Preparation for Laboratory Accreditation of Public Health Laboratory According to ISO 15189: 2012 of the Regional Medical Sciences Center 12/1 Trang

Abstract

       Preparation for medical laboratory accreditation according to ISO 15189: 2012 to increase the capacity and availability of laboratories for build the confidence to customers by studying specifications and proceed new requirements for quality management and technical management. Including laboratory safety requirements ISO 15190: 2003 provides a comprehensive ISO 15189: 2012 by studying the requirements increased from year 2007, as follows: quality management number of 13 items, technical management number of 28 items, and study the laboratory safety requirements ISO 15190:2003 number of 65 items. The regional medical sciences center 12/1 Trang has analyzed the requirements to improve of the clinical pathology laboratory. Firstly, the maximum of quality management consisted of 3 items representing 23.07 per cent, by increasing the quality indicators ISO 15189: 2012 in the quality manual for work processes of risk management procedures, and has improved the assessment of satisfaction as the same pattern. Secondly, it is the laboratory safety, mainly to supply security equipment in the laboratory number of 6 items representing 9.23 per cent. Finally, it is technical management number of 2 items representing 7.14 per cent by reviewing the test methods in accordance with the patient's condition, and increase the measurement uncertainty of analysis with statistical data. The data from this study were used to prepare the ability certifies medical laboratory standard ISO 15189: 2012 of the regional medical sciences center 12/1 Trang and cover according to requirements of quality management, and technical management includes the requirements of ISO 15190: 2003. Therefore, the regional medical sciences center 12/1 Trang certified ISO 15189: 2012 has a laboratory safety manual, and a risk management plan that complies with the quality management system ISO 9001: 2015.