Operational Procedures for ISO 13485:2016 Question on using audit checklist ISO 13485:2016Ĭustomer Property - ISO 13485:2016 Clause 7.5.10 Question regarding where "validations" fit according to ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems Enjoy the ride.Įlectronic Signatures - Non-Conformance - ISO 13485:2016 All impacted functions participate (but rarely Marketing).
There is no one way to deploy a QMS standard. I see that there is no response so far and here's a quick take to get things moving.