ISO 13485
Quality Systems - Medical Devices - Particular Requirements for the Application of ISO 9001
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| Organization: | ISO |
| Publication Date: | 15 December 1996 |
| Status: | inactive |
| Page Count: | 15 |
| ICS Code (Quality management and quality assurance): | 03.120.10 |
| ICS Code (Medical equipment in general): | 11.040.01 |
Document History
March 1, 2016
Medical devices - Quality management systems - Requirements for regulatory purposes
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...
August 1, 2009
Medical devices — Quality management systems — Requirements for regulatory purposes TECHNICAL CORRIGENDUM 1
General
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...
July 15, 2003
Medical devices - Quality management systems - Requirements for regulatory purposes
General
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...
ISO 13485
December 15, 1996
Quality Systems - Medical Devices - Particular Requirements for the Application of ISO 9001
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