Development of the Management Systems of Accreditation Body of Bureau of Laboratory Quality Standards in Accordance with ISO/IEC 17011:2017

Development of the Management Systems of Accreditation Body

Abstract

ISO/IEC 17011:2017 has been announced to replace the original edition (ISO/IEC 17011:2004) by International Organization for Standardization (ISO) and International Electrotechnical Commission (IEC) since November 2017. The Bureau of Laboratory Quality Standards (BLQS) of the Department of Medical Sciences is approved to be a full member and signatory to the Asia Pacific Accreditation Cooperation (APAC) Mutual Recognition Arrangement (MRA) and becomes a signatory to the International Laboratory Accreditation Cooperation (ILAC). Facing national challenges, BLQS needs to strengthen the capacity to provide accreditation of conformity assessment bodies in accordance with the new version standard ISO/IEC 17011:2017, and a peer evaluation process must be carried out by the APAC Evaluator within 3 years of the announcement date. By comparing the contrasting requirements between ISO/IEC 17011:2017 and ISO/IEC 17011:2004, BLQS was able to conduct a comprehensive analysis. With this information, BLQS could effortlessly incorporate the gap analysis, taking into account its current status. In doing so, BLQS could strategically devise a transition plan to ensure the maintenance of the APAC MRA across Accreditation Bodies. One notable accomplishment was the revision of the quality manual, which included updated requirements, and processes. BLQS had also succeeded for a significant development in competence, information, and risk managements. Nonconformities gained from accreditation process and views of interested parties were also discussed to identify opportunities for continuous improvement. Finally, our efforts had been acknowledged by the APAC, who had approved our
comprehensive report of ISO/IEC 17011:2017 on February 28, 2020. In addition, BLQS was also re-evaluated and approved to be a full member and signatory to APAC MRA and ILAC MRA in 2022. This information can be used as a guideline to plan the improvement of the organization to have a quality system that is accepted internationally as well as promoting the further development of the country’s bioeconomy.