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Translating laboratory quality management system into practice: strategic opportunities and challenges for ISO
Bruno Basil1, Ngozi Ijeoma Okoro2, Izuchukwu Nnachi Mba3
1International Institute of Pathology and Forensic Science Research, David Umahi Federal University of Health Sciences, Uburu, Nigeria.
Introduction:
Laboratory Quality Management Systems (LQMS) are fundamental to reliable diagnostic services and improved patient outcomes. Although Nigeria has made progress through quality improvement initiatives, implementation of internationally recognized standards remains limited. This review critically examines the relevance of ISO 15189:2022 for strengthening laboratory quality systems in Nigeria by evaluating its major revisions, current implementation status, challenges, opportunities, and evidence-based strategies for national adoption.
Methods:
A structured narrative review was conducted using evidence published between January 2010 and July 2026. Electronic databases (PubMed, PubMed Central, Web of Science, and Google Scholar) and institutional sources (WHO-AFRO, ASLM, MLSCN, NiNAS, and ILAC) were systematically searched. Evidence selection followed a PRISMA-informed process, while reporting adhered to the SANRA guideline. Of 379 records identified, 55 met the inclusion criteria, with 49 synthesized thematically and six retained for foundational and conceptual support.
Results:
The evidence showed that LQMS implementation in Nigeria remains heterogeneous, with stronger performance in donor-supported reference laboratories than in many public facilities. SLMTA and SLIPTA programmes have improved laboratory audit performance, including in Lagos State, yet fewer than 30 of Nigeria's over 5,000 clinical laboratories are currently ISO 15189 accredited. Major barriers include fragmented governance, inadequate financing, weak infrastructure, workforce shortages, limited digital integration, and poor quality culture. ISO 15189:2022 introduces patient-centred, risk-based quality management, integrated point-of-care testing, and flexible documentation, creating opportunities to modernize laboratory practice through strengthened governance, digital transformation, workforce development, and sustained investment.
Conclusion:
ISO 15189:2022 provides a practical framework for improving laboratory quality and technical competence in Nigeria. Successful implementation will require coordinated regulatory reforms, expanded stepwise quality improvement programmes, sustained financing, workforce capacity building, and digital innovation to strengthen diagnostic services and support resilient health systems.
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