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

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 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.