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INTEF~NATIONAL STANDARD

' Quality managem~nt systllms -. ' ReqUirements ·

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

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ISO 9001

Fourth edition 2001>-1 1-15

Aororonce number ISO 9001 <200B(E)

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Contents Page

1 Scope ....... ~ .......................... ,;_ .. :~~-· .. ~L~· ... ~.:.~~ .... : ....... ~ .............................................................................. . 1.1 General ................................................................................................................................................ .

'1.2 Application ................................. :.~ ................. : ................................................................................... .. 2

3

4

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

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

Quality m~nagement syotom ....... : ............... :, .................................................................................... . 4.1 General requirements' · · , .. ',,.,,. · '· · ;·:· '

'- " ' ' .......................... ~_ ........ ""'"''''''~··-···"·······""' .................................................... . '4.2. 'oiicume~tatlon' requirements' ••• :~::.: .. : ............. : ..... : ............................................. : ............................ .. 5 Management responsibility ............................................................................................................... .

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

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

5.3 Quolily policy ............ ~ ........... :.:· ..... ~ ..................................................................................................... . 5.4 Planning .............................................................................................................................................. .

5.5 Responsibility; authority nnd c~;m~unlcallon ..................... : ........................................................... . 5.6 J.lanagcmant review .......................................................................................................................... .

6 Resource management ....... ·.;, .... ;.~:L ... ·.: .... : ............................... ~ ......................................................... . 6.1 Provision ol resources ....................................................................................................................... .

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

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

6.4 Work environment .............................................................................................................................. .

7 Product reallzallon .............................................................................................................................. .

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

7.2 Customcr·rclatod proceascs ............................................................................................................. .

.·7.3 Design and development .................................................................................................................. . . ' 7.4 Purchasing ............ ). ........................ : .................................................................................................. ..

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

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

8 Measurement, analysis ond in1~rovement ...................................................................................... .

6.1 Gonoral •.. ~ .......................................................................................................................................... .

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

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

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

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

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

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

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

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Foreword

' 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 ···,

d:C1 General ' '

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

·a) Its_ organlzatlonat'1ei1VIronment, chang~s 'In !hat environment, and the risks associated with that environment, 1 ,

b) 11~ V.rying rieeds,

c) Its particular objectives,

d) the products It provides,

e) the processes It employs,

Q Its size and·organlzatlonal 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 1 j<J 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.,.

0.2 Process approach :.. ·'

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.

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

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

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 whether·the 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 level. '11'"'· 11. •·:' .•

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i NOTE . In addition, the melhO<Jolo!l)' known as "Pian·Do-Chock·Act" (PDCA • can be applied 10 all processes. PDCA can be briefly doscrlbod as

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Plan: establish the objectives and prOC43Sses necessary to de)lvor results in e ccordance with r.ustomor requirements and the organization's policies. ' '; ~}-

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.

Customers_

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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. - ' 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 succo•s 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, rdgulatory·or contractual use.1

:

0.4 Compatibility with other management sys(ems

During the deveiopine~t ~f -this trit~rnationat ;stands~, 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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INTERNATIONAL STANDAFID ISO 9001 :2008(E)

Quality, management systems - Requit·ements

1 Scope

1.1 General. . . I I ·. • .

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

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.

' NOTE 1 In this lntornat!onat Standarcf, tho term •producr only applies to

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

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

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

1.2 Application

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

Where any requlrcment(s) or this International Standard cannot be up plied due to the nature ol an organizaUon and its product, this can bo considered for exclusion.·.

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.": ·, ..• :- ... . ' \

•' 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.

' , /. I

ISO 9000:2005, Quality management systems- Furidamonta/s an:J vocabulary

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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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 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),

. ' ' b) determine tho sequence and Interaction of those processes,

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

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 /

9 implomcnt aclions necessary to achieve planned results and <:ontinullllmp!Dvement of these processes. ',.,, I , :

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.

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 to all custom-er, statutory and regulatory requirements. The type and Extent ol contrC~I to be applied to the outsourced process can be influoncod by factors such as

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

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

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 . ' ' . '

4.2,1 General

The quality management system' do<:umentallon shall include

a) documented stntemonts ol a quaUty policy and quality objectiv•ls,

b) a quality manual,

c) documentod proceduras and records required by this International Standard, and ' • I • ': · ~ · " " ; < .~ • • '" I •· ; " ,., >1 .. · ' ' ; ;

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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-;)- ··;-.::H_~:-~~~-A-i-~~·r;:!:~:\- :_: _i !{_:; !>:-: 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.

"' '"·<-!i·:·-···-· '1''·'·1-·,.. :· ,' ... : . 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 . . •,:; •. ·::

,~ _1 ~OTE 3 Tho d~umontatlon ca.n be ln anY form ~r type.~f ~edium.

. I 4.2.2 Quality manual

' ' Tho organization shall osi•tbllsh and maintain a quality manuatthat Includes

h) tho scope of .tho qtmllly managemont,system, including dc~tlls of and justification tor any exclusions (scot.2).

