医院ISO13485标准管理手册(1)

目 录前 言 30引言 40.1总则 40.2过程方法 40.3与其他标准的关系 40.4与其它管理体系的相容性 51范 围 51.1总则 51.2应用 52引用标准 63术语和定义 64质量管

目录 ...................................................................................................................................................... 前言3 0 ........................................................................................................................................................ 引言4 0.1 ............................................................................................................................................... 总则4 0.2 ....................................................................................................................................... 过程方法4 0.3 ....................................................................................................................... 与其他标准的关系4 0.4 ........................................................................................................... 与其它管理体系的相容性5 1 ...................................................................................................................................................... 范围5 1.1 ............................................................................................................................................... 总则5 1.2 ............................................................................................................................................... 应用5 2 ................................................................................................................................................ 引用标准6 3 ............................................................................................................................................ 术语和定义6 4 ........................................................................................................................................ 质量管理体系7 4.1 ........................................................................................................................................... 总要求7 4.2 ....................................................................................................................................... 文件要求8 5 ................................................................................................................................................ 管理职责9 5.1 ....................................................................................................................................... 管理承诺9 5.2 ..................................................................................................................... 以顾客为关注焦点9 5.3 ..................................................................................................................................... 质量方针9 5.4 ........................................................................................................................................... 策划10 5.5 ..................................................................................................................... 职责、权限和沟通10 5.6 ..................................................................................................................................... 管理评审10 6 .............................................................................................................................................. 资源管理11 6.1 ..................................................................................................................................... 资源提供11 6.2 ..................................................................................................................................... 人力资源11 6.3 ................................................................................................................................. 基础设施12 6.4 ................................................................................................................................. 工作环境12 7 .............................................................................................................................................. 产品实现12 7.1 ......................................................................................................................... 产品实现的策划12 7.2 ..................................................................................................................... 与顾客有关的过程13 7.3 ............................................................................................................................. 设计和开发13 7.4 ............................................................................................................................................. 采购15 7.5 ......................................................................................................................... 生产和服务提供16 7.6 ............................................................................................................. 监视和测量装置的控制18 8 .............................................................................................................................. 测量、分析和改进19 8.1 ............................................................................................................................................. 总则19 82 .............................................................................................................................. ．监视和测量19 8.3 ......................................................................................................................... 不合格品的控制20 8.4 ..................................................................................................................................... 数据分析20 8.5 ............................................................................................................................................. 改进21 A ..................................................................................................................................................... 附录22 B ..................................................................................................................................................... 附录26 ........................................................................................................................................ 参考文献目录50