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 the validation of calibration software. If you are implementing quality system software, you might also be interested in purchasing our Software Tool Validation Procedure (SYS-051).
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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About the Author
Robert Packard is a regulatory consultant with 25+ years of experience in the medical device, pharmaceutical, and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Robert was a senior manager at several medical device companies—including the President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certification. From 2009-2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Robert’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications, and 510(k) submissions. The most favorite part of his job is training others. He can be reached via phone 802.258.1881 or email. You can also follow him on Google+, LinkedIn or Twitter.