Happy Friday, y'all!
Has anyone ever written a nonconformance using the company's quality manual as the reference standard? The company is not registered to any ISO standard, but they are registered with the FDA (not sure if 21 CFR 820 applies to them, though). Their procedures are not written in such a way that they can be used as the reference standard (at least I don't think so), however, the quality manual is.
Just curious. Anyone care to share their experience with this kind of scenario?
Thanks...
Has anyone ever written a nonconformance using the company's quality manual as the reference standard? The company is not registered to any ISO standard, but they are registered with the FDA (not sure if 21 CFR 820 applies to them, though). Their procedures are not written in such a way that they can be used as the reference standard (at least I don't think so), however, the quality manual is.
Just curious. Anyone care to share their experience with this kind of scenario?
Thanks...