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

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

~~~Cont«;l, ol documont~ ' 3 i ..

1

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 giv•n in 4.2.4.

,,. A,.documented,pro~~ s~•all be establlshod to define the controls needed •. . . :"· . . '" ... ... . : .: ;·"'\! :·.·,:.:;:··:·. ··:i:··: ·,.: .

a) to approve documents for adequacy prior to Issue, ·

b) to review and update as ~ocessa~ and re·approve documents,

J 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 pou•ts of use, "/ e) to ensure that documents remain legible and readily identifiable

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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cJ~,4):ontr~l oi re'~,~~ •.. ; . ' . . 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,:·retOovo11i:·rotent1~n and.dlspositlon of ~ocords.

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, ,/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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includes a commitment to comply with requirements and continually improve tho oN activeness of the quality managomenlsystcm,

:,,._.1 c) provides a lramework for establishing and reviewing quality objecllvos,

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 leve·ls within the o1ganizatton. The quality obJectives shall be measurable an~ consistent wltll tho quality policy. .. 5.4.2 Quality manngentent system plarinlng

' ' ·, Top management shall ensuro thai'

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

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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,

. ' . . . ' ' . . ' b) reporting to top managomont on the performance of the qu.>lity management systom and any· need lor

Improvement, and : · '

c) ensuring the promotion of awareness of customer roqulremen !s throughout the organization.

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

5.5.3 lntornal communication·

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. ·· · · · · ·.· ·· · · · · ·

5.6 Management review

5.6.1 General

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. · ·

''I .!•. •'; Recoros from management reviews shall be maintained (see 4.2.< ).

5.6.2 . Review Input

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~. d) . statu~· of preventive ,and correcti.ie ~etions, c) follow-up acli~ns from provioUs manag~mont rov_iews.

f) . Clian.ges that toufd affect th~'quaJity manageme11t system, and , , ' I

9) recommendations for Improvement.

5.6.3 Rov\ew output

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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6.1 Provision of resources

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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·'' Personnel performing worl< afloctlng conformity to product requirements shall bo com potent on the basis of appropriate education, training, skills and experionce.

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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 ~ . . ' - ' ,

a) detonnine the necessary competence for personnel pertorrning work aflecting conformity to product requlr~ments1

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) . . ' . '

6.3 lnfrastruqturo ·. .;,-.. .·' '.; '"' '' '; ·'·'

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, • ·' I

b) process equipment (both hardware and software). and ·:·,.·· ['-'·_1,.~· .. :·.':'··''·~-(1:·'\··:'i·-~--~·-. ,, ··c!:! . I

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

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· 6.4 Work environment

Th·o 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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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, a• appropriate:

a) quality objectives and raqulrements for the product;

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

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

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d) recorc&needed to provide evidence that the realization process !Sand resultlng product meet requirements 1scci4.2.4).

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

NOTE 1 A document spocJtylng tho processes or the quality manager,enr system (fncfudlng the product realization processes) and tho resources 1o be applied to a specific product, project or contract can J:..o referred to as a quality plan.

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

. .

7.2 Customer·related process,es

7.2.1 Oetennlnatlon of requirements re.lated to the product

The organization shall doturmina

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.

NOTE Post·dalivory 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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'. 7.2.2 Rovlow of requtromonts relatod to the product

· Tha organization shaiL~evlow the, requirements flllat~ to tho prodL ct. This reviE•W st1all be conducted prior to 'the organization's commitment to.supply a product to the customer (e.g. submls•ion of tenders, acceptance of

contractS or·o·rders, ·.aoceptanco of.changes. tQ cohtracts or orders) and shall onsuro tt1at ···.~·.L,\'_., .... ·.1.·:··:,···~'1~··.:~':·.-:~_'~1 .. '] I' .

a) produ~ rcqui~0010hts:aro dilnned, '

contract or order requirements differing from thOse previously CJ~pressed are rasotvod, and ,. ': ·:. . :, ,: , .: ;, ,, .·, ',... I> :. ·,' ; ', '~: ': 'I

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.

