Quality Management in Molecular Biology Laboratories: A Comparative Analysis of ISO 15189 Compliance in Abuja Reference Laboratories

ISO 15189 accreditation provides the international benchmark for quality and competence in medical laboratory services, with molecular biology laboratories subject to unique quality considerations related to nucleic acid contamination prevention, assay validation, and reagent cold-chain management. This study comparatively analyzed ISO 15189 compliance in molecular biology laboratory sections at three National Reference Laboratories in Abuja, Federal Capital Territory. A structured gap analysis framework based on ISO 15189:2022 technical and managerial requirements was applied. Pre-examination processes (sample collection, transport, and storage), examination processes (assay performance, reagent validation, calibration), and post-examination processes (result reporting, interpretation, and turnaround time) were evaluated. Laboratory personnel competency records and internal quality control (IQC) data spanning 24 months were reviewed. Compliance with managerial requirements averaged 71%, while technical requirements compliance was lower at 58%, with the most significant gaps in measurement uncertainty documentation, method validation records, and external quality assessment (EQA) participation. Cross-contamination prevention infrastructure was adequate in only one of three facilities. These comparative findings provide a structured compliance roadmap to guide quality improvement investments ahead of formal ISO 15189 accreditation applications at federal reference laboratories in Abuja. Keywords: ISO 15189, quality management, molecular diagnostics, accreditation, Abuja.