Guidance Document on Establishment and Implementation of National Certification Programs (NCP) for ISO15189 compliance in Medical

 Labs in Africa

Reliable laboratory services are the foundation of resilient health systems, effective disease surveillance, and quality patient care. To support African Union member states in strengthening laboratory quality management systems (LQMS) and progressing toward ISO 15189 compliance, ASLM is pleased to share a new guidance document on the establishment and implementation of national certification programmes (NCPs) for medical laboratories in Africa.


The guidance provides a practical, country-led framework that builds on the success of the Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA), enabling laboratories at all levels to strengthen quality systems through nationally coordinated assessments, mentorship, workforce development, and continuous quality improvement.


What this guidance covers:

• Establishing nationally owned certification programs aligned with ISO 15189 and the WHO-AFRO SLIPTA framework

• Implementing a structured, stepwise pathway from national certification to SLIPTA recognition and international accreditation

• Building a national cadre of qualified laboratory assessors and mentors to sustain quality improvement efforts

• Delivering tiered mentorship tailored to laboratory maturity, from foundational quality management systems to accreditation readiness

• Strengthening governance through standardized assessments, transparent recognition processes, national quality dashboards, and sustainable financing mechanisms


The guidance also outlines how national certification programmes can help countries institutionalize laboratory quality improvement, strengthen diagnostic reliability, build sustainable pathways to ISO 15189 accreditation, and enhance health security through resilient, nationally owned laboratory systems.



📘 Access the full guidance document here

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