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What else do I need to be ISO 13485 certified when I am ISO 9001 certified?

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Guest user Created:   Feb 16, 2019 Last commented:   Feb 16, 2019

What else do I need to be ISO 13485 certified when I am ISO 9001 certified?

I am not currently ISO 13485 certified but 9001:2015 certified. What do I need to be also 13485 certified?
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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Verlene Law Feb 16, 2019

Answer:

In order for your company to be ISO13485 certified, you need to adapt your company's current QMS to take into account the type of product that you are dealing with in your organization such as the inclusion of medical device files, design and development file, software validation and sterilization process just to name a few.

For more information, please refer to:

- List of mandatory documents required by ISO 13485:2016- https://advisera.com/13485academy/blog/2017/01/18/list-of-mandatory-documents-required-by-iso-134852016/

- How to structure Quality Management System documentation according to ISO 1348-: https://advisera.com/13485academy/knowledgebase/how-to-structure-quality-management-system-documentation-according-to-iso-13485/

-Checklist of ISO 13485 implementation and certification steps
https://advisera.com/13485academy/knowledgebase/checklist-of-iso-13485-implementation-and-certification-steps/
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Feb 16, 2019

Feb 16, 2019