Evaluating the Effects of Quality Assurance: A Comparative Analysis between ISO 9001 Certified and Non-certified Hospitals in Turkey Ozkan Tutuncu, Assoc. Prof. Dr., Dokuz Eylul University, Quality Improvement and Accreditation in Healthcare Department, Turkey. Deniz Kucukusta, Ph D., Dokuz Eylul University, Quality Improvement and Accreditation in Healthcare Department, Turkey Abstract The main purpose of this study is to determine which dimensions of quality management system differs significantly in ISO certified and non-certified hospitals within the perceptions of healthcare employees in Turkey. A structured questionnaire was used to assess the perceptions of health care employees. A stratified random sampling method was used in 3 ISO certified and 3 non-certified medium scale hospitals in Izmir, Turkey. 1000 questionnaires were distributed and approximately 80% returned. Results show that the most important factor was continuous improvement in both service quality and quality management sytem. The differences of the perceptions of the respondents towards quality management dimensions were significant. Introduction Quality assurance aims to ensure that the product or service an organization provides is fit for its purpose and meets customer expectations. It is about managing business process so that both the supplier and the customer are satisfied with the quality and the consistency of the goods and services provided. In health care, Quality assurance (QA) can be defined as all activities that contribute to defining, designing, assessing, monitoring, and improving the quality of healthcare. These activities can be performed as part of the accreditation of facilities, supervision of health workers, or other efforts to improve the performance of health workers and the quality of health services. Quality Assurance and ISO Certification ISO 9000 has been the most commonly implemented quality innovation by US and European organizations in the last decade (The International Standards Organization survey of ISO 9000, 2000). It requires that organizations have verifiable routines and procedures in place for product design, manufacture, delivery, service and support. Vloeberghs & Bellens (1996) also argued that strong senior management commitment had a positive effect on ISO 9000 implementation. Additionally, the cross-functional management team is also an important factor for successful ISO 9000 implementation. One of the reasons why a team is important is that quality management is a collective activity which transcends both individuals and departments (Stamatis, 1995). Under the ISO 9000 standard, an organization must monitor strictly the sequence of steps it takes for the completion of a job (Cole 1999, Brunsson et al. 2000). For this purpose, it must follow process documentation; no shortcuts are supposed to take place. To guarantee compliance with the standard’s requirements, third-party auditors evaluate a supplier’s procedures and carry out site visits twice a year to verify compliance. The end-result is supposed to be an improvement in the organization’s performance. It is also important to empower employees, giving them the power to make decisions and take corrective actions where necessary to get the job done. Managements need to look at the firm’s benchmark partners to recognize its own weaknesses and take appropriate actions to improve efficiency.The ISO 9001: 2000 certification has its own chapter due its strong emphasis in customer satisfaction and the importance of quality management systems to improve organizational performance in all aspects (Chan, 2000). The ISO can be “a safe way” to get and offer quality. The quality offered by the establishment can meet or not the customer’s expectation but one important advantage for the establishment is having the certification of the establishment as a whole, from top to bottom after the firm has been submitted to hard quality procedures. ISO certification is identified as an important factor in implementing continuous quality improvement and total quality management and in promoting integration in health care systems. Certification and accreditation has also been identified as an important factor in promoting patient safety and error reduction in health care organizations (Tutuncu et al.,2007). Each management practice, especially ISO 9000, may have special characteristics, which make it different from other organizational practices (Naveh et al. 2004). This study aims to make a comparison between ISO certified and non-certified hospitals in order to evaluate the differences and effects of quality systems. Results may be beneficial for the hospitals or other health care organizations in the quality assurance process. Also this study may be enlightening for the healthcare organizations which parts of the quality system are perceived more important by the healthcare employees in the aspects of service quality and total quality management system and patient safety. Methodology Data was obtained by administrating a structured-questionnaire survey consisting two parts. The main part of the survey was made up of quality management system which inquires 39 questions. There were three overall statements in the second part, regarding dependent variables, which were representing general perceptions about the quality management system, service quality and patient safety. The last part inquired