Just wanted to let everyone know that we completed our upgrade audit on Nov. 4 & 5 and I am happy to state that we were recommended for certification! I want to thank everyone who contributes to this forum! The understanding I obtained on the standard was from this forum. From posting questions and receiving advise and opinions to reviewing other's questions and answers. I've spend (wasted) alot of money on the many books on the market before I found this site.
We had two minor ncs and two ofis. Believe it or not the ncs were not related to any of the new requirements. They were in document control and lag time in closing a corrective action.
The ofi was in the monitoring and measurement of the management process. We have a very reasonable auditor. He saw that we understood what needed to be done and was measuring and monitoring other processes. He also stated that many of the companies that he had audited was struggling with this. After the first day of the audit (when we covered this requirement), I visited one of the threads on management review and there was alot of good information.
Thanks again everyone. Marc, I thank God for you and your site
Congratulations... We also went through our upgrade registration this week (11/3 - 11/5) with a scope change (to include Design Verification and Validation) and passed with one observation and one minor Action Item (for last paragraph of 8.3 - positive recall happens so infrequently, we did not have recent evidence of this and our NCM procedure did not specifically address this requirement). All in all, that will be easy to address. The Auditor also had a few positive comments on some of our systems, especially our simple procedure which deals with infrastructure. ERL