ISO-TS16949：2009质量管理体系中英文对照版培训资料.doc

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1、Good is good, but better carries it.精益求精，善益求善。ISO-TS16949：2009质量管理体系中英文对照版-ISO/TS16949：2009技术规范TECHNICALSPECIFICATION质量管理体系汽车生产件及相关服务件组织应用ISO9001:2008的特殊要求QualitymanagementsystemsParticularrequirementsfortheapplicationofISO9001:2008forautomotiveproductionandrelevantservicepartorganizations目录Contents

2、前言Foreword7有关认证的说明Remarksforcertification9引言Introduction100.1总则General100.2过程方法Processapproach110.3与ISO9004的关系RelationshipwithISO9004130.4与其他管理体系的相容性Compatibilitywithothermanagementsystems140.5本技术规范的目的GoalofthisTechnicalSpecification151范围Scope161.1总则General161.2应用Application172引用标准Normativereference

3、173术语和定义Termsanddefinitions183.1汽车行业术语和定义Termsanddefinitionsfortheautomotiveindustry184质量管理体系Qualitymanagementsystem204.1总要求Generalrequirements204.1.1总要求补充GeneralrequirementsSupplemental214.2文件要求Documentationrequirements214.2.1总则General214.2.2质量手册Qualitymanual224.2.3文件控制Controlofdocuments224.2.3.1工程

4、规范Engineeringspecifications234.2.4记录控制Controlofrecords234.2.4.1记录保存Recordsretention245管理职责Managementresponsibility245.1管理承诺Managementcommitment245.1.1过程效率Processefficiency245.2以顾客为关注焦点Customerfocus245.3质量方针Qualitypolicy255.4策划Planning255.4.1质量目标Qualityobjectives255.4.1.1质量目标补充QualityobjectivesSupple

5、mental255.4.2质量管理体系的策划Qualitymanagementsystemplanning265.5职责、权限与沟通Responsibility,authorityandcommunication265.5.1职责和权限Responsibilityandauthority265.5.1.1质量职责Responsibilityforquality265.5.2管理者代表Managementrepresentative275.5.2.1顾客代表Customerrepresentative275.5.3内部沟通Internalcommunication275.6管理评审Managem

6、entreview275.6.1总则General275.6.1.1质量管理体系绩效Qualitymanagementsystemperformance285.6.2评审输入Reviewinput285.6.2.1评审输入补充ReviewinputSupplemental285.6.3评审输出Reviewoutput296资源管理Resourcemanagement296.1资源提供Provisionofresources296.2人力资源Humanresources296.2.1总则General306.2.2能力、培训和意识Competence,trainingandawareness30

7、6.2.2.1产品设计技能Productdesignskills306.2.2.2培训Training316.2.2.3岗位培训316.2.2.4员工的激励Employeemotivationandempowerment316.3基础设施Infrastructure316.3.1工厂、设施和设备策划Plant,facilityandequipmentplanning326.3.2应急计划Contingencyplans326.4工作环境Workenvironment326.4.1为达成产品要求符合性的人员安全Personnelsafetytoachieveconformityproductre

8、quirements326.4.2生产现场的清洁Cleanlinessofpremises327产品实现Productrealization337.1产品实现的策划Planningofproductrealization337.1.1产品实现的策划补充PlanningofproductrealizationSupplemental347.1.2接收准则Acceptancecriteria347.1.3保密性Confidentiality347.1.4更改控制Changecontrol347.2与顾客有关的过程Customer-relatedprocesses347.2.1与产品有关的要求的确D

9、eterminationofrequirementsrelatedtotheproduct357.2.1.1顾客指定的特殊特性Customer-designatedspecialcharacteristics357.2.2与产品有关的要求的评审Reviewofrequirementsrelatedtotheproduct357.2.2.1与产品有关的要求的评审补充ReviewofrequirementsrelatedtotheproducSupplemental367.2.2.2组织制造可行性Organizationmanufacturingfeasibility367.2.3顾客沟通Cust

10、omercommunication367.2.3.1顾客沟通补充CustomercommunicationSupplemental377.3设计和开发Designanddevelopment377.3.1设计和开发策划Designanddevelopmentplanning377.3.1.1多方论证方法Multidisciplinaryapproach377.3.2设计和开发输入Designanddevelopmentinputs387.3.2.1产品设计输入Productdesigninput387.3.2.2制造过程设计输入Manufacturingprocessdesigninput39

