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STANDARD

Fourth edition
2001>-1 1-15

ISO
9001

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Quality managem~nt systllms .
ReqUirements

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Systbmes de management do fa qua/ito- E<igances

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Aororonce number

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ISO 9001 <200B(E)

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ISO 9001 :2008(E)

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Contents

Page

Scope ....... ~.......................... ,;_..:~~-..~L~...~.:.~~ ....:.......~ ............................................................................... 1

1.1

General .................................................................................................................................................

'1.2 Application .................................:.~ ................. :.....................................................................................

Normative rctercncc5 ..........................................................................................................................

.Terms and definitions,.........................................................................................................................

4
Quality m~nagement syotom .......:...............:,.....................................................................................
4.1 General requirements' , .. ',,.,,. ~_ ' ""'"''''''~-"""'
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'4.2. 'oiicume~tatlon' requirements' :~::.: ..:.............:.....:.............................................:..............................
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Management responsibility ................................................................................................................

Management commitment ........:.........................................................................................................

5.2 Customer focus ............................................, ......................................................................................

5.3 Quolily policy ............ ~ ...........:.:.....~ ......................................................................................................

5.4 Planning ...............................................................................................................................................

5.6 J.lanagcmant review ...........................................................................................................................

6

Resource management ........;, .... ;.~:L

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5
6

6.1

Provision ol resources ........................................................................................................................

6.2

....:....:............................... ~..........................................................

Hun1nn resources ...................... ,............................ ,.......................................................................~ ... .

6.3 lnfrastructuro .......................................................................................................................................

6.4

Work environment ...............................................................................................................................

Product reallzallon ...............................................................................................................................

7.1

Planning ot product roallzatlon ..........................................................................................................

7.2 Customcrrclatod proceascs ..............................................................................................................

.7.3 Design and development ...................................................................................................................

7.4 Purchasing ............). ........................:....................................................................................................

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7.5 Production and servlc'o provlulun .... ~ ..........................;....................................................................

10

7.6 Control of monitoring and mea11urlng equipment ..........................................................................

11

in1~rovement

.......................................................................................

12

Measurement, analysis ond

6.1

Gonoral .. ~...........................................................................................................................................

12

8.2 Monitoring and measuroment ...........................:..............................................................................

12

Control of nonconforming product ..................................................................................................

13

8.4 Analysis of data ..........................................,......................................................................................

13

8.3

5.1

5.5 Responsibility; authority nnd c~;m~unlcallon .....................:............................................................

8.5 Improvement ......................................................................................................................................

14

Annex A (inlormalivo) Correspondence between ISO 9001 :2008 and ISO 14001 :2004 ..................... ..

15

Annex 8 (informative) Chan goo bolwcen ISO 9001:2000 and ISO 900'1:2006 ..................................... ..

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Bibliography ...............................................................................................................................................

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. .. ISO 9001 :2006(E)

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Foreword

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' ISO (the International Organization for Standardization) Is a worldwicle federation of national standards bodies
,JISO member bodies), Tho work'of preparing International Standmds is norrnnlly carried out through ISO
.'technical committees. Each member body Interested In a subject tor which a technical committee has been
"!''established has the right to bo represented on tha) committee. International organizations, governmental and
non-governmental, In liaison with ISO, also take part In the worl<. ISO collaborates closely wfth the International
Electrotochnical Commission (IE C) on all matters of eloctrotechnlcal standardization.

:c. .lntornatlonal Standards are drafted In accordance with the rules given In the ISO/IEC Directives, Part 2.
The main task ol technical committees Is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the meml>er bodies for voting. Publication as an
International Standard requires approval by at toast 75 %of the mo"ober bodies casting a vote.
. Attention ls.drawn to the possibility that some of the clements of this document may be the subject of patent
rfllhts. 1$0 shall not be hold responsible for Identifying any or all such patent rights.

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ISO 9001' .was prepared by Technical Committee tSOfTC 176, Owrlity management and qvafity assvrance,
Subcommittee SC 2, Quality systems.
This tourthedlllon cancels and replaces tho third edition (ISO 9001 ::WOO), which has been amended to clarify
points In the text and to enhance compatlblllly with ISO 14001 :2004.
Details of the changes between t11e third edition and this fourth editlcn are given in Annex B.

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ISO 9001 :2008(E)

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Introduction
d:C1

General ' '

The adoption ot a quality management system should bo a strategic ceclslon or an organization. Tho design
and Implementation of an organization's quality management system Is influenced by

a) Its_ organlzatlonat' 1ei1VIronment,

environment,
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chang~s 'In !hat environment, and the risks associated with that

b) 11~ V.rying rieeds,

c) Its particular objectives,

d) the products It provides,

e) the processes It employs,

Q Its size andorganlzatlonal structure.

It Is not the Intent of this International Standard to Imply uniformity in tihe structure of quality management
systems or uniformity or docurnontatlon.

The quality management system requlre~ents.speclfied In this .International Standard are complementary to
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requirements for products. Information marked "NOTE" Is tor guidance In understanding or clarifying the Nr'''""-""-'17- -~(j
associated requirement.
---

This lntornatlonal Standard can be used'by Internal and external pmtles, including certification bodies, to
assess tihe organization's ability to meet customer, statutory and regulatory requirements applicable to the
product, and the organization's own requirements.

Tho quality management principles stnted in ISO 9000 and ISO 9004 hE.ve been taken into consideration during
the development of this lnternutlonal Standard.,.

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0.2 Process approach

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This International Standard promotos lho adoption of a process approach when developing, implementing and
Improving the eHectiveness of a quality management system. to enh.mce customer satisfaction by meeting
customer roqulremcnts. "

For on organization to function effectively, I! has to deterntlne and nanage numerous linked activities. An
activity or set of activities using resources, and managed In ordet to nnablo tho transformation of Inputs Into
outputs, can be considered as a process. Often the output from one process directly forms the input to tihe next.
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Tho applica.Uon of_ a system of procesnEiS wfthfn an organlzatlorl. togathnr wllh the Identification and interactions
or theso processes, nnd their management to produce the des~red outc:Jmc, can be ruferred to as the ..process

approach".
An advantage of tho process approach Is tho ongoing control that It provides over the linkage between the
Individual processes within tho system ot processes, as well as over tholr combinati<n and Interaction.
When usod within a qual!ty rnnnagemonl system, such on approach emphasizes tho importance of

a) understanding and meeting requirements,

b) the need to consider processes In terms of added value,

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!SO 9001 :2008(E)

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c) obtaining results of 'process pe11ormanco and effectiveness, nnd

d) . continuallmproveme~.t of processes based on objective measur<ment.

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Tho model of a process-based quality management system shown in Figure 1 Illustrates the process linkages
presented In .Clauses. 4 to 8. This fllustration shows that. custo11ors play a significant role In defining
requirements as fnpu~ Monltorlng of customer satis(action requires the evaluation of Information relating to
customer perception as to whetherthe organization ~ met the cuntomer roqulroments. The model shown In
Figure 1 covors all lhe requlremorits of lhfs lntematlo~.af Standard, hut does not show processes at a detailed
1
level.
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NOTE . In addition, the melhO<Jolo!l)' known as "PianDo-ChockAct" (PDCA can be applied 10 all processes. PDCA can be
briefly doscrlbod as Jollows.
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Plan: establish the objectives and prOC43Sses necessary to de)lvor results in eccordance with r.ustomor requirements and the
organization's policies.
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Do: lmplomont tho procosses.

Check: monitor and moasuro proceues and prod~ct ago,;;,st potH:!es, ob. ectives and r&quirements lor the product and
repor1 the resu~ts.

ACt: take actions.~ COritinUa"lly rmprovo process porformanetl.

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Continual improvement ol
the quality managemenl system

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Customers

Resource
management

Customers_

Measuro nonl,
Satisfaction

at'\alys!a and
lmprovo1nent

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Output

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Figura 1 - Modal of a procosscbased qua ill)' managoment'system

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0.3 Relationship with ISO 9004

ISO 9001 and ISO 9004 are quality management system standards which have been designed to complement
each other, but can also be used Independently.

ISO 9001 specllles requirements for a quality management system tr.at can be used lor Internal application by
organizations, or for certification, or for contractual purposes. It focuses on the effectiveness of the quality

management system In meotlng customer requirementS.

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At the time ol publication ol this lntemaiional Standard, ISO 9004 s under revision. The revised edition of
ISO 9004 will prov\do gut dunce to management for ~ch\eving sustained succos for any organization .tn a
complex, demanding, and evor changing, envlronrl,1ent. ISO 90C04 provides a wider focus on quality
management than ISO 9001; It addmsscs tho neods and oxpoctatians of all lnlerested parties and their
satisfaction, by the systoma1lc and contlnuallmprovenu.)nt of tho organization's petformancc. However, it Is not
Intended for certification, rdgulatoryor contractual use. 1:

0.4 Compatibility with other management sys(ems

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deveiopine~t ~f

trit~rnationat ;stands~,

During the
-this
due constcleratlon was given to the provisions of
ISO t4001:2004 to onhanco tho compatibility of the ''iwo standards for the benefit of the user communlty.
Annex A shows the correspondence between ISO 9001:2008 and \SCI 14001 :2004.
This lnternotlonal Standard doo_s not include requirements specific lo other management systems, such as
those particular. to environmental managemimt, occupational health and saloty management, financial

management or risk management. However, this International Standard enables un organization to align or
Integrate its own quality management system with related management system requirements. It Is possible for
an organization to adapt Its oxistlng managemept syster,i>(s) In order t> establish a quality management system
that complies with the requirements of this_ International; Standard.

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For frain{ng Purpose only

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ISO 9001 :2008(E)

INTERNATIONAL STANDAFID

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Quality, management systems -

Requitements

1 Scope

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1.1 General.
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This International Standard specifies requirements for a quality mar1agement sy&tom where an organization

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a) needs to demonstroto Its ablll~/ to consistently provide product that moots customer and applicable

statulory and regulato1y requirements, and

b) aims to enhance customer s~Usfaclion through the effecUve application of the system, Including processes
lor continual Improvement of the system and the assurance ol conformity to customer and epplicabte
statutory and regulatory requirements.

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' tho term

NOTE 1 In this lntornat!onat Standarcf,

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producr only applies to

a) product intended for, or ruqulred by, a customer,

b) any intonded output resul~ing from tho product realization procossos.

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NOTE 2 Stat'utory O.nd regutmory requirements ca'n ba cxpr~sscd as foglll requirements.

1.2 Application

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All requirements of thiS lntornatlonal Standard om generic and are Intended to be applicable to all
organizations, regardless of typo, size and product provided.

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Where any requlrcment(s) or this International Standard cannot be

and its product, this can bo considered for exclusion..

up plied due to the nature ol an organizaUon

Where exclusions aro made, claims of conformity to this lnternation!ll Standard are not acceptable unless these
exclusions are limited to requirements within Clause 7, and such exclusions do not affect tho organization's
ability. or respcnslblllty, to provide product that meets eustomo1 and applicui.Jie statutory and regulatory
reqUirements.":
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2 Normative references
The following referenced documents are indispensable lor the application 'ol this document. For dated
relerences, only the edition clte.ct applies. For undated. references, tt e latest Cditiun ol the relerenced document
(including any amendments) nppll.as.
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ISO 9000:2005, Quality management systems- Furidamonta/s an:J vocabulary

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3 Terms and definitions

For tho purposes of this documen~ the terms and definitions given In ISO 9000 apply.
.. Throughout the text .of this International Standard, wherever the term "producr occurs, it can also mean
service'". .

