We have been 13485 certified for 6 years. We just had an third party auditor specify that we have to validate all software we use include our sharenet webpage as well as our corporate required training software.
This surprised us completely since we have never been asked this before.
Then the same auditor, while checking CAR's, picked an open CAR and wanted to see proof that actions had been taken even though the process was not complete or verified for effectiveness.
Is this out of the ordinary or typical of what to expect from an auditor?
This surprised us completely since we have never been asked this before.
Then the same auditor, while checking CAR's, picked an open CAR and wanted to see proof that actions had been taken even though the process was not complete or verified for effectiveness.
Is this out of the ordinary or typical of what to expect from an auditor?