NSAI-ISO Guide to ISO 13485:2016
Current
The latest, up-to-date edition.
Medical Devices a practical guide Advice from ISO/TC 210
Hardcopy , PDF
English
11-17-2017
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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
This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide This International Standard specifies requirements for a quality management and applicable regulatory requirements.
| Committee |
TC 210
|
| DocumentType |
Guide
|
| ISBN |
978-92-67-10774-5
|
| Pages |
224
|
| ProductNote |
THIS STANDARD ALSO REFERS TO ISO 27001, ISO 62366-1:2015, IEC/ISO 62366-1
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Standards | Relationship |
| ISO 13485 - PRACTICAL GUIDE : 2016 | Identical |
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