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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 . . ' i ' ··.<!_ '

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 " ·•. ·, ··' ,. . .: , I

c) customer feedback, Including customer complaints.

7.3 Design and duve!opment

7.3.1 Design and dovolopmentplannlng

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

During the design an~ dovolopment pllmnlng, the organization shall determine ' '' .. ,. ' ··- ,._ .. .,'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 desi£n 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; as·s·uitable for tho produc: and the Organization. ·

7.3.2 oe·stgn 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 t ' ~

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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Design and dovelopmont outputs shall

a) moot the Input requirements for design and development,

• b) provide approprtato Information for purchasing, production an·J service provision,

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

d) specify the characteristics C?.f .the product that •1,e essential fo1 Its safe and proper use. . . .. '' ," ·' •, ' ·- •:1:,, ... -.:·.)1': ·.-.:1 .!

NOTE l~forrnaUon lor prod~lon and·_~ervl~ p~ision ;~n Include del;: lis for the preservation ol product.

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.7.3.4 Design and development review '

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

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).

7.3.5 Design and development verification

Verification shall be performed In accordance with planned arran·Jements (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). ·----

7.3.5 Design and dovelopment vaUdatlon

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

' 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

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 pro·duct on subsequent product rea.:izatlon or tha ~·inal product.

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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, ., . ' .•.. ' -· ... __ .,.. , ·' : I

· b) requirements for quahflcatlon of personnel, and ' i'· ·... ' .

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 information.

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7.5 Production and service provision

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7.5.1 . Control of production and service 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 c•f 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. I . '

7.5.2 Validation of piocoa~~s (or production and ~ervlc• provJ,;ion .,...,..! 1.:!1 ~-'::•IJ' i:· I· •• : 'I'

The organization shal!l··~·udat·o·-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 proco~scs to achie'/1~ planned results.

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

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

b) approval of equipment and qualification of personnel,

c) use of specific methods and procedures,

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e) revalidation.

"' . ''· 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).. ·

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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 I

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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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 "\. · ., - · • ·' 'i r~_:;~f t": · '·"·" ., · · · ,. · ·. · 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

a) b.e calibrate~ o;~vorlflod, or both: at speel~ed 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 -J~·~~do; ~~··determine its calibration status: ,._.-i···' ,, , • .-- .. ·.~::,~·•t·C~,;,.,.', ,. :_.:: ..... -.-·

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).

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••• :;mr .. ,.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 intE·nded 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

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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. 1. 0 "-· ! ..,:· · . : .. ~':""::~Tr::·;~T:::::--:-:, -·-·.~·~-~·~··:·:-:··-·:--;-·- ···---··----· ..

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

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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 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.

~2_: Internal audit

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~t·systom 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 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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A dOS.l:JOlCntod procodura..sha\1 bu established to define tho responsit,ilitics and requirement~ lor planning and Conducting audits, establishing recordG and reporting results.

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

Tho managomonl responsible. for the area ~lng audited shall ens Jre that any necessary corrections and corroctivo actions arc takon without undue delay to eliminate detected nonconformitics ond their causes .

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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.

~.!ii. ,, :·:M!, 8.2.3 Monitoring and .measurement of processes : :I ;;:itj-he organlzatlon shat{appfy surtatite. methods !or monitoring and. Ylhere applicable. measurement of the qu!llfty e

.•·•'1' •.:.managoment systom.proeessos. These. methods shall demonstrate the abil11y of the procosses to achieve. . ') planned results. When planned results are not achieved, correction and corractlvo action shall be taken, as f j¥ .

