Implementing and Transitioning a Laboratory Quality Management System from ISO 15189:2012 to ISO 15189:2022: Experience from the Malawi-Liverpool Wellcome Research Programme, Blantyre

Abstract

Background: The implementation of a Quality Management System (QMS) in line with ISO 15189:2022 is essential for clinical and research laboratories striving to achieve technical competence and consistent delivery of valid results. This article presents the approach undertaken by Malawi Liverpool Wellcome Research Programme (MLW) laboratories to integrate and manage the QMS based on ISO 15189 and steps taken to successfully transition to the new version of the same standard. Methods: The implementation process involved several key steps, including mentorship, conducting an initial gap analysis, and implementing the quality management system. A quality officer was appointed to oversee the process, supported by leadership engagement and staff training to establish core competencies. Additional activities included the development of required documentation, participation in proficiency testing and Internal Quality Control (IQC) programmes, and the verification of test methods. Quality indicators were established to monitor performance. During the transition to the updated ISO 15189 standard, a second gap analysis was conducted, emphasising risk-based thinking and alignment with patient-centred requirements. Results: The outcomes demonstrate enhanced laboratory performance, improved documentation, and a stronger teamwork and culture of quality. This experience offers practical insights for laboratories seeking to implement ISO 15189 and underscores the importance of tailored implementation strategies that reflect the organizational context and laboratory scope. Conclusions: The successful implementation of a QMS demands a comprehensive, system-wide approach and robust teamwork to achieve established goals effectively. It necessitates ongoing periodic assessments and substantial support human and financial resources. Furthermore, continuous training and mentorship by qualified QMS professionals are essential to foster a culture of continuous improvement.