Question
I would like to know how ISO 9001 management system could facilitate a merger & acquisition. By speaking a common language and using the same exigencies, do you think ISO 9001 could facilitate this type of operation?
Answer
I’ve done this in the past but not with ISO 9001, instead using FDA Part 820 Quality System Regulation. I created a checklist from the regulation and then audited the facility being merged / acquired. This was done to determine the state of the quality management system and what needed to be done (including costs) to ensure the facility was in compliance.
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