Integrating Six Sigma into a Quality Management System in the Medical Device Industry

  • Nadica Hrgarek
  • Kerri-Anne Bowers
Keywords: medical device, QMS, quality improvement, quality management system, Six Sigma


Six Sigma is a valuable management strategy to improve business processes, reduce development and production costs, increase profit margin and improve customer satisfaction. The purpose of this paper is to describe how applicable Six Sigma concepts may complement and support formal quality management systems (QMS) in the medical device industry.

A significant number of issues, which increase the development costs and times, is often found during different phases of a medical device life cycle. Some defects with high patient safety risk may result in dangerous and very costly product recalls.

The basic idea of this paper is to explore the possibilities of integrating Six Sigma techniques with an existing QMS throughout the entire life cycle of a medical device. This paper addresses how Six Sigma techniques, when appropriately integrated into the QMS at medical device companies, can eliminate defects earlier in the medical device life cycle, identify major opportunities for cost savings, focus on customer needs and expectations, and improve the overall business processes.

How to Cite
N. Hrgarek and K.-A. Bowers, “Integrating Six Sigma into a Quality Management System in the Medical Device Industry”, JIOS, vol. 33, no. 1, Jul. 2009.