11、7.3.2.3特殊特性Specialcharacteristics397.3.3设计和开发输出Designanddevelopmentoutputs397.3.3.1产品设计输出补充ProductdesignoutputsSupplemental407.3.3.2制造过程设计输出Manufacturingprocessdesignoutput407.3.4设计和开发评审Designanddevelopmentreview417.3.4.1监视Monitoring417.3.5设计和开发验证Designanddevelopmentverification427.3.6设计和开发确认Designa

12、nddevelopmentvalidation427.3.6.1设计和开发确认补充DesignanddevelopmentvalidationSupplemental427.3.6.2样件计划Prototypeprogramme427.3.6.3产品批准过程Productapprovalprocess437.3.7设计和开发更改的控制Controlofdesignanddevelopmentchanges437.4采购Purchasing437.4.1采购过程Purchasingprocess447.4.1.1法规符合性Regulatoryconformity447.4.1.2供方质量管理体系

13、开发Supplierqualitymanagementsystemdevelopment447.4.1.3顾客批准的供方Customer-approvedsources447.4.2采购信息Purchasinginformation457.4.3采购产品的验证Verificationofpurchasedproduct457.4.3.1进货产品对要求的符合性Incomingproductconformitytorequirements457.4.3.2对供方监视Suppliermonitoring467.5生产和服务提供Productionandserviceprovision467.5.1生

14、产和服务提供的控制Controlofproductionandserviceprovision467.5.1.1控制计划Controlplan477.5.1.2作业指导书Workinstructions477.5.1.3作业准备验证Verificationofjobsetups477.5.1.4预防性和预见性维护Preventiveandpredictivemaintenance487.5.1.5生产工装的管理Managementofproductiontooling487.5.1.6生产计划Productionscheduling497.5.1.7服务信息反馈Feedbackofinform

15、ationfromservice497.5.1.8与顾客的服务协议Serviceagreementwithcustomer497.5.2生产和服务提供过程的确认Validationofprocessesforproductionandserviceprovision497.5.2.1生产和服务提供过程的确认补充ValidationofprocessesforproductionandserviceprovisionSupplemental507.5.3标识和可追溯性Identificationandtraceability507.5.3.1标识和可追溯性补充Identificationandt

16、raceabilitySupplemental507.5.4顾客财产Customerproperty517.5.4.1顾客所有的工装Customer-ownedproductiontooling517.5.5.产品防护Preservationofproduct517.5.5.1贮存和库存Storageandinventory517.6监视和测量设备的控制Controlofmonitoringandmeasuringequipment527.6.1测量系统分析Measurementsystemanalysis537.6.2校准/验证记录Calibration/verificationrecord

17、s537.6.3实验室要求Laboratoryrequirements537.6.3.1内部实验室Internallaboratory537.6.3.2外部实验室Externallaboratory548测量、分析和改进Measurement,analysisandimprovement548.1总则General558.1.1统计工具的确定Identificationofstatisticaltools558.1.2基础统计概念知识Knowledgeofbasicstatisticalconcepts558.2监视和测量Monitoringandmeasurement558.2.1顾客满意C

18、ustomersatisfaction558.2.1.1顾客满意补充CustomersatisfactionSupplemental568.2.2内部审核Internalaudit568.2.2.1质量管理体系审核Qualitymanagementsystemaudit578.2.2.2制造过程审核Manufacturingprocessaudit578.2.2.3产品审核Productaudit578.2.2.4内部审核计划Internalauditplans578.2.2.5内审员资格Internalauditorqualification578.2.3过程的监视和测量Monitoring

19、andmeasurementofprocesses588.2.3.1制造过程的监视和测量Monitoringandmeasurementofmanufacturingprocesses588.2.4产品的监视和测量Monitoringandmeasurementofproduct598.2.4.1全尺寸检验和功能试验Layoutinspectionandfunctionaltesting598.2.4.2外观项目Appearanceitems608.3不合格品控制Controlofnonconformingproduct608.3.1不合格品控制补充Controlofnonconforming

20、productSupplemental618.3.2返工产品的控制Controlofreworkedproduct618.3.3顾客通知Customerinformation618.3.4顾客特许Customerwaiver618.4数据分析Analysisofdata618.4.1数据分析和使用Analysisanduseofdata628.5改进Improvement628.5.1持续改进Continualimprovement628.5.1.1组织的持续改进Continualimprovementoftheorganization628.5.1.2制造过程的改进Manufacturing

