Analysis of Workflows, Infrastructure, and Nonconformities in the Accreditation Process of Biobanks in Thailand According to ISO 20387:2018

Workflows, Infrastructure, and Nonconformities in the Accreditation of Biobanks

Abstract

        Biobanks are critical scientific infrastructures that support long-term conservation of biological resources at the national level. The standard ISO 20387:2018 is a requirement for competence, impartiality, and operational consistency. This standard encompasses the entire biobanking process, including collection, reception, transportation, preparation, preservation, storage, data management, and distribution of biological materials and associated data (BMaD). This study aims to analyze the biobanking workflows and infrastructure, as well as to analyze the frequency and types of nonconformities identified during ISO 20387:2018 assessments of five biobanks conducted in Thailand between 2022 and 2024. The analysis of operational workflows provided the biobanks with a comprehensive overview of institutional components, while infrastructure analyses offered insights for optimizing resource allocation to improve process efficiency. A total of 139 nonconformities (NCs) were identified during the assessments, categorized under clauses 4, 5, 6, 7, and 8, with 16, 8, 31, 68, and 16 NCs, respectively. The 6 most frequent nonconformities occurred in: clause 6.3 (Facilities/dedicated Areas and Environmental Conditions), clause 4.1 (General Requirements), clause 7.8 (Quality Control of BMaD), clause 5 (Structural Requirements), clause 7.3 (Reception and Distribution of BMaD), and clause 7.7 (Storage of Biological Materials). Clause 7, Process Requirements, had the highest proportion of NCs, accounting for 48.9% of all findings. This information can be used as guidelines for development and preparation in applying for both initial accreditation and reaccreditation, ultimately promoting the effective utilization of biological resources in future research.