Internal audit ISO 13485

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.

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?

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:

• ISO 9001 Audit Checklist https://advisera.com/9001academy/knowledgebase/iso-9001-audit-checklist/

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

• Internal Audit Checklist https://advisera.com/9001academy/documentation/internal-audit-checklist/