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

. ' '

B.2.4 Monitoring and moasure(llent ol product ·. . ;:.:.·.;: :,"' 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) . .,..-- .

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 confo·m 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 conC•lSSion by a relevant au!hori1y and, where applicable, by the customer,

c) by taking actit>,~ 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 re·verification 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. TI•is shall includu data generated as a result of monitoring and moasuremont and from other relevant sources.

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. ):, . 'The analysis of data shall provide Information. ~ela~o\g to . ··.:v~ -~·. .· , :1., ,. , ..

• ~) 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 '-1•·1 & ·!) 5 " ;-: . ' b ·. • 't "'

~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 . ~~~-.....-.·-..·•""'- '""'"'-~rl I

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

f) reviewing the effectiveness of tho corrective action take.~.

/-::>-;;:," . '

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

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 a Heels 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

!'or Training P·npose 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

1:'1! ' ISO 9001:2008 ISO 14001 :~004

lr:'lroduction (title only) !ntroductlol\

Goneral 0.1

Procoss approach 0.2

Relationship with ISO 9004 0.3

Compatibility with othor managcrnunt systems 0.4

Scope (Iiiio only) 1 1 . Scope

Goncral 1.1

Application 1.2 --Normative references 2 2 ·. Normatlvo relerences --Torms and definitions 3 3 ' Terms and definitions

Quality management system {titlo only) 4 4 Environmental management system requirements (title only)

-Gonoral requirements . 4.1 4.1 General re =1uiremcnts

-Documentation requirements (title only) 4.2 .

General 4.2.1 4.4.4 Document; Ilion

Quality manua I 4.2.2

Control ol documents 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) 5

1 ~anagement commitment 5.1 4.2 Environmental policy

4.4.1 Resources, roles, respon liibiUty and authorlty -

Customer focus 5.2 4.3.1 Environmental aspects

4.3 2 Legal and :lthor requirements

4.6 Managemunt review

auaijty policy . 5.3 4,2 Environmental p•:>!icy

Planning (tit!o only) \ 5.4 4.3 Planning (litlo only)

Quality objectives\ 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 only) .

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) 5.6 4.6 Managom•mt review ----Goneral 5.6.1 4.6 t.tanagommt roviow

Rovi~w input 5.6.2 4.6 Managom•ml roviow -

Aaviow oulput 5.6.3 4.6 Managemmt review -

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) 6

-Provision of ro~ource~ 6.1 4.4.1 Resources roles, re~pon~<lbilily and authority

Human resources (title only) 6.2 Gonoral 6.2.1 4.4.2 Compotenc:(l, tr<lining and awaronoss

Competenco, training and awarenos.s 6.2.2 4.4.2 Compote01:e, training and uwareness

Infrastructure 6.3. 4.4.1 Rosources, roles, respon~~;ibility and authority

Work oi'Tolironmcnt . 6.4- .

-Product realization (titlo only) 7 / 4.4 !mplementltion and opcruUon (tiUc only)

Planning of product roa!izalion 7.1 4.4.6 Oporationsl control

Customor-rola tod procossos (title only) 7.2

Oetormination of roquiremonts related to the 7.2.1 4.3.1 Environmental a:3pocts product 4,3.2 Legal and •)thor requiromQnts

4,4,6 Operation~~ control -

Review of requiromonts rotated to the product 7.2.2 4.3.1 Environmental aspects

4.4.6 Operatiom.l control -Customer communication 7.2.3 4.4.3 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 Operatiom.l conUot

-Oosign and development verification 7.3.5 4.4.6 Operationitl control

-Design and development validation 7.3.6 4.4.6 Ope ratione:! control

-Control of design and developmonf changes 7.3.7 4,4.6 Operatlon~1 control

-Purchasing (title only) 7.4

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) 7.5 -Control of production and sorvico provision 7.5.1 .I 4.4.6 Oporat1onc11 control --Va!i~a_Uon ol processes for-production and service 7.5.2 4.4.6 Oparatiorutl control prOVISIOn

ldontiflcation and lruccability 7.5.3 -

Customer property 7.5.4 -PrOSG!Vation or product 7.5.5 4.4.6 OperaUonltl control

Control or monitoring and mG48urlng oquipmont 7.6 4.5.1 Monltoring and mo;:J.~urernvnt

Measurement, analysis and Improvement {title only) 8 4.5 Chocking !title only) -

Goneral 6.1 4.5.1 Monitoring and rnoa!:>urorr11.mt

Monitoring and moasuromont (titlo only) 6.2 . -

. Customer satisfaction 8.2.1 --lntornal audil 8.2.2 4.5.5 lntornal al dit --Monitoring and measurement of procossos 8.2.3 4.5.1 Monilorin' ond rnoasurcmcnt

4.5.2 Ewluation of CQmpliance -

,.,,.-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 ISO 14001 :>004

Mon~arlng and measurement of product 8.2.4 4.5.1 MonitorlnQ and maosurttmonl

4.5.2 Evaluatio1 of compliorlc•J

Control of nonconforming product 8.3 4.4.7 Emorgon :y preparodne~;s and response

4.5.3 Nonconfc rmity, corrcctJvU action and preventive action

Analysis ol data 8.4 4.5.1 Monitoring and measurament

Improvement (title only) 8.5 -

Continual improvement . 8.5.1 4.2 Environmental policy

4.3.3 Objectives, targets and programmc(s) . 4,6 Managenont rovtew

-Corroctive action 8.5.2 4.5.3 Nonconfc·rmity, corrocbv(.) action and preventive

action -

Provcntivo action 8.5.3 4.5.3 Nonconfc•rmity, correct.vo oction and preventive action

\

17

For Training Purpose o;1ly

~ '