21、processimprovement628.5.2纠正措施Correctiveaction638.5.2.1解决问题的方法Problemsolving638.5.2.2防错Error-proofing638.5.2.3纠正措施影响Correctiveactionimpact638.5.2.4拒收产品的试验/分析Rejectedproducttest/analysis638.5.3预防措施Preventiveaction64附录A控制计划AnnexA(normative)Controlplan65参考文献Bibliography67前言Foreword国际标准化组织(ISO)是由各国标准化机构（

22、ISO成员机构）组成的世界性联合会。国际标准的拟定由ISO技术委员会负责。各成员机构若对某技术委员会所选定的主题感兴趣，均有权参加该委员会的工作。与ISO保持联系的各国组织(官方的或非官方的)也可参加该项工作。ISO与国际电器委员会（IEC）在电工技术标准化方面保持密切合作的关系。ISO(theInternationalOrganizationforStandardization)isaworldwidefederationofnationalstandardsbodies(ISOmemberbodies).TheworkofpreparingInternationalStandardsisn

23、ormallycarriedoutthroughISOtechnicalcommittees.Eachmemberbodyinterestedinasubjectforwhichatechnicalcommitteehasbeenestablishedhastherighttoberepresentedonthatcommittee.Internationalorganizations,governmentalandnon-governmental,inliaisonwithISO,alsotakepartinthework.ISOcollaboratescloselywiththeInter

24、nationalElectrotechnicalCommission(IEC)onallmattersofelectrotechnicalstandardization.本国际标准是依照ISO/IEC导则第2部分中的规则制定的。InternationalStandardsaredraftedinaccordancewiththerulesgivenintheISO/IECDirectives,Part2.技术委员会的主要任务是制定国际标准。本国际技术标准草案已由技术委员会通过，并传阅各成员机构一共投票表决。国际标准的公布需要至少75%的参加投票的成员团体批准。Themaintaskoftech

25、nicalcommitteesistoprepareinternationalstandards.DraftInternationalStandardsadoptedbythetechnicalcommitteesarecirculatedtothememberbodiesforvoting.Publicationasaninternationalstandardrequiresapprovalbyatleast75%ofthememberbodiescastingavote.在其它情况下，特别是在市场急需某个文件时，技术委员会可以决定出版其他形式的规范文件：Inothercircumstan

26、ces,particularlywhenthereisanurgentmarketrequirementforsuchdocuments,atechnicalcommitteemaydecidetopublishothertypesofnormativedocument:ISO公布的可获得规范（ISO/PAS）代表一项在一个ISO工作小组内的技术专家达成的协议，在相应委员会的成员的投票中有50%投票赞成后就可以出版发行；anISOPubliclyAvailableSpecification(ISO/PAS)representsanagreementbetweentechnicalexperts

27、inanISOworkinggroupandisacceptedforpublicationifitisapprovedby50%ofthemembersoftheparentcommitteecastingavote;ISO技术规范（ISO/TS），是技术委员会成员之间达成的协议，在委员会成员所投票中有2/3投票赞成后就可以出版发行。anISOTechnicalSpecification(ISO/TS)representsanagreementbetweenthemembersofatechnicalcommitteeandisacceptedforpublicationifitisappr

28、ovedby2/3ofthemembersofthecommitteecastingavote.ISO/TS16949是由国际汽车工业特别行动小组（IATF），在ISO/TC176质量管理和质量保证技术委员会支持下制定的。ISO/TS16949waspreparedbytheInternationalAutomotiveTaskForce(IATF)withsupportfromISO/TC176,Qualitymanagementandqualityassurance.通过根据ISO9001:2008所作的技术修订，第三版的ISO/TS16949取消并替代了第二版(ISO/TS16949:2

29、002)ThisthirdeditionofISO/TS16949cancelsandreplacesthesecondedition(ISO/TS16949:2002),whichhasbeentechnicallyamendedaccordingtoISO9001:2008.方框内的文本是ISO9001：2008的原文内容，方框外是行业特殊补充的要求。BoxedtextisoriginalISO9001:2008text.Thesector-specificsupplementalrequirementsareoutsidetheboxes.在本技术规范中，“应”（shall）表示要求，“