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- ISO 9001 :2008(E)

4 Quality

manag~ment syst~m

4.1 Ge'!.ernl requirements

The organization shall establish, document, Implement and maintain a quallty management system and
con~nually
I

Improve Its offe~veness In accordance with tho requi1ements of this !nternatlonal Standanl.

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Th~ orgnnlza~on shall

a)

det~rmlno the. processes needed for the quality managcmen: system and their application throughout the/
organization (sea 1.2),
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b) determine tho sequence and Interaction of those processes,

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c) dotoimlne criteria and m~thods needed to ensure that both the operation and control of these processes
aro offoctivo,.

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d) ensure tho availability of resources and information necessary to support lhe operation and monitoring of
these processes,
e) monitor, measure. whore applicable, and analyse those proce~ses, and /

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implomcnt aclions necessary to achieve planned results and <:ontinullllmp!Dvement of these processes.
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These processes shall be managed by the organization in accordanco with the requirements of this
International Standard.

Where an organization chooses to outsource any process that af'ects product conformity to requirements, the
organization shall ensure control over such processes. The typo and extent at control to be applied to these
outsourced processes shall bo defined within th~ quality managenent system.

NOTE 1 Procossas neodod tor the quality managomoOt system raferrod to above iocludo processes for management
activities, provision of resources, product realization, measurement, ana!rsis and irtl.pro\lernent.

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NOTE 2 An auts.ourcod prOcess" is a process that the Organization nonds lor its quahty management systom and which

tho organization chooses to have per1ormed by an external party.

NOTE 3 Ensuring control over outsourced processes

do~s

not absolve lho organlzauo,, of tho responsibility of conformity

contrC~I to be applied to the outsourced

to all custom-er, statutory and regulatory requirements. The type and Extent ol

a)

tho potontitit ~rnpacl of the outsourcod process on the organization's capability to provide product that conforms to
requiremontsi \

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b)

tllo dcgrqo to whiCh t\1u control for tho Process Is sha~cd,

process can be influoncod by factors such as

c) tho capability ol achlovlng the n.C.ssary control through the applicali>n of 7.4.

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4.2 ,.Oocuinontatlon
requirements
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4.2,1 General
The quality management system' do<:umentallon shall include
a) documented stntemonts ol a quaUty policy and quality objectivls,
b) a quality manual,
c) documentod proceduras and records required by this International Standard, and
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d) documents, iricludlng records,. doterrriincd by tho organization to be nect3t>Sary to ensure the effective
plarinlng. oporaUon and contra! of its pro~esses.

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NOTE 1 Where tho term c~ocUm8nl'ed Pr0ced'ure~ . 8ppears within thl& lntornatlonal Standard, this means that the
. : procedure Is ostabllshod, documented, Implemented and m&intalned. A sin-,le document may address the requirements lor
'\ _:::i::::!~bo~-~~o~,~~re proc_~,ure~. A roqu\rom~n~- tor;~ doeu.~entQd procedure may to cOvered by rnore than one doeument.
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NOTE 2 The extent of tho quality management system documontalion car differ from one organization to snothor due to

, a) the slzo of organlzauon and typo of activltlos,

, b) . tho comploidly of proco,.os and their lntoractlo~s, and

.,,(_}c) the co~pelonce ol personnel . .,:; . ::

,~ ~OTE 3 Tho d~umontatlon ca.n be ln anY form ~r type.~f ~edium.

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4.2.2 Quality manual

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Tho organization shall ositbllsh and maintain a quality manuatthat Includes

h)

tho scope of .tho qtmllly managemont,system, including

(scot.2).

dc~tlls

of and justification tor any exclusions

/b) tho documented procoduros established for tho quality manage.nent system, or reference to them, and

