Expert Advice Community

Guest

Sub clause Explanation

  Quote
Guest
Guest user Created:   Jan 21, 2021 Last commented:   Jan 22, 2021

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 ??

0 1

Assign topic to the user

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Kristina Zvonar Brkić Jan 22, 2021
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:

Quote
0 0

Comment as guest or Sign in

HTML tags are not allowed

Jan 21, 2021

Jan 22, 2021