BS EN ISO 13485:2016
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
Medical devices. Quality management systems. Requirements for regulatory purposes
Hardcopy , PDF
09-30-2021
English
01-31-2017
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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