Improving ISO 9001:2008 with Six Sigma Methodology

ISO 9001:2008 presents a strong focus on measurement, analysis and improvement, but how to meet the new requirements and drive significant performance improvement with a complementary six-sigma program, is the basis of this paper. For many organisations actually process is consistent and repeatable: internal audits, corrective and preventive action systems help to maintain consistency, reduce variation, and even drive small improvements, but it is necessary to get ahead of the competition and not just keep up. Once today’s process is stable and consistent, there is a tendency to treat it like a frame, with strict rules. When challenged to change, people find it hard to think outside the frame. The ISO 9000 family of standards is based on eight quality management principles which, when applied, can help an organisation realize greater benefits; the six sigma program integrates the elements of management culture and quality techniques that are critical to driving performance improvement with a consistent process in four phases, Define, Measure, Analyze, Improve, Control (DMAIC). These phases were analysed and applied to a case study, and we have concluded that the result of a six sigma project is a revised process which is deployed and assured through the quality management system with its documented procedures, communications processes, and internal audit system.