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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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Aororonce number
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Contents
Page
1.1
General .................................................................................................................................................
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Quality m~nagement syotom .......:...............:,.....................................................................................
4.1 General requirements' , .. ',,.,,. ~_ ' ""'"''''''~-"""'
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'4.2. 'oiicume~tatlon' requirements' :~::.: ..:.............:.....:.............................................:..............................
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6.1
6.2
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6.4
7.1
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in1~rovement
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6.1
Gonoral .. ~...........................................................................................................................................
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8.3
5.1
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Annex A (inlormalivo) Correspondence between ISO 9001 :2008 and ISO 14001 :2004 ..................... ..
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Annex 8 (informative) Chan goo bolwcen ISO 9001:2000 and ISO 900'1:2006 ..................................... ..
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Bibliography ...............................................................................................................................................
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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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Introduction
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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
chang~s 'In !hat environment, and the risks associated with that
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.
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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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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
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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
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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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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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- - - Va!ua .. adding aetlyl,ies
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For
T~ainihg
Purpose cnly
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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
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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:
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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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ISO 9001 :2008(E)
INTERNATIONAL STANDAFID
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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
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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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 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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4 Quality
manag~ment syst~m
Improve Its offe~veness In accordance with tho requi1ements of this !nternatlonal Standanl.
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det~rmlno the. processes needed for the quality managcmen: system and their application throughout the/
organization (sea 1.2),
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c) dotoimlne criteria and m~thods needed to ensure that both the operation and control of these processes
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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
do~s
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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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
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/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.
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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.
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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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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
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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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Fo~~~aini~g Pu~pose cnly
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.a) com~unlcaUng to tho organization the Importance of meeUng customer as well as statutory and regulatory
reqUiroments,
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b) establishing the quality policy,
c) ensuring that quality objectives are. established,
d) conducting management reviews; and
o) ensuring tho availability ol resources.:
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Quality policy
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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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5.4 Planning
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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.
th~t responslbllitlos and ;.~uthorltles arc defined and cOmmunicated within the
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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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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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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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5.6.1 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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b) customericcdback,
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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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6 Resource management
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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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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
"lhe organization
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a) detonnine the necessary competence for personnel pertorrning work aflecting conformity to product
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requlr~ments 1
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b) where applicable, provide training or take other actions to achie\e lhG n9cossary competence,
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
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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,
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/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)
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).
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d) recorc&needed to provide evidence that the realization process !Sand resultlng product meet requirements
1scci4.2.4).
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7.2.1
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NOTE 2 Tho organization may also apply the requlromonts given in 7.3 to the dcvtrlopmont of product reallzaUon
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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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Tile output of this planning shull be in. a form suitable for the organi:oation's meth>J ol operations.
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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;
b) the noedto e~tablish processes, and doc:uments, and to provide resources spucific to 1t1e product;
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a appropriate:
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
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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.
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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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; Records nljhe rcsulls of the review and actions arising from the review shall be maintained (see 4.2.4).
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Whore the cuslomor provides no documented statement of roquiromcnt, tho cu;tomer requlromonts shall be
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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.
relation to
a) product infprmatlon,
b) enquiries, contracts or order handling. Including amendmerrts. and
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The organlzatio~ shall plan and ,control tre design and dovelo~ment of product.
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During the design an~ dovolopment pllmnlng, the organization shall determine
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~all dation tihat are appropriate to each design arid development stage, and
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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.
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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.
Inputs relating t~ product requirements shall be determined and records maintained (see 4.2.4). Those Inputs
shall inolude
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a) functional and porlormance requirements,
b) applicable s.tatutory and_rogulatory requirements,
c) where appllcablo,lnformaUon dertvod from previous simiiH doslgns, and
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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.
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d) specify the characteristics C?.f .the product that 1,e essential fo1 Its safe and proper use.
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l~forrnaUon lor prod~lon and_~ervl~ p~ision ;~n Include del;: lis for the preservation ol product.
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,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
'
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).
~
/~
:.~
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).
----
;.::,
:~
!l'
;a
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).
~~
'
-i~'
'
rt
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).
~
~
~
7.4 Purchasing
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.
w~
.a.
,;.,
-"'i\':-.
..,.
'
'\j,
I
,,
,
,
,'
,
,
)
,,,('
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,
.
'
...
'
- ... __ .,..
, '
Tho organizatlon shall ohsure tho adequacy of specl:1ed purchase requirements prior to thoir communication to
lhc supplier.
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
:)
7.5.1 . Control of production and service
;)
(/V"
'-"
''
/y
u
~c
provlslo~
Tho organization _shall Plan and carry .out production and serv ce provision under controlled conditions.
Controlled condiilons shalllncludo, as applicable,
.
:)
f)
'
..
~
;~
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.
The organization shall establish arrangements for the~e processes Including, as applicable,
i: I
'I'
proco~scs
to
achie'/1~
planned results.
..;)
:::)
10
;;;;,
~
~
,::
;)
'
~.:
,'
e) revalidation.
.
"'
''
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 .
.;
,,~
'
:/ .,.,,
'
'
)' :- . .-:~:~:-:,_:~:(:.. : :
._,'
:'
'
:', '
,i
- - ..... .
