Risk Based Approach for ISO 13485:2016 Form/Procedure

patmelad

Starting to get Involved
Finally, I updated our QMS for the risk-based approach by updating our "quality planning" procedure with a short "risk-management for processes" chapter for all (!) QMS processes, and renamed our "risk management" procedure to "product risk management".

So, all QMS processes requiring a formal risk management according to 14971 (e.g. during design and development) reference to the SOP "product risk management", and the control of all QMS processes is controlled by the SOP "quality planning".

Next month we are audited by our notified body - then I will know if this approach is alright...
What was your risk-management for processes" chapter for all can you share that?
 

James

Involved In Discussions
Finally, I updated our QMS for the risk-based approach by updating our "quality planning" procedure with a short "risk-management for processes" chapter for all (!) QMS processes, and renamed our "risk management" procedure to "product risk management". So, all QMS processes requiring a formal risk management according to 14971 (e.g. during design and development) reference to the SOP "product risk management", and the control of all QMS processes is controlled by the SOP "quality planning".

Next month we are audited by our notified body - then I will know if this approach is alright...

Hi Wolf - how did you get on with this approach?

Cheers

James
 

Wolf.K

Quite Involved in Discussions
Hi Wolf - how did you get on with this approach?

Cheers

James

Worked very well! Our auditor really liked it. I also copied all risks for all processes into a single FMEA-like spreadsheet file.

Currently I am updating the lists, as I want to get rid of the problem of "cognitive bias". So far I am glad, that very often I am in a bad, gloomy mood and like to think in very bad ways. This way, we covered many problems so far. During the last audit, the only problems the auditor found were related to things people were trained to to, knew they have to do them - but just forgot to do them. "I had so much to do, I just forgot to do THAT".
 

James

Involved In Discussions
Currently I am updating the lists, as I want to get rid of the problem of "cognitive bias". So far I am glad, that very often I am in a bad, gloomy mood and like to think in very bad ways

I guess cognitive bias when its 'awfulising' in risk management is a good thing - we want to imagine the worst possible scenarios happening with our products and plan for their mitigation. I like the quality planning vs product risk management separation, so I think I will follow suit. Thanks for sharing your experience
 
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