Hi Masters of Medical Devices.
I struggle to solve issue regarding timing required around closure of CA. Standard citate 'Any necessary CA shall be taken without undue delay'.
Certification Auditor insisted that we shall have timings assigned for each stage of the nonconformance process. I think sometimes you cannot close an NCRs, develop CA if you are for example dependant on external factors, or simply you just need more time to agree on CA. I would like to find out what would be the best way comply with above clause without having to assign exact timings in procedure?
Any advise would be greatly appreciated
I struggle to solve issue regarding timing required around closure of CA. Standard citate 'Any necessary CA shall be taken without undue delay'.
Certification Auditor insisted that we shall have timings assigned for each stage of the nonconformance process. I think sometimes you cannot close an NCRs, develop CA if you are for example dependant on external factors, or simply you just need more time to agree on CA. I would like to find out what would be the best way comply with above clause without having to assign exact timings in procedure?
Any advise would be greatly appreciated