品质管理质量认证IAF中英文对照版

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1、 4Contextoftheorganization品4.1UnderstandingtheorganizationanditscontextSeeISO9001:2015requirements.质Theorganizationshalldetermineexternalandinternalissuesthatarerelevanttoitspurposeanditsstrategicdirectionandthataffectitsabilitytoachievetheintendedresult(s)ofitsqualitymanagementsystem.Theorganizatio

2、nshallmonitorandreviewinformationabouttheseexternalandinter管nalissues.NOTE1Issuescanincludepositiveandnegativefactorsorconditionsforconsideration.NOTE2Understandingtheexternalcontextcanbefacilitatedbyconsideringissuesarisingfromlegal,technological,petitive,market,cultural,socialandeconomicenvironmen

3、理ts,whetherinternational,national,regionalorlocal.NOTE3Understandingtheinternalcontextcanbefacilitatedbyconsideringissuesrelatedtovalues,culture,knowledgeandperformanceoftheorganization.质4.2UnderstandingtheneedsandexpectationsofinterestedpartiesSeeISO9001:2015requirements.Duetotheireffectorpotential

4、effectontheorganizationsabilitytoconsistentl量yprovideproductsandservicesthatmeetcustomerandapplicablestatutoryandregulatoryrequirements,theorganizationshalldetermine:a)theinterestedpartiesthatarerelevanttothequalitymanagementsystem;b)therequirementsoftheseinterestedpartiesthatarerelevanttothequality

5、manag认ementsystem.Theorganizationshallmonitorandreviewinformationabouttheseinterestedpartiesandtheirrelevantrequirements.证4.3DeterminingthescopeofthequalitymanagementsystemSeeISO9001:2015requirements.TheorganizationshalldeterminetheboundariesandapplicabilityofthequalitymanagementsystemIAtoestablishi

6、tsscope.Whendeterminingthisscope,theorganizationshallconsider:a)theexternalandinternalissuesreferredtoin4.1;b)therequirementsofrelevantinterestedpartiesreferredtoin4.2;c)theproductsandservicesoftheorganization.TheorganizationshallapplyalltherequirementsofthisInternationalStandardiftheyareapplicablew

7、ithinthedeterminedscopeofitsqualitymanagementsystem. Thescopeoftheorganizationsqualitymanagementsystemshallbeavailableandbemaintainedasdocumentedinformation.Thescopeshallstatethetypesofproductsandservicescovered,andprovidejustificationforanyrequirementofthisInternationalStandardthattheorganizationde

8、terminesisnotapplicabletothescopeofitsqualitymanagementsystem.F中ConformitytothisInternationalStandardmayonlybeclaimediftherequirementsdeterminedasnotbeingapplicabledonotaffecttheorganizationsabilityorresponsibilitytoensuretheconformityofitsproductsandservicesandtheenhancementofcustomersatisfaction.英

9、4.3.1Determiningthescopeofthequalitymanagementsystem-supplemental文Supportingfunctions,whetheron-siteorremote（suchasdesigncentres,corporateheadquarters,anddistributioncentres）,对shallbeincludedinthescopeoftheQualityManagementSystem（QMS）.TheonlypermittedexclusionforthisAutomotiveQMSStandardrelatestoth照

10、eproductdesignanddevelopmentrequirementswithinISO9001,Section8.3.Theexclusionshallbejustifiedandmaintainedasdocumented版information（seeISO9001,Section7.5）.Permittedexclusionsdonotincludemanufacturingprocessdesign.4.3.2Customer-specificrequirements4.1Customer-specificrequirementsshallbeevaluatedandinc

11、ludedinthescopeoftheorganizationsqualitymanagementsystem.4.4Qualitymanagementsystemanditsprocesses4.4.1SeeISO9001:2015requirements理4.4.1Theorganizationshallestablish,implement,maintainandcontinuallyimproveaqualitymanagementsystem,includingtheprocessesneededandtheirinteractions,inaccordancewiththereq

