Sagai, thanks for your input.
Maybe I wasn't all that clear in my first post.
We *are* describing procedures for all the required activities in ISO 13485, that is not the issue here.
My question was more about how many *processes* you must formally describe in the quality manual. What we did so far was to describe only SW development (from ideas/inputs to release) and one more customer service-oriented process.
Based on the feedback I got (thanks all of you!), maybe I will change my approach a bit.
It sounds more reasonable to list all processes (HR, purchasing, management...) and document them in simple turtle diagrams. Won't bring any value to the company (a very small operation) but the auditor will feel at home...
Maybe I wasn't all that clear in my first post.
We *are* describing procedures for all the required activities in ISO 13485, that is not the issue here.
My question was more about how many *processes* you must formally describe in the quality manual. What we did so far was to describe only SW development (from ideas/inputs to release) and one more customer service-oriented process.
Based on the feedback I got (thanks all of you!), maybe I will change my approach a bit.
It sounds more reasonable to list all processes (HR, purchasing, management...) and document them in simple turtle diagrams. Won't bring any value to the company (a very small operation) but the auditor will feel at home...
And no, you can't avoid to write ...
br
Sz.
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