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Hello Laura, I'd be remiss not to point out that the US TAG to ISO TC 176 has an interpretations process that's designed to address your first two questions. They are excellent candidates for the interpretations process because they can be answered with a simple "yes or no." Email standards@asq.org ...

Hello Kelly, I'll tackle this from the ISO 9001/9000 perspective.... There was a requirement in earlier revisions of ISO 9001 to determine "exclusions" and to provide justifications, usually documented within the organization's quality manual. This changed in the 2015 revision of ISO 9001 to now require ...