Process monitoring is required, but do you know if monitoring each procedure is required by the FDA QSR or ISO 13485?

One of the elements that Medical Device Academy has included in every procedure we have created in our turnkey quality system is a section entitled 'monitoring and measurement'. The purpose of this section is to force each process owner to identify a process metric for monitoring each procedure. In some cases, we propose a benchmark that would be appropriate for most companies setting up a new quality system. In other procedures we use the following boilerplate:

“Enter a quality metric you want to track for this process in accordance with ISO 13485:2016, clause 8.2.5 and the Monitoring, Measurement and Analysis Procedure (SYS-017).”
Link to SYS-017 https://www.medicaldeviceacademy.com/data-analysis-procedure/

To learn more about why we made monitoring a requirement for every procedure in the quality system, read our blog post posted on Tuesday, April 26, 2022:
https://www.medicaldeviceacademy.com/monitoring/

To learn more about the process approach to auditing, follow this link:
https://youtu.be/6_kmlrqbjrE

If you have any questions or need our help setting up a quality system, you can schedule a call with Rob Packard at the following link:
https://calendly.com/13485cert/30min

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