The effectiveness of ISO 9000 Quality Management System in health care: A mixed methods study
Abstract
ISO 9000 Quality Management System is a structural framework of a business system that specifies, in very broad terms, the necessary components of a quality management system. Subjective studies suggest that ISO 9000 can help organizations improve their management practices. In this paper, the researcher examined the effectiveness of the ISO 9000 certification, and tested whether earning the ISO 9000 certification leads to improvement in quality management practices, in medication management practices, and in organizational management systems in health care setting. Using quantitative and qualitative methods, this study investigated a hospital pharmacy. The study was carried out in one phase, with both quantitative data and qualitative data collected during the same time period, and from the same four (4) participants. Using a survey questionnaire of 50 questions, and 15 structured interviews respectively, both quantitative data and qualitative data were analyzed separately during the findings part. The survey questionnaire was divided into two parts. The first part of the survey, 32 double questions, was designed to collect data pertaining to the effect of ISO 9000 on the quality management practices. The results indicated that ISO 9000 certification affected positively the quality management practices of this hospital pharmacy. Out of eight, the ISO 9000 certification improved seven quality management practices. The second part of the survey, 18 double questions, was designed to collect data pertaining to the effect of ISO 9000 on the medication management practices. The results indicated that ISO 9000 certification affected positively the medication management practices of this hospital pharmacy. Out of four, the ISO 9000 certification improved three medication management practices. In both parts, the researcher employed a comparison study methods to analyze the performances before and after the ISO 9000 certification of this hospital pharmacy. The qualitative approach of this study was designed to collect information pertaining to the effect of the ISO 9000 certification on the Organizational Management Systems, and to complement the quantitative approach of this study. Using a purposeful sampling method, the structured interviews enabled the researcher to gain perceptions on the effect of the ISO 9000 certification on the organizational management systems. Data were analyzed through a constant comparative method. As a result, the following three topics were investigated: Customers/Suppliers Relationship Management, Human Resources Management, and Operations Management. The findings revealed a friendly atmosphere, a strong collaborative partnership between the pharmacy and its internal customers (physicians, nurses, and other caregivers) and external customers (patients), a lack of direct interaction with its suppliers, employee participation in decision making was effective, a lack of training and educational program, and intense process management activities. However, the results showed this hospital pharmacy as deficient in using technology assessment services such as bar code medication administration system, preprinted order sets system, and computer decision support. A full usage of technology could have optimized the entire process. Overall, this study presents ISO 9000 Quality Management System as effective in improving the pharmacy management systems. A well documented and consistent ISO 9000 Quality Management System can contribute significantly to improve performances in health care setting.^
Degree
Ph.D.
Advisors
Linda Naimi, Purdue University.
Subject Area
Education, Technology of|Health Sciences, Health Care Management|Operations Research
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