ISOTS16949质量管理体系中英文对照版.docx

ISOTS16949质量管理体系中英文对照版.docx

《ISOTS16949质量管理体系中英文对照版.docx》由会员分享，可在线阅读，更多相关《ISOTS16949质量管理体系中英文对照版.docx（112页珍藏版）》请在冰点文库上搜索。

ISOTS16949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

Qualitymanagementsystems—

ParticularrequirementsfortheapplicationofISO9001:

2008forautomotiveproductionandrelevantservicepartorganizations

目录Contents

前言Foreword………………………………………………………………………………7

有关认证的说明Remarksforcertification…………………………………………………9

引言Introduction……………………………………………………………………………10

0.1总则General……………………………………………………………………………10

0.2过程方法Processapproach………………………………………………………………11

0.3与ISO9004的关系RelationshipwithISO9004………………………………………13

0.4与其他管理体系的相容性Compatibilitywithothermanagementsystems……………14

0.5本技术规范的目的GoalofthisTechnicalSpecification………………………………15

1范围Scope…………………………………………………………………………………16

1.1总则General……………………………………………………………………………16

1.2应用Application…………………………………………………………………………17

2引用标准Normativereference……………………………………………………………17

3术语和定义Termsanddefinitions…………………………………………………………18

3.1汽车行业术语和定义Termsanddefinitionsfortheautomotiveindustry………………18

4质量管理体系Qualitymanagementsystem………………………………………………20

4.1总要求Generalrequirements…………………………………………………………20

4.1.1总要求—补充Generalrequirements—Supplemental…………………………………21

4.2文件要求Documentationrequirements…………………………………………………21

4.2.1总则General…………………………………………………………………………21

4.2.2质量手册Qualitymanual……………………………………………………………22

4.2.3文件控制Controlofdocuments………………………………………………………22

4.2.3.1工程规范Engineeringspecifications………………………………………………23

4.2.4记录控制Controlofrecords…………………………………………………………23

4.2.4.1记录保存Recordsretention………………………………………………………24

5管理职责Managementresponsibility……………………………………………………24

5.1管理承诺Managementcommitment……………………………………………………24

5.1.1过程效率Processefficiency…………………………………………………………24

5.2以顾客为关注焦点Customerfocus……………………………………………………24

5.3质量方针Qualitypolicy………………………………………………………………25

5.4策划Planning……………………………………………………………………………25

5.4.1质量目标Qualityobjectives…………………………………………………………25

5.4.1.1质量目标—补充Qualityobjectives—Supplemental………………………………25

5.4.2质量管理体系的策划Qualitymanagementsystemplanning…………………………26

5.5职责、权限与沟通Responsibility,authorityandcommunication………………………26

5.5.1职责和权限Responsibilityandauthority……………………………………………26

5.5.1.1质量职责Responsibilityforquality…………………………………………………26

5.5.2管理者代表Managementrepresentative………………………………………………27

5.5.2.1顾客代表Customerrepresentative…………………………………………………27

5.5.3内部沟通Internalcommunication……………………………………………………27

5.6管理评审Managementreview…………………………………………………………27

5.6.1总则General……………………………………………………………………………27

5.6.1.1质量管理体系绩效Qualitymanagementsystemperformance……………………28

5.6.2评审输入Reviewinput………………………………………………………………28

5.6.2.1评审输入—补充Reviewinput—Supplemental……………………………………28

5.6.3评审输出Reviewoutput………………………………………………………………29

6资源管理Resourcemanagement…………………………………………………………29

6.1资源提供Provisionofresources…………………………………………………………29

6.2人力资源Humanresources………………………………………………………………29

6.2.1总则General……………………………………………………………………………30

6.2.2能力、培训和意识Competence,trainingandawareness……………………………30

6.2.2.1产品设计技能Productdesignskills…………………………………………………30

6.2.2.2培训Training…………………………………………………………………………31

6.2.2.3岗位培训……………………………………………………………………………31

6.2.2.4员工的激励Employeemotivationandempowerment………………………………31

6.3基础设施Infrastructure…………………………………………………………………31

6.3.1工厂、设施和设备策划Plant,facilityandequipmentplanning………………………32

6.3.2应急计划Contingencyplans…………………………………………………………32

6.4工作环境Workenvironment……………………………………………………………32

6.4.1为达成产品要求符合性的人员安全Personnelsafetytoachieveconformityproductrequirements…………………………………………………………………………………32

