ISO 13485 8.4 Analysis of Data - Procedure example

Jkc3usc12

Involved In Discussions
#1
Does anyone have a good procedure example of 8.4 Analysis of Data or maybe a Procedure that has that clause tied into it with others. I searched couldn't find any.

Thanks
 
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yodon

Staff member
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#2
You're probably already doing most of it in/for Management Review. How, for example, do you analyze the data from feedback? With suppliers, you might get into some statistical significance (do you have a threshold on % of material rejected, for example beyond which you take actions up to and including discontinuing use of the supplier?).

Start with what you're already doing and see how far you get on coverage of the minimum inputs. Ensure what you're doing and what you do (results of analysis) are documented.
 
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