'
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;;_,:f:i'gF<!,_,>~_,;-~"-
_ , .:' -
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 "\.
., - '
,. .
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);
,,
, .-- .. .~::,~tC~,;,.,.',
,.
:_.:: .....- . -
d) .be saleguard8d !rom, adjustments that would Invalidate lhe measurement result:
c) be protected from damugo and
.. ,..
detorl~ratlon
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
11
)
::.u,
::,r~~r
::.~;;
'".';, ...
,;,~ISO
9001:2008(E)
t:;;.::.:v;,, :;mr
,
i
. ,.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.
.. 8.1 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,
it.
1.
0 "-
This shall include detern\lrlailon of appllcabt'e methods, lncludlng stat1sticaltechniques, and the extent of their
use.
A:; one of the measurements of the performance of the quality mar~agement sy~tom, tho organization shall
')j. ,
'.,'
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
[ ..
: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
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
~
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
.
.
,,
-- .. ,,-,_.,~.'':' ,,
'
'
~the
~
.;:t
corroctivo actions arc takon without undue delay to eliminate detected nonconformitics ond their causes .
12
'~
I~
~3
~I
requirement~
.,:.-:
Follow-up activities shall Include the verification of the actions ta <en and the roporting of verification results
(see 8.5.2).
.
;,:
'
~;
~.!ii.
::M!,
::I
,
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.
- --------~-- __
..~~.,.:.,,
!I
I:'
~
~
t~-
;:.:..;: :,"'
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) .
.,..--
'
:9
'
,
\.,.;
.1
>
as f j.
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
.
actit>,~
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.:~
requlre~ents.
Rocords of tho nature of nonconformiUes and any subsequent actions taken, Including concessions obtained,
-matrbolnaintatned (see 4.2.4).
',
13
achieve. . ')
1~0
9001 :2008(E)
.):,
. 'The analysis of data shall provide Information. ~ela~o\g to
. .:v~
-~.
:1., ,. ,..
, .,
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
'
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 .
~~onconformities,
14
.L,..
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! '
!ntroductlol\
Goneral
Procoss approach
0.1
0.2
0.3
0.4
Goncral
1.1
Application
1.2
2
Normative references
Torms and definitions
Quality management system {titlo only)
3
4
1 .
Scope
2 .
Normatlvo relerences
'
(title only)
Gonoral requirements .
4.1
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
~anagement
5.1
4.2
Environmental policy
5.2
4.4.1
4.3.1
4.3 2
4.6
4,2
Managemunt review
4.3
5.4.1
4.3 3
5.4.2
4.33
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
5.5.1
4.1
Gonoral requlrernonts
4.4.1
Resource~,
Management rcproscntativo
5.5.2
4,4, 1
Internal communication
5.5.3
4.4 3
Communit ation
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
Table A.1 -Correspondence between ISO 9001 :2006 and lllO 14001 :2004 (continued)
ISO 0001:2008
ISO 14001:2004
Provision of
6
6.1
6.2
6.2.1
ro~ource~
Gonoral
6.2.2
6.3.
Infrastructure
Work oi'Tolironmcnt
Resources roles,
4.4.2
re~pon~<lbilily
4.4.1
4.4
4.4.6
Oporationsl control
4.3.1
Environmental a:3pocts
4,3.2
7.2.1
4,4,6
Operation~~
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
7.3.1
4.4.6
OperatiomJ control
7.3.2
4.4.6
Oporatiomtl control
7.3.3
4.4.6
Operaliom:l control
7.3.4
4.4.6
4,4.6
Operatlon~1
7.3.5
7.3.6
7.3.7
7.4
4.4.6
4.4.6
Operatiom.l conUot
Purchasing process
7.4.1
4.4.6
Operation,,/ control
Purchasing Information
7.4.2
4.4.6
Opera11omu conlrol
7.4.3
4.4.6
Operatlonc1l control
7.5
7.5.1 .I 4.4.6
Oporat1onc11 control
Va!i~a_Uon
7.5.2
Oparatiorutl control
--
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
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
4.5.1
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
Table A.1.- Correspondence between ISO 0001:2008 and ISO 14001:2004 (continuscf)
ISO 9001:2008
Mon~arlng
Analysis ol data
8.4
8.5
Continual improvement
. 8.5.1
4.5.1
4.5.2
Evaluatio1 of compliorlcJ
4.4.7
4.5.3
4.5.1
4.2
Environmental policy
4.3.3
4,6
Managenont rovtew
Corroctive action
8.5.2
4.5.3
Provcntivo action
8.5.3
4.5.3
action
action
17
~
'
r:t
!:t
ISO 14001:2004
lntroducUon
0.1
