Documenting Software Safety Classifications


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My company provides software engineering services to medical device manufacturers, and we have documented/tracked software safety classifications of software systems and items in different ways. I was wondering how others do it and what you think is best.

Most of the time, we include the software systems and a break down into software items, each with their classifications, in the software architecture document. But for some clients, we have had a separate form that lists each software system and item with its corresponding classification. We also have a column in our traceability matrix for the software item and its classification.

Where do you document the software safety classifications of your software systems and items?



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I generally prefer to put it in the Software Development Plan since that frames up what has to be done. I don't think there's a specific, "right" answer, though.


Trusted Information Resource
concur with Yodon.

Software development plan is a good place for the safety classification, which is where I typically put it, but as long as you have the classification somewhere, and it's properly referenced, and included in your Technical File (or DHF), then you should be good.


Involved In Discussions
Would either of you that responded post a scrubbed version of an SDP showing how you do it?

I'll tell you how I do it.

First off, there are reference documents (A) on the product and/or software architecture(s) that allow specific software systems to be identified.

Then there are hazard analyses (B) of the product and software system(s) that provide a basis for the classification(s).

Then in the SDP a section says "Software System X, as defined in document A, is classification Y based on document B per SOP 123."

Then the fun really gets going as the SDP describes how the quality practices for X will be performed for Y per SOP 123. Might be multiple of each X, A, Y, B and 123, to be sure.
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