demographic and nominal questions about the nurses. The items were rated on a five-point scale (1= strongly agree; 2=agree; 3=neither agree nor disagree; 4=disagree; 5=strongly disagree). The employees were asked to rate these statements. The survey was conducted in 3 certified and 3 non-certified, middle scale hospitals in Izmir, Turkey. To make the comparison possible, the hospitals were chosen with similar characteristics in terms of scale and number. In total, 1000 questionnaires distributed by the researchers and usable 803 questionnaires were returned, with a usable response rate of 80,3%, which is statistically acceptable for data analysis. Data obtained was analyzed by using a SPSS program. Data analysis consisted of frequency distribution, correlation analysis, factor analysis, and regression analysis at the base of derivative and inferential statistics. Findings 803 respondents have gone under the research. According to the frequency distribution 82 % of them were women and 18% were men. 75% of the respondents have minimum university degree. Of the respondents, 47% have ISO certification where the others have none. 60 % were nurses and 15 % were medical doctors where the rest of them were other medical staff. The reliability tests have been implemented on data at the base of derivative statistics. The general Cronbach’s alpha of data is found to be as 0,98. In accordance with Cronbach’s alpha result obtained, the factor analysis has been implemented on data.Table 1 shows the factor analysis, mean values and correlation analysis results. Table 1. Factor Analysis and Correlation Results FACTOR 1 – KAIZEN FACTOR 2 – Management Responsibility (MR) FACTOR 3 – Quality System Requirements (QSR) Eigenvalue Variance Explained Mean KAIZEN MGT RES 22,318 58,730 3,20 1 1,597 4,203 3,19 ,905 1 1,163 3,060 3,35 ,877 ,867 QSR 1 RM FACTOR 4– Resource 1,003 2,640 2,70 ,806 ,794 Management (RM) KMO= ,974 Total Variance Expl= 68,633 Barlett Test= 14238,865 Sig.=0,000 ,694 1 Regression analysis is made to determine the importance of independent variables (dimensions in Table 1) on dependent variables (take in Table 2,3 and 4). There were three dependent variables. Table 2. Regression Analysis of the Factors Affecting the Overall Quality Management System T Sig T KAIZEN ,344 5,310 ,000 Management Resp ,318 5,209 ,000 Quality Mgt System ,186 4,271 ,000 Resource Management ,124 3,183 ,002 Constant ,216 2,536 ,000 VARIABLES Multiple R=,845; R square =,714; Adjusted R Square =,712 F=421,400; Signif F=,001 Table 3. Regression Analysis of the Factors Affecting the Overall Service Quality T Sig T KAIZEN ,389 5,933 ,000 Resource Management ,174 3,921 ,000 Management Resp ,234 3,579 ,000 Constant ,544 10,647 ,000 VARIABLES Multiple R=,737; R square =,544; Adjusted R Square =,542 F=268,603; Signif F=,000 In order to compare the difference between ISO certified and non-certified hospitals, T-test was used. According to the T-test, the mean values of all the dimensions in both hospital types differ significantly (p=0,000). Table 4 shows the descriptive statistics of the T-test. Table 4. Descriptive statistics of T-test KAIZEN Mgt Resp Quality Mgt Sys Resource Mgt ISO Certified Non-certified Certified Non-certified Certified Non-certified Certified Non-certified N 380 422 380 420 380 319 380 416 Mean 3,9413 2,5438 3,8571 2,5978 4,0782 2,4915 3,3020 2,1583 Std. Deviation ,68066 ,69263 ,68677 ,65389 ,67747 ,93101 ,89392 ,59638 Std. Error Mean ,03492 ,03372 ,03523 ,03191 ,03475 ,05213 ,04586 ,02924 Conclusion In health care, Quality Management System (QMS) is identified as an important factor in implementing continuous quality improvement and total quality management and in promoting integration in health care systems. The quality management system was analyzd under 4 dimensions These dimensions were determined after the exploratory factor analysis. The main purpose of this study was to determine which dimensions of quality management system differs significantly in ISO certified and non-certified hospitals within the perceptions of healthcare employees in Turkey. The results of this study supports that the main and the most important factor of the quality system was named as KAIZEN, which represents measurement, analysis continuous improvement and service actualization. This core dimension has a very strong effect in both overall quality management system and service quality. Resource management and management responsibility also strongly affect quality system. All the dimensions are strongly and positively correlated with each other, meaning that the quality system and its parts are perceived almost unique. All the dimensions of the management system differ significantly between certified and non certified hospitals. In ISO certified hospitals, continuous improvement, management responsibility and resource management dimensions are perceived positively and more important. This result also shows how the quality management system leads to positive approach in healthcare staff towards management References ISO, 2000, The International Standards Organization Survey of ISO 9000 (Geneva: ISO). Stamatis, D. H. (1995). Understanding ISO 9000 and Implementing the Basics to Quality. New York: MarcelDekker Inc. Vloeberghs, D. & Bellens, J. (1996). Implementing the ISO 9000 standards in Belgium, Quality Progress, June, 43–48. Cole, E. 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