 4enera!

T%! management shall e)ie& the %gani5ati%nMs $uality management
system+ at !lanned inte)als+ t% ensue its "%ntinuing suita(ility+
ade$ua"y and e##e"ti)eness'
This e)ie& shall in"lude assessing %!!%tunities #% im!%)ements and
the need #% "hanges t% the $uality management system+ in"luding the
$uality !%li"y and $uality %(3e"ti)es'

Re"%ds #%m management e)ie&s shall (e maintained 7see 9'2'98

A%6%- :eview in*)t

The in!ut t% management e)ie& shall in"lude in#%mati%n %n

a8 esults %# audits+
(8 "ust%me #eed(a"-+
"8 !%"ess !e#%man"e and !%du"t "%n#%mity+
d8 status %# !e)enti)e and "%e"ti)e a"ti%ns+
e8 #%ll%&-u! a"ti%ns #%m !e)i%us management e)ie&s+
#8 "hanges that "%uld a##e"t the $uality management system+ and
g8 e"%mmendati%ns #% im!%)ement'
A%6%7 :eview o)t*)t

The %ut!ut #%m the management e)ie& shall in"lude any de"isi%ns
and a"ti%ns elated t%:

a8 im!%)ement %# the e##e"ti)eness %# the $uality management
system and its !%"esses+
(8 im!%)ement %# !%du"t elated t% "ust%me e$uiements+ and
"8 es%u"e needs'

@% :e#o)r.e mana"ement


6%1 (rovi#ion o re#o)r.e#

The %gani5ati%n shall detemine and !%)ide the es%u"es needed:

a8 t% im!lement and maintain the $uality management system and
"%ntinually im!%)e its e##e"ti)eness+ and
(8 t% enhan"e "ust%me satis#a"ti%n (y meeting "ust%me
e$uiements'

6%- H)man re#o)r.e#
6%-%1 4enera!
,es%nnel !e#%ming &%- a##e"ting "%n#%mity t%
!%du"t e$uiements shall (e "%m!etent %n the
(asis %# a!!%!iate edu"ati%n+ taining+ s-ills and
e6!eien"e'
NOT. 2%n#%mity t% !%du"t e$uiements "an (e
a##e"ted die"tly % indie"tly (y !es%nnel
!e#%ming any tas- &ithin the $uality management
system'
6%-%- /om*eten.e8 trainin" and awarene##

The %gani5ati%n shall:

a8 detemine the ne"essay "%m!eten"e #% !es%nnel !e#%ming
&%- a##e"ting "%n#%mity t% !%du"t e$uiements+
(8 &hee a!!li"a(le+ !%)ide taining % ta-e %the a"ti%ns t%
a"hie)e the ne"essay "%m!eten"e++
"8 e)aluate the e##e"ti)eness %# the a"ti%ns ta-en+
d8 ensue that its !es%nnel ae a&ae %# the ele)an"e and im!%tan"e
%# thei a"ti)ities and h%& they "%nti(ute t% the a"hie)ement %# the
$uality %(3e"ti)es+ and
e8 maintain a!!%!iate e"%ds %# edu"ati%n+ taining+ s-ills and
e6!eien"e 7see 9'2'98
6%7 Inra#tr).t)re

The %gani5ati%n shall detemine+ !%)ide and maintain the
in#astu"tue needed t% a"hie)e "%n#%mity t% !%du"t e$uiements'
In#astu"tue in"ludes:

a8 (uildings+ &%-s!a"e and ass%"iated utilities+
(8 !%"ess e$ui!ment 7(%th had&ae and s%#t&ae8+ and
"8 su!!%ting se)i"es 7su"h as tans!%t+ "%mmuni"ati%n %
in#%mati%n systems8
6%4% WorE environment
The %gani5ati%n shall detemine and manage
the &%- en)i%nment needed t% a"hie)e
"%n#%mity t% !%du"t e$uiements'
=OT;9 The term FworE environmentG re!ate# to
tho#e .ondition# )nder whi.h worE i# *erormed
in.!)din" *hy#i.a!8 environmenta! and other
a.tor# $#).h a# noi#e8 tem*erat)re8 h)midity8
!i"htin" or weather'%