12、uirementsofthisInternationalStandard. Theorganizationshalldeterminetheprocessesneededforthequalitymanagementsys解temandtheirapplicationthroughouttheorganization,andshall:a)determinetheinputsrequiredandtheoutputsexpectedfromtheseprocesses;b)determinethesequenceandinteractionoftheseprocesses;c)determin

13、eandapplythecriteriaandmethods(includingmonitoring,measurements组andrelatedperformanceindicators)neededtoensuretheeffectiveoperationandcontroloftheseprocesses;d)determinetheresourcesneededfortheseprocessesandensuretheiravailability;e)assigntheresponsibilitiesandauthoritiesfortheseprocesses;织f)address

14、therisksandopportunitiesasdeterminedinaccordancewiththerequirementsof6.1;g)evaluatetheseprocessesandimplementanychangesneededtoensurethattheseprocessesachievetheirintendedresults;及h)improvetheprocessesandthequalitymanagementsystem.4.4.1.1Conformanceofproductsandprocesses其Theorganizationshallensureco

15、nformanceofallproductsandprocesses,includingservicepartsandthosethatareoutsourced,环toallapplicablecustomer,statutory,andregulatoryrequirements（seeSection8.4.2.2）.境4.4.1.2ProductsafetyTheorganizationshallhavedocumentedprocessesforthemanagementofproduct-safetyrelatedproductsandmanufacturingprocesses,w

16、hichshallincludebutnotbelimitedtothefollowing,whereapplicable:a）见ISO9001:2015的要求。组织应确定与其目标和战略方向相关并影响实identificationbytheorganizationofstatutoryandregulatoryproduct-safetyrequirements；b）customernotificationofrequirementsinitema）；c）specialapprovalsfordesignFMEA；d）identificationofproductsafety-relatedc

17、haracteristics； 现其质量管理体系预期结果的各种外部和内部因素。组织应对这些内部和外部因素的相关信息进行监视和评审。注1：这些因素可以包括需要考虑的正面或负面的因素或条件；注2：可以通过考虑源于国际、国家、e）identificationandcontrolsofsafety-relatedcharacteristicsofproductandatthepointofmanufacture；f）specialapprovalofcontrolplansandprocessFMEAs；g）reactionplans（seeSection9.1.1.1）；h）definedrespo

18、nsibilities,definitionofescalationprocessandflowofinformation,includingtopmanagement,andcustomernotification；i）trainingidentifiedbytheorganizationorcustomerforpersonnelinvolvedinproduct 画safetyrelatedproductsandassociatedmanufacturingprocesses；j）changesofproductorprocessshallbeapprovedpriortoimpleme

19、ntation,includingevaluationofpotentialeffectsonproductsafetyfromprocessandproductchanges（seeISO9001,Section8.3.6）；k）transferofrequirementswithregardtoproductsafetythroughoutthesupplychain,includingcustomer-designatedsources（seeSection8.4.3.1）；l）producttraceabilitybymanufacturedlot（ataminimum）through

20、outthesupplychain（seeSection8.5.2.1）；m）lessonslearnedfornewproductintroduction. 地区NOTE:Specialapprovalofsafetyrelatedrequirementsordocumentsmayberequiredbythecustomerortheorganizationsinternalprocesses.4.4.2或本地的各种法律法规、技术、竞争、SeeISO9001:2015requirements.市场、4.4.2Totheextentnecessary,theorganizationshal

21、l:文化、a)maintaindocumentedinformationtosupporttheoperationofitsprocesses;社会 b)retaindocumentedinformationtohaveconfidencethattheprocessesarebeingcarr和经 iedoutasplanned.济因5Leadership素的情况,5.1Leadershipandmitment有助于理5.1.1General解外部环SeeISO9001:2015requirements.境。注3： 5.1.1General总则可以 Topmanagementshalldem

22、onstrateleadershipandmitmentwithrespecttothequalitym通过 anagementsystemby:考虑 a)takingaccountabilityfortheeffectivenessofthequalitymanagementsystem;组织 b)ensuringthatthequalitypolicyandqualityobjectivesareestablishedforthequa的价 litymanagementsystemandarepatiblewiththecontextandstrategicdirectionofthe值观

