Hello all,
What would be the appropriate calibration interval for monitoring & measuring tools used in medical device manufacturing? For instance, the instruments which are being used frequently say daily or 3 days in a week have been set 1 year as calibration interval. But what does not make sense to me is even the calibration cycle for the instruments & tools used less frequent say 1 or 3 times a month is also set 1 year as calibration interval. This takes huge toll on the economic condition of the company. So can the calibration interval can be made once a 2 years or 3 years based on the usability or is it mandatory to be calibrated every year to be compliant with ISO 13485?
Looking for your valuable insights on this. TIA.
What would be the appropriate calibration interval for monitoring & measuring tools used in medical device manufacturing? For instance, the instruments which are being used frequently say daily or 3 days in a week have been set 1 year as calibration interval. But what does not make sense to me is even the calibration cycle for the instruments & tools used less frequent say 1 or 3 times a month is also set 1 year as calibration interval. This takes huge toll on the economic condition of the company. So can the calibration interval can be made once a 2 years or 3 years based on the usability or is it mandatory to be calibrated every year to be compliant with ISO 13485?
Looking for your valuable insights on this. TIA.