Lessons from the Field

The road map for ISO 15189-laboratory accreditation: The Experience of Manhiça Health Research Centre (CISM) laboratory, in southern Mozambique

Delfino C. Vubil, Anelsio Cossa, Ergel Salvador, Miguel Bene, Geraldo Manhiça, Chenjerai Jairoce, Edson Mambuque, Lázaro Quimice, Eusébio V. Macete, Francisco Saute, Inacio Mandomando
African Journal of Laboratory Medicine | Vol 15, No 1 | a3153 | DOI: https://doi.org/10.4102/ajlm.v15i1.3153 | © 2026 Delfino C. Vubil, Anelsio Cossa, Ergel Salvador, Miguel Bene, Geraldo Manhiça, Chenjerai Jairoce, Edson Mambuque, Lázaro Quimice, Eusébio V. Macete, Francisco Saute, Inacio Mandomando | This work is licensed under CC Attribution 4.0
Submitted: 08 December 2025 | Published: 22 May 2026

About the author(s)

Delfino C. Vubil, Manhiça Health Research Centre (CISM), Maputo, Mozambique
Anelsio Cossa, Manhiça Health Research Centre (CISM), Maputo, Mozambique
Ergel Salvador, Manhiça Health Research Centre (CISM), Maputo, Mozambique
Miguel Bene, Manhiça Health Research Centre (CISM), Maputo, Mozambique
Geraldo Manhiça, Manhiça Health Research Centre (CISM), Maputo, Mozambique
Chenjerai Jairoce, Manhiça Health Research Centre (CISM), Maputo, Mozambique
Edson Mambuque, Manhiça Health Research Centre (CISM), Maputo, Mozambique
Lázaro Quimice, Manhiça Health Research Centre (CISM), Maputo, Mozambique
Eusébio V. Macete, Manhiça Health Research Centre (CISM), Maputo, Mozambique; and National Institute of Health (INS), Maputo, Mozambique
Francisco Saute, Manhiça Health Research Centre (CISM), Maputo, Mozambique; and National Institute of Health (INS), Maputo, Mozambique
Inacio Mandomando, Manhiça Health Research Centre (CISM), Maputo, Mozambique; National Institute of Health (INS), Maputo, Mozambique; and ISGlobal, Barcelona, Spain

Abstract

Background: Accreditation is an effective way to recognise the quality and competence of a clinical laboratory. Here we describe the steps towards ISO 15189:2012 accreditation of the Manhiça Health Research Centre laboratory, in Mozambique.
Intervention: The accreditation process started in 2012 with a pre-assessment through the Stepwise Laboratory Improvement Process Towards Accreditation, followed by application to the Portuguese Accreditation Institute in 2014, which conducted two audits in 2018 and 2019. Most findings from the accreditation audits were related to personnel management, equipment and reagents. In 2020, the laboratory obtained the accreditation for ISO 15189:2012 and competence for identification and quantification of Plasmodium species by microscopy; full blood count; determination of creatinine, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, total bilirubin, gamma glutamyl transferase, urea; CD4 count; identification and quantification of interferon-γ; detection and quantification of P. falciparum by real-time polymerase chain reaction; rotavirus genotyping; detection of rotavirus by enzyme-linked immunosorbent assay; and bacterial culture, identification and antimicrobial susceptibility testing.
Lessons learnt: Laboratory accreditation is a complex process, which is only possible with the involvement of the whole organisation. Continuous improvement is essential to achieve accreditation.
Recommendations: In preparation for ISO 15189 accreditation, a medical laboratory should focus on building a robust quality management system to ensure the competence of the whole laboratory.
What this study adds: This study demonstrates the importance of strengthening quality management systems towards accreditation. To our best knowledge, this is the first report of ISO 15189 accreditation in a private non-profit research organisation in Mozambique.


Keywords

laboratory accreditation; quality management systems; ISO 15189; CISM; Mozambique

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