ISO 9001 Secondary review
The company I work for is a biotechnology company and we hold ISO 9001 certification. We keep records as required by ISO, however, I was wondering if the quality department needs to perform a secondary review on all or some of the records.
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No, records should be reviewed by the function with the authority to do it. If we are speaking of records from the purchasing area perhaps your quality system determines that review for content and approval is made by a function in the purchasing department.
During internal audits, auditors can audit records for content and approval.
You can find more information about documentation below:
- New approach to document and record control in ISO 9001:2015 - https://advisera.com/9001academy/blog/2015/06/30/new-approach-to-document-and-record-control-in-iso-90012015/
- 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/
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Feb 26, 2021