• ~

r:t !:t !

~ > ~ ~ ~

",;;,

ISO 9001 :2008(E)

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

ISO 14001:2004 ISO 9001 :200U

lntroducUon -· Introduction (titlo only)

0.1 General

0.2 Process ap~ roach

0.3 Rolationshl~ with ISO 9004

0.4 Compalibili~r with othor manaoement systems -Scope 1 1 Scope (title ,,..y)

1.1 General

1.2 Application -Normative relercnccs 2 2 Normative mlerencos

-Tenns and definitions 3 . 3 Terms and clefinitions

Environmental management system roquirern~nts 4 4 Quality management system (titlo only) (title only)

- ---General rcquirernonts 4.1 4.1 General requirements

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

5.5.1 Rosponsibility and authoriiy -

Environmental policy 4.2 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 Ol rcquir~ments related to the product

7.2.2 Roviow of tl)qUirements reiCJtod to tho produ.ct

Legal and othor roquirotnonts 4.3.2 5.2 Customer focus

7.2.1 Determination or requirements rolatod to the product

Objoctivos, targets and programme(s) 4.3.3 5.4.1 Quality objt!Ctives

5.4.2 Quality ma11agernont sysloJrn planning

6.5.1 Continual ilnprovemont -

Implementation and operation (title only) 4.4 7 Product ro~.Hzation (title only) --------·--· --Resources, roles, rcspOnstbJiity and authority . 4.4.1 5.1 Management commitment

' 5.5.1 Responsibility a~d al!thonty I

5.5.2 Management represontati<Jo

6.1 Provision of resources

6.3 ln!rastructvre -

Competence, !mining and awareness 4.4.2 6.2.1 {Human tQnourcos) Gonoral

6.2.2 Compotenc:e, training ano Hwaraness -

Communica!ion 4.4.3 5.5.3 Internal cornmunication

7.2.3 Customer t:ommunicntion

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

I lo

ISO 9001 :2008(E)

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

- -ISO 14001:2004 ISO !X J01 :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 of wquirornonts related to tho produ:t

7.2.2 RevfeN of roquiromto nts retatod to tlla product

7.3.t Ooslgn and dovolopt nont planning

7.3.2 OesiQn and dovolopr nent inputs

7.3.3 Design and devolopr nent outputs

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 un d development changes

7.4.1 Purer asing procu~s

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 VatiduUon of proce~ ses for production and service provit.lon

7.5.5 PresE·rva.tion ol proo uct --Emergency prepo.rodnoss and respon:sG 4.4.7 8.3 Control ol nonconfor ming product

Chocking (tltfo only) 4.5 8 Measurement, anal~· sis and improvurncnt (title only)

Monitoring and moasurement 4.5.t 7.6 Contr::.J of 11)0nitorin\ l o.nd measuring cqulprnenl

8.t (Mea ;urement, anal ysis and improvamont) Goneral

8.2.3 Mon~oring and moa surarnent ot processos .

B.2.4 Monitoring and moo suremonl of product

8.4 Anal~ sis of data

Evaluation or complianco 4.5.2 8.2.3 Monitoring and men suroment of processes

8.2.4 Moniloring and rnou surcmont of product --Nonconformity, co1roctivo action and prevontivo 4.5.3 8.3 Control of nonconfo, ·rning product action 84 Anal~ sis of data

' 8.5.2 Com ctivo action

\ 8.5.3 Provt1ntive action

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 output

8.5.t Continuallmprovll/r. ent

19

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/ M<llll.oD ISO &001:2000 Flguro/ (A) or

Clau.a No.

1

Tab.lo/ Dolelleft Nato (D)

Foroword Pnra 2 D•A '

Foroword Paro J, A Scnwnco 1

Foroword Para 4, D•A Scntonco 1

ForoworrJ Para 5 D

Foreword Pilra G D

A

fOIIJWOfd Pi<ril 7 0

Foroworcl rara 0 0

Foreword Now para 7 A

0.1 Para 1, D Scntof"lco 2

A

I

Sentence 3 Now a new para

0.1 Para 4 A

-0.2 l'ar~ 2 D+A

20

Amunde~ text

lntomalional Standal'dt are druhod in accordance with tho rulo.s gt 11an In the tSOfiEC Directive c. Paf+-3[~.

Ib.i:.main..lil5k of tochnlct!l commilltes jslo orepe!D..ln1.c1!flll1i.Q

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.

if,tvtuotiom~oodafd ISO 0001 was proparad 'JI/ Tochn;c.al Co maJlilQ<lmflnl and qwlity assuro.nco, Subcommillllo SC 2. Quality

•TIInittoo ISO/TC 176, 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 rwio+o-n-Q4-lt!OOO-dUOOfliQI\ltr.

0V03+f004-ifHIIO-P<JG\-mUji-IJ(jQ !o00r0o.f100-Witf:l.4..,2,

wil.lt-l&<f·OOOJH~SG-OG·:i3i-IG04,-H-(IOA6\l<u\Q&-Q-k!vlt~l~l

nl06•)-(>fg.a.flila~tu~Hlc.GO~S0-0002i-KI-04-aOO-i&G-lhiv4il!O~OOikll\3t~..O!,Oiu<:l~liOIR-fEquk&fHOI"IIU.ffi·a

.DJ.is....lmll.lb..Jsllth:~o C:IQ,uJs, aod...lil~ll...l.bitd f!d~it:!l (ISO ~!lfl<l to c!Arjtv oo!nt!i. In ]ho !axt aod !o eohan ~ . i"

•J001·20~1JJai...ll.o..o.n

~!fl t$0 J.10QUQ.Qi.

:riW1-I~le--oJ.~n-·le-~i6o:..>U~\~~'d-41o-kvl tlG-6Vfll-flOQ!..~I-O·fUG!·lh.:±i..;lw-quaJily-fl~f\a90-A...:!HHI't.

Uli6.~~1 1&~0001, in-<:.~:liLion-l~l&GUf"altCO-Oi-po

{lOr~~~~~lily

ti-'<Jfll-f<K\vlfOiflOfii&-Lpovlft<XHfl O<Juct,......alw-aim-to-oo~

uV6lOm<of-~HtiG~

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

.!1rtJ.uD B!!! g!ypo jo AD')r>X 0, D.llllllls ... nUl:u:: cbacgas beiYlccaLlllll..ll'lnl cdl!l!:lo a 1d I IllS tcumtl c

"f.ho-0-GG!gn--aA"' lm~lemGfltalioo-··€fi-.dfHifgaAlza4ie~wlil'f""fi\ill'o i'o\}<HMA~~~ pr00Ct£.601Hif~Tho ll-)'-...,.i::lfyil'lfr·H6·0®,.-p~·~:Aarvti'>O\i'.'%r·lho-prOO\.H~v-pnwiUoOrU.O

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

o; aJllil.!)l syr,!ern js !o(\imnccd .l1lf....!j~joo nod !mp]emen]a!jotL¥ an orqao]zat(or:uw.al.i1¥...roan.a. trl

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

b) U:U""'In~

C) ll:Ul.illllc!J!nr Qblcc]jyc~·

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...

11 Is not lha Intent ol this lntern.llional Standard "0 imply umlorn l·ty in the structvre ol quality management aystems or uniforrr1!ty of documentatoon.

