Trend Analysis of Conditions from Nonconformities to ISO/IEC 17025:2017 and ISO 15189:2012 Requirements of Regional Medical Sciences Center 1/1 Chiang Rai during 2020–2023

Trend Analysis of Nonconformity of RMSc 1/1 Chiang Rai, 2020–2023

Abstract

         Accreditation of laboratory competence according to ISO/IEC 17025:2017 and ISO 15189:2012 standards was a process that indicates the quality of a laboratory to develop and improve the quality management system. The purpose of the study was to analyze the trends of problems and causes of nonconformities, classified according to internal audit and assessment to analyze the data for frequency, percentage and trends of the causes of nonconformities requirements, using the data on nonconformities collected from internal audits from 2020 through 2023 and the assessment and accreditation of medical and public health laboratories competence in 2021. Results of this study from the Quality and Technical Development Group and five laboratories revealed 139 items of nonconformities and 98 other items from internal audits of which 65 were based on ISO/IEC 17025:2017 standards, 33 on ISO 15189:2012 standards, and 41 on laboratory competence assessment. Based on the laboratory competence assessment according to ISO/IEC 17025:2017 and ISO 15189:2012 standards, 34 items and 7 items were found, respectively. The problem analysis showed trends of causes, based on the 5M 1E approach, in five requirements including personnel, equipment, quality management, test results/methods, and workplace and environmental conditions. Therefore, training sessions should be provided on knowledge and awareness for personnel especially the testing process and workplace including environmental conditions that affect the risk management and development and improvement of laboratory quality management systems, aiming to maintaining the quality management system as an organization providing effective testing services.