6.4.2生产现场的清洁Cleanlinessofpremises……………………………………………32

7产品实现Productrealization………………………………………………………………33

7.1产品实现的策划Planningofproductrealization………………………………………33

7.1.1产品实现的策划—补充Planningofproductrealization—Supplemental……………34

7.1.2接收准则Acceptancecriteria…………………………………………………………34

7.1.3保密性Confidentiality…………………………………………………………………34

7.1.4更改控制Changecontrol………………………………………………………………34

7.2与顾客有关的过程Customer-relatedprocesses…………………………………………34

7.2.1与产品有关的要求的确Determinationofrequirementsrelatedtotheproduct………35

7.2.1.1顾客指定的特殊特性Customer-designatedspecialcharacteristics…………………35

7.2.2与产品有关的要求的评审Reviewofrequirementsrelatedtotheproduct…………35

7.2.2.1与产品有关的要求的评审—补充Reviewofrequirementsrelatedtotheproduc—Supplemental…………………………………………………………………………………36

7.2.2.2组织制造可行性Organizationmanufacturingfeasibility…………………………36

7.2.3顾客沟通Customercommunication…………………………………………………36

7.2.3.1顾客沟通—补充Customercommunication—Supplemental………………………37

7.3设计和开发Designanddevelopment……………………………………………………37

7.3.1设计和开发策划Designanddevelopmentplanning…………………………………37

7.3.1.1多方论证方法Multidisciplinaryapproach…………………………………………37

7.3.2设计和开发输入Designanddevelopmentinputs……………………………………38

7.3.2.1产品设计输入Productdesigninput…………………………………………………38

7.3.2.2制造过程设计输入Manufacturingprocessdesigninput……………………………39

7.3.2.3特殊特性Specialcharacteristics……………………………………………………39

7.3.3设计和开发输出Designanddevelopmentoutputs……………………………………39

7.3.3.1产品设计输出—补充Productdesignoutputs—Supplemental……………………40

7.3.3.2制造过程设计输出Manufacturingprocessdesignoutput…………………………40

7.3.4设计和开发评审Designanddevelopmentreview……………………………………41

7.3.4.1监视Monitoring……………………………………………………………………41

7.3.5设计和开发验证Designanddevelopmentverification………………………………42

7.3.6设计和开发确认Designanddevelopmentvalidation………………………………42

7.3.6.1设计和开发确认—补充Designanddevelopmentvalidation—Supplemental……42

7.3.6.2样件计划Prototypeprogramme……………………………………………………42

7.3.6.3产品批准过程Productapprovalprocess…………………………………………43

7.3.7设计和开发更改的控制Controlofdesignanddevelopmentchanges………………43

7.4采购Purchasing………………………………………………………………………43

7.4.1采购过程Purchasingprocess…………………………………………………………44

7.4.1.1法规符合性Regulatoryconformity…………………………………………………44

7.4.1.2供方质量管理体系开发Supplierqualitymanagementsystemdevelopment………44

7.4.1.3顾客批准的供方Customer-approvedsources………………………………………44

7.4.2采购信息Purchasinginformation……………………………………………………45

7.4.3采购产品的验证Verificationofpurchasedproduct…………………………………45

7.4.3.1进货产品对要求的符合性Incomingproductconformitytorequirements…………45

7.4.3.2对供方监视Suppliermonitoring……………………………………………………46

7.5生产和服务提供Productionandserviceprovision……………………………………46

7.5.1生产和服务提供的控制Controlofproductionandserviceprovision………………46

7.5.1.1控制计划Controlplan………………………………………………………………47

7.5.1.2作业指导书Workinstructions………………………………………………………47

7.5.1.3作业准备验证Verificationofjobsetups……………………………………………47

7.5.1.4预防性和预见性维护Preventiveandpredictivemaintenance……………………48

7.5.1.5生产工装的管理Managementofproductiontooling………………………………48

7.5.1.6生产计划Productionscheduling……………………………………………………49

7.5.1.7服务信息反馈Feedbackofinformationfromservice………………………………49

7.5.1.8与顾客的服务协议Serviceagreementwithcustomer………………………………49

7.5.2生产和服务提供过程的确认Validationofprocessesforproductionandserviceprovision……………………………………………………………………………………49

