Abstract
Background:
Biobanks have evolved from simple repositories into complex research infrastructures that require robust governance frameworks to ensure traceability, data integrity, and operational reliability. ISO 20387 provides internationally harmonized accreditation standards for biobanking; however, empirical evidence evaluating its organizational impact remains limited.
Methods:
We conducted a longitudinal observational study of a hospital-based biobank between 2019 and 2025. ISO 20387 accreditation obtained in 2022 was considered the structural intervention point in the analysis. Governance and quality indicators were evaluated across the sample lifecycle, including labeling error rate, metadata completeness, traceability completeness, nonconformity rate per 100 aliquots, on-time processing, and Corrective Action and Preventive Action (CAPA) closure time.
Results:
Operational activity expanded substantially during the study period, with annual aliquot production increasing from 2142 aliquots in 2019 to a peak of 7668 in 2022. Governance indicators improved progressively during the pre-accreditation phase and stabilized following accreditation. Metadata completeness increased from 74% to 86% before accreditation to 99%–100% afterward, while traceability completeness rose from 71%–73% to 98%–99%. Nonconformity rates declined from 2.03–2.43 per 100 aliquots before accreditation to 0.75–0.90 afterward. On-time processing improved from 87%–93% to 98.5%–99%, and median CAPA closure time decreased from 53–63 to 39–42 days.
Conclusions:
ISO 20387 accreditation was associated with structural stabilization of governance processes in a hospital-based biobank undergoing substantial operational expansion. These findings suggest that accreditation can act as a catalyst for governance maturation, helping biobanking infrastructures maintain operational control and quality performance while scaling activity.
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