0% (rod).t :ea!ization


0%1% (!annin" o *rod).t rea!ization

The %gani5ati%n shall !lan and de)el%! the !%"esses needed
#% !%du"t eali5ati%n' ,lanning %# !%du"t eali5ati%n shall (e
"%nsistent &ith the e$uiements %# the %the !%"esses %# the
$uality management system 7see 9'18

In !lanning !%du"t eali5ati%n+ the %gani5ati%n shall detemine
the #%ll%&ing+ as a!!%!iate:

a8 $uality %(3e"ti)es and e$uiements #% the !%du"t+
(8 the need t% esta(lish !%"esses and d%"uments+ and t%
!%)ide es%u"es s!e"i#i" t% the !%du"tN
"8 e$uied )ei#i"ati%n+ )alidati%n+ m%nit%ing+ measuement+
ins!e"ti%n and test a"ti)ities s!e"i#i" t% the !%du"t and the
"iteia #% !%du"t a""e!tan"eN
d8 e"%ds needed t% !%)ide e)iden"e that the eali5ati%n
!%"esses and esulting !%du"t meet e$uiements 7see
9'2'98

The %ut!ut %# this !lanning shall (e in a #%m suita(le #% the
%gani5ati%nMs meth%d %# %!eati%ns'
N%te 1: A d%"ument s!e"i#ying the !%"esses %# the $uality
management system 7in"luding the !%du"t eali5ati%n !%"ess8
and the es%u"es t% (e a!!lied t% a s!e"i#i" !%du"t+ !%3e"t %
"%nta"t+ "an (e e#eed t% as a $uality !lan'

N%te 2: The %gani5ati%n may als% a!!ly the e$uiements
gi)en in A'= t% the de)el%!ment %# !%du"t eali5ati%n
!%"esses'

0%- /)#tomer-re!ated *ro.e##e#

0%-%1 6etermination o re+)irement# re!ated to the
*rod).t

The %gani5ati%n shall detemine:

a8 e$uiements s!e"i#ied (y the "ust%me+ in"luding the e$uiements
#% deli)ey and !%st-deli)ey a"ti)ities+
(8 e$uiements n%t stated (y the "ust%me (ut ne"essay #% s!e"i#ied
% intended use+ &hee -n%&n+
"8 statut%y and egulat%y e$uiements a!!li"a(le t% the !%du"t+ and
d8 any additi%nal e$uiements detemined "%nsideed ne"essay (y
the %gani5ati%n'
NOT.N ,%st-deli)ey a"ti)ities in"lude+ #% e6am!le+ a"ti%ns unde
&aanty !%)isi%ns+ "%nta"tual %(ligati%ns su"h as maintenan"e
se)i"es+ and su!!lementay se)i"es su"h as e"y"ling % #inal
dis!%sal'
0%-%- :eview o re+)irement# re!ated to the *rod).t

The %gani5ati%n shall e)ie& the e$uiements elated t% the !%du"t'
This e)ie& shall (e "%ndu"ted !i% t% the %gani5ati%nMs "%mmitment
t% su!!ly a !%du"t t% the "ust%me 7e'g' su(missi%n %# tendes+
a""e!tan"e %# "%nta"ts % %des+ a""e!tan"e %# "hanges t% "%nta"ts
% %des8 and shall ensue that:

a8 !%du"t e$uiements ae de#ined+
(8 "%nta"t % %de e$uiements di##eing #%m th%se !e)i%usly
e6!essed ae es%l)ed+ and
"8 the %gani5ati%n has the a(ility t% meet the de#ined e$uiements'

Re"%ds %# the esults %# the e)ie& and a"ti%ns aising #%m the
e)ie& shall (e maintained 7see 9'2'98
/hee the "ust%me !%)ides n% d%"umented statement %#
e$uiement+ the "ust%me e$uiements shall (e "%n#imed
(y the %gani5ati%n (e#%e a""e!tan"e'

