Developing a quality management system implementation process for a medical device manufacturer

Abstract

Purpose – The purpose of this paper is to develop and test a quality management system (QMS) implementation process for a medical devices manufacturer, which are covered by ISO 13485:2007 and RDC No. 59:2000 and based on operations strategy content definitions. Design/methodology/approach – The research strategy is based on the Cambridge approach which is supported by action research techniques for producing “application” processes. This research strategy is also known as the “Process Approach” or “the Engineering Approach” and was developed in the mid-1990s by researchers from the “Institute for Manufacturing” (IFM/University of Cambridge). Findings – The results reveal how real conditions “shape” implementation, indicating solutions for integrating procedures for performance and control indicators that represent manufacturing strategy objectives. The regulatory framework and the manufacturing environment offer these real conditions. The operations strategy that is underlying implementation shows how to reconcile regulation and strategy through its content. Research limitations/implications – The developed process can be improved by increasing the number of test cases until they bring no new contributions for its evolution. However, because it is a long-term and complex implementation process, the present research was concluded with a full understanding of process development. Practical implications – The QMS implementation process based on the Cambridge Engineering approach creates several opportunities for discussing QMS design requirements, but also in testing procedures for quality policy deployment. Learning by doing is a practical contribution of the process as a participative component effectively applied in different moments at the mentioned workshops – WSH. The logical organization of the QMS implementation process shows causalities among manufacturing strategy, QMS and performance measurements, creating strategic coherence among the connected elements. Originality/value – Although many studies had approached the QMS implementation, few of them actually addressed the system integration with the business strategic objectives. None of the studies to date related the implementation to the ISO 13485:2003 and the RDC No. 59.