7.5.2.1生产和服务提供过程的确认—补充Validationofprocessesforproductionandserviceprovision—Supplemental……………………………………………………………50

7.5.3标识和可追溯性Identificationandtraceability………………………………………50

7.5.3.1标识和可追溯性—补充Identificationandtraceability–Supplemental……………50

7.5.4顾客财产Customerproperty…………………………………………………………51

7.5.4.1顾客所有的工装Customer-ownedproductiontooling……………………………51

7.5.5.产品防护Preservationofproduct……………………………………………………51

7.5.5.1贮存和库存Storageandinventory…………………………………………………51

7.6监视和测量设备的控制Controlofmonitoringandmeasuringequipment……………52

7.6.1测量系统分析Measurementsystemanalysis…………………………………………53

7.6.2校准/验证记录Calibration/verificationrecords………………………………………53

7.6.3实验室要求Laboratoryrequirements…………………………………………………53

7.6.3.1内部实验室Internallaboratory………………………………………………………53

7.6.3.2外部实验室Externallaboratory……………………………………………………54

8测量、分析和改进Measurement,analysisandimprovement……………………………54

8.1总则General……………………………………………………………………………55

8.1.1统计工具的确定Identificationofstatisticaltools……………………………………55

8.1.2基础统计概念知识Knowledgeofbasicstatisticalconcepts………………………55

8.2监视和测量Monitoringandmeasurement……………………………………………55

8.2.1顾客满意Customersatisfaction………………………………………………………55

8.2.1.1顾客满意—补充Customersatisfaction—Supplemental……………………………56

8.2.2内部审核Internalaudit………………………………………………………………56

8.2.2.1质量管理体系审核Qualitymanagementsystemaudit……………………………57

8.2.2.2制造过程审核Manufacturingprocessaudit…………………………………………57

8.2.2.3产品审核Productaudit………………………………………………………………57

8.2.2.4内部审核计划Internalauditplans…………………………………………………57

8.2.2.5内审员资格Internalauditorqualification……………………………………………57

8.2.3过程的监视和测量Monitoringandmeasurementofprocesses………………………58

8.2.3.1制造过程的监视和测量Monitoringandmeasurementofmanufacturingprocesses58

8.2.4产品的监视和测量Monitoringandmeasurementofproduct…………………………59

8.2.4.1全尺寸检验和功能试验Layoutinspectionandfunctionaltesting…………………59

8.2.4.2外观项目Appearanceitems…………………………………………………………60

8.3不合格品控制Controlofnonconformingproduct………………………………………60

8.3.1不合格品控制—补充Controlofnonconformingproduct—Supplemental…………61

8.3.2返工产品的控制Controlofreworkedproduct………………………………………61

8.3.3顾客通知Customerinformation………………………………………………………61

8.3.4顾客特许Customerwaiver……………………………………………………………61

8.4数据分析Analysisofdata………………………………………………………………61

8.4.1数据分析和使用Analysisanduseofdata……………………………………………62

8.5改进Improvement………………………………………………………………………62

8.5.1持续改进Continualimprovement……………………………………………………62

8.5.1.1组织的持续改进Continualimprovementoftheorganization………………………62

8.5.1.2制造过程的改进Manufacturingprocessimprovement……………………………62

8.5.2纠正措施Correctiveaction……………………………………………………………63

8.5.2.1解决问题的方法Problemsolving…………………………………………………63

8.5.2.2防错Error-proofing…………………………………………………………………63

8.5.2.3纠正措施影响Correctiveactionimpact……………………………………………63

8.5.2.4拒收产品的试验/分析Rejectedproducttest/analysis………………………………63

8.5.3预防措施Preventiveaction……………………………………………………………64

附录A控制计划AnnexA（normative）Controlplan………………………………………65

参考文献Bibliography………………………………………………………………………67

前言Foreword

国际标准化组织（ISO）是由各国标准化机构（ISO成员