/hee !%du"t e$uiements ae "hanged+ the %gani5ati%n
shall ensue that ele)ant d%"uments ae amended and that
ele)ant !es%nnel ae made a&ae %# the "hanged
e$uiements'

N%te: In s%me situati%ns+ su"h as intenet sales+ a #%mal
e)ie& is im!a"ti"al #% ea"h %de' Instead the e)ie& "an
"%)e ele)ant !%du"t in#%mati%n su"h as "atal%gues %
ad)etising mateial'
0%-%7 /)#tomer .omm)ni.ation

The %gani5ati%n shall detemine and im!lement e##e"ti)e
aangements #% "%mmuni"ating &ith "ust%mes in
elati%n t%:

a8 !%du"t in#%mati%n+
(8 en$uiies+ "%nta"ts % %de handling+ in"luding
amendments+ and
"8 "ust%me #eed(a"-+ in"luding "ust%me "%m!laints'
0%7 6e#i"n and 6eve!o*ment

0%7%1 6e#i"n and deve!o*ment *!annin"

The %gani5ati%n shall !lan and "%nt%l the design and
de)el%!ment %# !%du"t'

Duing the design and de)el%!ment !lanning+ the %gani5ati%n
shall detemine:

a8 the design and de)el%!ment stages+
(8 the e)ie&+ )ei#i"ati%n and )alidati%n that ae a!!%!iate t%
ea"h design and de)el%!ment stage+ and
"8 the es!%nsi(ilities and auth%ities #% design and
de)el%!ment'
The %gani5ati%n shall manage the inte#a"es
(et&een di##eent g%u!s in)%l)ed in design and
de)el%!ment t% ensue e##e"ti)e "%mmuni"ati%n
and "lea assignment %# es!%nsi(ility'

,lanning %ut!ut shall (e u!dated+ as a!!%!iate+
as the design and de)el%!ment !%gesses'
NOT.: Design and de)el%!ment e)ie&+
)ei#i"ati%n and )alidati%n ha)e distin"t !u!%ses'
They "an (e "%ndu"ted and e"%ded se!aately %
in any "%m(inati%n+ as suita(le #% the !%du"t and
the %gani5ati%n'
0%7%- 6e#i"n and deve!o*ment in*)t#

The in!uts shall (e e)ie&ed #% ade$ua"y' Re$uiements shall (e
"%m!lete+ unam(igu%us and n%t in "%n#li"t &ith ea"h %the'

a8 #un"ti%nal and !e#%man"e e$uiements+
(8 a!!li"a(le statut%y and egulat%y e$uiements+
"8 &hee a!!li"a(le+ in#%mati%n dei)ed #%m !e)i%us simila designs+
and
d8 %the e$uiements essential #% design and de)el%!ment'

0%7%7 6e#i"n and deve!o*ment o)t*)t#

The %ut!uts %# design and de)el%!ment shall (e in a #%m suita(le #%
)ei#i"ati%n against the design and de)el%!ment in!ut and shall (e
a!!%)ed !i% t% elease'

Design and de)el%!ment %ut!uts shall:

a8 meet the in!ut e$uiements #% design and de)el%!ment+
(8 !%)ide a!!%!iate in#%mati%n #% !u"hasing+ !%du"ti%n and se)i"e
!%)isi%n+
"8 "%ntain % e#een"e !%du"t a""e!tan"e "iteia+ and
d8 s!e"i#y the "haa"teisti"s %# the !%du"t that ae essential #% its sa#e
and !%!e use'
=OT;9 Inormation or *rod).tion and #ervi.e *rovi#ion .an in.!)de
detai!# or the *re#ervation o *rod).t%
0%7%4 6e#i"n and deve!o*ment review

At suita(le stages+ systemati" e)ie&s %# design and de)el%!ment shall
(e !e#%med in a""%dan"e &ith !lanned aangements 7see A'='18:

a8 t% e)aluate the a(ility %# the esults %# design and de)el%!ment t%
meet e$uiements+ and
(8 t% identi#y any !%(lems and !%!%se ne"essay a"ti%ns'
,ati"i!ants in su"h e)ie&s shall in"lude e!esentati)es %# #un"ti%ns
"%n"ened &ith the design and de)el%!ment stage7s8 (eing e)ie&ed'
Re"%ds %# the esults %# the e)ie&s and any ne"essay a"ti%ns shall
(e maintained 7see 9'2'98'
0%7%A 6e#i"n and deve!o*ment verii.ation

