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
09-26-2021
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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
This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
| Committee |
ISO/TC 210
|
| DocumentType |
Standard
|
| Pages |
116
|
| ProductNote |
The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document. THIS STANDARD IS REFERSTO : GHTF/SG1/N055:2009, GHTF/SG5/N4:2010, GHTF/SG1/N70:2011, GHTF/SG1/N071:2012
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 13485:2016 | Identical |
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