A new approach in the development of quality management systems for (micro)electronics

摘要

This paper presents the new approach in the analysis of the Quality Management Systems (QMS) of companies, based on the revised standard ISO 9001:2015. In the first part of the paper, QMS based on ISO 9001 certification are introduced; the changes and the updates proposed for the new version of ISO 9001:2015 are critically analyzed, based on the documents elaborated by ISO/TC 176. The approach based on ISO 9001:2015 could be considered as "beginning of a new era in development of quality management systems". A comparison between the between the "old" standard ISO 9001:2008 and the "new" standard ISO 9001:2015 is made. In the second part of the paper, steps to be followed in a company to implement this new standard are presented. A peculiar attention is given to the new concept of risk-based thinking in order to support and improve application of the process based approach. The authors conclude that, by considering risk throughout the organization the likelihood of achieving stated objectives is improved, output is more consistent and customers can be confident that they will receive the expected results. Finally, the benefits of the new approach in the development of quality management systems are outlined, as well as how they are reflected in the management of companies in general and those in electronics field, in particular. As demonstrated in this paper, well understood and properly applied, the new approach based on the revised standard ISO9001:2015 could offer a better quality management for companies operating in electronics and beyond.