I.S. EN ISO 13485:2016/A11:2021
Current
The latest, up-to-date edition.
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
Hardcopy , PDF
English
26-09-2021
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management system
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
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