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ISO 13485《医疗器械质量管理体系》  2009-11-9

 

  
 ............................................................................................................................................................................... 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.......................................................................................................................................................... ................... 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
附录A............................................................................................................................................................... ............ 22
附录B..........................................................................................................................................................................   26
参考文献目录............................................................................................................................................................... 50

 

 

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