spamman
19th September 2006, 05:45 PM
All: I recently went through our 1st ISO13485:2003 certification audit. We had 1 major and 3 minors that we are working on fixing and completing in an aggressive timeframe. I have a pretty good grasp on the the findings and the plan to fix, however 1 minor was: No procedure for external document control and revision control therein. So, for example, the electronic and paper copy of the ISO13485:2003 directive is kept in a binder in the quality library. It is stated as such in our control of documents procedure but we have not way to ensure it is the MOST recent revision. That is an example, but we will build a master list of all documents that require control. SO, can anyone recommend a service or services that will e-mail, or call, or mail when upcoming revisions are being proposed or released? For example, we subscribe to "CyberRegs" for 21-CFR, 40-CFr, 29-CFR updates. We get a daily update. i would like the same for other documents. Thoughts? peace: e3





