ISOTS16949质量管理体系中英文对照版.docx

1、ISOTS16949质量管理体系中英文对照版ISO/TS16949：2009技术规范TECHNICAL SPECIFICATION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Quality management systems Particular requirements for the application of ISO 9001:2008 for automotive production and relevant service part organizations目录Contents 前言Foreword7 有关认证的说明Remarks for

2、certification9 引言Introduction10 0.1总则General10 0.2过程方法Process approach11 0.3与ISO 9004的关系Relationship with ISO 900413 0.4与其他管理体系的相容性Compatibility with other management systems14 0.5本技术规范的目的Goal of this Technical Specification15 1范围Scope16 1.1总则General16 1.2应用Application17 2引用标准Normative reference17 3

3、术语和定义Terms and definitions18 3.1汽车行业术语和定义Terms and definitions for the automotive industry18 4质量管理体系Quality management system20 4.1总要求General requirements 20 4.1.1总要求补充General requirementsSupplemental21 4.2文件要求Documentation requirements21 4.2.1 总则General21 4.2.2 质量手册Quality manual22 4.2.3文件控制Control

4、 of documents22 4.2.3.1工程规范Engineering specifications23 4.2.4记录控制Control of records23 4.2.4.1记录保存Records retention 24 5管理职责Management responsibility24 5.1管理承诺Management commitment24 5.1.1过程效率Process efficiency24 5.2以顾客为关注焦点Customer focus24 5.3质量方针Quality policy 25 5.4策划Planning25 5.4.1质量目标Quality ob

5、jectives25 5.4.1.1质量目标补充Quality objectivesSupplemental25 5.4.2质量管理体系的策划Quality management system planning26 5.5职责、权限与沟通Responsibility, authority and communication26 5.5.1职责和权限Responsibility and authority26 5.5.1.1质量职责Responsibility for quality26 5.5.2管理者代表Management representative27 5.5.2.1顾客代表Custo

6、mer representative27 5.5.3内部沟通Internal communication27 5.6管理评审Management review27 5.6.1总则General27 5.6.1.1质量管理体系绩效Quality management system performance28 5.6.2评审输入Review input28 5.6.2.1评审输入补充Review inputSupplemental28 5.6.3评审输出Review output29 6资源管理Resource management29 6.1资源提供Provision of resources2

7、9 6.2人力资源Human resources29 6.2.1总则General30 6.2.2能力、培训和意识Competence, training and awareness30 6.2.2.1产品设计技能Product design skills30 6.2.2.2培训Training31 6.2.2.3岗位培训31 6.2.2.4员工的激励Employee motivation and empowerment31 6.3基础设施Infrastructure31 6.3.1工厂、设施和设备策划Plant, facility and equipment planning32 6.3.2

8、应急计划Contingency plans32 6.4工作环境Work environment32 6.4.1为达成产品要求符合性的人员安全Personnel safety to achieve conformity product requirements32 6.4.2生产现场的清洁Cleanliness of premises32 7产品实现Product realization33 7.1产品实现的策划Planning of product realization33 7.1.1产品实现的策划补充Planning of product realizationSupplemental34

9、 7.1.2接收准则Acceptance criteria34 7.1.3保密性Confidentiality34 7.1.4更改控制Change control34 7.2与顾客有关的过程Customer-related processes34 7.2.1与产品有关的要求的确Determination of requirements related to the product35 7.2.1.1顾客指定的特殊特性Customer-designated special characteristics35 7.2.2与产品有关的要求的评审Review of requirements relat

10、ed to the product35 7.2.2.1与产品有关的要求的评审补充Review of requirements related to the produc Supplemental36 7.2.2.2组织制造可行性Organization manufacturing feasibility36 7.2.3顾客沟通Customer communication36 7.2.3.1顾客沟通补充Customer communicationSupplemental37 7.3设计和开发Design and development37 7.3.1设计和开发策划Design and devel

11、opment planning37 7.3.1.1多方论证方法Multidisciplinary approach37 7.3.2设计和开发输入Design and development inputs38 7.3.2.1产品设计输入Product design input38 7.3.2.2制造过程设计输入Manufacturing process design input39 7.3.2.3特殊特性Special characteristics39 7.3.3设计和开发输出Design and development outputs39 7.3.3.1产品设计输出补充Product des

