Sub clause Explanation
Assign topic to the user
1. In which clause does the recording of FPA approval , Daily check sheets, Recording of clean room temperature comes under??
In my opinion, FPA approval will be under the 7.5 productions and service provision, Daily checks sheets can be under:
6.3 Infrastructure if it is daily checks of the machines and equipment6.4.1 Work environment if it is checked for the cleaning6.4.2 Contamination control - temperature or humidity monitoring
2. Under which clause does the naming (Document number, Rev no, Date) for a format comes ??
Management of the documents comes under 4.2.4 Control of documents and 4.2.5 Control of records.
For more information regarding documentation control please see the following articles:
- Common mistakes with ISO 13485:2016 documentation control and how to avoid them https://advisera.com/13485academy/blog/2018/03/14/common-mistakes-with-iso-134852016-documentation-control-and-how-to-avoid-them/
- How to structure Quality Management System documentation according to ISO 13485 https://advisera.com/13485academy/knowledgebase/how-to-structure-quality-management-system-documentation-according-to-iso-13485/
Comment as guest or Sign in
Jan 22, 2021