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Calibration SOP

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Guest user Created:   Jan 25, 2021 Last commented:   Jan 26, 2021

Calibration SOP

HI, I'm trying to find out if I need a calibration SOP for Design Controls. Since V&V are part of Design Controls, I would think that a calibration SOP has to be in place to ensure that a verification or validation is valid when using equipment that requires calibration. Any thoughts?.

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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 Jan 26, 2021

Calibration SOP is a request of ISO 13485:2016 covered in requirement 7.6 Control of monitoring and measuring equipment. I agree with you that equipment that is used to make verification and validation during design must be calibrated. SO, you can cover it in this documented procedure. 

For more information regarding this topic, see the following article:

In our ISO 13485:2016 documentation toolkit, we have Procedure for Equipment Maintenance and Measurement Equipment: https://advisera.com/13485academy/documentation/procedure-for-equipment-maintenance-and-measurement-equipment-iso-13485-2016/

Here you can see how our Maintenance and calibration record looks like: https://advisera.com/13485academy/documentation/maintenance-and-calibration-record-iso-13485-2016/

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Jan 25, 2021

Jan 26, 2021

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