lhis lnternauonar Standar<fcan l>o used by lntornal and external t•arllos,lncludlnQ cortilicalion Qr, '"la~<[!pry end regulatory n ruquiremonls.

bodies, to asseu tho organi2.llion's ability 10 meot custom fCQUirornonla ~~Q~t, and the O(!J41"1itatior(s ow

For 1111 cirganinllon to !unction p!!tJCtlvoly, it has·l~lily Cclu 1111hl.il and mo.nogOJ numcrooG no managed In order to anai.Jie poO.:C$~.

linkod acUvltloa. An a~ivily QU~...oLa!.::!.i.vl11. usln 1 resourcos, a tho transforrnation of Inputs Into uutputs, can be CC•nsidorod u~ a

For Training PL'rpose or1ly

~ ' ~~ ;~ ~·

~ ~ ~ ISO 9001 :2:0 00

CIIUU No,

;~ 0.2

l

~ , t ~

~ t~ .~ I

f ~ ·~ l e ,~

l~ "l~ t~ l:)

0.3

0.3

0.4

1.1

1.2 '

~-

··~ 't~ -·~ ~

"" !, ''1-l 1

'---·

ISO 9001 :2008(E)

Tablo B.1- Chan~Jcs between ISO 9001:2000 and ISO 9001 :2UU8 (continuecf)

Par•graphl_ Figure/ • TabiW Not•

Para3

Para 1

ParaJ

Para 1

8ullota)

Bulla! b)

Nolo

Uuw Note 2

' !"'ora 3

Para 1

AJllll1lnn (A) or

Dolo< .... (01

A

D+A

D+A

D+A

A

A

0

A

A

A

--···-D+A

A

D•A

Amende-d ltl):\

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

.can bo re!erred to as_tho 'process opprcath•.

=l:n&pte&bflledl'iaf\s 1)!.4S0 9001 and ISO ~004 haw~ -boon (;uaUty management syslom i.ilandards which ha"o boun , byt eun also ba used lnJepcndonlly. AHktvflh-U~-"i~w-it~ 6-0~~"nllar..c.lf\IO\UfOO..IH-ot"4lf40-aGGJGH1Mf-

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

do\l~k.p~fl(;i(.loo-1~ are Jut;ignorj tu comp!omont oach o!hor, Wtnal~~~ttlcr--f~ i.lt){ll1wlloi'l----lliO--O--IoGiG-Iitnl.-p!llft

-vl-G~\af\6000~ II IOfl.--of-...Gn-efQOOiletfoo'&--owfGII tloo.!~tk.oular~f~t'ttifwol--iiJIPIOV<o

ffe.r~mf\llfiQI 1AdQ.f~I)Q'f;-M~6--lt&-~~. ~~~tg$!1\i~p-monogJ;~tMOOHt4GMG-4o·nloYO-t

clliO~­o-(V(IU.~~~\fo--01~

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

!~Jh~lJ~on.0-l:li!.i.lillOLna1klliW...SlJJ.ru1;:ut1,.JS1 ).~01 js under rJttJ?ioo Jho ceyi;Wd ll.!!H Dtb(mlog su313joed WCCASS for

l!i\L.Jl.U'l!IJmmnO! !SO 9QCH mmjdos

ld~ lt.:IJt,J/1\' Rod cmtiaW!//ropmycmcnf of

ruJ.!:d lor certjficalico mqu!aJqry or

!~lU?n or 1$0 900:1 wil!..Jtr.~i:.!~LQU~~mu Llffi'_oroanlzaHon In a cQ1nr.~.o;Jicruaru1ina .• .anl1J!·ruJjl.ilflL tlJ.Idd~tL . ..rnanao;:u!D.Jll1llhn.tLlS!l.JlOO.L!La! It( a1! jnMrn;rtcd pcrn ... s_w:l.1Jl..u.!£Lsa1i~;1lQo_t~'...llu:-sy..s. lllL.Q!QDDil!!,llan's rt>d.'!"'f"'l~~~c...JLi~_JlQLJr.Ut:: ~;MJrn.~

.. ~=-hie~to~\D.n-dntd-ho()-Oooo--61tlft0d-Y~ith---l80·1 oo-mpa-l~Gtn.-.d.:or-dv---f~OA&G\--ol-tho--IJG()

4 001-i4-il06-lft-ofd<:f··IG-C~•M~ H;oo;munityt

D.udng tho developmcot_oLU,j'i !n!t•rna!llWll.S.l.il.ruian:L

l!lQ).']SiOGS Qf ISO l~O!ll:.2QQ:ll? C:Ob!lO!:iC 'ha.J<.Qr:~ l}~_y~r commuoltr t,n~rv t, ShOW$ ilw:tJilJLll2Qllii lS.Q 1 •IOQ1•?004

{l) nacds to dcmonstruw Us obility to con:;istenUy p!u'oi:Jt.: <tp~l!ca.ble stetutory e!lli rc:Julaloty requirements, anc

d,IJ!) COO$!dn@riqo WfiS gjveo IQ !hC !J~3!octhcboneHiqf

c . .n.-:e 11otwceo (SO 9f"'IQ1·?008 anct

product that meets customer and

,,, ~!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

conts. customer and applicable s.lnl!..lll:!rLll.O.d regJia\o1y roqOJircrr.

I·IOT-E~Iiofltlf--Sl.ln<iaf-d,..tho-~ ~wOOuvF-.:~p

(IHoqutf~tomor.

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

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

t>) eny !nlooded otf!Q• ti.f.'!i!UlinVromJI:ln pmdt 1ct rr'!J.!.!.!Jl

JlQJE 2 SlalliJC:~J: ~od '!l'.lula.l.Q[yJ!tQl.J.lamt.ni.!.L.!:.!!O.Jl.!Ul.:

Wht!ff! Cl'iclusions '" made, c!Jhns ol conlvrrl"'lity " acct:ptable uni&$S tho!".!: exclusions ... limitull to roqu UKCiusions ~not al!ocl tho org;mizatlon's abilit;. or rospOt <:ustomcr and app!lcat:lc! r,IJ!•i!Q!:'t aod rctulatory rcquirur1

liun.procosws

tttis !nternallonal Standard o.re not •Cttmcnts wHhin Cli!UGe 7, and such ~~ibility, to p1ovido product !hat meots ·cnts.

:r.oo~ivo-doouo1c-ffl~iliM-PFIWIG-IortC---'< ffiiuft,--Uw-oogiH<>Iorv~~t; Fvt-:hltotl-folefDf"~G~bGaqtl(Hll '16-~'f,..-pit~O

OOMliiWI& PF0''\GirHJG-----1JI-It~fi!OffliN+t~~Of\QU+d.-i)ff'~~k.k>oo-il{rl)~~liitt ~~..(I(H~orn<Hiofl&l..S.)Ada-4d-;)-l'-<l~;)Wfl~----odiiioo-ol--tM-~1-iltiw-

I'Ole-~t\-041-..l-iltU--AO~~W!WI"".

IEC-~t}IGtofG-of·OUfrortlly-yalid----lft iOfRO\kxlo~G\.:tl

o---ooo<klletgdd-1~\o--lt\o---p~ OC.C.U.lwnl-indioaled--bokH/~ rol-alr00-t-G---&j}j)41o&...UvoW()f-u~

i-.k.rdv.

Ih.Q_Hir!wfog mfurcrc~:Ul~!!ill!1ll~~lliab~U2! .iJlUOOifcnlkJQ ol1tlli.J1Q;;umoot for ~Q. rc1erences tho late~! (>(!jHon o!lbo !1Mr•d 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~

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

21

-

ISO 900\:2000(E)

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

Parugrcph/ . ISO 9001:2000 Flgurel

ClaUliO No. Tabla/ Hoi I

3 f>~:~ra I

3 Pnru.s 2, 3

4.1 Bullot "a)

4.1 Oullot e)

4.1 PoilU 4

4.1 Notal

4.1 Now Notot< 2 & 3

4.2.1 Oullet c)

4.2. t !3ullotd)

4.2. 1 6uUel e}

4.2.1 Nolo 1

-4 .' :.l Uult~t r) :, ~--~l..-

Para 1 --4 ~ ~

5.5.2 Para 1

6 . .2. 1 Para 1

New Nolo

'--·

22

-Allllli!Jln (A) or

Amo O.I•U~n

nded hn:t

(D)

D•A f'or 1h11 purposos Olthis ~un:.c.nt !(lto/Mtl r:so !Woo ap~lf.

.c terms <Hid deftn1lions gwen In

- - -·· 0 -n•o-loUowlfi{HOfft\&rWJOO·ItHIJ.HGlliol+-{)1-.t

' I>Ut\1!00-lG->vnvot-~ho -woo bvi.afJ'-V\.Itl\l!l;it->1-C t-upr•ll-er-T-IH'g .. nl.l.atl.;;tl-~t~vm'Of ~ ll4;!-\e-1tt~f9flj\-ii!Giior~o~:-fopluootr..UW -4Q;m-·~ ~.r,J ~ o wl.kliHI~lo r1wlivrwl- b11.1nJurU- upy H .:.~ub-x>nlfoolo,;