Bei#i"ati%n shall (e !e#%med in a""%dan"e &ith
!lanned aangements 7see A'='18 t% ensue that the
design de)el%!ment %ut!uts ha)e met the design and
de)el%!ment in!ut e$uiements' Re"%ds %# the esult
)ei#i"ati%n and any ne"essay a"ti%ns shall (e
maintained 7see 9'2'98'
0%7%6 6e#i"n and deve!o*ment va!idation

Design and de)el%!ment )alidati%n shall (e !e#%med in
a""%dan"e &ith !lanned aangements 7see A'='18 t%
ensue that the design de)el%!ment %ut!uts ha)e met the
design and de)el%!ment in!ut e$uiements' Re"%ds %#
the esults %# )ei#i"ati%n and any ne"essay a"ti%ns shall
(e maintained 7see 9'2'98'
0%7%0 /ontro! o de#i"n and deve!o*ment
.han"e#

Design and de)el%!ment "hanges shall (e identi#ied
and e"%ds maintained' The "hanges shall (e
e)ie&ed+ )ei#ied and )alidated+ as a!!%!iate+ and
a!!%)ed (e#%e im!lementati%n' The e)ie& %# design
and de)el%!ment "hanges shall in"lude e)aluati%n %#
the e##e"t %# the "hanges %n "%nstituent !ats and
!%du"t aleady deli)eed' Re"%ds %# the esults %# the
e)ie& %# "hanges and any ne"essay a"ti%ns shall (e
maintained 7see 9'2'98'
0%4 ()r.ha#in"
0%4%1 ()r.ha#in" *ro.e##

The %gani5ati%n shall ensue that !u"hased !%du"t "%n#%ms t%
s!e"i#ied !u"hase e$uiements' The ty!e and e6tent %# "%nt%l
a!!lied t% the su!!lie and !u"hased !%du"t shall (e de!endent
u!%n the e##e"t %# the !u"hased !%du"t %n su(se$uent !%du"t
eali5ati%n % the #inal !%du"t'

The %gani5ati%n shall e)aluate and sele"t su!!lies (ased %n thei
a(ility t% su!!ly !%du"t in a""%dan"e &ith the %gani5ati%nMs
e$uiement s' 2iteia #% sele"ti%n+ e)aluati%n and e-e)aluati%n
shall (e esta(lished' Re"%ds %# the esults %# e)aluati%ns and any
ne"essay a"ti%ns aising #%m the e)aluati%n shall (e maintained
7see 9'2'98'
0%4%- ()r.ha#in" inormation

,u"hasing in#%mati%n shall des"i(e the !%du"t t% (e !u"hased+
in"luding &hee a!!%!iate

a8 e$uiements #% a!!%)al %# !%du"t+ !%"edues+ !%"esses and
e$ui!ment+
(8 e$uiements #% $uali#i"ati%n %# !es%nnel+ and
"8 $uality management system e$uiements'

The %gani5ati%n shall ensue the ade$ua"y %# s!e"i#ied !u"hase
e$uiements !i% t% thei "%mmuni"ati%n t% the su!!lie'
0%4%7 ?erii.ation o *)r.ha#ed *rod).t

The %gani5ati%n shall esta(lish and im!lement the ins!e"ti%n %
%the a"ti)ities ne"essay #% ensuing that !u"hased !%du"t meets
s!e"i#ied !u"hase e$uiements'

/hee the %gani5ati%n % its "ust%me intends t% !e#%m )ei#i"ati%n
at the su!!lieMs !emises+ the %gani5ati%n shall state the intended
)ei#i"ati%n aangements and meth%d %# !%du"t elease in the
!u"hasing in#%mati%n'
0%A (rod).tion and #ervi.e *rovi#ion
0%A%1 /ontro! o *rod).tion and #ervi.e *rovi#ion

