Re: Repeat Major Nonconformance - External Audit by Registrar
...i.e.: a "can of worms?"
Stijloor.
Exactly.
OK, Adaline, please understand all here are trying to help, and not frustrate you. Thank you for providing more details.
By your post, this is what appears to me: There was a problem. Management assumed someone in the company took care of the problem, without ever determining what the problem really was, and if it was truly corrected.
Not sure how many instruments we're talking about, but someone (oh, say, an upper manager this phase of the game) needs to take the list and make sure you have your tools/instruments under control. If your tools are under control, get them all in current calibration by sending them to a competent labs qualified for those instruments.
If you have instruments coming back failed from calibration, then you need to deal with that. If they are within tolerance, then you can have confidence in your instruments.
Then, given the superb suggestions by others, your organization needs to make the necessary process improvements and develop good communication with the auditor. (Just an aside-if you have been performing internal audits and this major problem was never addressed, that may be another area ripe for improvement.)
No one expects a system to be perfect. It is, though, supposed to improve and generate original mistakes.