This study presents the systematic implementation of a quality management system and enhanced biosafety protocols for Mpox outbreak response at the Rodolphe Merieux Laboratory INRB-Goma, maintening diagnostic reliability is a critical challenge. Using the Slipta 2023 checklist, aligned with ISO 15189:2022 and ISO 15190:2020, we conducted a cross sectional descriptive study from January 2023 to july 2025.The baseline audit revealed an overall score of 39%, highlighting significant gaps in technical documentation and metrology. The implementation phase involved developing eight core standard operating procedures including equipment management, risk assessment and non-conformity handling alongside intensive staff capacity building. Structural improvements were achieved in sample reception and laboratory workflow optimization. Performance was monitored trough monthly key performance indicators focused on environmental control and analytical accuracy. Our results demonstrate that a robust quality management significantly improves diagnostic reliability and personnel safety during infectious disease outbreaks in resource limited settings. This structured approach serves as a scalable and replicable model for other laboratories facing similar public health emergencies.

Ntwali Kabundula Herve is a Laboratory scientist at Rodolphe Merieux Laboratory INRB-Goma, Head of consultation and clinical analyses department, researcher infectious diseases, clinical biology and quality management system. I focus on strengthening diagnostic systems for emerging viruses, play a key role in the Mpox and Ebola response in North-Kivu through quality management and personnel training.