Evaluation of the Effectiveness of the ISO/IEC 17025:2017 Quality Management System at the Laboratory of Regional Medical Sciences Center 12 Songkhla

Abstract

         The laboratory of Regional Medical Sciences Center 12 Songkhla implemented ISO/IEC 17025:2005 for quality management and later transitioned to ISO/IEC 17025:2017, which introduced additional requirements on risk management and impartiality. As a result, the management approach has shifted toward evaluating the strategic effectiveness of the quality management system. This study aimed to evaluate the effectiveness of the laboratory quality management system at Regional Medical Sciences Center 12 Songkhla under ISO/IEC 17025 by applying the Balanced Scorecard (BSC) framework. A descriptive case study design was employed, analyzing secondary data collected between 2019 and 2024 across four perspectives: financial, customer, internal process, and learning and growth. The results indicate that the quality management system demonstrates a high level of effectiveness. The accuracy and timeliness of test reports exceeded 99 percent on average, while the mean customer satisfaction level was 90.27 percent. Personnel development was fully achieved in accordance with the established plans (100 percent), and laboratory capability was expanded through the development of 15 new testing scopes. In addition, revenue generated from laboratory services showed a continuous upward trend. Nevertheless, certain periods revealed risks related to staff satisfaction and customer satisfaction. Overall, the findings suggest that the Balanced Scorecard is an effective tool for evaluating the performance of an ISO/IEC 17025:2017 quality management system beyond traditional compliance-based assessment. Its application supports strategic management, risk-based thinking, and the sustainable improvement of laboratory quality management systems.