Production Process deviated from Documented Procedure

P

pangchiaboon

#1
Dear Sirs,

FDA part 820 sec 820.70 describes the requirement on production and process change, but i can't find the same requirement from ISO 13485.

If happened that a production process (non special process) changed / deviated from documented procedure without subjected to review and approval, which is the most related Clause in ISO13485?

Thanks.
 
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jkuil

Quite Involved in Discussions
#3
With respect to production controls 21CFR820.70 relates to ISO 13485:2003 7.5.1 Control of production and service provision.
With respect to production and process changes 21CFR820.70(b) relates to 7.3.7 Control of design and development changes.
 
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