Our site is not currently ISO certified but our parent company is (we were recently acquired, we provide similar products). It is not clear to me how to best and accurately respond to the supplier survey questions as it relates to Inspections by regulatory bodies and our QMS. The parent company has been audited by regulatory bodies against the QMS that we are not fully integrated into (working on it) but the site has been added to the Quality Manual Scope. My thought is to simply respond as our own entity with the company name and make sure to specify on a note that this site is not certified. Is that the best approach?
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In these situations I always recommend sharing concerns and your suggestion with your company’s legal team. Besides that general approach, I would follow your own suggestion. Answer as your own business unit and make clear that on a note you specify that you were acquired and now have a project in place to get certification and regulatory inspection in the near future.
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Sep 23, 2022