The %gani5ati%n shall !lan and "ay %ut !%du"ti%n and se)i"e !%)isi%n
unde "%nt%lled "%nditi%ns+ "%nt%lled "%nditi%ns shall in"lude+ as
a!!li"a(le

a8 the a)aila(ility %# in#%mati%n that des"i(es the "haa"teisti"s %# the
!%du"t+
(8 the a)aila(ility %# &%- instu"ti%ns+ as ne"essay+
"8 the use %# suita(le e$ui!ment+
d8 the a)aila(ility and use %# m%nit%ing and measuing e$ui!ment+
e8 the im!lementati%n %# m%nit%ing and measuement+ and
#8 the im!lementati%n %# !%du"t elease+ deli)ey and !%st-deli)ey
a"ti)ities''
0%A%- ?a!idation o *ro.e##e# or *rod).tion and #ervi.e
*rovi#ion
The %gani5ati%n shall )alidate any !%"esses #% !%du"ti%n
and se)i"e !%)isi%n &hee the esulting %ut!ut "ann%t (e
)ei#ied (y su(se$uent m%nit%ing % measuement and+ as a
"%nse$uen"e+ de#i"ien"ies (e"%me a!!aent %nly a#te the
!%du"t is in use % the se)i"e has (een deli)eed'
Validation shall demonstrate the ability of these processes
to achieve planned results.
The organization shall establish arrangements for these
processes including, as applicable
a8 de#ined "iteia #% e)ie& and a!!%)al %# the !%"esses+
(8 a!!%)al %# e$ui!ment and $uali#i"ati%n %# !es%nnel+
"8 use %# s!e"i#i" meth%ds and !%"edues+
d8 e$uiements #% e"%ds 7see 9'2'98+ and
e8 e)alidati%n'
0%A%7 Identii.ation and tra.ea5i!ity

/hee a!!%!iate+ the %gani5ati%n shall identi#y the !%du"t (y
suita(le means th%ugh%ut !%du"t eali5ati%n'

The %gani5ati%n shall identi#y the !%du"t status &ith es!e"t t%
m%nit%ing and measuement e$uiements th%ugh%ut !%du"t
eali5ati%n'

/hee ta"ea(ility is a e$uiement+ the %gani5ati%n shall "%nt%l
the uni$ue identi#i"ati%n %# the !%du"t and maintain e"%ds 7see
9'2'98'

N%te: In s%me industy se"t%s+ "%n#iguati%n management is a
means (y &hi"h identi#i"ati%n and ta"ea(ility ae maintained'
0%A%4 /)#tomer *ro*erty

The %gani5ati%n shall e6e"ise "ae &ith "ust%me !%!ety &hile it is
unde the %gani5ati%nMs "%nt%l % (eing used (y the %gani5ati%n'
The %gani5ati%n shall identi#y+ )ei#y+ !%te"t and sa#eguad
"ust%me !%!ety !%)ided #% use % in"%!%ati%n int% the !%du"t'
I# any "ust%me !%!ety is l%st+ damaged % %the&ise #%und t% (e
unsuita(le #% use+ the %gani5ati%n shall e!%t this t% the "ust%me
and maintain e"%ds 7see 9'2'98'
NOT. 2ust%me !%!ety "an in"lude intelle"tual !%!ety and
!es%nal data'

0%A%A (re#ervation o *rod).t

The %gani5ati%n shall !ese)e the !%du"t duing
intenal !%"essing and deli)ey t% the intended
destinati%n in %de t% maintain "%n#%mity t%
e$uiements' As a!!li"a(le+ !ese)ati%n shall in"lude
identi#i"ati%n+ handling+ !a"-aging+ st%age and
!%te"ti%n' ,ese)ati%n shall als% a!!ly t% the
"%nstituent !ats %# a !%du"t'

0%6 /ontro! o monitorin" and mea#)rin" e+)i*ment

The %gani5ati%n shall detemine the m%nit%ing and
measuement t% (e undeta-en and the m%nit%ing and
measuing e$ui!ment needed t% !%)ide e)iden"e %#
"%n#%mity %# !%du"t t% detemined e$uiements'

