YY/T 0595—2020
医疗器械  质量管理体系YY/T 0287—2017 应用指南
Medical Devices-Quality Management System-Guidance on the Application of YY/T 0287—2017
2020-02-21 发布
2020-04-01 实施
目次
前言................................................1
引言..................................................1
0.1总则..............................................1
0.2阐明概念...........................................1
0.3过程方法..........................................1
0.4 与 ISO 9001 的关系...............................2
0.5与其它管理体系的相容性.....................................2
1范围.................................................2
2规范性引用文件............................................3
3术语和定义..............................................3
4质量管理体系............................................11
4.1总要求............................................11
4.2文件要求...........................................17
4.2.1 总则.........................................17
4.2.2质量手册........................................19
4. 2. 3医疗器械文档....................................20
4.2.4文件控制........................................21
4.2.5记录控制........................................23
5管理职责
25
5.1管理承诺.............................................25
5.2以顾客为关注的焦点........................................26
5.3质量方针.............................................27
5.4策划...............................................28
5.4.1质量目标..........................................28
5.4.2质量管理体系策划......................................29
5. 5职责、权限、沟通........................................30
5.5.1职责和权限.........................................30
5. 5.2管理者代表........................................30
5.5.3内部沟通..........................................31
5.6管理评审.............................................32
5.6.1 总则...........................................32
5.6.2评审输入..........................................33
5.6.3评审输出..........................................35