Calibration- Cold Storage
I am not able to find anything in the standard (ISO9001 or 13485) about placing a calibrated item into cold storage and using it after the next due date shown on the certificate. EX: I calibrate a micrometer on 4/15/2019 and the calibration is valid until 4/15/2020, I then place this gage into cold storage, meaning that I don't use it at all. If I take it out on 3/9/2020, would I have 1 year from 3/9/2020 as my new start date? If there is no industry standard related to this then would our internal procedures dictate how we are to handle this?
3 Replies
Amanda Foster 1083
652 Posts
The standards try not to be more prescriptive than necessary, so I'm not surprised that you can't find anything there. If there are no industry standards, then yes, your internal procedures should dictate how you handle this.
I would say you can calibrate the tool before usage to restart the annual need for calibration.  By calibrate you could mark that it is still sealed and unused since the last calibration.  That would be the route I would take.  That way you have a new record of it being calibrated from 3/9/20 to 3/9/21.
Duke Okes 1670
101 Posts
Not an expert on any regulations in this area, but in my mind it might depend on type of measurement device and what might cause calibration to be incorrect.  If, for example, it's drift over time just due to aging of components then recalibration before use would be necessary.  If instead it would be due to mechanical wear, since it's not been used recalibration would not be needed.