D•A ,, Utmtily dll1e!mine tho procec~oo nood&J appliculion throughout UHl ort~anlzalion (see· ---- --A ,,, mcnitor, moasure l'rlie.I.ll..W~. and.

O•A Where an ocgoniution choo~os to outsouroo requirements, the organization shalt onsuro c cnJl!J~l.1ll..!J.c..W~l.lll::!l..P~ilnr'2

1tJ..ln'l11 "0li'Ol S::iSI.!:m.

j;IQTE I -D•A Procossas needed ~Jr U10 quality lin:;:ludo processus lor f7'1<1113'JOrnent acUvillo: r1oasuromont, anal~n.a::Liru~.l!llli!nL

-·---A tiOIE...2..M "!:lld~OIIH:Cd Q~·· IS ' ou:

tl.Jlfl,ll,l£illlilll~m .... Dm1 whjch !he ncc,anii ~·.art~

ttn'[E..3 Ec:un:hlc cant·c~ ~!....Q!.l!S!liJ!~ DSil'lOSrhjJhv pf c;onfQ!JD.]t~JQ...alLc:~ l'.¥'..!:!11 o! cOO![QI jo be ll[)Q~U~! i!Ll!w-"l2tllltii!.l!JlruJ.cLQ! the Olrl'lmJrced t:

1;m·J.C' that coo!OJm~lt'.lf:..Q!.tiiffilfal:i.. ! tUb~ Cflgt£:~ 112 l'l'!lli:tlJtl:l..C!l.'l!n:!ll::tr !be CCl CWJD capabmty r•l "':lill:ll~C:Ilil!is.ll!Y-

l!oU-tho-·~ppl~{)Min,-~OOCH

up.plivt4i>JcU·i.l-t JG.-/,!Q.L),-\hU·\'.Jfll'

~ 0·0\Xli-:-\OO·h-Ut".tl-tdU"fl)-lo-il~<..! .:G~Jpj,;lo?f\OW'fiJi;.low&.ltw·Mfm

lor th1! quality rn" 1.2).

rhlgcmefll system and ltlcir

-malyse~ those ptVC! lS:les, W1d

any prm;o:;s that l!\l!ol ovor~uch 1 :(!!i.:O.ti.J:ll.i!.!LA.C...!!

aiJccl~ prodt.~et con!ormlty ¥Mt J.g, >lliCCG!iOS..Ih.a.JJp.c.,a'll1..Qxt.eJll.QL

i!lUIC'! wjthiQ Jh!! Q\IVIrty

-otvm rolouod to abovo ·""'~ manavomunt ~~

1, pro·•i~leotl of ro HIUICOS, product IQJ.Iil..ltk>n, &fid

-oil.OiLl.ttan oc~s: /Q( ils ~ ju:we porlarmed by Wl.J:li!J.!llal

-· ~!:l'£1: !bill Q[g~oiZ.J 1jQ:O O! lbll

W.JYJaiV.llr.a.mMt'i Tha tyLJ$Ulld ~u_d.llilS..fu.ll.. i!.W11m' ..ailitro<J!.!L.i ~~n.t ~L.Qn....ll.l.Ul!

e..~u~clo'~ sutll as ~'li.Z..tl!i.Q!l) C!jQ<]'lilil'f to NIJVldQ

~s..!:u:.-t't:l:.e::l. ::wtlt.cl.1l::u..illJ~hJt ..c .ou:;~~Uon.alll

A~=]~i documenred procedure:s ~ req• -national Stand.aro',llilll lired by this lntur

~\-J:.Obytho 1

:ontrol of Its pfDC\1 A•O

0 ---

A

A

<I c!O<:uments !nd! 1Qjn" l.!l..:'Q.!r:!.::.., f\!>0000 ~ tiiJ:lnl:zation lQ.J::t:c_nru;~ to cnsuro the eHoctlw plo.nnlng, operation and t sses. '"" - -~He~ll!.~!tlefna\io;fi.II-S~

-NOTE 1 .iU1In th;s lntornali0nal Standard. Where the torm ··documontod proc Hluro' appv.:tr:; 1

-d, documented, .\ls....ku..Qilll.!lr.mPI .tUILlllZI~~

this means l'lal lha procedure Is ostabriSh~ ~irull~ docymqnt may ad.\!l.f..S.SJ!l'J ux:11i•cmm ~JL:~'Wflalgd nmCQd,rrg may....b.l1.J:'.J.'lel!l~

~~ tc• ansurathat de<;umont3 ol ox lerna! orlg ~:O.UlQJ2(aanl!lU->lruLP.P !..!J1!· ~tl -i:'~_1ll!!_...Q1U

lc'stntJullon controllcO, umJ

n dmaul!U:n:.~JJ:I. ~~-.IOJ!Jlll:,j~!t:.L:!ll

imptemunted and mainlainad. t:. e.!1!i"'~ .. Area.wir!1.01.1illl.lli !lJ!J .. Qnt,

-- -UtC-PJ!;ID.niratiU!LI!.l W!.Jlll~.S~ .~:.-:.tcm nrc 11Jcn\d:cd nncJ Uu:!ir

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

•tu; of conlonnhy to r<.quiromonts to pro·.11Jv u..,.ido nanagornuol sy~ tlfio....,blo,

---A

-·--

~nd ol the olfl..-cllw opora\ion ol tho quaUiy 1~111 '~ .aw.Lrolliiii. ~~IJ chall-f&ffla~~oo.:J;Jt-+Jofi\HiabkHJM~< lb.Q...giU~!Lt~iilbliSh a documcr controls no&docllor thelctontilication, stOfa(la

tod proco<,:urc u protection, tiilile

•i>li-W-uGl<.~ViiG-lwU to daf!no tho Viii, nMntion 1im6 and disposition

ot ro.;ords. fif.s:ml1 ~ ·ball [l'tDII!t.JI{:~!bLl...mA.di!y_k!.w.tl.Jil

Top mr.nagementsha.!! appoint a mombotof ~ I.!Ullll~:S ~~and GUU101ity th other responsibililies, sna:l haVQ rc~pon3ib!li

... maM·JOtllcnt who, iiiOGpecli~e of ..1! includes

·------A•D I f;~;nnol porlormlnQ work affocllr.o ~

loompotoo< oo tho ba''' ol '"'""~" oduca

1!: rmil!U.o prod~ ion, tralnlng, skll '

qua\!\'t lWwlltil!S. liM If bo k< ~nd oxpar!onca.

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

··- -- ------·------

For Training Purpose or.ly

ISO 9001:2000 Clav•o No.

6.2.2

6.2.2

'·' 0.4

-7.1

7.1

7 .2.1

"1.0.1

7.3.2

. 7.3.3

7.3.3

7 .3.3

7.3.7

7 .5.1

7.5.1 I

7.5.2

7 .. 5.3

7.5.3

7.5.4

.ISO 9001 :2008(E)

Tnbll~ 0.1 - Chan!)CU betwet:ln ISO 9001:2000 nne I ISO 9001:2006 (continued)

Paragraph/ Flgurc/ Tablol Note

Clouse title

aullots o}&b)

Uullot c)

Now Not~

Bullol b)

Oullot c)

Oullot c)

8ullol d),

New No to

Now Nolo

Parn 2

Paru1-

Uullot !J)

New Nolc

Paras 1 8. 2

. ::-cc--Outlet~)

Oullet !)

Pnru 1

Pnm2

Para 3

Para 1, Sontonco 3

Nato

AdJ1lllilJl (.lit) or .,., .....

(0)

A tO

A t·D

A

A

-·::--AtD

--A

J\1ncnd111d toxt

Competence, ~d awareness &n~i-lroiAin-o ------

II} determine the nocoasary oompotoncll lor por$onnel p •rtormlng 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,

1:) :!upporting services (such as transpon, communlcalioo or lntorrna!Joo svstcmal,

!iOIE_Ih!Lillrm_l'iO!Y.. .CflVlrcnmonC!!lW I• tLlQJ!:\Q!HLC. Qll®}Q:Il.L.I..!D.d.er whjch wort Is porlpanod .:tUi£..l!llil<ll,..\<ilJ1lfllAhili>Jwmill}11'-illl:llr .. liO!L~IC.C.l.J.OYlrnrun.a.aLlLll!llL..!l' J.ll:r..Jil.Cl.J:l.CUW

liQh!iog QC wultla£1

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

t;) required vorificalion, valldill!on, monltc dng, Q~ :;podfic to tho product und tho crltorla lor prcx.luct oocepuu

IUtl. lnsPQcdon and test activities teo;

-.,...---D +A 1:) statutory and rogul.:.ttory roqulromont;; robtod iJJJ$ ilbiillo the product, and

D•A

A

-·--A

D ~-;::-

DtA

--

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

JjQIJLfo~<;JirillcLinaludo....lllr.....uxamplJJ rootmc!t•nl ol:ili.Q~IllU'DC.a~c.QL.a

•• J!.:tiona !mdor Wa[rantv proyjl;jaos. 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 jnutjoo as !jlljlab!Q !or the prorluCf and J<aD. be condt rctod pod recorded SCQIIraJCC~QL.ln .. nny cqmb

Jlul..~aniu.JJ.on.

