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TECHNICALISO/TSSPECIFICATION16949ThirdEdition2009-06-15质量管理体系－汽车生产件和相关服务件组织应用ISO9001:2008的特别要求Qualitymanagementsystems－ParticularrequirementsfortheapplicationofISO9001:2008forautomotiveproductionandrelevantservicepartorganizationsReferencenumberISO/TS16949:2009(E)©ISO2009ContentsForewordRemarksforcertificationIntroduction0.1General总则0.2Processapproach过程方法0.3RelationshipwithISO9004与ISO9004的关系0.3.1IATFGuidancetoISO/TS16949:2002IATF关于ISO/TS16949:2002的指南0.4Compatibilitywithothermanagementsystems与其他管理体系的相容性0.5GoalofthisTechnicalSpecification本技术规范的目标1Scope范围1.1General总则1.2Application应用2Normativereference规范性引用文件3Termsanddefinitions术语和定义3.1Termsanddefinitionsfortheautomotiveindustry汽车行业的术语和定义4Qualitymanagementsystem质量管理体系4.1Generalrequirements总要求4.1.1Generalrequirements–Supplemental总要求-补充4.2Documentationrequirements文件要求4.2.1General总则4.2.2Qualitymanual质量手册4.2.3Controlofdocuments文件控制4.2.3.1Engineeringspecifications工程规范4.2.4Controlofrecords记录控制4.2.4.1Recordsretention记录保存5Managementresponsibility管理职责5.1Managementcommitment管理承诺5.1.1Processefficiency过程效率5.2Customerfocus以顾客为关注焦点5.3Qualitypolicy质量方针5.4Planning策划5.4.1Qualityobjectives质量目标5.4.1.1Qualityobjectives–Supplemental质量目标-补充5.4.2Qualitymanagementsystemplanning质量管理体系策划5.5Responsibility,authorityandcommunication职责权限与沟通5.5.1Responsibilityandauthority职责和权限5.5.1.1Responsibilityforquality质量职责5.5.2Managementrepresentative管理者代表5.5.21Customerrepresentative顾客代表5.5.3Internalcommunication内部沟通5.6Managementreview管理评审5.6.1General总则5.6.1.1Qualitymanagementsystemperformance质量管理体系绩效5.6.2Reviewinput评审输入5.6.2.1Reviewinput–Supplemental评审输入-补充5.6.3Reviewoutput评审输出6Resourcemanagement资源管理6.1Provisionofresources资源提供6.2Humanresources人力资源6.2.1General总则6.2.2Competence,awarenessandtrainingandawareness能力、意识和培训和意识6.2.2.1Productdesignskills产品设计技能6.2.2.2Training培训6.2.2.3Trainingonthejob岗位培训6.2.2.4Employeemotivationandempowerment员工激励和授权6.3Infrastructure基础设施6.3.1Plant,facilityandequipmentplanning工厂、设施和设备策划6.3.2Contingencyplans应急计划6.4Workenvironment工作环境6.4.1Personnelsafetytoachieveconformitytoproductqualityrequirements与实现产品质量要求符合性相关的人员安全6.4.2Cleanlinessofpremises生产现场的清洁7Productrealization产品实现7.1Planningofproductrealization产品实现的策划7.1.1Planningofproductrealization–Supplemental产品实现的策划-补充7.1.2Acceptancecriteria接收准则7.1.3Confidentiality保密7.1.4Changecontrol更改控制7.2Customer-relatedprocesses与顾客有关的过程7.2.1Determinationofrequirementsrelatedtotheproduct与产品有关的要求的确定7.2.1.1Customer-designatedspecialcharacteristics顾客指定的特殊特性7.2.2Reviewofrequirementsrelatedtotheproduct与产品有关的要求的评审7.2.2.1Reviewofrequirementsrelatedtotheproduct-Supplemental与产品有关的要求的评审-补充7.2.2.2Organizationmanufacturingfeasibility组织制造可行性7.2.3Customercommunication顾客沟通7.2.3.1Customercommunication–Supplemental顾客沟通-补充7.3Designanddevelopment设计和开发7.3.1Designanddevelopmentplanning设计和开发策划7.3.1.1Multidisciplinaryapproach多方论证方法7.3.2Designanddevelopmentinputs设计和开发输入7.3.2.1Productdesigninput产品设计输入7.3.2.2Manufacturingprocessdesigninput制造过程设计输入7.3.2.3Specialcharacteristics特殊特性7.33Designanddevelopmentoutputs设计和开发输出7.3.3.1Productdesignoutputs–Supplemental产品设计输出-补充7.3.3.2Manufacturingprocessdesignoutput制造过程设计输出7.3.4Designanddevelopmentreview设计和开发评审7.3.4.1Monitoring监视7.3.5Designanddevelopmentverification设计和开发验证7.3.6Designanddevelopmentvalidation设计和开发确认7.3.6.1Designanddevelopmentvalidation–Supplemental设计和开发确认-补充7.3.6.2Prototypeprogramme样件计划7.3.6.3Productapprovalprocess产品批准过程7.3.7Controlofdesignanddevelopmentchanges设计和开发更改的控制7.4Purchasing采购7.4.1Purchasingprocess采购过程7.4.1.1Regulatoryconformity法规的符合性7.4.1.2Supplierqualitymanagementsystemdevelopment供方质量体系的开发7.4.1.3Customer-approvedsources顾客批准的供货来源7.4.2Purchasinginformation采购信息7.4.3Verificationofpurchasedproduct采购产品的验证7.4.3.1Incomingproductqualityconformitytorequirements进货产品质量要求的符合性7.4.3.2Suppliermonitoring对供方的监视7.5Productionandserviceprovision生产和服务提供7.5.1Controlofproductionandserviceprovision生产和服务提供的控制7.5.1.1Controlplan控制计划7.5.1.2Workinstructions作业指导书7.5.1.3Verificationofjobset-ups作业准备的验证7.5.1.4PreventiveandPredictivemaintenance预防性和预见性维护7.5.1.5Managementofproductiontooling生产工装的管理7.5.1.6Productionscheduling生产计划7.5.1.7Feedbackofinformationfromservice服务信息反馈7.5.1.8Servicingagreementwithcustomer与顾客的服务协议7.5.2Validationofprocessesforproductionandserviceprovision生产和服务提供过程的确认7.5.2.1Validationofprocessesforproductionandserviceprovision-Supplemental生产和服务提供过程的确认-补充7.5.3Identificationandtraceability标识和可追溯性7.5.3.1Identificationandtraceability-Supplemental标识和可追溯性-补充7.5.4Customerproperty顾客财产7.5.4.1Customer-ownedproductiontooling顾客所有的生产工装7.5.5Preservationofproduct产品防护7.5.5.1Storageandinventory贮存和库存7.6Controlofmonitoringandmeasuringdevicesequipment监视和测量装置设备的控制7.6.1Measurementsystemanalysis测量系统分析7.6.2Calibration/Verificationrecords校准/检定（验证）记录7.6.3Laboratoryrequirements实验室要求7.6.3.1Internallaboratory内部实验室7.6.3.2Externallaboratory外部实验室8Measurement,analysisandimprovement测量、分析和改进8.1General总则8.1.1Identificationofstatisticaltools统计工具的确定8.1.2Knowledgeofbasicstatisticalconcepts基本统计概念只是8.2Monitoringandmeasurement测量和监视8.2.1Customersatisfaction顾客满意8.2.1.1Custome