JeantheBigone
Quite Involved in Discussions
Quality system documents typically contain features such as :
Title
Version / Revision number
Effective / Authorization date
Number of pages
etc.
and sometimes contain an expiry date on which the document is to be reviewed for changes / re-approval.
21 CFR 820.40 does not specify this level of detail, nor does ISO 9001;2008 or ISO 13485;2003. The only standard I have seen which explicitly requries specific fields is ISO 15189.
My question is what is the source of these individual fields? Is there a standard that specifies which fields must be included or is it simply good accepted practice?
Title
Version / Revision number
Effective / Authorization date
Number of pages
etc.
and sometimes contain an expiry date on which the document is to be reviewed for changes / re-approval.
21 CFR 820.40 does not specify this level of detail, nor does ISO 9001;2008 or ISO 13485;2003. The only standard I have seen which explicitly requries specific fields is ISO 15189.
My question is what is the source of these individual fields? Is there a standard that specifies which fields must be included or is it simply good accepted practice?