ISO 13485 - PRACTICAL GUIDE : 2016
Current
ISO 13485:2016 - MEDICAL DEVICES - A PRACTICAL GUIDE
Hardcopy , PDF
English
01-01-2016
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 |
ISO/TC 210
|
| DocumentType |
Guide
|
| ISBN |
978-92-67-10774-5
|
| Pages |
0
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Standards | Relationship |
| SA HB 13485:2020 | Identical |
| NSAI-ISO Guide to ISO 13485:2016 | Identical |
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