AS ISO 13485:2017 ✓ Most Recent [ Current ]

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Medical devices - Quality management systems - Requirements for regulatory processes

standard by Standards Australia , 12/14/2017

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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. See more

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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

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Product Details

Edition:

3rd

Published:

12/14/2017

ISBN(s):

9781760359669

Number of Pages:

35

File Size:

1 file , 1.5 MB

Product Code(s):

10157274, 10157230, 10157238

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This product is restricted and cannot be purchased in these countries.