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ISO 13485:2016 Chapter 8 Integration of the subsections

01mercy

Involved In Discussions
#1
Dear all,

I'm searching for feedback with clear motivation how to see the integration, of the different topics of Chapter 8, into the processes in scope of the QMS.

I have tried to make a schematic sketch of it for myself which is attached.

My goal is to have a clear understanding how the different sections of Ch8 are integrated into the processes in scope of the QMS.
I think it might help a lot when I get input from knowledgeable people here on the forum.

Thanks a lot :thanx:
 

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indubioush

Quite Involved in Discussions
#2
I think you are generally on the right track. Do you have specific questions? Every company does things a little differently.
 

01mercy

Involved In Discussions
#3
Hi Indubioush, thank you for your input. Sorry for my later reply.
A specific question I have is what includes feedback? I see different interpretations over the internet.
 

indubioush

Quite Involved in Discussions
#4
Feedback is any information the helps you know whether you have met customer requirements. It could be product monitoring data, clinical data, complaints, etc. It is the way you know your product is working, and if there is a problem, you make improvements through your improvement processes. Does that help?
 
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