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Order this standard with ISO 13485:2003 and save 30%!

ISO/TR 14969:2004 provides guidance for the application of the requirements for quality management systems contained in ISO 13485. It does not add to, or otherwise change, the requirements of ISO 13485. It does not include requirements to be used as the basis of regulatory inspection or certification assessment activities.

This guidance can be used to better understand the requirements of ISO 13485 and to illustrate some of the variety of methods and approaches available for meeting the requirements of ISO 13485.

 

Document History

  1. ISO 13485:2016 Plus Redline


    Medical devices - Quality management systems - Requirements for regulatory purposes

    • Historical Version
  2. ISO 13485:2016


    Medical devices - Quality management systems - Requirements for regulatory purposes

    • Most Recent
  3. ISO/TR 14969:2004

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    Medical devices - Quality mangement systems - Guidance on the application of ISO 13485: 2003

    • Historical Version
  4. ISO 13485 AND 14969 PACKAGE


    ISO 13485:2003 and ISO/TR 14969:2004 Quality Managment Systems Medical Devices Package

    • Historical Version
  5. ISO 13485:2003


    Medical devices - Quality management systems - Requirements for regulatory purposes

    • Historical Version
  6. ISO 13485:1996


    Quality systems - Medical devices - Particular requirements for the application of ISO 9001

    • Historical Version