ISO 与ISO及ISO 条款对照

1、ISO 13485:2003与ISO13485:1996及ISO 90012008条款对照ISO 90012008EN ISO 13485:2012/ISO 13485:2003EN ISO 13485:2003/ ISO 13485:1996Contents目录Contents附录Foreword前言Foreword前言0 Introduction引言0 Introduction引言0.1 General总则0.1 General总则0.2 Process approach过程方法0.2 Process approach过程方法0.3 Relationship with ISO 9004与I

2、SO9004的关系0.3 Relationship with other standards与其他标准的关系0.3.1 Relationship with ISO 9001:2000与 ISO 9001:2000 的关系0.3.2 Relationship with ISO/TR 14969与 ISO/TR 14969的关系0.4 Compatibility with other management systems与其他管理体系的兼容性（相容性）0.4 Compatibility with other management systems与其他管理体系的兼容性Quality manageme

3、nt systems Requirements质量管理体系要求Medical devices Quality management systems Requirements for regulatory purposes医疗器械质量管理体系用于监管目的的要求1 Scope范围1 Scope范围1 Scope范围1.1 General总则1.1 General总则1.2 Application应用1.2 Application应用2 Normative references规范性引用文件2 Normative references规范性引用文件2 Normative references规范性引

4、用文件3 Terms and definitions术语和定义3 Terms and definitions术语和定义3 Definitions定义4 Quality management system质量管理体系4 Quality management system质量管理体系4 Quality system requirements title only质量管理要求4.1 General requirements总要求4.1 General requirements总要求4.2.1 General总要求4.2 Quality system title only质量体系4.2 Documen

5、tation requirements文件要求4.2 Documentation requirements文件要求4.2.1 General总则4.2.1 General总则4.2.2 Quality system procedures质量体系程序4.2.2 Guality manual质量手册4.2.2 Guality manual质量手册4.2.3 Control of documents 文件控制4.2.3 Control of documents 文件控制4.5 Document and data control title only文件和数据控制4.5.1 General 总则4.5

6、.2 Document and data approval and issue 文件和数据批准与发布4.5.3 Document and data changes文件变更4.2.4 Control of records记录控制4.2.4 Control of records记录控制4.16 Control of quality records质量记录控制5 Management responsibility管理职责5 Management responsibility管理职责4.1 Management responsibility title only 管理职责5.1 Management

7、commitment管理承诺5.1 Management commitment管理承诺5.2 Customer focus以顾客为关注焦点5.2 Customer focus以顾客为关注焦点5.3 Quality policy质量方针5.3 Quality policy质量方针4.1.1 Quality policy质量方针5.4 Planning策划5.4 Planning策划5.4.1 Quality objectives质量目标5.4.1 Quality objectives质量目标5.4.2 Quality Management system Planning质量管理体系策划5.4.2

8、 Quality Management system Planning质量管理体系策划4.2.3 Quality planning质量策划5.5 Responsibility, authority and communication职责、权限与沟通5.5 Responsibility, authority and communication职责、权限与沟通5.5.1 Responsibility and authority 职责和权限5.5.1 Responsibility and authority 职责和权限5.5.2 Management representative管理者代表5.5.2

9、 Management representative管理者代表5.5.3 Internal communication内部沟通5.5.3 Internal communication内部沟通5.6 Management review管理评审5.6 Management review管理评审5.6.1 General 总则5.6.1 General 总则5.6.2 Review input 评审输入5.6.2 Review input 评审输入5.6.3 Review output 评审输出5.6.3 Review output 评审输出6 Resource management资源管理6 Re

10、source management资源管理4.1.2.2 Resources资源6.1 Provision of resources资源提供6.1 Provision of resources资源提供6.2 Human resources人力资源6.2 Human resources人力资源6.2.1 General 总则6.2.1 General 总则6.2.2 Competence，training and awareness 能力、培训和意识6.2.2 Competence，training and awareness 能力、培训和意识4.18 Training培训6.3 Infrast

11、ructure基础设施6.3 Infrastructure基础设施4.9 Process control过程控制4.19 Servicing维修6.4 Work environment工作环境6.4 Work environment工作环境4.9 Process control过程控制7 Product realization产品实现7 Product realization产品实现7.1 Planning of product realization产品实现的策划7.1 Planning of product realization产品实现的策划7.2 Customer-related pr

12、ocesses与顾客有关的过程7.2 Customer-related processes与顾客有关的过程7.2.1 Determination of requirements related to the product与产品有关的要求的确定7.2.1 Determination of requirements related to the product与产品有关的要求的确定7.2.2 Review of requirements related to the product与产品有关的要求的评审7.2.2 Review of requirements related to the pro

13、duct与产品有关的要求的评审4.3 Contract review title only合同评审4.3.1 General title only总则4.3.2 Review 评审4.3.3 Amendment to a contract 合同变更4.3.4 Records记录7.2.3 Customer communication顾客沟通7.2.3 Customer communication顾客沟通7.3 Design and development设计和开发7.3 Design and development设计和开发4.4 Design control title only设计控制4.

