Guidance Document on Establishment and Implementation of National Certification Programs (NCP) for ISO 15189 compliance in Medical Laboratories in Africa

Guidance Document on Establishment and Implementation of National Certification Programs (NCP) for ISO 15189 compliance in Medical Laboratories in Africa

Guidance Document on Establishment and Implementation of National Certification Programs (NCP) for ISO 15189 compliance in Medical Laboratories in Africa

NCP

Reliable and quality-assured laboratory services are a cornerstone of strong and resilient health systems. They underpin timely disease detection, accurate diagnosis, antimicrobial resistance monitoring, outbreak preparedness, and effective patient management. Across the African continent, the role of laboratories in strengthening health security and advancing Universal Health Coverage (UHC) is increasingly recognized. Despite this recognition, many laboratories face persistent challenges. These include fragmented quality management systems (QMS), shortages of skilled personnel, limited access to standardized tools, poor infrastructure, non-functional equipment due to lack of proper maintenance, lack of resources, and inconsistent regulatory oversight. As a result, laboratory results can vary in reliability and may not meet internationally recognized standards such as ISO 15189.

To address these challenges, the African Society for Laboratory Medicine (ASLM), in collaboration with Africa CDC (Center for Disease Control and Prevention) and the World Health Organization Africa Regional Office (WHO-AFRO), has developed regional frameworks to support laboratories in their stepwise journey towards accreditation. One of these frameworks, the Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA), has been successfully implemented across several African Union Member States. SLIPTA has demonstrated that progressive, structured improvement pathways are critical for ensuring sustainable quality gains.

The National Certification Program (NCP) builds on this continental success. It provides a country-owned and sustainable approach to nationalize the SLIPTA process, ensuring that every laboratory, irrespective of its size or location, has a structured pathway to achieve internationally recognized standards of quality and competence. The NCP seeks to strengthen national laboratory systems by embedding quality management and certification into existing regulatory, policy, and financing structures, thereby reducing dependence on externally driven initiatives.

Now we have the document in French and Portuguese.

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