The %gani5ati%n shall esta(lish !%"esses t% ensue that
m%nit%ing and measuement "an (e "aied %ut and ae
"aied %ut in a manne that is "%nsistent &ith the
m%nit%ing and measuement e$uiements'
/hee ne"essay t% ensue )alid esults+ measuing e$ui!ment
shall:

a8 (e "ali(ated % )ei#ied+ % (%th+ at s!e"i#ied inte)als+ % !i%
t% use+ against measuement standads ta"ea(le t%
intenati%nal % nati%nal measuement standadsN &hee n%
su"h standads e6ist+ the (asis used #% "ali(ati%n %
)ei#i"ati%n shall (e e"%ded 7see 9'2'98N
(8 (e ad3usted % e-ad3usted as ne"essay+
"8 ha)e identi#i"ati%n in %de t% detemine its "ali(ati%n statusN
d8 (e sa#eguaded #%m ad3ustments that &%uld in)alidate the
measuement esult+
e8 (e !%te"ted #%m damage and detei%ati%n duing handling+
maintenan"e and st%age'
In additi%n+ the %gani5ati%n shall assess and e"%d the )alidity %#
the !e)i%us measuing esults &hen the e$ui!ment is #%und n%t t%
"%n#%m t% e$uiements' The %gani5ati%n shall ta-e a!!%!iate
a"ti%n %n the e$ui!ment and any !%du"t a##e"ted' Re"%ds %# the
esults %# "ali(ati%n and )ei#i"ati%ns shall (e maintained 7see 9'2'98
/hen used in the m%nit%ing and measuement %# s!e"i#ied
e$uiements+ the a(ility %# "%m!ute s%#t&ae t% satis#y the intended
a!!li"ati%n shall (e "%n#imed' This shall (e undeta-en !i% t%
initial use and e"%n#imed as ne"essay'

NOT.: 2%n#imati%n %# the a(ility %# "%m!ute s%#t&ae t% satis#y the
intended a!!li"ati%n &%uld ty!i"ally in"lude its )ei#i"ati%n and
"%n#iguati%n management t% maintain its suita(ility #% use'
,% Mea#)rement8 ana!y#i# and
im*rovement

,%1 4enera!

The %gani5ati%n shall !lan and im!lement the m%nit%ing+
measuement+ analysis and im!%)ement !%"esses needed:

a8 t% dem%nstate "%n#%mity t% !%du"t e$uiements+
(8 t% ensue "%n#%mity %# the $uality management system+ and
"8 t% "%ntinually im!%)e the e##e"ti)eness %# the $uality
management system'

This shall in"lude deteminati%n %# a!!li"a(le meth%ds+
in"luding statisti"al te"hni$ues+ and the e6tent %# thei use'

,%- Monitorin" and Mea#)rement

,%-%1 /)#tomer #ati#a.tion

As %ne %# the measuements %# the !e#%man"e %# the
$uality management system+ the %gani5ati%n shall
m%nit% in#%mati%n elating t% "ust%me !e"e!ti%n as t%
&hethe the %gani5ati%n has met "ust%me e$uiements'
The meth%ds #% %(taining and using this in#%mati%n shall
(e detemined'
NOT.: M%nit%ing "ust%me !e"e!ti%n "an in"lude
%(taining in!ut #%m s%u"es su"h as "ust%me
satis#a"ti%n su)eys+ "ust%me data %n deli)eed !%du"t
$uality+ use %!ini%n su)eys+ l%st (usiness analysis+
"%m!liments+ &aanty "laims and deale e!%ts'
,%-%- Interna! a)dit

The %gani5ati%n shall "%ndu"t intenal audits at !lanned
inte)als t% detemine &hethe the $uality management system:

a8 "%n#%ms t% the !lanned aangements 7see A'18+ t% the
e$uiements %# this Intenati%nal Standad and t% the
$uality management system e$uiements esta(lished (y
the %gani5ati%n+ and
(8 is e##e"ti)ely im!lemented and maintained'

