DS/EN ISO 13485
Quality systems - Medical devices - Particular requirements for the application of EN ISO 9001
inactive
| Organization: | DS |
| Publication Date: | 9 February 2001 |
| Status: | inactive |
| Page Count: | 22 |
| ICS Code (Quality management and quality assurance): | 03.120.10 |
| ICS Code (Medical equipment in general): | 11.040.01 |
scope:
The standard specifies, in conjunction with ISO 9001, the quality system requirements for the design/development, production, and when relevant, installation and servicing of medical devices. The standard, in conjunction with ISO 9001, is applicable when there is a need to assess a medical device supplier's quality system.
Document History
September 13, 2021
Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016)
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...
April 3, 2018
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...
January 6, 2017
Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016)
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...
March 1, 2016
Medical devices – Quality management systems – Requirements for regulatory purposes
A description is not available for this item.
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, 2012
Medical devices - Quality management systems - Requirements for regulatory purposes - Technical Corrigendum 1
ISO 13485:2003 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...
February 28, 2012
Medical devices – Quality management systems – Requirements for regulatory purposes
ISO 13485:2003 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...
September 30, 2009
Medical devices - Quality management systems - Requirements for regulatory purposes
This 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...
July 23, 2007
Medical devices - Quality management systems - System requirements for regulatory purposes
This 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...
August 29, 2003
Medical devices - Quality management systems - System requirements for regulatory purposes
This 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...
DS/EN ISO 13485
February 9, 2001
Quality systems - Medical devices - Particular requirements for the application of EN ISO 9001
The standard specifies, in conjunction with ISO 9001, the quality system requirements for the design/development, production, and when relevant, installation and servicing of medical devices. The...
Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016)
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...
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO/DIS 13485:2015)
This International Standard specifies requirements for an organization that needs to demonstrate that its quality management system has the ability to manage the life-cycle of medical devices and...
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO/FDIS 13485)
This International Standard specifies requirements for an organization that needs to demonstrate that its quality management system has the ability to manage the life-cycle of medical devices and...
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