Process development for Laboratory Accreditation of Public Health Laboratory according to ISO/IEC 17025 : 2005 Bureau of Laboratory Quality Standards

Abstract

       Laboratory Accreditation for Public Health Laboratory according to ISO/IEC 17025 : 2005 is a process used to resolve trade barriers between countries. To promote the health product of the country's for exports. And prepare for the liberalization of trade in ASEAN in the year 2558. Bureau of Standards Laboratories has developed a laboratory accreditation process by analyzing the results of operations and laboratory quality assessment report for the year 2011 to 2013 on 258 reports from 237 laboratories. The accreditation process was analysis using SIPOC model, Stakeholder Value Analysis, Plan Do Check Act (PDCA), Failure Effect Mode Analysis (FMEA) and Balanced Score Card (BSC). Found that the non-conformance according to the requirement of ISO/IEC 17025 : 2005 were 2270 items which was the defects from quality management 39.5 percent and technical management 60.5 percent. The laboratory accreditation process provides a fast and meets the needs of customer and stakeholder. Can shorten the time in an accredited laboratory to only 162 days in the year 2013 from the time specified in the year 2011 is 240 days, a period decreased 32.5 percent. It also provides technical accreditation of drug testing laboratory. Set up the specifications and key performance indicators to track the implementation of the accreditation process. For transparency and convenience, the laboratory could fee paid by teller payment. The laboratories have satisfied the certification has increased in the year 2554 to 2556 was 82.7, 83.4 and 85.7, respectively.