An audit !%gamme shall (e !lanned+ tal-ing int% "%nsideati%n the
status and im!%tan"e %# the !%"esses and aeas t% (e audited+ as
&ell as the esults %# !e)i%us audits' The audit "iteia+ s"%!e+
#e$uen"y and meth%ds shall (e de#ined' The sele"ti%n %# audit%s
and "%ndu"t %# audits shall ensue %(3e"ti)ity and im!atiality %# the
audit !%"ess' Audit%s shall n%t audit thei %&n &%-'

A d%"umented !%"edue shall (e esta(lished t% de#ine the
es!%nsi(ilities and e$uiements #% !lanning and "%ndu"ting audits+
esta(lishing e"%ds and e!%ting esults'
Re"%ds %# the audits and thei esults shall (e maintained ;see9'2'9<'
The management es!%nsi(le #% the aea (eing audited shall ensue
that any ne"essay "%e"ti%ns and "%e"ti)e a"ti%ns ae ta-en
&ith%ut undue delay t% eliminate dete"ted n%n"%n#%mities and thei
"auses'
?%ll%&-u! a"ti)ities shall in"lude the )ei#i"ati%n %# the a"ti%ns ta-en
and the e!%ting %# )ei#i"ati%n esults ;see 8'>'2<'
=OT;9 See ISO 19011 #% guidan"e'
,%-%7 Monitorin" and mea#)rement o *ro.e##

The %gani5ati%n shall a!!ly suita(le meth%ds #% m%nit%ing and+
&hee a!!li"a(le+ measuement %# the $uality management system
!%"esses' These meth%ds shall dem%nstate the a(ility %# the
!%"esses t% a"hie)e !lanned esults' /hen !lanned esults ae
n%t a"hie)ed+ "%e"ti%n and "%e"ti)e a"ti%n shall (e ta-en+ as
a!!%!iate+ /hen !lanned esults ae n%t a"hie)ed+ "%e"ti%n and
"%e"ti)e a"ti%n shall (e ta-en+ as a!!%!iate'
=OT;9 /hen detemining suita(le meth%ds+ it is ad)isa(le that the
%gani5ati%n "%nside the ty!e and e6tent %# m%nit%ing %
measuement a!!%!iate t% ea"h %# its !%"esses in elati%n t%
thei im!a"t %n the "%n#%mity t% !%du"t e$uiements and %n the
e##e"ti)eness %# the $uality management system'

,%-%4 Monitorin" and mea#)rement o *rod).t

The %gani5ati%n shall m%nit% and measue the "haa"teisti"s %#
the !%du"t t% )ei#y that !%du"t e$uiements ha)e (een met' This
shall (e "aied %ut at a!!%!iate stages %# the !%du"t eali5ati%n
!%"ess in a""%dan"e &ith the !lanned aangements 7see A'18'
.)iden"e %# "%n#%mity &ith the a""e!tan"e "iteia shall (e
maintained'
Re"%ds shall indi"ate the !es%n7s8 auth%i5ing elease %# !%du"t
#% deli)ey t% the "ust%me 7see 9'2'98'
The elease %# !%du"t and deli)ey %# se)i"e t% the "ust%me shall
n%t !%"eed until the !lanned aangements 7see A'18 ha)e (een
satis#a"t%ily "%m!leted+ unless %the&ise a!!%)ed (y a ele)ant
auth%ity and+ &hee a!!li"a(le+ (y the "ust%me'
,%7 /ontro! o non - .onormin" *rod).t

The %gani5ati%n shall ensue that !%du"t &hi"h d%es n%t "%n#%m
t% !%du"t e$uiements is identi#ied and "%nt%lled t% !e)ent its
unintended use % deli)ey' A d%"umented !%"edue shall (e
esta(lished t% de#ine the "%nt%ls and elated es!%nsi(ilities and
auth%ities #% dealing &ith n%n - "%n#%ming !%du"t'
/hee a!!li"a(le+ the %gani5ati%n shall deal &ith n%n - "%n#%ming
!%du"t (y %ne % m%e %# the #%ll%&ing &ays:

a8 (y ta-ing a"ti%n t% eliminate the dete"ted n%n - "%n#%mity+
(8 (y auth%i5ing its use+ elease % a""e!tan"e unde "%n"essi%n (y a
ele)ant auth%ity and+ &hee a!!li"a(le+ (y the "ust%me'
"8 (y ta-ing a"ti%n t% !e"lude its %iginal intended use % a!!li"ati%n'
d8 (y ta-ing a"ti%n a!!%!iate t% the e##e"ts+ % !%tential e##e"ts+ %# the
n%n - "%n#%mity &hen n%n"%n#%ming !%du"t is dete"ted a#te deli)ey
% use has stated'