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a descrlptlon of the lntoraction between the processes of the quality managernent system.

~~~Cont;l, ol documont~ '

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Documents required by Ute quality ,;.anagemenl systom shall. be conlrolled. Flocords are a special type of
document and shall bo controlled according to the requirements givn in 4.2.4.

,,. A,.documented,pro~~ s~all be establlshod to define the controls needed

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a) to approve documents for adequacy prior to Issue,

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b) to review and update as

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and reapprove documents,

to ensure that changes and the current revlsion status of docurr ents are identified,

) to ensure that relevant versions ol applicable documents arc av011lable at pouts of use,

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e) to ensure that documents remain legible and readily identifiable

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0 ,, lo' en$'urethat d'ocumeiits ol eXte.mal origin determined by the otganlzation to be necessary for the planning
and operation of tile quality manageroont,systom are identified and their dlstlibvtion controlled, and
g) to prevent the unintended use or Obsolete' dC?cuments, and to appty suitable identification to them if they are

'retained fotany purpose.

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Records. established to p1ovlde ovldonco of conformity to roquircnents and of tne effcclivo operation of the
quality. management system shall bo. controlled.
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, . . Th~ urga~tza.tion shall est,abllsh ~JlJ<Um'!,Qt,e.~_p,rg.c.~~Y.~..,to definu the control; necued tor the identification,
:P~ ' "~'i1q~3 /,'-~Ait~i!~;:.'tft storago{protecuon,:retOovo1 1i:rotent1~n and.dlspositlon of ~ocords.
, ,/Records shall remain legible, readily, ldentifiablo and retrlovable.

5 Management responsibility
5,1 Management commitment
Top ffi3n~ge~cnt shall Pr~vlde ,,~~idenco of ils commitment to th ~ devolopmoot and implementation ol the
quality management system and continually Improving Its effectiveness by
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.a) com~unlcaUng to tho organization the Importance of meeUng customer as well as statutory and regulatory
reqUiroments,
.
,
b) establishing the quality policy,
c) ensuring that quality objectives are. established,
d) conducting management reviews; and
o) ensuring tho availability ol resources.:
'

5.2 Customer focus

Top managernetit shall cnsuro lhot customer requirements are determined and are met with the aim of

enhancing customer salislaction {see 7.2.1 and 6.2.1).

~ 5.3

Quality policy

Top management shall cnsuro that tho quality policy

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Is appropriate to' tho purposeof the organization,

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b) includes a commitment to comply with requirements and continually improve tho oN activeness of the quality

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managomenlsystcm,
c) provides a lramework for establishing and reviewing quality objecllvos,

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d) Is communicated and understood wtthln the organlzaLon, and

c) is reviowed for continuing suitability.

5.4 Planning

5.4.1 Quality objectives

Top management shall onsuro that quality objectives, lncl"ding those nE oded to meet requirements lor product
[see 7.1 a)], are established at relevant tuncllons and levels within the o1ganizatton. The quality obJectives shall
be measurable an~ consistent wltll tho quality policy.

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5.4.2 Quality manngentent system plarinlng

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, Top management shall ensuro thai'

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aT thO plannin{) of .the quallty'maOaoerilent &ystem is carriod Out in order to meet tho requiraments given in 4.1,
as well as Um quality objactlves,.llnd
b) tho Integrity or tho quality management system Is maintained who 1 changes to U1e quality management
system are planned and lmptemon!ed.

5.5 Responsibility, authority nnd communicatio;,

5.5.1 Responsibility and authority.

Top management shall ensure
organization.

th~t responslbllitlos and ;.~uthorltles arc defined and cOmmunicated within the

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Tiai~ing P~rpose orly

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ISO 9001 :2008(E)

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5.5.2 Management representative

Top management sh;1fl oppolnt a member of thll organizatlor 's management who, lrrespective of other
responsibilities, shall havo rcspcnslblllty and authority that includes

a) ensuring that processes needed for the quality management system are established, Implemented and
mafn1ained,

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b) reporting to top managomont on the performance of the qu.>lity management systom and any need lor
Improvement, and
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c) ensuring the promotion of awareness of customer roqulremen !s throughout the organization.

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NOTE Tilll roohonsibijlty ot a man~goment reprosonraUJO can Include liaison with oxternal partios on martors ralatfng to
the quality mana9(lmont systom.

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5.5.3 lntornal communication

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Top managoment shall ensure .that appropriate communication processes are established within the
organization and that communication. takes place regarding tl''' effectiveness of the quality management
system.

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5.6 Management review

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5.6.1 General

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Top management shall ro"lew the organlzatiop's quality managemunt system, at planned intervals,to ensure Its
continuing suitability, adequacy and effectiveness. This review shall include assessing opportunities for
improvement nnd the noed for changes to the quality managem.~nt system, Including the quality policy and
quality objectives.

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Recoros from management reviews shall be maintained (see 4.2.< ).

5.6.2 . Review Input

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The Input to management review shaU.include \nformaflon on

a) results of audits,

b) customericcdback,

/c) ~r~6~~s ~ert~}manco and product conform I~.

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d) . statu~ of preventive ,and correcti.ie ~etions,

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c) follow-up acli~ns from provioUs manag~mont rov_iews.

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f) . Clian.ges that toufd affect

,

th~'quaJity manageme11t system, and

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9) recommendations for Improvement.

.,.,.

5.6.3 Rov\ew output

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Tho output from tho management rov!OVf shall Jncluce any declslor s and action related to
'a) improvement of the elfocUveness of the quality ri,anagcmont srstem and Its processes,
b) improvement of product related to customer req';irements, and
c} rosourco needs .

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For jraining Purpose only

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ISO 9001 :200B(E)

6 Resource management

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6.1 Provision of resources

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Tho organization shall detElrmine and provide tho resources needotl

a) to Implement and maintain the quality management system anc continually improve Its effectiveness, and
b) to enha~ce customer satisfaction by meeti~g cusiomer requirements.
. .. :
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6.2 Human resources

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6.2.1 General

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Personnel performing worl< afloctlng conformity to product requirements shall bo com potent on the basis of
appropriate education, training, skills and experionce.
NOTE Conformity to product requlremonts can be affected. directly or lndlrt!Ctly by personl"'ul per1orming any task within the

quality managomont system.

6.2.2 Competence, t;alnlng and awaneness

"lhe organization
shall
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a) detonnine the necessary competence for personnel pertorrning work aflecting conformity to product
. I;

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requlr~ments 1

, ' ,'

b) where applicable, provide training or take other actions to achie\e lhG n9cossary competence,

c) evaluate tho effecllvoness of t11e actions taken,

d) ensuro thot its porsonnel are aware or the relevance and Importance of their activities and how they
contribute to the achievement of the quality objectives, and

...
.,

~ ma1rii~1~:. appr~priate ruc9fds of,education,

training, skills and ~XJerionco (seu 4.2.4) .
.
'

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6.3 lnfrastruqturo
.

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The organization s~ll determine, p(ovlde and maintain the lnfrastructuro noodcd to ochievo conformity to
product requirements. lhlmsttucture lnciudos, as applicable,
n) buildings, worl<space and ass9ciated utilities,

'

b) process equipment (both hardware and software). and

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c) supporting servlces,(such us uansport, communlcallon or Information system).

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6.4 Work environment

Tho organization shall doturmlno and manage the work onvironrncnt needed to hchicvc conformity to product

/ulromonts.
NOTE Tho torm "work environment relates. to thoso conditions under which work i!. e.ortormed including physical,
cnvironmOntal and other factots (such as: noise. temperature, humidity, lighting or woather1,

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,ISO 9001:2008{E)

Y 7.1. Planning of prciduct realization

The organization shall:plon and develop lhe processes needed br product realization. Planning of product
realization shall bo conslstont wltl1 the requirements of the other pr:x:esses of the quality management system
(see 4.1).

In planning product roallzution, the organization shall delermlne thE following,

\.,

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d) recorc&needed to provide evidence that the realization process !Sand resultlng product meet requirements

1scci4.2.4).

The organization shall doturmina

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the quality manager,enr system (fncfudlng the product realization

i:'

processes.

7.2.1

I,
,,

NOTE 2 Tho organization may also apply the requlromonts given in 7.3 to the dcvtrlopmont of product reallzaUon

i.

processes) and tho resources 1o be applied to a specific product, project or contract can J:..o referred to as a quality plan.

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or

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Tile output of this planning shull be in. a form suitable for the organi:oation's meth>J ol operations.

.
.
7.2 Customerrelated process,es

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''

cj roqulrcd vorillcatlon, 'validation, monitoring, measurement, lnnpection and test activities specific to the
product and tho criteria for product acceptance;

NOTE 1 A document spocJtylng tho processes

b) the noedto e~tablish processes, and doc:uments, and to provide resources spucific to 1t1e product;

't

a appropriate:

a) quality objectives and raqulrements for the product;

Oetennlnatlon of requirements re.lated to the product

a) requirements specified by tho customer, Including the rcquiremwts for delivery and post-delivery activities,

b) requirements not stated by the customer but necessary for specified or lntentJcd use, where known,
c) statutory ilnd 'regul~toi)o requlrenlents applicable to the product, and
''

'

'

d) any additional roqulremonts considered necessary by .tho organ zation.

.:
' 1'

NOTE Postdalivory activiliOB Include, for example', actions under warm 1ty proviuions, l:ontractual obligatioos such as
maintenance servic~s, ~nd supplementary services such as recycling or final disposal.

~;

1:

Tha organization shaiL~evlow the, requirements flllat~ to tho prodL ct. This reviEW st1all be conducted prior to
'the organization's commitment to.supply a product to the customer (e.g. submlsion of tenders, acceptance of
contractS ororders, .aoceptanco of.changes. tQ cohtracts or orders) and shall onsuro tt1at
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produ~ rcqui~0010hts:aro dilnned,

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contract or order requirements differing from

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'. 7.2.2 Rovlow of requtromonts relatod to the product

a)

thOse previously CJ~pressed are rasotvod, and

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tho organization, has tho ability to meet the do fined requirement''

; Records nljhe rcsulls of the review and actions arising from the review shall be maintained (see 4.2.4).
'

'

'

Whore the cuslomor provides no documented statement of roquiromcnt, tho cu;tomer requlromonts shall be

confirmed by tho _organization before accoptance.

7
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For Training Purpose only

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ISO 9001 :2008(E)

..
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Where product requirements ore ~hanged, the organization shell ensure that relevant documents are amended
and that relevant personnel are made aware of the changed requirements .

.'

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NOTE In somo situations. such as Internet sBtes, a formal review Is IITtpractlcal for each order. Instead tho review can cover
rolovant product lnformalion such as catalogues or advertising materiEJ.

7.2.3 Customer communication

The organization shall determine and Implement effective arrangements for communlcallng willr customers In

relation to

a) product infprmatlon,
b) enquiries, contracts or order handling. Including amendmerrts. and
"

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c) customer feedback, Including customer complaints.

7.3
7.3.1

Design and duve!opment

Design and dovolopmentplannlng

The organlzatio~ shall plan and ,control tre design and dovelo~ment of product.

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I

During the design an~ dovolopment pllmnlng, the organization shall determine
' ''

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,._ .. .,'11: '-:-,,,. ,.

a) tho design and dovolopment stages,'

b) Uhe ,;,_,lew, verification and

~all dation tihat are appropriate to each design arid development stage, and

c) tho rospon~lbllitlos and authOrities for design and devolopr1ent.

, :

I,

The organization shall manage the interlaces between different groups involved In design and developmom to
ensure effective communication and clear assignment of resp<>nsibility.
Planning output shall be updated, as ~pproprlate, as tihe desin and development progresses.

'

NOTE 'OesiQn and devoloprnent revieW, '~rllication and validation have distinct (JtJrp0$05. Thoy can be conducted and
recorded ~epamtely or in anY combination; assuitable for tho produc: and the Organization.

7.3.2 oestgn ond development Inputs

Inputs relating t~ product requirements shall be determined and records maintained (see 4.2.4). Those Inputs
shall inolude

--.
a) functional and porlormance requirements,
b) applicable s.tatutory and_rogulatory requirements,
c) where appllcablo,lnformaUon dertvod from previous simiiH doslgns, and
'

'

1.

d) otiher rcqulrcmonts essential fordeslgri and development.

' 1

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The inputs shall be reviewed lor ad~quacy. Requirements shall be comploto, unambiguous and not in conflict
with each other.
7.3.3 Design and development outputs

The outputs of design and dCvelopment shall be in a form suitable for verification against the design and
dovelopmenllnput and shall be approved prior to release.

For Training Purpose only

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. ISO 9001 :2008(E)

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Design and dovelopmont outputs shall

a)

moot the Input requirements for design and development,

b) provide approprtato Information for purchasing, production anJ service provision,

,_c) contain or _reference product acceptance crlterl<t, and

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d) specify the characteristics C?.f .the product that 1,e essential fo1 Its safe and proper use.
.

NOTE

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l~forrnaUon lor prod~lon and_~ervl~ p~ision ;~n Include del;: lis for the preservation ol product.
II

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.7.3.4 Design and development review

,3

At suitable stages, systomatlc reviews of design and devefopntent shall be pe!iormed In accordance with
planned arrangements (see 7.3. t)

i3

a) to evaluate the ability of the results of design and developmeflt to meet requirements, and

b) to ldentlfy any probloms and propose necessary actlons.

'

Participants In such reviews' shall Include repr<>sentatlves of functions concerned with the design and
development stago(s) buing reviewed. Records of V1e results of tt e reviews and any nocassary actions shall be
maintained (see 4.2.4).

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7.3.5 Design and development verification

:.~

Verification shall be performed In accordance with planned arranJements (sou 7.3.1) lo ensure that the design
and development outputs have met tho design an<t qovelopment input requirements. Records ot tho results of
the verification and any nccossary actions shall be maintained (s3:e 4.2.4).
----

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7.3.5 Design and dovelopment vaUdatlon

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Design and dovolopmont validation shall be performed in accordcnce with planned arrangements (see 7.3.1) to
ensure that the resultlng product ts capable of '"eating lho requirements for the specified application or
intended use, whore known. Wherever practica~le, validation shall be completed prior to the delivery or
Implementation of tho product. ~.Id_..of the fesults of validation and any necossary actions shall be
maintained (sec 4.2.4).

~~

'

. 7.3.7 Control o!,doslgn and development changes

-i~'

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Design and development changes shall be fdentlfl;(d and recorda maintained. The changes shall be reviewed,
vertfied and validated, as appropriate, and ap~:roved before implomentalton. Tho review of design and
development changes shall Include evaluation of the effect of ti1e changes 011 constituent parts and product
already,detlverod. Accords or the results of th~ review of ctangcs and any nocossary actions shall be
maintained (soe 4.2:>1).

~
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7.4 Purchasing

7.4.1 Purchasing process

The organization shall onnuro lhat purd.asod product conforms to specifiod purchase requirements. Tho typo
and extent of control applied to the supplier nnd 1110 purchased oroduct shall be dependent upon the effect of
the purchasod product on subsequent product rea.:izatlon or tha ~inal product.

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For Training Purpose only

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ISO 9001 :2008(E)

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The organization shall ovalualo and select supplie"'. based on lhet, abiiHy to supply product in accordance with
tho organization's requirements. Crlterta for sele<Uon, evaluatic'n and ro-oval~aUon shall be established.
Record~~~ the results of ovalua.llons and any n~cesSary actions ar slng from tho ovatuation shall be maintained
!see 4.2.4).
.
.
7-.4-2 Purchasing lnlonnatlon

Purchasing infor_r::natlon shall deScribe that product to;be purchased, Including, whore appropriate,
a) requlromonts for approval of product, procedures,., processes and equipment,
.

'

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, '

b) requirements for quahflcatlon of personnel, and '

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c) quality management system requirements.

Tho organizatlon shall ohsure tho adequacy of specl:1ed purchase requirements prior to thoir communication to
lhc supplier.

7.4.3 Vcrlncatlon of purchased product

Tho organization shall oslabllsh and Implement tho inspection or other activities necessary for ensuring that
purchased product meels spodfied purchase r6quire:nenls.
.
i

Where tho organization or ItS customer intends to porlorm vc,rtlication at U1e supplie~s premises, the
organization shall state tho Intended verification arrangements and method of product release in tile purchasing

,
3

information.
V',(1

7.5

Production and service provision

:)
7.5.1 . Control of production and service

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provlslo~

Tho organization _shall Plan and carry .out production and serv ce provision under controlled conditions.
Controlled condiilons shalllncludo, as applicable,
.

a) the availability of lnforrnaUon thai describes the ct'taracterlstics cf the product.

b) lhe availability of work instructions. as necessary,

c) tho use of suitable equipment,

:)

d) tho availa~ility and uso of monitoring and measur\ng equipment

e) the lmplamentaJion of monitoring and measurom,nt. and

f)

'

..

the Jmplementati6n of product rele~se, delivery and post-deliver 1 activities.

. '

7.5.2 Validation of piocoa~~s (or production and ~ervlc provJ,;ion

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The organization shal!l~udato-a~y-proce~ses for prq,ductlon and S1Jrvice provision where the resulting output
cannot bo veriOod by subuequent monitoring or moa:surement and, as a consoquence, doficiencios bocome
apparent only after the product Is In use or the sorvlcq has been del verod.

Validation shall demonstnlto the ability or the~e

The organization shall establish arrangements for the~e processes Including, as applicable,

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proco~scs

to

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planned results.

a) dofinod criteria for revluw and approval of the processes,

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b) approval of equipment and qualification of personnel,

c) use of specific methods and procedures,

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For Training Pu:pose on .. y

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ISO 9001 :2008(E)

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e) revalidation.
.

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7.5.3 lden!lllcatlon and traceability

Where appropriate, the organization shall Identify the product by sui table means throughout product realization.
The organization shallldontify tHe product talus with respect to nonitoring and measurement requirements
throughout product realization.
'

Whore traceability Is a requirement, lhe organization shall controllha uniquo Identification ol the product and
,.. maintain records (see 4.2.4)..

NOTE In some Industry ,uctors, configuration manngement is o moans by which idontilication and traceability are
maintained .
.;

,,~

7.5.4 Customer property

The organization shall exorcise care with customer property while It Is under tho organization's control or being
used by the organization. The organization shall lclentily, vorlly, protect and sufeguard customer property
provided for use or Incorporation Into the product. If a~y customer p10perty Is losr. damaged or olherwlse found
to bo unsuitable for use, the organization shall report this to the customer and maintain ~rd~J.see 4.2.4).
.

}. NOTE Cusfomer property can lncludelntollectual proporty'and personal d:lta .

1'1

7.5.5 Preservation ot product

. ; :
The organization shall preseivo lhe product during Internal processing and dolivory lo tho intended destination
In order to maintain conformity to requirements. As applicable, preservation shall Include Identification,
handling, packaging, storage and Protection; Preservation shall also apply to the ~onstltuont parts of a product.
.

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'7;6 Control of inol11torhtg:aod measurtng,eqtllpment

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The organization shall dotormlne the monitoring and measurement to bo under1aken and the monttoring and
moasurlng equipment needed to provide evidence of conformity ol product 10 determined requirements.
' .. :' : : ' 1 "\.

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The organization shall establish processes to ensure that monltorinl and measurernenl can be carried out and
are carried out in amapn~.r.t~at Js.consistentwith the monitoring ami mcasuremont requirements.
Whore neccssaiy to ensuro valid results, measuring equipment shall

calibrate~ o;~vorlflod,

speel~ed

a) b.e
or both: at
Intervals, or prio to use. against moasuroment slandards
traceabh' to international or natlon'al tneasuremoilt standards; Nhcre no sw;l1 standards exist. tho basis
used lor calibration otverlftcatlon shall be record~ (see 4.2:4);

b) be adjusted or re-adjusted as'nocessary;

c) have 1dcntlftcation
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-J~~~do; ~~determine its calibration status:

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d) .be saleguard8d !rom, adjustments that would Invalidate lhe measurement result:
c) be protected from damugo and

.. ,..

detorl~ratlon

during handling, m<: lntcnanco and storage .

In addition, lhe organization shall assess and rocor<!J!>e validity ol tho previous rnoasuring results when the
equipment Is lound not to conlorrn to requircimliifs: Tho organi<ation shall tat-o appropriate act1on on the
equipment and any product aHected.
f!!>mrds

or the results otcoUbraQon' and verification shall be malntafr,ed (see 4.2.4).

11

For Training Purpose only

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,;,~ISO

9001:2008(E)

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. ,.When used ln tha monitoring and measurement of specified requlrontents, tho ability of computer software to
c::. satisfy tho Intended application shall bo confirmed. This shall be unde,-taken prior to loltlal use and recoofirmed

,
,
'
,

as necessary.
, NOTE Confirmation of the ability of computer software to satisty tho intEnded application would typically Include lis
, verlfi~tlon and conliguraUon ma~gement to maintain !ts suitability for use.

,; 8 Measurement, analysis iind Improvement

,..,,...

.. 8.1 Goneral

The organization shall plan and implement the monitoring, moasuref'T.'lt!nl, analysis and lrnprovcmont processes

needed
a) to demonstrate conformity to product requirements,

b) to ensure conformity of the quality management system, and

'c) to continually Improve tho effectiveness of the quality management system.
..,: . : .. ~':""::~Tr::;~T:::::--:-:, --.~~-~~::-:-:--;-- ------- .

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This shall include detern\lrlailon of appllcabt'e methods, lncludlng stat1sticaltechniques, and the extent of their

use.

8.2 !oloniloring and measurement

8.2.1 Customer satisfaction

A:; one of the measurements of the performance of the quality mar~agement sy~tom, tho organization shall

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rl)Onitor information relallng to customer perception as to wheth~~r the organization has met customer
requirements. Tho meth9dS for obtaining and uslrlg this Information st1all bo doterrninod.

.. ;

NOTE Monitoring customor perception c1111 Include obtaining input from sources such as customer sutisfaction survoys,
customer data on delivorod product quality, user opinion survl!ys,lo!>t business enolysis, cortlpliments, warranty claims and

doaler reports.

13
[ ..

~2_: Internal audit

:3

The organizati_on shall conduct Internal auEi!_~~~-_p_IE~nedJD.!eo1als to dclc1ntine wtlctller the quality

management system

'

a) conforms to the pl!>nne~ arrangements (see 7.1), to the requirom>nls of t~is lnlomational Standard and to
the qual~y manageme~tsystom reqwlroments eslabfished by the mganlzation, and

b) Is effectively impl6ment0d and malntaln~d.

AQ audit pr()j)ramme ShaJI.be planned, laking Into consideration the sl< tus !l_nd Importance of a,e processes and
a~OUdltecr as woU as the results of preyioys gydits The audit criteria, scopo, froquoncy and methods

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t3

shaii bo defined. The selection ol auditors and conduct of audits shal ensure objodivity and impartiality of the
audit
process.
Auditors
shall not audit their own work
.
.
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'

Conducting audits, establishing recordG and reporting results.

'

A dOS.l:JOlCntod procodura..sha\1 bu established to define tho responsit,ilitics and

~the

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~lng audited shall ens Jre

that any necessary corrections and

corroctivo actions arc takon without undue delay to eliminate detected nonconformitics ond their causes .

12

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For Training Purpose o1ly

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lor planning and

audits and U1olr results shall be maintained. (see 4.2.4).

Tho managomonl responsible. for the area

~3

~I

requirement~

.,:.-:

ISO 9001 :2008(E)

Follow-up activities shall Include the verification of the actions ta <en and the roporting of verification results
(see 8.5.2).
.

NOTE SooiSO 19011 for guidance.

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8.2.3 Monitoring and .measurement of processes

;;:itj-he organlzatlon shat{appfy surtatite. methods !or monitoring and. Ylhere applicable. measurement of the qu!llfty

.'1' .:.managoment systom.proeessos. These. methods shall demonstrate the abil11y of the procosses to

planned results. When planned results are not achieved, correction and corractlvo action shall be taken,
appropriate.
- --------~-- __

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The organization shaft monitor and measure the characteristics of the product to verify that product
roquiromonts have boon met. This shall be carried out at appropr1;>te stages of tt1e product realization process
In accordance with the planned arrangements (see 7. 1). Evidence ol conformity w~h tho accoptance cnteria
shall bo maintained.
RecorQ.s_.~halllndicato tho person(s) authorizing release of product tor delivery to. the customer (see 4.2.4) .
.,..--

'

B.2.4 Monitoring and moasure(llent ol product

:9

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and on tho effectlvonos.s of lhe quulity management system.

.1

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NOTE Whon dotorminlng aultablo methods, It Is a~sable that the org.an zation considur the type and extent of monitoring
or me~surement approprla.to to oach or its processes In relation to their I Tlpacl on tho t:ontormity to product requirements

,!.'

The release of product and dulivery of service to the customer shaft not proceed until the planned arrangements
(see 7. t) have been satlsfactorily completed, unless otherwise approved by H relevant authority and, where
applicable, by the customer
.

~ontrol ol nonconforming product

The organization shall ensure that product which does not confom to product rcquiromonts is Identified and
controllod to provent Its unintended use or delivery. A documented procedur9_ st1all be established to define the
controls and related. responsibilities and authorities for dealing witl1 nonconforming product.
Where applicable, tho organization shall deal with nonconforming product by one or more of the following ways:
a) by taking action to eliminate the detected nonconformity;
b) by authorizing its uso, release or ecceptanco under conClSSion by
applicable, by the customer,
c) by taking

actit>,~

relevant au!hori1y and, where

to procfude Its priglnal.intended use or npplic!ltion;

d) by taking actio~ appropr1ate to the effects, or potential effect::, of the nonconformity when nonconforming
product Is detected after delivery or use has started.
When nonconforming product fs corrected It shall be subject to reverification

t.:~

demonstrate conformity to the

requlre~ents.

Rocords of tho nature of nonconformiUes and any subsequent actions taken, Including concessions obtained,
-matrbolnaintatned (see 4.2.4).

8.4 Analysis of data

The o(\lanizatlon shall.llotormlne, collect and analyse appropriate data to domonstrat~ the suitability and
effecUvonoss of lhe quality managoment system and to eva uate whero <.:Ontlnual 1mprovement of the
offoctivonoss of tho quality management system can be made. TIis shall includu data generated as a result of
monitoring and moasuremont and from other relevant sources.

',

13

For Training Purpose cnly

achieve. . ')

1~0

9001 :2008(E)

.):,
. 'The analysis of data shall provide Information. ~ela~o\g to

. .:v~

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~) customer satisfaction (see 6.2.1),

.>i."L

b) conformity to product requirements (see 6.2.4),

c) charactorlstlcs and trends of processes and products, including opportunities for provontivo action

(seo 6.2.3,and 8.2.4), and

d) suppliers (see 7.4).

, .,

8.5 Improvement ,
8.5.1 Contlnuallmprovoment

!> (,

Tho organization shall continually Improve the effectiveness of tho quality management system through U1o use
of the quality policy, quality objocUvos, audit results, analysis of data, cnrrective and prevenllvo actions and
)Tianagemont rovle~.... ,
J
. I
I
.
<.,.
/
b J, 6 '-11
& !)
b .
't

5"

;-: . '

~i)corrocUvc action
Tho organization shalitake action to eliminate the causes of nonconformities in orde1 to prevent recurrence.
Corrective acllons shall bo appropriate to the effects of tho nonconformiUes encountered.
A. documented procedure shall be established to define requirements
for
I
~~~-.....-.-..""'-

