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Can I read ISO 13485:2016 vs ISO 9001:2015 Overview on EtoBox?

ISO 13485:2016 vs ISO 9001:2015 Overview by suman is a document available to read on EtoBox.

What is ISO 13485:2016 vs ISO 9001:2015 Overview about?

This document compares the requirements of ISO 13485:2016 for medical device quality management systems to ISO 9001:2015. It notes that while ISO 13485 is still based on the structure of ISO 9001:2008, ISO 9001:2015 introduced changes to numbering and headings. Organizations seeking dual certification must choose between separate quality systems for each standard or an integrated hybrid system. Maintaining consistency with ISO 13485

Author
suman
Language
EN

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