/hen n%n - "%n#%ming !%du"t is "%e"ted it shall (e su(3e"t t% e-
)ei#i"ati%n t% dem%nstate "%n#%mity t% the e$uiements'

Re"%ds %# the natue %# n%n - "%n#%mities and any su(se$uent a"ti%ns
ta-en+ in"luding "%n"essi%ns %(tained+ shall (e maintained 7see 9'2'98'
,%4 Ana!y#i# o data

The %gani5ati%n shall detemine+ "%lle"t and analy5e a!!%!iate
data t% dem%nstate the suita(ility and e##e"ti)eness %# the $uality
management system and t% e)aluate &hee "%ntinual im!%)ement
%# the e##e"ti)eness %# the $uality management system "an (e
made' This shall in"lude data geneated as a esult %# m%nit%ing
and measuement and #%m %the ele)ant s%u"es'
The analysis %# data shall !%)ide in#%mati%n elating t%:

a8 "ust%me satis#a"ti%n 7see 8'2'18
(8 "%n#%mity t% !%du"t e$uiements 7see A'2'18 7see 8'2'98+
"8 "haa"teisti"s and tends %# !%"esses and !%du"ts+
in"luding %!!%tunities #% !e)enti)e a"ti%n 7see 8'2'= and
8'2'98+ and
d8 su!!lies 7see A'98'


,%A Im*rovement

,%A%1 /ontin)a! im*rovement

The %gani5ati%n shall "%ntinually im!%)e the e##e"ti)eness %# the
$uality management system th%ugh the use %# the $uality !%li"y+
$uality %(3e"ti)es+ audit esults+ analysis %# data+ "%e"ti)e and
!e)enti)e a"ti%ns and management e)ie&'
,%A%- /orre.tive a.tion
The %gani5ati%n shall ta-e a"ti%n t% eliminate the "auses %#
n%n"%n#%mities in %de t% !e)ent e"uen"e% 2%e"ti)e a"ti%ns
shall (e a!!%!iate t% the e##e"ts %# the n%n"%n#%mities en"%unteed'

A d%"umented !%"edue shall (e esta(lished t% de#ine e$uiements
#%:

a8 e)ie&ing n%n - "%n#%mities 7in"luding "ust%me "%m!laints8+
(8 detemining the "auses %# n%n - "%n#%mities+
"8 e)aluating the need #% a"ti%n t% ensue that n%n"%n#%mities d% n%t
e"u+
d8 detemining and im!lementing a"ti%n needed+
e8 e"%ds %# the esults %# a"ti%n ta-en 7see 9'2'98+ and
#8 e)ie&ing the e##e"ti)eness %# the "%e"ti)e a"ti%n ta-en'
,%A%7 (reventive a.tion

The %gani5ati%n shall detemine a"ti%n t% eliminate the "auses %#
!%tential n%n"%n#%mities in %de t% !e)ent thei %""uen"e'
,e)enti)e a"ti%ns shall (e a!!%!iate t% the e##e"ts %# the !%tential
!%(lems'
A d%"umented !%"edue shall (e esta(lished t% de#ine
e$uiements #%:

a8 detemining !%tential n%n - "%n#%mities and thei "auses+
(8 e)aluating the need #% a"ti%n t% !e)ent %""uen"e %# n%n -
"%n#%mities+
"8 detemining and im!lementing a"ti%n needed+
d8 e"%ds %# esults %# a"ti%n ta-en 7see 9'2'98+ and
e8 e)ie&ing the e##e"ti)eness %# the !e)enti)e a"ti%n ta-en'
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