Re: Anyone know Coke's QA system?
Sean
Working in an FDA environment is similar in many ways to ISO. Yes, FDA systems are a little tighter than ISO systems. The FDA will tell you that not only do you need to maintain quality records but you need to say how long you keep them. They will check to see that you are performing your internal audits, mgmt review, however, they are not allowed to review the contents of the audits or mgmt review meetings. Complaints are another big area for the FDA. All in all the FDA and ISO are very similar. JMHO
