TWA - not the airline
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Paul, thanks for this interpretation. For me whiteout always has been a No No, especially as I'm now regulated by 13485 and 820CFR, but I've been always under the impression that GDP was more or less independent from the standards...
Yes, I too cannot find in the ISO 9001 standard anything about white out. But if as a company you prefer to use Good Manufacturing Practices you can put this into you upper level procedures for documents. ie "No entries on documents can be erased or whited out. If a mistake is made a simple line with the correction and correctors initials must be used" You can even specify the color of pen used. It is all up to you. If you do have this wording in your procedures then yes it would be a non-conformance.
