JUSE Press Illustrated new ISO9001

The quality management system standard ISO 9001 was significantly revised in November 2015 as ISO 9001: 2015 for the first time in 15 years. The purpose of the revision is to integrate the management system of the organization (company) with the ISO 9001 system, to build and operate a quality management system that considers the risks of the organization, to emphasize performance (results), and to strengthen the process approach operation. This document aims not only to explain the revised new ISO 9001 standard requirements, but also to explain the process approach and how to implement risk response in an easy-to-understand manner. It also cites ISO 9001 as a basic standard and adds requirements specific to the automobile industry, including the contents of the IATF 16949 standard, which is a sector standard for the automobile industry. The ISO 9001 standard requires risk-based thinking to be incorporated into quality management systems. This risk-based process approach is referred to in this document as the "risk-based process approach."