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I work for a pharmaceutical company that is new to devices & ISO. All of our procedures were designed to comply with 21 CFR 211. – I recently initiated some requests to begin evaluating the suppliers for our new medical device product. We have an existing procedure for approving suppliers which begins with sending the suppliers a 13 page “supplier quality system questionnaire”. I looked at the regulations and it seems to me that both ISO and 820 only require that you establish a procedure evaluating and approving suppliers. They don’t require a particular format or any specific questions, so the current questionnaire seems sufficient to me. - However, our internal auditor objected to our use of the existing questionnaire because hasn’t been tailored to medical devices. Does anyone have any thoughts on this? Do I need a device specific questionnaire?