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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
A description is not available for this item.
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