Practical Field Guide for ISO 13485:2016
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The purpose of this expanded field guide is to assist organizations, step-by-step, in implementing a quality management system (QMS) in conformance with ISO 13485:2016, whether "from scratch" or by transitioning from variations of the ISO 13485 family. In keeping with ISO 9000:2015''s definition of quality as the "degree to which a set of inherent characteristics fulfills requirements," Myhrberg, ...
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The purpose of this expanded field guide is to assist organizations, step-by-step, in implementing a quality management system (QMS) in conformance with ISO 13485:2016, whether "from scratch" or by transitioning from variations of the ISO 13485 family. In keeping with ISO 9000:2015''s definition of quality as the "degree to which a set of inherent characteristics fulfills requirements," Myhrberg, ...
Read more
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