Japanese Standards Association ISO13485: 2016 Quality Management System Practice Guide

The only official guide for ISO13485: 2016 certified organizations !! This is the Japanese version of "ISO13485: 2016-Medicaldevices-Apracticalguide-AdvicefromISO/TC210" published by ISO in 2017. As a practical guide for building ISO13485: 2016, which is the basis of quality management of medical organizations, the explanation is given by quoting the original ISO13485: 2016 article by article. Explanations not mentioned in the original standard, such as the intent of the requirements of ISO13485: 2016 and the concrete approach, are prepared by a task group of experts of the ISO/TC210 technical committee, and ISO13485: 2016 It will be a great help in building. Whether you are an organization working on ISO13485 for the first time this time or an organization that has already built a management system based on the previous edition published in 2003, this guide will provide equally relevant advice.