A Practical Field Guide for ISO 13485
Myhrberg, Erik V. / Raciti, Joseph A.
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, Raciti, and Myhrberg have identified the requir...