12、ign outputsSupplemental40 7.3.3.2制造过程设计输出Manufacturing process design output40 7.3.4设计和开发评审Design and development review41 7.3.4.1监视Monitoring41 7.3.5设计和开发验证Design and development verification42 7.3.6设计和开发确认Design and development validation42 7.3.6.1设计和开发确认补充Design and development validationSuppleme

13、ntal42 7.3.6.2样件计划Prototype programme42 7.3.6.3产品批准过程Product approval process43 7.3.7 设计和开发更改的控制Control of design and development changes43 7.4 采购Purchasing43 7.4.1采购过程Purchasing process44 7.4.1.1法规符合性Regulatory conformity44 7.4.1.2供方质量管理体系开发Supplier quality management system development44 7.4.1.3顾客

14、批准的供方Customer-approved sources44 7.4.2采购信息Purchasing information45 7.4.3采购产品的验证Verification of purchased product45 7.4.3.1进货产品对要求的符合性Incoming product conformity to requirements45 7.4.3.2对供方监视Supplier monitoring46 7.5 生产和服务提供Production and service provision46 7.5.1生产和服务提供的控制Control of production and

15、service provision46 7.5.1.1控制计划Control plan47 7.5.1.2作业指导书Work instructions47 7.5.1.3作业准备验证Verification of job setups47 7.5.1.4预防性和预见性维护Preventive and predictive maintenance48 7.5.1.5生产工装的管理Management of production tooling48 7.5.1.6生产计划Production scheduling49 7.5.1.7服务信息反馈Feedback of information fro

16、m service49 7.5.1.8与顾客的服务协议Service agreement with customer49 7.5.2生产和服务提供过程的确认Validation of processes for production and service provision49 7.5.2.1生产和服务提供过程的确认补充Validation of processes for production and service provisionSupplemental50 7.5.3标识和可追溯性Identification and traceability50 7.5.3.1标识和可追溯性补充I

17、dentification and traceabilitySupplemental50 7.5.4顾客财产Customer property51 7.5.4.1顾客所有的工装Customer-owned production tooling51 7.5.5.产品防护Preservation of product51 7.5.5.1贮存和库存Storage and inventory51 7.6监视和测量设备的控制Control of monitoring and measuring equipment52 7.6.1测量系统分析Measurement system analysis53 7.

18、6.2校准/验证记录Calibration/verification records53 7.6.3实验室要求Laboratory requirements53 7.6.3.1内部实验室Internal laboratory53 7.6.3.2外部实验室External laboratory54 8测量、分析和改进Measurement, analysis and improvement54 8.1总则General55 8.1.1统计工具的确定Identification of statistical tools55 8.1.2基础统计概念知识 Knowledge of basic stat

19、istical concepts55 8.2 监视和测量Monitoring and measurement55 8.2.1顾客满意Customer satisfaction55 8.2.1.1顾客满意补充Customer satisfactionSupplemental56 8.2.2内部审核Internal audit56 8.2.2.1质量管理体系审核Quality management system audit57 8.2.2.2制造过程审核Manufacturing process audit57 8.2.2.3产品审核Product audit57 8.2.2.4内部审核计划Int

20、ernal audit plans57 8.2.2.5内审员资格Internal auditor qualification57 8.2.3过程的监视和测量Monitoring and measurement of processes58 8.2.3.1制造过程的监视和测量Monitoring and measurement of manufacturing processes 58 8.2.4产品的监视和测量Monitoring and measurement of product59 8.2.4.1全尺寸检验和功能试验Layout inspection and functional tes

21、ting59 8.2.4.2外观项目Appearance items60 8.3不合格品控制Control of nonconforming product60 8.3.1不合格品控制补充Control of nonconforming productSupplemental61 8.3.2返工产品的控制Control of reworked product61 8.3.3顾客通知Customer information61 8.3.4顾客特许Customer waiver61 8.4数据分析Analysis of data61 8.4.1数据分析和使用Analysis and use of

22、data62 8.5改进Improvement62 8.5.1持续改进Continual improvement62 8.5.1.1组织的持续改进Continual improvement of the organization62 8.5.1.2制造过程的改进Manufacturing process improvement62 8.5.2纠正措施Corrective action63 8.5.2.1解决问题的方法Problem solving63 8.5.2.2防错Error-proofing63 8.5.2.3纠正措施影响Corrective action impact63 8.5.2.4拒收产品的试验/分析Rejected product test/analysis63 8.5.3预防措施Preventive action64 附录A控制计划Annex A (normative) Control plan65 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（ISO成员