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    <p>I work in a 21 CFR 820 (regulated Medical Device)/ISO 13485 environment, but the "big picture" is much the same as ISO 9001. I agree with all the things above about ISO 9001 being about process, not tools. </p> <p>However, you may be working in an area where you need to implement procedures for engineering design controls, and design controls will touch on the processes, tools, and work instructions used by developers. In particular, in the medical device arena we have to worry about any software tools that have bearing on the safety or effectiveness of the product. This includes tools for configuration management and version control (if you can't control which version of the software you are building, you can't say convincingly that you know which version(s) are in the field, so you can't tell which customers to contact for a recall). </p> <p>For such tools, we have to have "Computer Systems Validation" (CSV) documentation. CSV for a third-party tool includes (1) a tool specification which describes the use cases within the product development cycle and how they affect quality and (2) test cases which can provide objective evidence that the tool is effective in the intended use cases. </p> <p>For a version control system, this would mean basically a white paper describing the features you use (checkin, checkout, branches, tags) and some tests of those features demonstrating that they work. For bonus points, if the software has its own test suite you can include evidence that it runs and passes its own tests. </p>
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    1. POWhat are the implications of ISO 9001/CMMI for source control in general, and Git/Mercurial/DVCS in particular?
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