'""'"'-~rl

a) rcviowing nonconformitios (including Customer complairts),

b) determining t11e causes of nonconformities,

c) evaluating the need for acuon to ensure that nonconforryues do not recur,

'

d) determining and imptomo~tlng action needed,

e) ~ or'the results of action'takcn (see 4.2.4), and

reviewing the effectiveness of tho corrective action

f)

/-::>-;;:,"

take.~.

'

~:~-':Proven!lve actlorjo,
I

~:e
~
~"~
r

Tho organization shall dctermlno uctlon to eliminate the causos of potential nonconrornlities in order to prevent
!heir occurrence. Preventive ncUIJilS shall be appfopriato to the aHeels olthe potcnllal1'oblems .

A docum~_proccdure shall be established tO define reql.Jircments for

a) determining potential nonconlonmlties and their causes,

b) evaluating the need for action to prevent occurrence ol

~~onconformities,

c) determining and implementing action needed,

d) records of results ol acUon taken (see 4.2.4), and
-~
~)

reviewing the effectiveness ot tho praventivo actlon taken.

14

.L,..

E'

!'or Training Pnpose only

"'

ISO 9001 :2008(E)

Annex A
(Informative)
Correspondence between ISO 9001:2008 and ISO 14001:2004
Table A.1-Correspondonce between ISO 9001:2008 and ISO 14001:2004
ISO 14001 :~004

ISO 9001:2008

1:'1! '

lr:'lroduction (title only)

!ntroductlol\

Goneral
Procoss approach

0.1
0.2

Relationship with ISO 9004

0.3

Compatibility with othor managcrnunt systems

0.4

Scope (Iiiio only)

Goncral

1.1

Application

1.2
2

Normative references
Torms and definitions
Quality management system {titlo only)

3
4

1 .

Scope

2 .

Normatlvo relerences

'

Terms and definitions

Environmental management system requirements

(title only)

Gonoral requirements .

4.1

Documentation requirements (title only)

4.2

--

--

4.1

General re =1uiremcnts
.

4.4.4

Document; Ilion

4.2.3

4.4.5

Control of ~:Socuments

Control of records

4.2.4

4.5.4

Control ot ,ecords

Management responsibility (Iitie only)

~anagement

5.1

4.2

Environmental policy

Resources, roles, respon liibiUty and authorlty

5.2

4.4.1
4.3.1
4.3 2

Legal and :lthor requirements

4.6
4,2

Managemunt review

4.3

Planning (litlo only)

5.4.1

4.3 3

Objoctivos, targuts and programme(~)

Quality management system planning

5.4.2

4.33

Objectives. targets and prc..grammc-(s)

Responsibility, authority and communico.tiOn (tillo

5.5

General

4.2.1

Quality manua I

4.2.2

Control ol documents

commitment

Customer focus

auaijty policy
Planning (tit!o only)

5.3
5.4

Quality objectives\

only)

Environmental aspects

Environmental p:>!icy

Responsibility and authority

5.5.1

4.1

Gonoral requlrernonts

4.4.1

Resource~,

roles, responsibility and authority

Management rcproscntativo

5.5.2

4,4, 1

Resource~, rolo:>, rosponsibility and autt1odty

Internal communication

5.5.3

4.4 3

Communit ation

Management review (titlo only)

4.6

Managommt review

Goneral

5.6
5.6.1

4.6

---t.tanagommt roviow

Rovi~w

5.6.2

4.6

Managomml roviow

5.6.3

4.6

Managemmt review

input

Aaviow oulput

15

For Training Purpose c'nly

ISO 9001 :2008(E)

Table A.1 -Correspondence between ISO 9001 :2006 and lllO 14001 :2004 (continued)
ISO 0001:2008

ISO 14001:2004

Rosource managomonl (tltlo only)

Provision of

6
6.1
6.2
6.2.1

ro~ource~

Human resources (title only)

Gonoral

Competenco, training and awarenos.s

6.2.2
6.3.

