Re: ISO9001 recognition
The company that I work for has decided to try and get ISO9001 recognition.
As I understand it, there is an ISO requirement to keep track of all review
comments for documentation - so you can prove that a QC procedure is in
place and has been followed. At the minute, most people read what I have
produced on hard copy and mark-up any changes that they would like (mainly
scribbled on the hard copy). More often than not, when these changes have
been put in place the reviewed copy is binned.
Any pointers/experiences to help me would be gratefully received.
Marked up review copies should be initialed (or preferably signed, but in any case identified to the reviewer) and dated. They can be stored as hard copy, scanned, or microfilmed. Keep all the review copies that pertain to a single version of a single document together. Bundle these with a copy of the finished document (after review comments have been incorporated or rejected) with a signoff sheet that shows approval of the finished document by whoever is responsible. The change history within the document should show who implemented the review changes. If there are courtesy review copies sent to people whose remarks are irrelevant, I suppose you could not bother to collect those; but the review copies sent to people signing the final doc must be preserved.
When the document is next revised, the entire package of the superseded version goes into an archive file with other, earlier, versions. Only the most recently approved version stays in the active file.
YES I AM TALKING ABOUT PAPER (unless you go the scan or microfilm route). You can avoid all this if you enforce an electronic-only review and markup regime, such as one using Acrobat. Otherwise, when the product finally ships and the development project is over, all the paper you have saved gets microfilmed and then goes into storage files that you ship to Iron Mountain (or some such company) for retention for some fixed period. In the case of regulated industries like medical devices, there are specific rules on how long to save this stuff. In unregulated environments, I guess you make your own rules.
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- Re: ISO9001 recognition, Sean Brierley
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