Improvement of a Quality System of Public Health Laboratory Accreditation from ISO/IEC 17025: 2005 to ISO/IEC 17025: 2017

Abstract

The laboratory accreditation of public health laboratory to the international standard ISO/ IEC 17025 is a competence assessment of laboratories for laboratory quality systems covering two main clauses, management and technical. This accreditation is for the purpose of consumer protection and ensure the quality of goods and service provided. Accordingly, changing of accreditation of competence of testing and calibration laboratories, from ISO/IEC 17025:2005 to ISO/IEC 17025:2017, is important for laboratories to reflect the changes in market conditions and technology. This study aims at improving services for laboratory accreditation process of the accredited laboratory and Bureau of Laboratory Quality Standards (BLQS). The improving of the general requirements are based on major changes in the 2017 revision. The study collected data from 208 laboratory assessments performed from 2018-2020 to examine the trend of nonconformities obtained during the year of assessments. Marketing mix and mind map were used to analyze the accreditation process. The results suggest that 1,991 nonconformities were found from laboratory consisting of nonconformity in general requirements (6.53%), structural requirements (3.82%), resource requirements (23.66%), process requirements (50.23%) and management system requirements (15.77%). The BLQS also improve the laboratory accreditation process by using 3 factors of marketing mix including promotion, personnel and processes. Online service and fast track service channel were introduced, consequently, the accreditation of laboratories is faster by reducing the time for certification from 220 days in year 2018 to 140 days in year 2019. In this regard, about 63.52% of accreditation was improved in efficiency. In addition, Key Performance Indicators (KPIs) for certification process was reviewed from within 15 days to 7 days in year 2020. Accordingly, 91.84% of laboratories accreditation were certified within 7 days. As a result, company or organization can use certificates in building trust, enhancing business reputation and the business operations are able to keep up with the changing economic conditions.