14、4.1 General title only总则7.3.1 Design and development Planning设计和开发策划7.3.1 Design and development Planning设计和开发策划4.4.2 Design and development planning设计和开发策划4.4.3 Organizational and technical interfaces组织和技术接口7.3.2 Design and development inputs设计和开发输入7.3.2 Design and development inputs设计和开发输入4.4.4 De

15、sign input设计输入7.3.3 Design and development outputs设计和开发输出7.3.3 Design and development outputs设计和开发输出4.4.5 Design output设计输出7.3.4 Design and development Review设计和开发评审7.3.4 Design and development Review设计和开发评审4.4.6 Design review设计评审7.3.5 Design and development verification设计和开发验证7.3.5 Design and devel

16、opment verification设计和开发验证4.4.7 Design verification设计验证7.3.6 Design and development validation设计和开发确认7.3.6 Design and development validation设计和开发确认4.4.8 Design validation设计确认7.3.7 Control of Design and development changes设计和开发更改的控制7.3.7 Control of Design and development changes设计和开发更改的控制4.4.9 Design

17、 changes设计变更7.4 Purchasing采购7.4 Purchasing采购4.6 Purchasing title only采购4.6.1 General title only总则7.4.1 Purchasing process采购过程7.4.1 Purchasing process采购过程4.6.2 Evaluation of subcontractors分承包商评价7.4.2 Purchasing Information采购信息7.4.2 Purchasing Information采购信息4.6.3 Purchasing data采购数据7.4.3 Verification

18、 of purchased product采购产品的验证7.4.3 Verification of purchased product采购产品的验证4.6.4 Verification of purchased product采购产品的验证4.10.2 Receiving inspection and testing进货检验7.5 Production and service provision生产和服务提供7.5 Production and service provision生产和服务提供4.15 Handling, storage, packaging, preservation &am

19、p; delivery title only处理、储存、包装、防护与交付7.5.1 Control production and service provision生产和服务提供的控制7.5.1 Control of production and service provision 生产和服务提供的控制7.5.1.1 General requirements 总要求7.5.1.2 Control of production and service provision . Specific requirements 生产和服务提供的控制规定要求7.5.1.2.1 Cleanliness of p

20、roduct and contamination control 产品的清洁和污染的控制7.5.1.2.2 Installation activities 安装活动7.5.1.2.3 Servicing activities 服务活动7.5.1.3 Particular requirements for sterile medical devices 无菌医疗器械的专用要求4.9 Process control过程控制4.15.6 Delivery交付7.5.2 Validation of processes for production and service provision生产和服务提

21、供过程的控制7.5.2 Validation of processes for production and service provision 生产和服务提供过程的确认7.5.2.1 General requirements 总要求7.5.2.2 Particular requirements for sterile medical devices 无菌医疗器械的专用要求4.9 Process control过程控制7.5.3 Identification and traceability标识和可追溯性7.5.3 Identification and traceability 标识和可追溯性

22、7.5.3.1 Identification 标识7.5.3.2 Traceability 可追溯性7.5.3.2.1 General 总则7.5.3.2.2 Particular requirements for active implantable medical devices and implantable medical devices 有源植入性医疗器械和植入性医疗器械的专用要求7.5.3.3 Status identification 状态标识4.8 Product identification and traceability产品标识与可追溯性7.5.4 Customer pr

23、operty顾客财产7.5.4 Customer property顾客财产4.7 Control of customer-supplied product顾客提供产品的控制7.5.5 Preservation of product产品防护7.5.5 Preservation of product产品防护4.15.1 General 总则4.15.2 Handling 处理4.15.3 Storage 储存4.15.4 Packaging 包装4.15.5 Preservation 防护7.6 Control of monitoring and measuring equipment监视和测量设

24、备的控制7.6 Control of monitoring and measuring devices监视和测量设备的控制4.11 Control of inspection, measuring and test equipment title only检查、测量和试验装置的控制4.11.1 General 总则4.11.2 Control procedure控制程序8 Measurement, analysis and improvement测量、分析和改进8 Measurement, analysis and improvement测量、分析和改进8.1 General总则8.1 Gen

25、eral总则4.20.1 Identification of need 需求识别4.20.2 Procedures程序8.2 Monitoring and measurement监视和测量8.2 Monitoring and measurement监视和测量8.2.1 Customer satisfaction顾客满意8.2.1 Feedback 反馈8.2.2 Internal audit内部审核8.2.2 Internal audit内部审核4.17 Internal quality audits内部质量审核8.2.3 Monitoring and measurement of proce

26、sses过程的监视和测量8.2.3 Monitoring and measurement of processes过程的监视和测量8.2.4 Monitoring and measurement of product产品的监视和测量8.2.4 Monitoring and measurement of product产品的监视和测量8.2.4.1 General requirements 总要求8.2.4.2 Particular requirement for active implantable medical devices and implantable medical devices

27、 有源植入性医疗器械和植入性医疗器械的专用要求4.10 Inspection and testing title only检验与试验4.10.1 General总则4.10.3 In-process inspection and testing 工序检验与试验4.10.4 Final inspection and testing 最终产品检验与试验4.10.5 Inspection and test records检验与试验记录8.3 Control of nonconforming product不合格品控制8.3 Control of nonconforming product不合格品控制4.13 Control of nonconforming product title only不合格品控制4.13.1 General 总则4.13.2 Review and disposition of nonconforming product不合格品的评审与处置8.4 A