Believe what, Joe? I've seen just as much of the bad as anyone, but that has
nothing to do with the standard itself, you've moved the discussion to
enforcement and conformance.
I've read on this board about how great ISO is compared to GMP as a quality
system. I'm not convinced. I worked at a non-pharma biotech that was ISO
certified, by none other than Lloyd's, and our quality systems were okay,
but not as good as some of the non-ISO pharma quality systems I had worked
under previously or since.
I think that sums it up for me. You have to see ISO and GMP when they're not
combined to appreciate the strengths and weaknesses of both.
-Mike
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