EN ISO 13485:2016/AC:2018
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES (ISO 13485:2016)
09-18-2021
03-28-2018
European foreword
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
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