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About This Item

 

Full Description

Specifies, for suppliers of medical devices, quality systems requirements that are more specific than those given in ISO 9001.
 

Document History

  1. AS ISO 13485:2017


    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

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    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