:r~\Q~ Ihll Inputs shall bo rovlowod lor adoquacy. HOQ!Jiroments shall bo comploto, unambiguous and not In coni~C1 wllh oach other.

Tho outputs of dosign aM dovolopmonl st\all bo pfovid .N--ffi--a--fofli\41ii.it--oooOio6 Ja.....a..Jo..c t Input and ohall be approvod prior to ;I:Ul1;ll:lWa! verification against tho dosl9n and dovolopmott

roloaso. -

D !)) provide appropriate information lor pu ·chasing, produc tkm and lof sa Nice provision, ---

A

--NoJ text changu. PH[U~

now merged ----,---D +·A --

A

D•A

i~TE !n!Nmgljp[! ~~.n....o.ruls.cctlcc proylsjQ .n..caa.~ctajJS tor thS prgsorvotloo

,liJlllldu!;J.

Oc$ign and dcvotoprnent changes shall b1• identified and r bo roviowed, vori!iod and validalod, as appropriata, and a

.cords maintained .. The changes shall t.Jprovod before Implementation. Tho VoJ.lua.tton ot tho eflcc1 ol tho ehanges .o;ds ol the results ot tho review al de 4.2.4).

rovlElw of doSi!Jn and doveloprnont chan!!PS shall include ll •XI c''n!>li!Uent ports and product alread r Uolivared. RtH ·=I:<Jil(JU$ and any noct.!ssary aclions shall bo ma!ntainod (•

·j) U1o availability 11nd usc of monitoring Wid ntOa!lutino d

f) tho lmplt'mcntalion ulllliK1lJd roi(!OISU, deliwry and po -The orgat:~lzatlon shol! vulidnte any proct·~scs lor produ' rcsiJfllng output cannot bo vcrincd by sub::oquont monitotl Pf·O<:)O~fV a.rut .. O.U.!&OSQQU!l.llC.f!, doliclcncios boc in uso or the sorv;co has boon dolivorod.

a¥looo ~t$ln.CD..I.

'l·dttlivery activities.

lion o:nd Garvlce provision where tho lltl or mcasuromont i.fil6.ioo~ or no Hpparent only aftorthe produe1 is

A --·The orfjanlz!ltlon shull iocnllly thO produ< t staws witn ros p.:!Cf to monitoritl9 aml moasuremont

-..,..-D+A

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 4). ldcntltlc<ltion of the prWuct flill.UrullnL'Iin..·~ {:~oo 4.2

Di·A -- II any cvstomor property Is lost, damago~ or othorwis(l lou nd to bo vnsultii-bla lor uso, t~ omRn[zpUpu :;ball report lhj$ to the 00-I'OpOf~o<:HG-4ho-ouGtoowf-ur.d--foooni<H·MifltuiM<.l thu

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

A NOTE Custom{lf proporty can indudu int~tloctual proport

---- --

23

For Training Purpose 1)nly

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 F!auroJ (A) ot

Amend1td tol(t C!auto·No. Tablo/ D!fl.Jtlkl-tl

7 ,5,5

Nolo (D)

Pam 1 D +A Tl o c(ganizat\on shall prcG ~rw tho oook:H'-11-~'-01 product during Internal proco&.$1ng ~nd doawry IO lh~ Intended dastlnallon ICJU.d~r to mvlntlia..c.o£1!0~~. +fW; A$ 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!,

.1:,~.,,-----1:,~,_~,--~--fo; A--te· ntrol of monitoring and r.loasuring ~.l!.®ll;l.o:L!Ul.l -----------1 t,~.,::-------+p~,~,.,c-:-,---+D::-~-A---Ti (l O(ganlzatlon shan dnUrmlno the monllorino ar~d 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

~land<~ Ids 11ncoablc to Jnto1n.J!ionu1 or flO lion; II mu•u;urom011I ~tufldards; whore no such sland:Hd!.l o~lsl, tho basis t•liOd lor calibraHon or vorilieul!on sho~~Jr bo roco1d0d !.Sllti2.1.1:

.,-.6--------· ~ii~--;)-- ·r;-.-A--- ;;)~;:;;;:;:;wtoo·to an.at.H-1} ~~&<>.111tlruti<HH,l.1~ ~&-lo~~; cJ-1lil!L~mirul.i!l.Qq~~l.clli!:Ua!io~

7.6 '

wflllo1,1 c!1.tr1Qtl. j

;;;;;;;.,--- ~-~~~ now I fi,;;:;;,~~~~.iib<OI>oc< "'d 'OdC -;<1-1~:-,-,-~,,~,~lb-,-,-,·.\i ·:,--lo~in_c_d_[_~e-o-4-.2~.~,)-.----1 Sontonco J po1a 5,

I:,-.,----· ~- 0:~~ IN9H.:_soo400-H"',.Ol~kHW·lOO-\::..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) ,,,)l~JWncluO'LI!A..¥.et.lHc.aJfO..arui~I.II.a.Ij[.l1111UI..flO.gf.'IDe!ll.lQ.~!.alli.liWQLJJAI~.,

~B~.,,.------+n~o~II~OI~a~)---\D • A a) lo domonstrate c0l11om·.i!y e~-l~odveUQJl.rlld.uw.tl.QI.!ir.om.QD:.t.s., -----· ------r.----- ---------·------~---:·---:-----,---------1 8 2 1 /~ow No<o A ti.Jlli.J&:-nt!Q!in~i.QmtL~O~~D ~t!~UUOiltg. joout from tlpurcps s.v,:h 65

. . --~--- c1 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. Q;illtts.inD~s.....c.QJnlilimc.alsJ.tij[r.t1J'i ~mi.ll..O~t.~

-:·c:---:-::-:-c-:-----·-,----·----,---,.-,-l 8.2.2 Para 2 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 1 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 rQlT\i!Hi-Mtd-fflUi-filotr.iAg-roo.:.,.QG.-{~'4)-Gh91+-bo--Of:f+n~-~AI-Od,,oooOOte-r 0 ; II fu~r~..aUhul.l.ctil.s_amULei• results shnl! tm.Illillal~J...2...51

~8~.2~.7,-----+p~,-r,--:,----r.N-;;.;- n1c maoagemont rospoosibJo k:Jr tho orea bolng auditod s,;;;-~~-,-"~,-,.-,-,~h-.,-Jlm:-:.Jl--<l«-,-,a£¥--l Sollll.!oco 1 pur>.~ 5 C..O.rL!l'li9.n.s....n.nd...ou.ccti.Yc actions aro t:lk·ln wittrcvt und\..o delay to eliminate deluclcd

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

I·,-,-.-,------1-,-Jo_to __ . __ ~~;- NOTE ~~QO'\+-i,~:CHWH-\-"M·IE0---Hfi}-t4_.&'"$o; iS"o.J.2Ull lor guidanc~. ~,-,,·.:,,------lp~,~· ,-,~;.,.\~ u--.. - When plannoo" f'QSUI!S aro 'not achiavod, corroC!IOO <md corr.::ti~c action shall bo lakctl, as

1 Sontcricc 3 apptoprialu,-4()--{l(~f-IHXJIIIMHI~y-of-tho-pn0u;l.

B.i3_._:_ ~~~i";;- 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 iliY•fi)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

f'Jra 2 D<A

o.A

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:.•.J•Jllh.rbtUIC<::.DP l<l.il::ll.Cril !:rlil.ShilJUJ~ Lfllaial iililc.JJ...

6¥-:Uonoo.<if-*Flk+rmily-wiU>. -lhe-a.oroptaPtoo-\il il.ofla-i.I>Oa·l>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).

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'

L ':.omplulod, unloss olhfrrwis~ approvod Dy J otovont nulhorit) und, whoro apphcu~e, by tho

u:;tomllr,

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24

for Training PurpoEe only