In Reply to Parent Post by IZAKK
Hi, First off, this is a great forum; I can’t believe all of the information that is available here. Second, this is my first post so please take it easy on me.
I have recently been given the task of reviewing our QMS documents and performing gap analysis to ISO 13485. In the Document Control procedure that I am reviewing there is a section for periodic document review with a requirement to have review performed on controlled documents every two years at a minimum.
My question is where exactly is the requirement / clause for this in the 13485 standard? And since documents of external origins are controlled do they need to have this review as well? Thanks in advance for any help.
Hello IZAKK... Welcome to the COVE.
Reviewing QMS documents is just not for the sake of reviewing after any defined time. This is rather an undesireable method which seems to have got into your doc procedure, and is nowhere asked for.
The "as necessary" part in the 4.2.3 b) are the various necessary situations that you will come upon during your business journey.
1. Medical device engineering change
2. Audit finding
3. Internal non-conformance
4. Customer complaint
5. New or revised regulation
6. Other external changes and information
... and some more
Any of these can trigger a revisit and review of effected documented procedures.
Do not just put into your document control procedure a time based necessity for document review. Some of the necessary points for review are as I have listed up. When you agree, use these as the basis for deciding when document will be reviewed and approved, and be aware and sensitive to these necessities.