ArticleBMC health services research2020
Impact of ISO/IEC 17025 laboratory accreditation in sub-Saharan Africa: a case study.
Article in BMC health services research, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.
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Who cites it
7 citing papers in PubMed, 23 citations in OpenAlex.
- Analysis of Quality Normative Requirements: Contributions to the Alignment and Standardization of Standards Applied in Health Laboratories.Biotech (Basel (Switzerland)) · 2026Article
- Implementing laboratory quality management systems in Ghana: A quality audit of accreditation readiness in clinical and public health laboratories (2021-2023).African journal of laboratory medicine · 2026Article
- The road map for ISO 15189-laboratory accreditation: The Experience of Manhiça Health Research Centre (CISM) laboratory, in southern Mozambique.African journal of laboratory medicine · 2026Article
- Impact of SAAC accreditation on laboratories in Saudi Arabia according to ISO/IEC 17025:2017.Scientific reports · 2025Article
- Article
- Potency and Powder X-ray Diffraction (PXRD) Evaluation of Levothyroxine Sodium Tablets under Ambient, Accelerated, and Stressed Conditions.Pharmaceuticals (Basel, Switzerland) · 2023Article
- Emerging Antimicrobial Drug Resistance in Africa and Latin America: Search for Reasons.Risk management and healthcare policy · 2022Review
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Authors and funding
5 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe number and severity of nonconformities generated during an audit of a medicine testing laboratory indicates its level of quality compliance. Quality standards are established and maintained to ensure the reliability of laboratory test reports. The National Medicines Regulatory Authority (NMRA) Quality Control laboratories assess the quality of medicines used by the populace as part of their regulatory function. Although countries desire to have reliable medicine testing facilities, accrediting a national laboratory to international standards poses financial and technical challenges for many low-income countries. Sharing the benefits of laboratory accreditation could help more countries within sub-Saharan Africa overcome existing challenges to achieve accreditation and robust quality systems. This study investigated the impact of ISO/IEC 17025 accreditation on the performance of an NMRA Quality Control laboratory to provide evidence of improved quality compliance within a low-resource setting.
methodsPre- and post- accreditation audits of nonconformities for management and technical requirements of the ISO/IEC17025:2005 standards were evaluated from a Quality Control laboratory in the National Agency for Food and Drug Administration and Control (NAFDAC), located in Nigeria, West Africa. The following research questions were addressed: "does accreditation impact the adherence to quality standards?" and "does accreditation decrease the severity of nonconformities in Quality Control laboratory audits?"
resultsStatistical analysis of the pre- to post- accreditation audits from the years 2013 through 2017 revealed a significant decrease in the total number of nonconformities (χ
conclusionsA higher level of quality compliance was exhibited for the laboratory during the post-accreditation years. Overall, ISO/IEC 17025 accreditation of the NMRA Quality Control laboratory resulted in improved reliability of test reports and enhancement of the laboratory quality system.
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