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Tag: "marketing" - Expert Advice Community

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  • Do people working in departments excluded from scope have to be trained for QMS?

    I have a question regarding how to decide if a person needs to be trained in various parts of a QMS set up for 13485:2016 compliance. People processing medical device have to be trained. But what about a person for example in marketing, who has nothing to do with any part of the work affecting product quality. Do people working in departments excluded from the scope of the QMS (for example finance, legal, marketing) have to be trained in various procedures contained in the quality manual?