ISO 13485-2003版与ISO13485-1996与ISO 9001-2008 条款对照.docVIP

ISO 13485:2003与ISO13485:1996及ISO 9001—2008条款对照ISO 9001—2008EN 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ISO9004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 management 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 Documentation 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4.5.2 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 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 Pl