23、、organization;文化、c)ensuringtheintegrationofthequalitymanagementsystemrequirementsintotheor知识 ganizationsbusinessprocesses;和组 d)promotingtheuseoftheprocessapproachandrisk-basedthinking;织绩 e)ensuringthattheresourcesneededforthequalitymanagementsystemareavailable效等;相关 f)municatingtheimportanceofeffecti

24、vequalitymanagementandofconformingtothe因素 qualitymanagementsystemrequirements;状况,g)ensuringthatthequalitymanagementsystemachievesitsintendedresults;有助 h)engaging,directingandsupportingpersonstocontributetotheeffectivenessoft于理 hequality解内 managementsystem;部环 i)promotingimprovement;境。 j)supportingoth

25、errelevantmanagementrolestodemonstratetheirleadershipasitappliestotheirareasofresponsibility.NOTEReferenceto“business”inthisInternationalStandardcanbeinterpretedbroadly4tomeanthoseactivitiesthatarecoretothepurposesoftheorganizationsexistence,whethertheorganizationispublic,private,forprofitornotforpr

26、ofit. .25.1.1.1CorporateresponsibilityTheorganizationshalldefineandimplementcorporateresponsibilitypol理 icies,includingataminimumananti-briberypolicy,解 anemployeecodeofconduct,andanethicsescalationpolicy相 （“whistle-blowingpolicy”）.关 5.1.1.2Processeffectivenessandefficiency方 Topmanagementshallreviewt

27、heproductrealizationprocessesandsupport的 processestoevaluateandimprovetheireffectivenessandefficiency.The需 resultsoftheprocessreviewactivitiesshallbeincludedasinputtothema求 nagementreview（seeSection9.3.2.1.）.和 5.1.1.3Processowners期 Topmanagementshallidentifyprocessownerswhoareresponsibleformanag望 in

28、gtheorganizationsprocessesandrelatedoutputs.Processownersshal见lunderstandtheirrolesandbepetenttoperformthoseroles（seeISO9001,ISO9Section7.2）.001:2015的要求。由于相关方对组织持续提供满足顾客和适用的法律5.1.2CustomerfocusSeeISO9001:2015requirements.Topmanagementshalldemonstrateleadershipandmitmentwithrespecttocustomerfocusbyen

29、suringthat:a)customerandapplicablestatutoryandregulatoryrequirementsaredetermined,understoodandconsistentlymet;b)therisksandopportunitiesthatcanaffectconformityofproductsandservicesandtheabilitytoenhancecustomersatisfactionaredeterminedandaddressed;c)thefocusonenhancingcustomersatisfactionismaintain

30、ed.5.2Policy 法规要求的产品和5.2.1EstablishingthequalifypolicySeeISO9001:2015requirements.服务 Topmanagementshallestablish,implementandmaintainaqualitypolicythat:的能 a)isappropriatetothepurposeandcontextoftheorganizationandsupportsitsstrat力产 egicdirection;生影 b)providesaframeworkforsettingqualityobjectives;响或 c

31、)includesamitmenttosatisfyapplicablerequirements;潜在 d)includesamitmenttocontinualimprovementofthequalitymanagementsystem.影响,5.2.2Communicatingthequalitypolicy因此,组织SeeISO9001:2015requirements.应确定： Thequalitypolicyshall:a)与 a)beavailableandbemaintainedasdocumentedinformation;质量 b)bemunicated,understoo

32、dandappliedwithintheorganization;管理 c)beavailabletorelevantinterestedparties,asappropriate.体系5.3Organizationalroles,responsibilitiesandauthorities有关的相SeeISO9001:2015requirements.关方；b)这 Topmanagementshallensurethattheresponsibilitiesandauthoritiesforrelevantr些相 olesareassigned,municatedandunderstoodw

33、ithintheorganization.关方 Topmanagementshallassigntheresponsibilityandauthorityfor:的要 a)ensuringthatthequalitymanagementsystemconformstotherequirementsofthisIn求。ternationalStandard;组织 b)ensuringthattheprocessesaredeliveringtheirintendedoutputs;应对 c)reportingontheperformanceofthequalitymanagementsystem

