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. 2020 Nov 23;20(1):1065.
doi: 10.1186/s12913-020-05934-8.

Impact of ISO/IEC 17025 laboratory accreditation in sub-Saharan Africa: a case study

Mercy A Okezue  1   2 , Mojisola C Adeyeye  3 , Steve J Byrn  4 , Victor O Abiola  3 , Kari L Clase  5
Affiliations

Impact of ISO/IEC 17025 laboratory accreditation in sub-Saharan Africa: a case study

Mercy A Okezue et al. BMC Health Serv Res. .

Abstract

Background: The 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.

Methods: Pre- 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?"

Results: Statistical analysis of the pre- to post- accreditation audits from the years 2013 through 2017 revealed a significant decrease in the total number of nonconformities (χ2 = 74, p-value = 9.99e-05, r = 0.67). Further examination of audits from the years 2013 through 2018 audits also revealed a reduction in the number of nonconformities (χ2 = 53, p-value = 9.99e-05, r = 0.62). A reduction in the number of major observations and a decrease in the severity of nonconformities was also observed.

Conclusions: A 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.

Keywords: Accreditation; Audits; ISO/IEC17025: 2005; Nonconformities; Quality control laboratory; Sub-Saharan Africa.

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Conflict of interest statement

1st Author worked as a regulatory officer at NAFDAC laboratory for 15 years and is currently a PhD student at Purdue University.

2nd and 5th authors are Management personnel at NAFDAC, Nigeria.

3rd and 4th Authors are Professors, academic advisors to 1st author in her PhD program.

The authors declare that they have no conflict of interest.

Figures

Fig. 1
Fig. 1
Summary of total number of nonconformities (NCs) pre- and post-accreditation. Total number of NCs for the laboratory declined pre- to post-accreditation
Fig. 2
Fig. 2
Summary for severity of laboratory’s nonconformities (NCs) pre- and post-accreditation, show major management and technical NCs decreased post accreditation. There were decreased numbers of major NCs, for both management and technical requirements, pre to post-accreditation years of audits
See this image and copyright information in PMC

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