Foreword
0 Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management system
5 Management
6 Resource management
7 Product realization
8 Measurement, analysis and improvement
Annex A (informative) - Explanation of differences
between ISO 13485:201x and
ISO 9001:2008
Annex B (informative) - Explanation of differences
between ISO 13485:201x and
ISO 13485:2003
Annex ZA (informative) - Relationship between this
European Standard and the Conformity
Assessment Requirements of EU Directive
90/385/EEC
Annex ZB (informative) - Relationship between this
European Standard and the Conformity
Assessment Requirements of EU Directive
93/42/EEC
Annex ZC (informative) - Relationship between this
European Standard and the Conformity
Assessment Requirements of EU Directive
98/79/EC
Bibliography