Infrastructure

Work oi'Tolironmcnt

Product realization (titlo only)

Planning of product roa!izalion
Customor-rola tod procossos (title only)

Resources roles,

4.4.2

Compotenc:(l, tr<lining and awaronoss

re~pon~<lbilily

Compote01:e, training and uwareness

4.4.1

Rosources, roles, respon~~;ibility and authority

.

!mplementltion and opcruUon (tiUc only)

4.4
4.4.6

Oporationsl control

4.3.1

Environmental a:3pocts

4,3.2

Legal and )thor requiromQnts

Oetormination of roquiremonts related to the

product

7.2.1

4,4,6

Operation~~

Review of requiromonts rotated to the product

7.2.2

4.3.1

Environmental aspects

7.2.3

4.4.6
4.4.3

Operatiom.l control

Customer communication
Oosign and development (title only)

7.3

Design and dcyefopment planning

7.3.1

4.4.6

OperatiomJ control

Design and dovolopmcnt inputs

7.3.2

4.4.6

Oporatiomtl control

Doslgn and development outputs

7.3.3

4.4.6

Operaliom:l control

Doslgn and development revlow

7.3.4

4.4.6

Ope ratione:! control

4,4.6

Operatlon~1

Purchasing (title only)

7.3.5
7.3.6
7.3.7
7.4

4.4.6
4.4.6

Operatiom.l conUot

Oosign and development verification

Purchasing process

7.4.1

4.4.6

Operation,,/ control

Purchasing Information

7.4.2

4.4.6

Opera11omu conlrol

Veriricatlon or purchased product

7.4.3

4.4.6

Operatlonc1l control

Production and $Crvicc provision (title only)

Control of production and sorvico provision

7.5
7.5.1 .I 4.4.6

Oporat1onc11 control

Va!i~a_Uon

7.5.2

Oparatiorutl control

--

Design and development validation

Control of design and developmonf changes

ol processes for-production and service

4.4.6

control

Communication

Operationitl control
control

prOVISIOn
ldontiflcation and lruccability

7.5.3

Customer property

7.5.4

PrOSG!Vation or product
Control or monitoring and mG48urlng oquipmont

7.5.5
7.6

Measurement, analysis and Improvement {title only) 8

Goneral
Monitoring and moasuromont (titlo only)

6.1
6.2

4.4.6
4.5.1

lntornal audil
Monitoring and measurement of procossos

8.2.2
8.2.3

OperaUonltl control
Monltoring and mo;:J.~urernvnt

4.5

Chocking !title only)

4.5.1

Monitoring and rnoa!:>urorr11.mt

4.5.1

-lntornal al dit
-Monilorin' ond rnoasurcmcnt

4.5.2

Ewluation of CQmpliance

8.2.1

. Customer satisfaction

and authority

4.4.2

6.4-

7
7.1
7.2

4.4.1

4.5.5

,.,,.-

16

For Training Purpose 011ly

ISO 9001 :200U(E)

Table A.1.- Correspondence between ISO 0001:2008 and ISO 14001:2004 (continuscf)
ISO 9001:2008
Mon~arlng

and measurement of product

Control of nonconforming product

ISO 14001 :>004

8.2.4
8.3

Analysis ol data

8.4

Improvement (title only)

8.5

Continual improvement

. 8.5.1

4.5.1

MonitorlnQ and maosurttmonl

4.5.2

Evaluatio1 of compliorlcJ

4.4.7

Emorgon :y preparodne~;s and response

4.5.3

Nonconfc rmity, corrcctJvU action and preventive

action

4.5.1

Monitoring and measurament

4.2

Environmental policy

4.3.3

Objectives, targets and programmc(s)

4,6

Managenont rovtew

Nonconfcrmity, corrocbv(.) action and preventive

Corroctive action

8.5.2

4.5.3

Provcntivo action

8.5.3

4.5.3

action

Nonconfcrmity, correct.vo oction and preventive

action

17

For Training Purpose o;1ly

~
'

ISO 9001 :2008(E)

r:t
!:t

Table A.2- Correspondence between ISO 14001:2004 and ISO 9001:2006

ISO 14001:2004

ISO 9001 :200U

-

lntroducUon

0.1

>

~
~
~

",;;,

Scope

Introduction (titlo only)

General
ap~

0.2

Process

0.3

Rolationshl~

0.4

Compalibili~r with othor manaoement systems

Scope (title ,,..y)

roach

with ISO 9004

1.1

General

1.2

Application

Normative mlerencos

Terms and clefinitions

Normative relercnccs

Tenns and definitions

Environmental management system roquirern~nts

Quality management system (titlo only)

4.1

4.1

General requirements

5.5

Responsib!l ty, authority l&nd communication (li!la

(title only)
General rcquirernonts

---

only)
Environmental policy

4.2

5.5.1

Rosponsibility and authoriiy

5.1

Managomoot cornmltmcnt

5.3

Quality poll1:y

6.5.1

Continual i1'1lprovomortl

----

Planning (title only)

4.3

5.4

Planning (title only)

Environmental aspects

4.3.1

5.2

Customer focus

7.2.1

Determination
product

7.2.2

Roviow of tl)qUirements reiCJtod to tho produ.ct

5.2

Customer focus

7.2.1

Determination
product

5.4.1

Quality objt!Ctives

4.3.2

Legal and othor roquirotnonts

4.3.3

Objoctivos, targets and programme(s)

Ol

rcquir~ments

-related

to the

or requirements rolatod to the

5.4.2

Quality ma11agernont sysloJrn planning

6.5.1

Continual ilnprovemont

Product ro~.Hzation (title only)

Implementation and operation (title only)

4.4

Resources, roles, rcspOnstbJiity and authority .

4.4.1

5.1

---------- - Management commitment

5.5.1

Responsibility a~d al!thonty

5.5.2

Management represontati<Jo

6.1

Provision of resources

'

Competence, !mining and awareness

4.4.2

6.3

ln!rastructvre

6.2.1

{Human tQnourcos) Gonoral

6.2.2

Compotenc:e, training ano Hwaraness

5.5.3

Internal cornmunication

7.2.3

Customer t:ommunicntion

Communica!ion

4.4.3

Documentation

4.4.4

4.2.1

(Documen1atlon roq_~:nts) General

Control of documents

4.4.5

4.2.3

COntrol of documcnt~

18

For Training Purpose c>nly

ISO 9001 :2008(E)

Tabla A.2- Correspondence between ISO 14001:2004 and ISO 900 I :2008 (continued)

--

ISO 14001:2004

ISO !XJ01 :2008

Operational control

4.4.6

7.1

Planning of product roaliz.ation

7.2

Customer-rolated pr vcossos (title only)

7.2.t

Oeter.nination
produ:t

7.2.2

RevfeN of roquiromto nts retatod to tlla product

7.3.t

Ooslgn and dovolopt nont planning

of

wquirornonts

7.3.2

OesiQn and dovolopr nent inputs

7.3.3

Design and devolopr nent outputs

related

7.3.4

Design and devolopt nent review

7.3.5

Desisn and dovoropt non! verification

7.3.6

Design and devolop' non! validation

7.3.7

Contr.)l ol design und development changes

procu~s

7.4.1

Purer asing

7.4.2

Purct asinu informal on

7.4,3

Verifit:atlon of purch ased product

7.5

Production and ser.- ico provision (t1Uo only)

7.5.t

Control ol productior 1 and service provision

7.5.2

to tho

VatiduUon of proce~ ses for production and service

provit.lon
7.5.5

PresErva.tion ol proo uct

Emergency prepo.rodnoss and respon:sG

4.4.7

8.3

Control ol nonconforming product

Chocking (tltfo only)

4.5

Measurement,

Monitoring and moasurement

4.5.t

7.6

Contr::.J of 11)0nitorin\l o.nd measuring cqulprnenl

Evaluation

or complianco

4.5.2

Nonconformity, co1roctivo action and prevontivo

action

4.5.3

'\

--

anal~ sis

and improvurncnt (title only)

8.t

(Mea ;urement, anal ysis and improvamont) Goneral

8.2.3

Mon~oring

B.2.4

Monitoring and moo suremonl of product

8.4

Anal~ sis of data

and moa surarnent ot processos

8.2.3

Monitoring and men suroment of processes

8.2.4

Moniloring and rnou surcmont of product

8.3

Control of nonconfo,rning product

--

84

Anal~ sis

8.5.2

Com ctivo action

8.5.3

Provt1ntive action

of data

Control of robards

4.5.4

4.2.4

Control of records

Internal audit

4.5.5

8.2.2

Internal audit

Management reviow

4.6

5.1

Mancgement comn. ilrnont

5.0

Mant: gemcnt rcviuw (!itlo only)

5.6.1

Gone rat

5.6.2

Rovi11W input

5.G,3

Revi~,w

8.5.t

Continuallmprovll/r. ent

output

19
I
lo

For Training Purpose <>ryly

ISO 9001 :2008(E)

Annex B
(informative)
Changes between ISO 9001::2000 and ISO 9001:2008
Table 6.1 -Changes between ISO U001 ;2000 nnd ISO 9001:2000

;.! Puagraph/
Flguro/

ISO &001:2000
Clau.a No.

Tab.lo/
Nato

M<llll.oD
(A) or
Dolelleft

Foroword

Pnra 2

Amunde~

text

(D)

DA '

lntomalional Standal'dt are druhod in accordance with tho rulo.s gt11an In the tSOfiEC Directive c.
Paf+-3[~.

commilltes jslo orepe!D..ln1.c1!flll1i.Q

Foroword

Paro J,
A
Scnwnco 1

Foroword

Para 4,
Scntonco 1

DA

Altllntion Is drawn to tho poc:>tuUity ttmt somo cl tho utornunt:>'

!iQ.\;;1.'./lJ.C".n.l may be the lJUbjoct ol potent rights.

ForoworrJ

Para 5

if,tvtuotiom~oodafd

Foreword

Pilra G

Ib.i:.main..lil5k of tochnlct!l

ISO 0001 was proparad 'JI/ Tochn;c.al Co TIInittoo ISO/TC 176, Quality
maJlilQ<lmflnl and qwlity assuro.nco, Subcommillllo SC 2. Quality systums.
f.hitHI.tl'd-odil.toA e!ISG 9QG-1--ooi>oc-lr,-H~ 5-th<Kcoood cdl liOtt--tf&O-OOOH~Ot/4}-togot\.of
wil.lt-l&<fOOOJH~SG-OG:i3i-IG04,-H-(IOA6\l<u\Q&-Q-k!vlt~l~l

rwio+o-n-Q4-lt!OOO-dUOOfliQI\ltr.

nl06)-(>fg.a.flila~tu~Hlc.GO~S0-0002i-KI-04-aOO-i&G- 0V03+f004-ifHIIO-P<JG\-mUji-IJ(jQ
lhiv4il!O~OOikll\3t~..O!,Oiu<:l~liOIR-fEquk&fHOI"IIU.ffia !o00r0o.f100-Witf:l.4..,2,

fOIIJWOfd

Pi<ril 7

.DJ.is....lmll.lb..Jsllth:~o C:IQ,uJs, aod...lil~ll...l.bitd f!d~it:!l (ISO J00120~1JJai...ll.o..o.n

. i"
~!lfl<l to c!Arjtv oo!nt!i. In ]ho !axt aod !o eohan ~~!fl
t$0 J.10QUQ.Qi.

