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AS ISO 13485:2017 [ Current ]

Medical devices - Quality management systems - Requirements for regulatory processes

standard by Standards Australia , 12/14/2017

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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.
 

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 unavailable in Ukraine, Russia, Belarus
 

Document History

  1. AS ISO 13485:2017

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    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