ISO13485标准下载-医疗器械质量管理体系用于法规要求

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Contents Page
Foreword.................................................................................................... iv
0 Introduction ............................................................................................. v
0.1 General ................................................................................................ v
0.2 Process approach ....................................................................................... v
0.3 Relationship with other standards ...................................................................... vi
0.4 Compatibility with other management systems ............................................................ vi
1 Scope..................................................................................................... 1
1.1 General ................................................................................................ 1
1.2 Application............................................................................................. 1
2 Normative references ..................................................................................... 2
3 Terms and definitions..................................................................................... 2
4 Quality management system .............................................................................. 4
4.1 General requirements ................................................................................... 4
4.2 Documentation requirements ............................................................................. 4
5 Management responsibility................................................................................. 6
5.1 Management commitment................................................................................... 6
5.2 Customer focus.......................................................................................... 6
5.3 Quality policy........................................................................................... 6
5.4 Planning ................................................................................................ 7
5.5 Responsibility, authority and communication.............................................................. 7
5.6 Management review........................................................................................ 8
6 Resource management........................................................................................ 8
6.1 Provision of resources ................................................................................ 8
6.2 Human resources.......................................................................................... 9
6.3 Infrastructure........................................................................................... 9
6.4 Work environment......................................................................................... 9
7 Product realization........................................................................................ 10
7.1 Planning of product realization ......................................................................... 10
7.2 Customer-related processes............................................................................... 10
7.3 Design and development................................................................................... 11
7.4 Purchasing............................................................................................... 13
7.5 Production and service provision .................................................................... 14
7.6 Control of monitoring and measuring devices ........................................................... 17
8 Measurement, analysis and improvement....................................................................... 17
8.1 General .................................................................................................. 17
8.2 Monitoring and measurement................................................................................ 18
8.3 Control of nonconforming product ......................................................................... 19
8.4 Analysis of data.......................................................................................... 19
8.5 Improvement............................................................................................... 20
Annex A (informative) Correspondence between ISO 13485:2003 and ISO 13485:1996........................... 21
Annex B (informative) Explanation of differences between ISO 13485:2003 and ISO 9001:2000 ............ 25
Bibliography ............................................................................................... 57