:riW1-I~le--oJ.~n-le-~i6o:..>U~\~~'d-41o-kvl {lOr~~~~~lily
tlG-6Vfll-flOQ!..~I-OfUG!lh.:i..;lw-quaJily-fl~f\a90-A...:!HHI't.
ti-'<Jfll-f<K\vlfOiflOfii&-Lpovlft<XHfl

Uli6.~~1 1&~0001, in-<:.~:liLion-l~l&GUf"altCO-Oi-po O<Juct,......alw-aim-to-oo~

uV6lOm<of-~HtiG~

Foroworcl

rara 0

Foreword

Now para 7 A

0.1

Para 1,

Annexos A-aAO-B-oHhlG-k\ffi-llii)K.,.,;:,;.s!unJaf<J..i.f!HeHAkrl"HW.!too

D.llllllls. .nUl:u:: cbacgas beiYlccaLlllll..ll'lnl cdl!l!:lo a1d IIllS tcumtl c.!1rtJ.uD B!!! g!ypo

jo AD')r>X 0,

"f.ho-0-GG!gn--aA"' lm~lemGfltalioo-fi-.dfHifgaAlza4ie~wlil'f""fi\ill'o i'o\}<HMA~~~

ll-)'-...,.i::lfyil'lfrH60,.-p~~:Aarvti'>O\i'.'%rlho-prOO\.H~v-pnwiUoOrU.O pr00Ct.601Hif~Tho

Scntof"lco 2

(;iW -anG-GtrOOit~l&-oHhe-of!J'lfhl<ilioo,

.l1lf....!j~joo nod !mp]emen]a!jotL

an orqao]zat(or:uw.al.i1...roan.a.o; aJllil.!)l syr,!ern js !o(\imnccd

trl
it :i...Jl!Q.I10iza !]non! eoyj mn[D!,'.fl..u;han!Je....Jn...lhtll...C..I:Uil:o.nm.

I
I

0.1

0.2

Sentence 3

Now a

Para 4

l'ar~

lllJl.tJ:Jl~

b)

U:U""'In~

C)

ll:Ul.illllc!J!nr

d)

tll!l.JlWd!!ciS ]t pmyldcs

o)

UJQI:!t!le:fl::i'i!Ui i! Sl:IDC:I~

I)

Us.ro.im and o~acltaUO:naLHuc.tULll...

Qblcc]jyc~

11 Is not lha Intent ol this lntern.llional Standard "0 imply

new para management aystems or uniforrr1!ty of documentatoon.

umlorn lty in the structvre ol quality

lhis lnternauonar Standar<fcan l>o used by lntornal and external tarllos,lncludlnQ cortilicalion
bodies, to asseu tho organi2.llion's ability 10 meot custom Qr, '"la~<[!pry end regulatory
fCQUirornonla ~~Q~t, and the O(!J41"1itatior(s ow n ruquiremonls.

D+A

For 1111 cirganinllon to !unction p!!tJCtlvoly, it hasl~lily Cclu1111hl.il and mo.nogOJ numcrooG
linkod acUvltloa. An a~ivily QU~...oLa!.::!.i.vl11. usln 1 resourcos, a no managed In order to anai.Jie
tho transforrnation of Inputs Into uutputs, can be CCnsidorod u~ a

20

For Training PL'rpose or1ly

poO.:C$~.

'

~~
;~

ISO 9001 :2008(E)

~
~

~
;~

Tablo B.1- Chan~Jcs between ISO 9001:2000 and ISO 9001 :2UU8 (continuecf)
ISO 9001 :2:0 00
CIIUU No,

Pargraphl_ AJllll1lnn
Figure/
TabiW
Not

(A) or

Amende-d ltl):\

Dolo<....
(01

0.2

Para3

The application of a &ytotl!m ol proc~sses vlthin an organl1 ation, together wllh !ftc ldanlilication
Md interactions ot lhrsnu procoGS{)S, and their mo.no.gem ~o~nt llLJlLOtlw:e...lhu...WilrJilld...o.ull:amfl,
.can bo re!erred to as_tho 'process opprcath.

0.3

Para 1

D+A

=l:n&pte&bflledl'iaf\s 1)!.4S0 9001 and ISO ~004 haw~ -boon do\l~k.p~fl(;i(.loo-1~ are
(;uaUty management syslom i.ilandards which ha"o boun ,Jut;ignorj tu comp!omont oach o!hor,
byt eun also ba used lnJepcndonlly. AHktvflh-U~-"i~w-it~ Wtnal~~~ttlcr--f~
6-0~~"nllar..c.lf\IO\UfOO..IH-ot"4lf40-aGGJGH1Mf- i.lt){ll1wlloi'l----lliO--O--IoGiG-Iitnl.-p!llft

