Review of QMS procedures
My question is about the review of QMS procedures: I there any requirement to review internal procedures at planned intervals (e.g. once a year)?
If so, what should be the scope of such a review? I usually send SOP’s for review once a year just for the owners to confirm whether the document is still valid/current or not. Other than this, a procedure will be review in terms of content, when the owner sees an opportunity for improvement, or as a result of corrective action.
Assign topic to the user
ISO 9001 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 9001 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 9001 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
There is no requirement in ISO 9001:2015 to review internal procedures at planned intervals. However, I already worked with organizations that had to be audited by the FDA and in their case, it was mandatory to review internal procedures at planned intervals. So, there may be other external requirements besides ISO 9001:2015 requiring that review.
Concerning ISO 9001:2015, you are right, a procedure should be reviewed in terms of content when the owner sees an opportunity for improvement, or as a result of corrective action.
You can find more information about the documentation below:
- Some tips to make Document Control more useful for your QMS - https://advisera.com/9001academy/blog/2014/05/20/tips-make-document-control-useful-qms/
- Free online training ISO 9001:2015 Foundations Course - https://advisera.com/training/iso-9001-foundations-course/
- Book - Managing ISO Documentation: A Plain English Guide - https://advisera.com/books/managing-iso-documentation-plain-english-guide/
Comment as guest or Sign in
Dec 15, 2020