34、andonopportunities这些forimprovement(see10.1),inparticulartotopmanagement;相关 d)ensuringthepromotionofcustomerfocusthroughouttheorganization;方及 e)ensuringthattheintegrityofthequalitymanagementsystemismaintainedwhencha其要求的相关信息进行监视和评审。ngestothequalitymanagementsystemareplannedandimplemented.5.3.1Organiza

35、tionalroles,responsibilities,andauthorities-supplementalTopmanagementshallassignpersonnelwiththeresponsibilityandauthoritytoensurethatcustomerrequirementsaremet.Theseassignmentsshallbedocumented.Thisincludesbutisnotlimitedtotheselectionofspecialcha4 .3racteristics,settingqualityobjectivesandrelatedt

36、raining,correctiveandPreventiveactions,productdesignanddevelopment,确 capacityanalysis,logisticsinformation,customerscorecards,定 andcustomerportals.质 5.3.2Responsibilityandauthorityforproductrequirementsandcorrecti量 veactions管 Topmanagementshallensurethat:理 a）体 personnelresponsibleforconformitytoprod

37、uctrequirementshavetheaut系 horitytostopshipmentandstopproductiontocorrectqualityproblems；的 NOTEDuetotheprocessdesigninsomeindustries,范 itmightnotalwaysbepossibletostopproductionimmediately.Inthiscase,围 theaffectedbatchmustbecontainedandshipmenttothecustomerprevented见.ISO9b）001:2015的要求。组织应确定质量管理体系的边界

38、和适用性,以确定其personnelwithauthorityandresponsibilityforcorrectiveactionarepromptlyinformedofproductsorprocessesthatdonotconformtorequirementstoensurethatnonconformingproductisnotshippedtothecustomerandthatallpotentialnonconformingproductisidentifiedandcontained；c）productionoperationsacrossallshiftsarest

39、affedwithpersonnelinchargeof,ordelegatedresponsibilityfor, 范围。在确定质量管理体系范围时,组织应考虑：a)ensuringconformitytoproductrequirements.6Planning6.1Actionstoaddressrisksandopportunities6.1.1and6.1.2SeeISO9001:2015requirements.6.1.1Whenplanningforthequalitymanagementsystem,theorganizationshallconsidertheissuesref

40、erredtoin4.1andtherequirementsreferredtoin4.2anddeterminetherisksandopportunitiesthatneedtobeaddressedto:在4.1中涉 a)giveassurancethatthequalitymanagementsystemcanachieveitsintendedresult(及的 s);各种 b)enhancedesirableeffects;外部 c)prevent,orreduce,undesiredeffects;和内 d)achieveimprovement.部因 6.1.2Theorgani

41、zationshallplan:素； a)actionstoaddresstheserisksandopportunities;b)b)howto:1)integrateandimplementtheactionsintoitsqualitymanagementsystemproces在4.2ses(see4.4);中涉2)evaluatetheeffectivenessoftheseactions.及的 Actionstakentoaddressrisksandopportunitiesshallbeproportionatetothepotentiali有关 mpactontheconfo

42、rmityofproductsandservices.相关 NOTE1Optionstoaddressriskscanincludeavoidingrisk,takingriskinordertopursueano方要 pportunity,eliminatingtherisksource,changingthelikelihoodorconsequences,shari求； ngtherisk,orretainingriskbyinformeddecision.c)组 NOTE2Opportunitiescanleadtotheadoptionofnewpractices,launching

43、newproducts,ope织的 ningnewmarkets,addressingnewcustomers,buildingpartnerships,usingnewtechnology产品 andotherdesirableandviablepossibilitiestoaddresstheorganizationsoritscustom与服 ersneeds.务。6.1.2.1Riskanalysis对于本标Theorganizationshallincludeinitsriskanalysis,ataminimum,准中适用lessonslearnedfromproductrecalls,productaudits,于组织确fieldreturnsandrepairs,plaints,scrap,andrework.定的质量Theorganizationshallretaindocumentedinformationasevidenceofthere管理体系 范围的全部要求,组织应予以实施。组织的质量管知识改变命运2