Analysis of Non-conformities and Guidelines for Accreditation System Development of the Bureau of Laboratory Quality Standards Comply with ISO/IEC 17011:2017

Abstract

         Laboratory accreditation is vital for strengthening national quality infrastructure and enhancing the international credibility of testing results. The Bureau of Laboratory Quality Standards (BLQS), Department of Medical Sciences (DMSc), serves as the National Accreditation Body (AB) in accordance with ISO/IEC 17011:2017 and is a signatory to the Mutual Recognition Arrangements (MRA) of the Asia Pacific Accreditation Cooperation (APAC) and the International Laboratory Accreditation Cooperation (ILAC), requiring peer evaluation every four years to maintain its signatory status. This study aimed to analyze corrective and improvement approaches addressing nonconformities identified during the APAC peer evaluation alongside internal quality audit findings from fiscal years 2023–2025 to develop preventive strategies against recurrent nonconformities. Data were collected and analyzed from APAC evaluation and internal quality audit reports and categorized by ISO/IEC 17011:2017 requirements. The results showed that the APAC evaluation identified eight nonconformities and four recommendations, with clause 7 (process requirements) being the most frequently cited for both nonconformities and recommendations. This finding was consistent with the internal quality audit results for fiscal years 2023–2025, which revealed recurring nonconformities in the same clause over a three-year period. Furthermore, combined analysis of the APAC evaluation and internal quality audit findings identified four common areas of concern within clauses 7.4, 7.6, 7.9, and 7.11. These findings highlight areas within ISO/IEC 17011:2017 that require continuous and systematic improvement to enhance the management
system's effectiveness of the accreditation body, ensure sustained compliance with international standards, and strengthen preparedness for future peer evaluations.