NSAI/ISO Guide to ISO 13485:2016
Current
Current
The latest, up-to-date edition.
Medical Devices a practical guide Advice from ISO/TC 210
Available format(s)
Hardcopy , PDF
Language(s)
English
Published date
11-17-2017
Publisher
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 — Guidance for small organizations
Bibliography
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