30、应当”（should）表示建议。标示有“注”（NOTE）的段落是对理解或澄清相关要求的指南。InthisTechnicalSpecification,theword“shall”indicatesarequirement.Theword“should”indicatesarecommendation.Paragraphsmarked“NOTE”areforguidanceinunderstandingorclarifyingtheassociatedrequirement.所有用“例如”引出的建议都只具有指导性作用.Wheretheterm“suchas”isused,anysuggestio

31、nsgivenareforguidanceonly.附录A是本技术规范的引用文件，构成技术规范的一部分。AnnexAformsanormativepartofthisTechnicalSpecification.有关认证的说明Remarksforcertification按照IATF的认证方案（见IATF认可规则）所获取的本技术规范的认证，包括任何的顾客特殊要求（如果有），将获得IATF的顾客成员的认可。详细情况可以从以下的国际汽车推动小组的当地监督办公室处获得：意大利汽车工业协会(ANFIA)www.anfia.it美国国际汽车监督署(IAOB)www.iaob.orgIATF-France

32、www.iatf-英国汽车制造与贸易商谢(SMMT)www.smmt.co.uk德国汽车工业协会-质量管理中心(VDA-QMC)www.vda-qmc.deThecertificationtothisTechnicalSpecification,includingcustomer-specificrequirementsifany,isrecognizedbythecustomermembersofIATFwhenachievedaccordingtotheIATFcertificationscheme(seethe“RulesforachievingIATFrecognition”).Det

33、ailscanbeobtainedattheaddressesofthelocaloversightofficesofIATFcitedbelow:AssociazioneNazionaleFraIndustrieAutomobilistiche(ANFIA)Website:www.anfia.itInternationalAutomotiveOversightBureau(IAOB)Website:www.iaob.orgIATF-FranceWebsite:www.iatf-SocietyofMotorManufacturersandTradersLtd.(SMMTLtd.)Website

34、:www.smmt.co.ukVerbandderAutomobilindustrieQualit?tsmanagementCenter(VDA-QMC)Website:www.vda-qmc.de引言Introduction0.1总则GeneralISO9001:2008质量管理体系要求ISO9001:2008QualitymanagementsystemsRequirements引言Introduction0.1总则General采纳质量管理体系是组织的一项战略性决策。一个组织的质量管理体系的设计和实施受下列因素的影响：Theadoptionofaqualitymanagementsyst

35、emshouldbeastrategicdecisionofanorganization.Thedesignandimplementationofanorganizationsqualitymanagementsystemisinfluencedby:a)组织的环境、该环境的变化或与该环境有关的风险；b)组织不断变化的需求；c)组织的具体目标；d)组织所提供的产品；e)组织所采用的过程；f)组织的规模和组织结构。a)Itsorganizationalenvironment,changesinthatenvironment,andtherisksassociatedwiththatenviron

36、ment;b)Itsvaryingneeds;c)Itsparticularobjectives;d)Theproductsitprovides;e)Theprocessesitemploys;f)Itssizeandorganizationalstructure.统一质量管理体系的结构或文件不是本标准的目的。ItisnottheintentofthisInternationalStandardtoimplyuniformityinthestructureofqualitymanagementsystemsoruniformityofdocumentation.本标准规定的质量管理体系要求是对

37、产品要求的补充。“注”是理解和说明有关要求的指南。ThequalitymanagementsystemrequirementsspecifiedinthisInternationalStandardarecomplementarytorequirementsforproducts.Informationmarked.“NOTE”isforguidanceinunderstandingorclarifyingtheassociatedrequirement.本标准能用于内部和外部（包括认证机构）评价组织满足顾客、适用于产品的法律法规要求和组织自身要求的能力。ThisInternationalSt

38、andardcanbeusedbyinternalandexternalparties,includingcertificationbodies,toassesstheorganizationsabilitytomeetcustomer,regulatoryandtheorganizationsownrequirements.本标准的制定已经考虑了GB/T19000和GB/T19004中所阐明的质量管理原则。ThequalitymanagementprinciplesstatedinISO9000andISO9004havebeentakenintoconsiderationduringthedevelopmentofthisInternationalStandard.0.2过程方法ProcessapproachISO9001:2008质量管理体制体系要求ISO9001:2008QualitymanagementsystemsRequirements本标准鼓励