The first thing one needs when working with quality management, as with numerous other areas within and outside the medical device industry, is their own copy of the standard. ISO 13485:2016 is the Medical devices – Quality management systems standard and it can be...
This article is aimed at people working with quality management systems since it will present how to create controlling documents that are essential for QMS. It will focus on purpose and scope which may seem simple at a first glance. And sure enough, writing a purpose...
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