With tones of pages to describe everything and nothing. I see a lot of companies that have an ISO 13485 Manual that is built like a book. Why?īecause this is the first document that you should know if you want to understand the Quality Management System.ĭo you know one of the common issues I see when I review some Quality Manual? One of the first things I look when I arrive at a Medical Device company or to one supplier is the ISO 13485 Quality Manual.
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