0.3

ParaJ

D+A

~t,

-~00-~d.lnoo--vn-a--wWoH&tll~bj<Joliw&

-vl-G~\af\6000~
tloo.!~tk.oular~f~t'ttifwol--iiJIPIOV<o II IOfl.--of-...Gn-efQOOiletfoo'&--owfGII
ffe.r~mf\llfiQI 1AdQ.f~I)Q'f;-M~6--lt&-~~.clliO~

~~~tg$!1\i~p-monogJ;~tMOOHt4GMG-4onloYO-t o-(V(IU.~~~\fo--01~
~~pUroWil

t~

.~

Jho ceyi;Wd
!~lU?n or 1$0 900:1 wil!..Jtr.~i:.!~LQU~~mull.!!H Dtb(mlog su313joed WCCASS for
Llffi'_oroanlzaHon In a cQ1nr.~.o;Jicruaru1ina ..anl1J!ruJjl.ilflLl!i\L.Jl.U'l!IJmmnO! !SO 9QCH mmjdos
tlJ.Idd~tL...rnanao;:u!D.Jll1llhn.tLlS!l.JlOO.L!La! ld~
It( a 1! jnMrn;rtcd pcrn ... s_w:l.1Jl..u.!Lsa1i~;1lQo_t~'...llu:-sy..s. lt.:IJt,J/1\' Rod cmtiaW!//ropmycmcnf of
lllL.Q!QDDil!!,llan's rt>d.'!"'f"'l~~~c...JLi~_JlQLJr.Ut:: ruJ.!:d lor certjficalico mqu!aJqry or
~;MJrn.~

Para 1

0.4

..

D+A

~=-hie~to~\D.n-dntd-ho()-Oooo--61tlft0d-Y~ith---l801 4001-i4-il06-lft-ofd<:fIG-C~M~

oo-mpa-l~Gtn.-.d.:or-dv---f~OA&G\--ol-tho--IJG() H;oo;munityt
D.udng tho developmcot_oLU,j'i !n!trna!llWll.S.l.il.ruian:L d,IJ!) COO$!dn@riqo WfiS gjveo IQ !hC
l!lQ).']SiOGS Qf ISO l~O!ll:.2QQ:ll? C:Ob!lO!:iC 'ha.J<.Qr:~ !J~3!octhcboneHiqf
l}~_y~r commuoltr t,n~rv t, ShOW$ ilw:tJilJLll2Qllii c..n.-:e 11otwceo (SO 9f"'IQ1?008 anct
lS.Q 1IOQ1?004

8ullota)

1.1

1.2

,~

't~
-~

!, ""
' 1-l

nacds to dcmonstruw Us obility to con:;istenUy p!u'oi:Jt.: product that meets customer and
stetutory e!lli rc:Julaloty requirements, anc

,,,

~!mG to enhance cu<;tomer &aliMactior. through th'J ollt. c!tvo appUcution oltha liystom,
L1cludin{l processes lor c.:>ntlnunl improvoment of th~ sy::t: n und the assurance of conlormify to
customer and applicable s.lnl!..lll:!rLll.O.d regJia\o1y roqOJircrr. conts.

Nolo

IIOT-E~Iiofltlf--Sl.ln<iaf-d,..tho-~ ~wOOuvF-.:~p

J;QIE I to tfl!l;!ntemuJ&nill...S.lilll!la!d..Jt~~-=1

(IHoqutf~tomor.

{l)

Bulla! b)

l~
"l~
t~
l:)

<tp~l!ca.ble

eeA&IFIU&HfflpKI'fOAIOf\1-of..p&ricoffftOOOO;-\-~:.-wr,U-iG-floHoleOOQd-4o-f-oofW~

!~Jh~lJ~on.0-l:li!.i.lillOLna1klliW...SlJJ.ru1;:ut1,.JS1 ).~01 js under rJttJ?ioo

af

liJHlQfti(~~

~-

t>)

eny !nlooded

otf!Q ti.f.'!i!UlinVromJI:ln pmdt 1ct rr'!J.!.!.!Jl liun.procosws

SlalliJC:~J: ~od '!l'.lula.l.Q[yJ!tQl.J.lamt.ni.!.L.!:.!!O.Jl.!Ul.:

Uuw Note 2 A

JlQJE 2

!"'ora 3

tttis !nternallonal Standard o.re not

made, c!Jhns ol conlvrrl"'lity
limitull to roqu Cttmcnts wHhin Cli!UGe 7, and such
acct:ptable uni&$S tho!".!: exclusions
UKCiusions ~not al!ocl tho org;mizatlon's abilit;. or rospOt ~~ibility, to p1ovido product !hat meots
<:ustomcr and app!lcat:lc! r,IJ!i!Q!:'t aod rctulatory rcquirur1 cnts.

Para 1

D+A

'

'

prMj(ct lnlpndcd !orJlU.eJJ.ul.r..r:.d..b.x a st!slom"r

a)

Wht!ff! Cl'iclusions

---

'"

...

"

:r.oo~ivo-doouo1c-ffl~iliM-PFIWIG-IortC---'< ffiiuft,--Uw-oogiH<>Iorv~~t;
PF0''\GirHJG-----1JI-It~fi!OffliN+t~~Of\QU+d.- Fvt-:hltotl-folefDf"~G~bGaqtl(Hll

OOMliiWI&

i)ff'~~k.k>oo-il{rl)~~liitt '16-~'f,..-pit~O

~~..(I(H~orn<Hiofl&l..S.)Ada-4d-;)-l'-o---ooo<klletgdd-1~\o--lt\o---p~
<l~;)Wfl~----odiiioo-ol--tM-~1-iltiw- OC.C.U.lwnl-indioaled--bokH/~
I'Ole-~t\-041-..l-iltU--AO~~W!WI"".rol-alr00-t-G---&j}j)41o&...UvoW()f-u~

IEC-~t}IGtofG-ofOUfrortlly-yalid----lft iOfRO\kxlo~G\.:tl i-.k.rdv.

mfurcrc~:Ul~!!ill!1ll~~lliab~U2! .iJlUOOifcnlkJQ ol1tlli.J1Q;;umoot for

~Q. rc 1erences tho late~! (>(!jHon o!lbo
!1Mrd ro!orences only Vl~J!_jjJirn cjiCd B&Pii.e~...J:.Q.L.J..Hl""l
t~cod g~urneol !itKI'l~inoJ i'o~ am~r!1!nml.tl..i:l.:,Qii.:t~

Ih.Q_Hir!wfog

DA
'---

ISO 9000:2000.2.00.5... Oualily m.:w.:~gomenl systvm:;- ru1 nfanll>nlals 11nd VOCllbufary

_.

-----

21

ISO 900\:2000(E)

Tt~blo
. ISO 9001:2000
ClaUliO No.

B.l- C~lan~Jos between ISO 9001:2000 ond !liO 9001:2000 (con/inusd)

Hoi I
f>~:~ra

Parugrcph/ Allllli!Jln
Flgurel
(A) or
Tabla/
O.IU~n

Amo nded hn:t

(D)

DA

f'or 1h11 purposos Olthis

r:so !Woo

Pnru.s 2, 3

~un:.c.nt

!(lto/Mtl

.c terms

ap~lf.

- -no-loUowlfi{HOfft\&rWJOOItHIJ.HGlliol+-{)1-.t
-

'

<Hid deftn1lions gwen In

l!oU-tho-~ppl~{)Min,-~OOCH

I>Ut\1!00-lG->vnvot-~ho -woo bvi.afJ'-V\.Itl\l!l;it->1-C

t-uprll-er-T-IH'g .. nl.l.atl.;;tl-~t~vm'Of
~ ll4;!-\e-1tt~f9flj\-ii!Giior~o~:-fopluootr..UW -4Q;m-~

up.plivt4i>JcUi.l-t ~ 00\Xli-:-\OOh-Ut".tl-tdU"fl)-lo-il~<..!

~.r,J ~ o wl.kliHI~lo r1wlivrwl- b11.1nJurU- upy HJG.-/,!Q.L),-\hU\'.Jfll' .:G~Jpj,;lo?f\OW'fiJi;.low&.ltwMfm

,,

.:.~ub-x>nlfoolo,;

4.1

Bullot "a)

DA

4.1

Oullot e)

---,,,-A

4.1

PoilU 4

OA

Where an ocgoniution choo~os to outsouroo any prm;o:;s that aiJccl~ prodt.~et con!ormlty Mt J.g,
requirements, the organization shalt onsuro c l!\l!ol ovor~uch 1>lliCCG!iOS..Ih.a.JJp.c.,a'll1..Qxt.eJll.QL
cnJl!J~l.1ll..!J.c..W~l.lll::!l..P~ilnr'2 :(!!i.:O.ti.J:ll.i!.!LA.C...!! i!lUIC'! wjthiQ Jh!! Q\IVIrty
1tJ..ln'l 11 "0li'Ol S::iSI.!:m.

4.1

Notal

DA

j;IQTE I Procossas

Utmtily dll1e!mine tho procec~oo nood&J lor th1! quality

appliculion throughout UHl ort~anlzalion (see 1.2).

rn" rhlgcmefll system and ltlcir

mcnitor, moasure l'rlie.I.ll..W~. and. malyse~ those ptVC! lS:les, W1d

needed

~Jr

U10 quality manavomunt ~~ otvm rolouod to abovo

""'~
proi~leotl of ro HIUICOS, product IQJ.Iil..ltk>n, &fid

lin:;:ludo processus lor f7'1<1113'JOrnent acUvillo: 1,

r1oasuromont, anal~n.a::Liru~.l!llli!nL

4.1

Now
Notot< 2 & 3

---- tiOIE...2..M
A

"!:lld~OIIH:Cd Q~ IS

tl.Jlfl,ll,lilllilll~m....Dm1 whjch !he

-oil.OiLl.ttan

ou:
ncc,anii

oc~s: /Q( ils ~

ju:we porlarmed by Wl.J:li!J.!llal

'

~.art~

ttn'[E..3 Ec:un:hlc

cantc~ ~!....Q!.l!S!liJ!~ ~u_d.llilS..fu.ll.. ~!:l'1: !bill Q[g~oiZ.J 1jQ:O O! lbll

DSil'lOSrhjJhv pf c;onfQ!JD.]t~JQ...alLc:~ i!.W11m' ..ailitro<J!.!L.i W.JYJaiV.llr.a.mMt'i Tha tyLJ$Ulld
l'.'..!:!11 o! cOO![QI jo be ll[)Q~U~! ~~n.t e..~u~clo'~ sutll as
i!Ll!w-"l2tllltii!.l!JlruJ.cLQ! the Olrl'lmJrced t: ~L.Qn....ll.l.Ul! ~'li.Z..tl!i.Q!l) C!jQ<]'lilil'f to NIJVldQ

;mJ.C' that coo!OJm~lt'.lf:..Q!.tiiffilfal:i..

!1

tUb~ Cflgt:~ 112 l'l'!lli:tlJtl:l..C!l.'l!n:!ll::tr !be CCl ~s..!:u:.-t't:l:.e::l.

CWJD capabmty rl "':lill:ll~C:Ilil!is.ll!Y- ::wtlt.cl.1l::u..illJ~hJt ..c .ou:;~~Uon.alll

4.2.1

Oullet c)

A~=]~i

4.2. t

!3ullotd)

AO

<I c!O<:uments
cnsuro the

6uUel e}

4.2.1

Nolo 1

--A

-4 .' :.l

Uult~t

~--~l..4

~ ~

r)

Para 1 - -

!nd! 1Qjn" l.!l..:'Q.!r:!.::.., f\!>0000 ~ ~\-J:.Obytho 1tiiJ:lnl:zation lQ.J::t:c_nru;~ to

eHoctlw plo.nnlng, operation and t :ontrol of Its pfDC\1 sses.

4.2. 1

:,

documenred procedure:s ~ req lired by this lntur national Stand.aro',llilll

~He~ll!.~!tlefna\io;fi.II-S~

'""

NOTE 1 Where the torm documontod proc Hluro' appv.:tr:; 1.iU1In th;s lntornali0nal Standard.
this means l'lal lha procedure Is ostabriSh~ -d, documented, imptemunted and mainlainad. t:.
~irull~ docymqnt may ad.\!l.f..S.SJ!l'J ux:11icmm.\ls....ku..Qilll.!lr.mPI e.!1!i"'~ .. Area.wir!1.01.1illl.lli
~JL:~'Wflalgd nmCQd,rrg may....b.l1.J:'.J.'lel!l~ .tUILlllZI~~ !lJ!J.Qnt,

--

~~

tc ansurathat de<;umont3 ol ox lerna! orlg n dmaul!U:n:.~JJ:I. UtC-PJ!;ID.niratiU!LI!.l W!.Jlll~.S~

~:O.UlQJ2(aanl!lU->lruLP.P !..!J1! ~tl -i:'~_1ll!!_...Q1U ~~-.IOJ!Jlll:,j~!t:.L:!ll .~:.-:.tcm nrc 11Jcn\d:cd nncJ Uu:!ir

lc'stntJullon controllcO, umJ

--~----

O:A-~~Icc()fds W-.:lll-00 estabh~t1od .~0~~

to pro.11Jv u..,.ido tu; of conlonnhy to r<.quiromonts

ol the olfl..-cllw opora\ion ol tho quaUiy nanagornuol sy~ 1~111 '~ .aw.Lrolliiii. ~~IJ
chall-f&ffla~~oo.:J;Jt-+Jofi\HiabkHJM~< tlfio....,blo,
lb.Q...giU~!Lt~iilbliSh a documcr tod proco<,:urc u i>li-W-uGl<.~ViiG-lwU to daf!no tho
controls no&docllor thelctontilication, stOfa(la protection, tiilile Viii, nMntion 1im6 and disposition
ot ro.;ords.
fif.s:ml 1 ~ ball [l'tDII!t.JI{:~!bLl...mA.di!y_k!.w.tl.Jil
~nd

...

5.5.2

Para 1

--A

6..2. 1

Para 1

AD

- - - - --qua\!\'t lWwlltil!S. liM If bo

loompotoo< oo tho ba''' ol '"'""~" oduca ion, tralnlng, skll k<' oxpar!onca.

t IO.T.t.: ..C!.!nllll!Dit:LlQ.Jllil::: uel~l.litllOl!ll.llS. ..! :.aa...IN...a.lli..dc:!l. J..''l!C~Lif~1tJ~c}

: C.:!.tf:nl'iDO rJC}! lil ~~ :ott!Ji" .li.l!LC!LJli.tY..DlJlla:J. >men! "Y' '"'Il

New Nolo

'--

Top mr.nagementsha.!! appoint a mombotof ~ I.!Ullll~:S maMJOtllcnt who, iiiOGpecli~e of

other responsibililies,
haVQ rc~pon3ib!li ~~and GUU101ity th ..1! includes

--- I f;~;nnol

sna:l

porlormlnQ work affocllr.o

~ 1!: rmil!U.o

prod~

~nd

--

22

For Training Purpose or.ly

------------

.ISO 9001 :2008(E)

Tnbll~ 0.1 -

Chan!)CU betwet:ln ISO 9001:2000 nne I ISO 9001:2006 (continued)

ISO 9001:2000
Clavo No.

Paragraph/ AdJ1lllilJl
Flgurc/
(.lit) or
Tablol
Note
(0)

6.2.2

Clouse title

A tO

Competence,

6.2.2

aullots
o}&b)

A tD

oompotoncll lor por$onnel prtormlng work affeeUng confoqnlty !p

product qyaUty Wl.ulmman.l.:i..
IL'tdl!WJ llQC!I~ablc, provide training or h.ko other aclion
I~tsS,lrv compate:rn;.a,

''

Uullot c)

1:) :!upporting services (such as transpon, communlcalioo

!iOIE_Ih!Lillrm_l'iO!Y.. .CflVlrcnmonC!!lW I tLlQJ!:\Q!HLC.Qll}Q:Il.L.I..!D.d.er whjch wort Is porlpanod

