How do we implement a Process Approach ISO 13485:2016 - Existing GMP QMS



Hey everybody!

We are going for the ISO 13485:2016 certification, as we are going to be manufacturing Medical devices for Private Label.
Our current QMS is build on GMP, as we also deal with Pharmaceuticals. Some SOPs are/will be shared for the QMS.

We are located in the EU.

My problem: How do we implement a process approach, as required by the ISO 13485:2016 without having to change our entire QMS?
In my view, the GMP and ISO 13485 does not align in regard to the process approach.
Is it enough with a process-map/diagram?

I hope this all makes sense!

- AneMedDev


AneMedDev: The quesiton generates a variety of questions; Do you have or have the ability to diagram (map) your existing existing QMS that includes your policy/procedures and associated control/decision points?



Yes, I think I/we will be able to do that. I am in the process of creating such a map, but I am unsure, what to do with it. I am planning on placing it in the quality manual - maybe as part of the QMS-description.
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