The Effectiveness of ISO 9001 and Six Sigma in Healthcare

textabstractIn our Introduction a description and the relevancy of the subject of this thesis are given. We then provide a brief overview of quality management tools and principles. The aims of this thesis are expressed in four research questions to be answered. Subsequently we account for the methodology that has been applied in this study. The core of the methodology consists of the longitudinal case study research method since we studied quality management over a period of six years in the Red Cross Hospital. In addition we used principles of action research because our study was performed during and in interaction with the process of organizational change, i.e. the implementations of quality management tools. To eliminate shortcomings related to case study methodology we also used principles of multi grounded theory, which allowed us to generate theory grounded in qualitative date. Finally we provide the content and the structure of this thesis. An overview of this study is given in chapter 1. A more or less chronological description of our activities is given and the various choices that have been made along the course are accounted for. We describe our first positive experiences with ISO in a radiology department. We then picture policy deployment in the Red Cross Hospital based on three strategic goals; moderate growth, efficiency improvement and optimizing quality. Subsequently we describe our considerations related to quality management system selection and the outcome of the selection process. We have chosen ISO 9000 above the INK-model and the NIAZ Accreditation system because ISO supported best the achievement of our three strategic goals. We then describe the implementation of ISO 9000 and our results. This is followed by our, partly disappointing, experiences related to quality improvement that we experienced some years after the implementations of our ISO 9000 quality management system. We then describe the features and the implementation process of Six Sigma, followed by the results we achieved by working with Six Sigma in the Red Cross Hospital. The differences between healthcare and industry with respect to quality management are analysed and described. The main difference is the fact that in healthcare the patient is part of and experiences the manufacturing i.e. the healthcare process. This means that flaws in the healthcare process directly affect the quality from the perspective of the patient. Consequently, improvements of the healthcare process directly enhance quality perception and in addition lower the costs. This observation explains for the positive effect of Six Sigma in healthcare; it improves quality and lowers costs. We then briefly explain why ISO 9000 and Six Sigma are highly complementary. They both focus on processes, customers’ demands, continuous improvement, employee involvement, fact based decisions and a systems approach on management. We then describe the results of five years working with ISO 9000 and Six Sigma in the Red Cross Hospital. We were able to grow ten percent in five years and lower the costs per inhabitant with slightly more than eight percent. We were also able to keep our patient satisfaction scores high and constant for five years, indicating that efficiency improvement did not affect quality. Finally we provide evidence that adding Lean principles to Six Sigma provides an even more powerful quality improvement instrument.