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Internal audit ISO 13485

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Guest user Created:   Oct 18, 2021 Last commented:   Oct 22, 2021

Internal audit ISO 13485

Hi does the internal audit checklist also cover the requirement for iso 9001? We got a non conformity for this.  
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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
Kristina Zvonar Brkić Oct 20, 2021

The internal audit checklist for ISO 13485:2016 does not cover all requirements from ISO 9001:2015. For example, it does not cover the requirements regarding the context of the organization, requirements regarding the interested parties, or risks and opportunities. Other requirements regarding the management review, internal audit, non-confrorming products, and documented information are covered because those requirements are very similar to the ISO 9001:2015.

If you had an audit for ISO 13485:2016, I do not understand why it was asked for the requirements from the ISO 9001.

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Guest user Oct 20, 2021

In the internal checklist procedure, it was stated that iso 9001 caluse 9,2 is applied. I then belived that the iso 13485  checklist itself was integrated with iso 9001. Is this the case?  If not What parts of iso 9001 is missing from the 13485 checklist?

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Kristina Zvonar Brkić Oct 22, 2021

No, Iso 13485Internal audit checklist responds only to the requirements stated in the ISO 13485:2016. Missing elements from the ISO 9001:2015 are the ones considering context, interested parties, and business risks. 

More information regarding the Internal audit checklist for ISO 9001 you can find on the following link:

How it is constructed in our ISO 9001:2015 Documentation toolkit you can find on the following link:

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