The Effect of ISO 9001 and the EFQM Model on Improving Hospital Performance: A Systematic Review

CONTEXT: This study aimed to explore the effect of the International Organization for Standardization (ISO) ISO 9001 standard and the European foundation for quality management (EFQM) model on improving hospital performance. EVIDENCE ACQUISITION: PubMed, Embase and the Cochrane Library databases were searched. In addition, Elsevier and Springer were searched as main publishers in the field of health sciences. We included empirical studies with any design that had used ISO 9001 or the EFQM model to improve the quality of healthcare. Data were collected and tabulated into a data extraction sheet that was specifically designed for this study. The collected data included authors’ names, country, year of publication, intervention, improvement aims, setting, length of program, study design, and outcomes. RESULTS: Seven out of the 121 studies that were retrieved met the inclusion criteria. Three studies assessed the EFQM model and four studies assessed the ISO 9001 standard. Use of the EFQM model increased the degree of patient satisfaction and the number of hospital admissions and reduced the average length of stay, the delay on the surgical waiting list, and the number of emergency re-admissions. ISO 9001 also increased the degree of patient satisfaction and patient safety, increased cost-effectiveness, improved the hospital admissions process, and reduced the percentage of unscheduled returns to the hospital. CONCLUSIONS: Generally, there is a lack of robust and high quality empirical evidence regarding the effects of ISO 9001 and the EFQM model on the quality care provided by and the performance of hospitals. However, the limited evidence shows that ISO 9001 and the EFQM model might improve hospital performance.