>
~
~
~
",;;,
Scope
General
ap~
0.2
Process
0.3
Rolationshl~
0.4
roach
1.1
General
1.2
Application
Normative mlerencos
Normative relercnccs
4.1
4.1
General requirements
5.5
(title only)
General rcquirernonts
---
only)
Environmental policy
4.2
5.5.1
5.1
Managomoot cornmltmcnt
5.3
Quality poll1:y
6.5.1
Continual i1'1lprovomortl
----
4.3
5.4
Environmental aspects
4.3.1
5.2
Customer focus
7.2.1
Determination
product
7.2.2
5.2
Customer focus
7.2.1
Determination
product
5.4.1
Quality objt!Ctives
4.3.2
4.3.3
Ol
rcquir~ments
-related
to the
5.4.2
6.5.1
Continual ilnprovemont
4.4
4.4.1
5.1
5.5.1
5.5.2
Management represontati<Jo
6.1
Provision of resources
'
4.4.2
6.3
ln!rastructvre
6.2.1
6.2.2
5.5.3
Internal cornmunication
7.2.3
Customer t:ommunicntion
Communica!ion
4.4.3
Documentation
4.4.4
4.2.1
Control of documents
4.4.5
4.2.3
COntrol of documcnt~
18
Tabla A.2- Correspondence between ISO 14001:2004 and ISO 900 I :2008 (continued)
--
ISO 14001:2004
Operational control
4.4.6
7.1
7.2
7.2.t
Oeter.nination
produ:t
7.2.2
7.3.t
of
wquirornonts
7.3.2
7.3.3
related
7.3.4
7.3.5
7.3.6
7.3.7
7.4.1
Purer asing
7.4.2
7.4,3
7.5
7.5.t
7.5.2
to tho
provit.lon
7.5.5
4.4.7
8.3
4.5
Measurement,
4.5.t
7.6
Evaluation
or complianco
4.5.2
4.5.3
'\
--
anal~ sis
8.t
8.2.3
Mon~oring
B.2.4
8.4
8.2.3
8.2.4
8.3
--
84
Anal~ sis
8.5.2
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
5.0
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
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[~.
Foroword
Paro J,
A
Scnwnco 1
Foroword
Para 4,
Scntonco 1
DA
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
: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
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,
Scntof"lco 2
(;iW -anG-GtrOOit~l&-oHhe-of!J'lfhl<ilioo,
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)
Qblcc]jyc~
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
poO.:C$~.
'
~~
;~
~
~
~
;~
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~
af
liJHlQfti(~~
~-
t>)
eny !nlooded
Uuw Note 2 A
JlQJE 2
!"'ora 3
Para 1
D+A
'
'
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~
Ih.Q_Hir!wfog
DA
'---
_.
-----
21
ISO 900\:2000(E)
Tt~blo
. ISO 9001:2000
ClaUliO No.
Hoi I
f>~:~ra
Parugrcph/ Allllli!Jln
Flgurel
(A) or
Tabla/
O.IU~n
(D)
DA
r:so !Woo
Pnru.s 2, 3
~un:.c.nt
!(lto/Mtl
.c terms
ap~lf.
- -no-loUowlfi{HOfft\&rWJOOItHIJ.HGlliol+-{)1-.t
-
'
l!oU-tho-~ppl~{)Min,-~OOCH
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~<..!
,,
.:.~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
needed
~Jr
4.1
Now
Notot< 2 & 3
---- tiOIE...2..M
A
"!:lld~OIIH:Cd Q~ IS
-oil.OiLl.ttan
ou:
ncc,anii
'
~.art~
ttn'[E..3 Ec:un:hlc
!1
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 - -
4.2. 1
:,
~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,
--
~~
...
5.5.2
Para 1
--A
6..2. 1
Para 1
AD
New Nolo
'--
--- I f;~;nnol
sna:l
~ 1!: rmil!U.o
prod~
~nd
--
22
------------
Tnbll~ 0.1 -
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
''
Uullot c)
0.4
.,.,.....
Now
Not~
J\1ncnd111d toxt
~d
awareness &n~i-lroiAin-o
------
or lntorrna!Joo svstcmal,
-7.1
Bullol b)
AtD
7.1
Oullot c)
7 .2.1
Oullot c)
D +A
1:)
8ullol d),
DA
<1)
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.
Parn 2
D~-;::-
Paru1- DtA
. 7.3.3
:r~\Q~
;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
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
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
The
-..,..-
Sontonco 3
----
int~tloctual
proport
-23
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
t,~.,::-------+p~,~,.,c-:-,---+D::-~-A---Ti
-----------1
ar~d
~----~~~~---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
sland:Hd!.l
~tufldards;
whore no such
cJ-1lil!L~mirul.i!l.Qq~~l.clli!:Ua!io~
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~.,
---------------~---:---:-----,---------1
joout from tlpurcps s.v,:h 65
ti.Jlli.J&:-nt!Q!in~i.QmtL~O~~D ~t!~UUOiltg.
Sentence J
a dil
procccs.
<4
0 ; II
~8~.2~.7,-----+p~,-r,--:,----r.N-;;.;Sollll.!oco 1
pur>.~ 5
I,-,-.-,------1-,-Jo_to__.__ ~~;~,-,,.:,,------lp~,~,-,~;.,.\~
1
u--..-
n1c
s,;;;-~~-,-"~,-,.-,-,~h-.,-Jlm:-:.Jl--<l-,-,a--l
NOTE
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
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
o.A
,: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