0.4

.,.,.....

Now

Not~

J\1ncnd111d toxt

~d

awareness &n~i-lroiAin-o

II} determine the nocoasary

------

or lntorrna!Joo svstcmal,

illl:llr. liO!L~IC.C.l.J.OYlrnrun.a.aLlLll!llL..!l' J.ll:r..Jil.Cl.J:l.CUW.:tUi..l!llil<ll,..\<ilJ1lfllAhili>Jwmill}11'liQh!iog QC wultla1

-7.1

Bullol b)

AtD

7.1

Oullot c)

7 .2.1

Oullot c)

D +A

1:)

statutory and rogul.:.ttory roqulromont;; robtod iJJJ$ilbiillo the product, and

8ullol d),

DA

<1)

any addlt!ono! requirements dolofmln(-d k.!lf!';!dQCCd 06 ~by \1)1) Or{lan!zalion .

New No to

JjQIJLfo~<;JirillcLinaludo....lllr.....uxamplJJJ!.:tiona

Now Nolo

"1.0.1

-::--

I>) the oocd 10 establish prccos3es lll)Sj d x:umonts, and L.l provide resources spocllic tothe
product;

- - t;)

required vorificalion, valldill!on, monltc dng, Q~IUtl. lnsPQcdon and test activities
:;podfic to tho product und tho crltorla lor prcx.luct oocepuu teo;

-.,...---

---

!mdor

Wa[rantv

proyjl;jaos.

rootmc!tnl ol:ili.Q~IllU'DC.a~c.QL.a 011 spppJamonliJ.ry saodcos such as

t:fi..Q'c.lioc C( [mal di.spos.a.J.
J:LQJ...Qe..sia.n...aruLdmot'la~rneol LnYIIM....~~ril.r.cmiQn..a rui...Y.liJ.iliallaa.b.a.Y.ulis.li.Ll.CU2J.Lmo;,es They
SCQIIraJCC~QL.ln..nny cqmb jnutjoo as !jlljlab!Q !or the prorluCf and
Jlul..~aniu.JJ.on.

J<aD. be condt rctod pod recorded

7.3.2

Parn 2

D~-;::-

Paru1- DtA

. 7.3.3

Ihll Inputs shall bo rovlowod lor adoquacy. HOQ!Jiroments shall bo comploto,

unambiguous and not In coni~C1 wllh oach other.

:r~\Q~

Tho outputs of dosign aM dovolopmonl st\all bo pfovid .N--ffi--a--fofli\41ii.it--oooOio6 Ja.....a..Jo..c

;I:Ul1;ll:lWa! verification against tho dosl9n and dovolopmottt Input and ohall be approvod prior to
7.3.3

Uullot !J)

7.3.3

New Nolc

7.3.7

Paras 1 8. 2

----

--

NoJ text

changu.
PH[U~

now
merged

. ::-cc-- ----,---

Outlet~)

7 .5.1

D +A

roloaso.

provide appropriate information lor pu chasing, produc tkm and lof sa Nice provision,

!))

i~TE !n!Nmgljp[!
,liJlllldu!;J.

~~.n....o.ruls.cctlcc proylsjQ.n..caa.~ctajJS

tor thS prgsorvotloo

Oc$ign and dcvotoprnent changes shall b1 identified and r.cords maintained . The changes shall
roviowed, vori!iod and validalod, as appropriata, and at.Jprovod before Implementation. Tho
rovlElw of doSi!Jn and doveloprnont chan!!PS shall include ll VoJ.lua.tton ot tho eflcc1 ol tho ehanges
XI c''n!>li!Uent ports and product alread r Uolivared. RtH .o;ds ol the results ot tho review al
=I:<Jil(JU$ and any noct.!ssary aclions shall bo ma!ntainod ( de 4.2.4).

bo

U1o availability 11nd usc of monitoring Wid ntOa!lutino d alooo ~t$ln.CD..I.

j)

Oullet !)

- - f)
A

7.5.2

Pnru 1

DA

7. 5.3

Pnm2

7.5.3

Para 3

D+A

7.5.4

Para 1,

DiA -- II any cvstomor property Is lost, damago~ or othorwis(l lou nd to bo vnsultii-bla lor uso, t~

7.5.1

tho lmplt'mcntalion ulllliK1lJd roi(!OISU, deliwry and po 'ldttlivery activities.

The

orgat:~lzatlon shol! vulidnte any proct~scs

lor produ' lion o:nd Garvlce provision where tho

rcsiJfllng output cannot bo vcrincd by sub::oquont monitotl lltl or mcasuromont i.fil6.ioo~
PfO<:)O~fV a.rut. O.U.!&OSQQU!l.llC.f!, doliclcncios boc or no Hpparent only aftorthe produe1 is
in uso or the sorv;co has boon dolivorod.
--The orfjanlz!ltlon shull iocnllly thO produ< t staws witn ros p.:!Cf to monitoritl9 aml moasuremont
roquirements lbrw~b.Qll!Jlr.Q~l..I,.e.alizJillil.

-..,..-

Where lraC(labllity Is a fOQUircmc.nt, th l organlznt!OI'I h~o!l control el\od-fcooH tno unique

ldcntltlc<ltion of the prWuct flill.UrullnL'Iin..~ {:~oo 4.2 4).
00-I'OpOf~o<:HG-4ho-ouGtoowf-ur.d--foooni<HMifltuiM<.l

Sontonco 3

thu omRn[zpUpu :;ball report lhj$ to the

~s.te:mD[ ao!:l maiotaia u:~:<Qrd~ {sea 4.'2.;J.

Nato

----

NOTE Custom{lf proporty can indudu

int~tloctual

proport

-23

For Training Purpose )nly

1

ISO 9001 :2008(E)

Tablo 0.1 - Cho:mges betwoon ISO 9001:.2000 and l!iO 9001 :200U (continusdj
r---------~r-,-,-,9-,-,-.,-v~~A~~r-
rso 0001:2000
C!autoNo.
7,5,5

F!auroJ
Tablo/
Nolo
Pam 1

-------------------,

(A) ot
D!fl.Jtlkl-tl
(D)

Amend1td tol(t

Tl o c(ganizat\on shall prcG ~rw tho oook:H'-11-~'-01 product during Internal proco&.$1ng ~nd doawry
IO lh~ Intended dastlnallon ICJU.d~r to mvlntlia..c.o1!0~~. +fW; A$ ago!k:ab!e
proui'Villion Ghall include ldentitlcation. handlhlQ, pachg111g, t.1orn~o and protoClion.
Prcsorvation shall also '~P!:iY to the constltutJIII parts or a proo'IJC!,

D +A

.1:,~.,,-----1:,~,_~,--~--fo;A--te

ntrol of monitoring

and r.loasuring ~.l!.ll;l.o:L!Ul.l

t,~.,::-------+p~,~,.,c-:-,---+D::-~-A---Ti

-----------1

ar~d

(l O(ganlzatlon shan dnUrmlno the monllorino

moasuremont to bo under1aken and the
monirorklg and mcasurl11~ clOY\c.<XJ DC.l!IU 01 ncodod to ptovldo ovi&lr.eo of conformity ol

prOduct to dotormlnod roqUircmon!s (G00--1,2, l).

~----~~~~---4-.~
-,-:-;:-~----~---~----~!
7.6
Ourtul a)
A
a) b~ calibtatod or V(!ri(IO(I, QL.l.>OJ!J, at $pccil od inlervuls, Ql p.ior to u&o, aguinst nH.lU3uremcnt

; ; ; ;.,- j

~land<~ Ids

11ncoablc to Jnto1n.J!ionu1 or flO lion; II muu;urom011I

sland:Hd!.l

o~lsl, tho basis tliOd lor calibraHon

~tufldards;

whore no such

or vorilieul!on sho~~Jr bo roco1d0d !.Sllti2.1.1:

.,-.6--------~ii~--;)-- r;-.-A--- ;;)~;:;;;:;:;wtooto an.at.H-1} ~~&<>.111tlruti<HH,l.1~ ~&-lo~~;

7.6

cJ-1lil!L~mirul.i!l.Qq~~l.clli!:Ua!io~

~-~~~ now fi,;;:;;,~~~~.iib<OI>oc< "'d 'OdC -;<1-1~:-,-,-~,,~,~lb-,-,-,.\i:,--lo~in_c_d_[_~e-o-4-.2~.~,)-.----1

po1a 5,
wflllo1,1

Sontonco J

'

c!1.tr1Qtl.

I:,-.,---- ~- 0:~~

IN9H.:_soo400-H"',.Ol~kHWlOO-\::..f!-..;'-9vid~;::;--~-:nr.....contw.nati~o..o1Jhll. '1Qill4'~Qill.OJ.ili'1.io.!..t'ltam.~U.W.I.hC...ID.lcn~.ua.lu:a~l~io~o~w~owu~~L)

~B~.,,.------+n~o~II~OI~a~)---\D A

-----
------r.----82 1
No<o
A
/~ow

. .
8.2.2

Para 2

,,,)l~JWncluO'LI!A...et.lHc.aJfO..arui~I.II.a.Ij[.l1111UI..flO.gf.'IDe!ll.lQ.~!.alli.liWQLJJAI~.,

a) lo domonstrate c0l11om.i!y e~-l~odveUQJl.rlld.uw.tl.QI.!ir.om.QD:.t.s.,

---------------~---:---:-----,---------1
joout from tlpurcps s.v,:h 65

ti.Jlli.J&:-nt!Q!in~i.QmtL~O~~D ~t!~UUOiltg.

--~- - - c tS.I&J&.L.:lA.tWlu:lllil...:uJ.ru~;~...cWlJ..Q.mcJ..dilliL :Jr.l..li'il!lli.l.llrQQUd.Q.~!:f op1rjro 'irrr:.&J'!i.

1Q;illtts.inD~s.....c.QJnlilimc.alsJ.tij[r.t1J'i ~mi.ll..O~t.~
-:c:---:-::-:-c-:- - -- - - ,--------,---,.-,-l
A
TilO soloction of audilors and CO>'lduc! o/ auc its shan ensure lUjecUvity end impartiality ollhe

Sentence J

a dil

procccs.

-,.-,.-,---- /i;;-~~f.~~JiA- -- A..;;;~-=--""-".l---,-~-.-,J-rJ)-_W-t~-:::--,_-,-mtJJ:-c::-.s.l::illQ1Q...doit.r1D.Jb.UJ~USiPilitic5 and reoujruwenls for

o.ln,nnJog and oond1rctirg al_:dt~ establlsbln:JJ~rdS pod r!!PQ.Jiil~

~8".2".,,----- p;;J--~.;-- ~~~~q~~~lMioj}--Gfid...eono~-.----.~-~----.---.-l

pari!

<4

0 ; II

~8~.2~.7,-----+p~,-r,--:,----r.N-;;.;Sollll.!oco 1

pur>.~ 5

I,-,-.-,------1-,-Jo_to__.__ ~~;~,-,,.:,,------lp~,~,-,~;.,.\~
1

u--..-

n1c

maoagemont rospoosibJo k:Jr tho orea bolng auditod

s,;;;-~~-,-"~,-,.-,-,~h-.,-Jlm:-:.Jl--<l-,-,a--l

C..O.rL!l'li9.n.s....n.nd...ou.ccti.Yc actions aro t:lkln wittrcvt und\..o delay to eliminate deluclcd

noncontorm/Uos a11<1 thuir c,ruser..

NOTE

~~QO'\+-i,~:CHWH-\-"MIE0---Hfi}-t4_.&'"$o; iS"o.J.2Ull lor guidanc~.

corr.::ti~c action shall bo lakctl,

When plannoo" f'QSUI!S aro 'not achiavod, corroC!IOO <md

as

apptoprialu,-4()--{l(~f-IHXJIIIMHI~y-of-tho-pn0u;l.

Sontcricc 3

B.i3_._:_ ~~~i";;-

rQlT\i!Hi-Mtd-fflUi-filotr.iAg-roo.:.,.QG.-{~'4)-Gh91+-bo--Of:f+n~-~AI-Od,,oooOOte-r
fu~r~..aUhul.l.ctil.s_amULei results shnl! tm.Illillal~J...2...51

A. - - t.KliE...Yib.!W. J1!!tC!mink'l[J..!:IJ.i\ill.lJ!Llll!l.!hlJ.I~~ w~-.:d_o._lio

___l-ll~:jh~:.QHlWJ.lL~SJ!llikl~...lill!
IY-.C!DJl.O.d..c.Uanlo!J:Mn!tO.dlt~.w.:i.U!ll.!llil!.ll iliYfi)Ori[)jo ro -o~Cil.JU...il.s..wncossM ja rotatlon to
lbJllLJII1Mk1...Mlttc.....c.Qnllia.!iUJO..Il.llill.lo:t.l.m'lirt~o.d...Q.IL.1b~.J2Lill~
lllil!lD.~t~~su:m..

1~-----+~----r.------t~~
8.2.4
Pilm 1
A
fho org:lnllation

-~--~~~

shall mor,itor and moanuru the <.'frarilclorisl>Ct> of tho product to verify Ulal
pr<Jdvc:t roqulrernonts havo boon mot. Thls fhall 00 carried <Ul at appiopriala tolaQes ollho
product rea!lza!lon procoss m accordance wl1h tho plannod arra-lgoments (seo 7, 1). ~!
C.OJJ.!Qanlr:..JJllh.rbtUIC<::.DP l<l.il::ll.Cril !:rlil.ShilJUJ~ Lfllaial iililc.JJ...

f'Jra 2

'--------~------

D<A

6-:Uonoo.<if-*Flk+rmily-wiU>. -lhe-a.oroptaPtoo-\il il.ofla-i.I>Oal>o--m;.iutalnod~-llocords shal! indica l~

the porSOil(s) authorizing r~.oaso of producl/c~.l.'!Y.!QJ!~u.:i.l.Qrruu (.~cc 4.2.4).

o.A

P(HdU()r-U~IooV(Hlf\d--!,Of'1'ko-d!iWf)' Th.L!CtuiWLJ~~_ang_Q!:(iy.ilQ': o! ~ewce In lhe

,:u:;tpmar shall not proccod until the ptannc~J erran'OI'.:flrcnls {seu 7.1) have bt!cn satlslactoriiJ'
:.omplulod, unloss olhfrrwis~ approvod Dy J otovont nulhorit) und, whoro apphcu~e, by tho
u:;tomllr,

L---- '--------------------------------------------

24

for Training PurpoEe only