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![]() ![]() ![]() FDA QSR states, “Each manufacturer shall have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by this part are correctly performed.” The corresponding requirement in ISO 13485 and ISO 9001, says, “Personnel performing work affecting conformity to product requirements shall be competent on the basis of appropriate education, training, skills, and experience”.Īn FDA Inspection or a Notified Body audit will cover the methods you established to determine competency, evaluate employees, and take actions.
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