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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.
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.