The purpose of this 4-page calibration procedure is to control measuring and test equipment, to ensure that its accuracy and fitness for purpose.
This calibration procedure covers all measuring and test equipment used within the scope of your company’s quality management system, including product development and production. The procedure has been updated to the requirements for ISO 13485:2016. References to EN ISO 10012:2007 were added for companies that have more technical questions regarding calibration requirements.
There is also a new section in the procedure that specifies the requirements for software validation of calibration management software. This requirement is stated in ISO 13485:2016, but this procedure includes a reference to ISO/TR 80002-2:2017. That standard includes an example specific to validation of calibration software.
This is the primary document meeting the applicable regulatory requirements for Control of Monitoring and Measuring Devices, as defined in your company’s Quality System Manual (POL-001).
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SYS-016 Control of Monitoring & Measurement Devices (i.e. Calibration) Procedure – This procedure covers all measuring and test equipment used within the scope of your quality management system, including product development and production. This procedure also includes validation and revalidation requirements for software used to control and monitor calibrated devices.
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