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Calibration Intervals

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Guest user Created:   Apr 21, 2020 Last commented:   Apr 22, 2020

Calibration Intervals

Hello I am looking for rationale for calibration due date being set at end of month.

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Apr 22, 2020

You need to prove that in that time from the calibration due date to the end of the month there is nothing wrong with your device. So in your rationale, you can state how often do you use the device in that time (is it daily, weekly), have the conditions of storage the equipment changed, did you remove the equipment or not (if it is applicable for your type calibration device). If you can prove that there are no risks in that time that can influence the accuracy of the calibration device, it will be a good rationale.

For more information on Calibration requirements in ISO 13485, please see the following article:
Calibration requirements in ISO 13485 https://advisera.com/13485academy/blog/2019/03/08/calibration-requirements-in-iso-13485/

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Apr 21, 2020

Apr 22, 2020

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