Integrating six sigma and lean production into ISO 9000 quality management system

The new ISO 9001:2015 standard explicitly expects organizations to identify and address risks affecting product and service compliance; resulting in improved customer satisfaction. To prevent and correct unwanted actions and outcomes, this research proposes a framework for integrating Six Sigma and lean production into ISO 9000 quality management system in order to overcome the lack of addressing “how to do” in the ISO 9000 system and to establish an efficient and effective documentation system that will support continuous improvement. A case study is included which describes the experience of a local company using the proposed approach in its new product development department. By reviewing its procedure manual, several possible sources of risk were identified. After applying design for Six Sigma (DFSS) methodology DMADV (define, measure, analyze, design, verify) and lean production with value stream mapping (VSM) problem solving steps, a new procedure has been developed and implemented to improve operating efficiency in the department. The result shows that the time needed to develop a new product is shortened by 25% and the cost is down by 20%. The study also shows that by integrating Six Sigma and lean production into ISO 9000 system can help companies reduce costs/wastes, improve efficiencies, and increase profits. Moreover, to ensure continuous improvement of business continuity. © 2019, Chinese Society for Quality. All rights reserved.