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About This Item

 

Full Description

Adopts ISO 13485:2016 to specify 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.
 

Document History

  1. AS ISO 13485:2017

    👀currently
    viewing


    Medical devices - Quality management systems - Requirements for regulatory processes

    • Most Recent
  2. AS ISO 13485-2003


    Medical devices - Quality management systems - Requirements for regulatory purposes

    • Historical Version
  3. AS ISO 13485-2002


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

    • Historical Version
  4. AS ISO 13488-2002


    Quality systems - Medical devices - Particular requirements for the application of ISO 9002

    • Historical Version