have a question in relation to our external calibration .
I have started a new job and a new role in calibration .
my question is for years the company has had some of the equipment calibrated from an external company and as i was going through some of the calibration certs and i noticed that their reference equipment had a tolerance of +- 1.5 % rH and our equipment has a tolerance 3% rH. is this expectable for ISO13485 (this means a ration 2:1)
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
Considering the requirement 7.6 Control of monitoring and measuring equipment, it is not prescribed what is the tolerance for calibration measuring. This mostly depends on some technical standards, but also how precise must be what you are measuring. It is not the same if you calibrate a thermometer for the warehouse where it is allowed to have a temperature range from 5 to 30 Celsius degree or a thermometer for a fridge where it is allowed a temperature range from +2 to +8 Celsius degrees.
For more information, please see the following article:
- Calibration requirements in ISO 13485 https://advisera.com/13485academy/blog/2019/03/08/calibration-requirements-in-iso-13485/
You can see how our document for Maintenance and Calibration Record looks in our ISO 13485:2016 Documentation toolkit: https://advisera.com/13485academy/documentation/maintenance-and-calibration-record-iso-13485-2016/
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Feb 03, 2021