Where requirement comes from to monitor and or record temperature and humidity during calibrations?
What I am attempting to figure out is where the requirement comes from to monitor and or record temperature and humidity during calibrations? Any information on this topic would be appreciated.
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No, there is no direct requirement to measure and record temperature and humidity while calibrating inspection in the ISO 13485:2016 in section 7.6 Control of monitoring and measuring equipment. There is only a requirement that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements. This statement indicates that it should be assessed separately for each measuring instrument according to the rules of the profession what is the manner that is needed to calibrate monitoring and measuring equipment.
For more information about calibration, please see following article:
- Calibration requirements in ISO 13485 - https://advisera.com/13485academy/blog/2019/03/08/calibration-requirements-in-iso-13485/
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Oct 19, 2020