We Achieved ISO Certification! Now What?
Global Medical Device Podcast powered by Greenlight Guru
The FDA May Come Auditing Your Quality Management System, but You Don't Want It to Come Out Right
There's a nagging question in my mind that says, okay, philosophically, I agree with what you're saying. But at some point, the FDA may come audit me and I would like to leave as much out of my QMS or my auditable system. How do you answer that question or what does that look like when you talk about including or not including something? Yeah. This isn't going to come out right, but the less you serve up during the regulatory audit, you know, almost almost the better in trying to keep things focused. So on the other hand, when we had our certification audit, sales was included. Sales was actually a half day conversation with our
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