Hi,
We recently had an ISO 13485 2016 change audit. The NB auditor pointed out that we should increase the calibration frequency of verniers that we use daily from once in a year to once every quarter . There was no proper justification given . He just stated that for daily use instruments the validation frequency of one year is too long.We have not had any problems with these instruments for last more than three years .
What should we do ? As our cost go very high we have 100 such instruments
Can we do some verification or validation ourselves every quarter and if yes what would be procedure. We are just checking OD . ID and depth with these instruments.
Any help would be highly appreciated.
Thanks
Michelle
We recently had an ISO 13485 2016 change audit. The NB auditor pointed out that we should increase the calibration frequency of verniers that we use daily from once in a year to once every quarter . There was no proper justification given . He just stated that for daily use instruments the validation frequency of one year is too long.We have not had any problems with these instruments for last more than three years .
What should we do ? As our cost go very high we have 100 such instruments
Can we do some verification or validation ourselves every quarter and if yes what would be procedure. We are just checking OD . ID and depth with these instruments.
Any help would be highly appreciated.
Thanks
Michelle