The purpose of this calibration procedure is to control measuring and test equipment, to ensure that its accuracy and fitness for purpose.
Calibration Procedure SYS-016 and Webinar Bundle ($299)
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).
What is included with the Calibration Procedure:
Document control lists and forms are also included within this procedure. These documents are updated for the US FDA Quality System Regulation (QMSR), ISO 13485:2016, and the new European Regulations. The following is a list of documents included:
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SYS-016 Calibration Procedure – FDA 21 CFR 820.72
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LST-006 0.2 Equipment Register
- a recording of the webinar you can replay anytime
- the native slide deck for this webinar
If you would like to ask specific questions about the document control procedure and process, please submit them via email or schedule a call using the calendly app on our contact us page. All deliveries of content will be sent via AWeber emails to confirmed subscribers. If you don’t receive the content automatically, please check your spam folder.
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To review a sample Medical Device Academy procedure click below:
About Your Instructor
Rob 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. Rob 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 certifications. From 2009 to 2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Rob’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 at +1.802.281.4381 or by email. You can also follow him on YouTube, LinkedIn, or Twitter.