Using internal audits as part of document reviews

[cgaro62]

Good day @cgaro62 ;
Yes, what I am saying (if I am understanding your situation correctly) is that...
1- a "periodic review" of your QMS documentation is not required.
2- It is required to have a documented procedure (ISO 13485--4.2.4) to define your organization's controls specific to "a~h"
3- it is required to "...when CREATING and UPDATING ...(ISO 9001--7.5.2) shall...review for suitability and adequacy".

Hope this helps.
Be well.

Love it! Love it! love it!!

 

[QualityMoo]

I have used the internal audit program as a supplemental document review. While we are auditing the process, part of the value is looking at whether the process is in alignment with the documents. We conduct periodic reviews of the documents to ensure continued applicability and the audit to see if we are following them. In some cases, documents are missed in the reviews (still managing in an antiquated method) so the audits help raise concerns. Audits are not a replacement for the document review, but an added set of eyes.