Table of Contents

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management system
5 Management responsibility
6 Resource management
7 Product realization
8 Measurement, analysis and improvement
Annex A (informative) - Comparison of content between
        ISO 13485:2003 and ISO 13485:2016
Annex B (informative) - Correspondence between ISO 13485
        :2016 and ISO 9001:2015
Bibliography
Annex ZA (informative) - Relationship between this
         European Standard and the Conformity
         Assessment Requirements of EU Directive
          90/385/EEC (as amended)
Annex ZB (informative) - Relationship between this
         European Standard and the Conformity
         Assessment Requirements of EU Directive
         93/42/EEC (as amended)
Annex ZC (informative) - Relationship between this
         European Standard and the Conformity
         Assessment Requirements of EU Directive
         98/79/EC

Abstract

Provides requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	British Standards Institution
Pages
ISBN
Committee	CH/210/1
Supersedes	14/30257644 DC : 0 02/560598 DC : DRAFT FEB 2002 BS EN 46003 : 1999 BS EN ISO 13488 : 2001 15/30321131 DC : 0