ISO 13485 & EU MDR / Sub clause Explanation
1. In which clause does the recording of FPA approval , Daily check sheets, Recording of clean room temperature comes under??
2. Under which clause does the naming (Document number , Rev no , Date ) for a format comes ??
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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:
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