The World Health Organization African Region Laboratory Accreditation Process

TLDR

Few developing countries have affordable, implementable laboratory quality standards, and WHO AFRO’s accreditation process offers an interim pathway toward international ISO 15189 compliance. The WHO AFRO aims to establish a stepwise, star‑based accreditation approach that encourages laboratories to progress toward ISO 15189 certification. The process assigns 0‑5 stars based on assessment scores, with 55 % as the minimum threshold for a star and 95 % or higher earning a 5‑star rating. The stepwise approach provides laboratories with clear progress feedback, rewards improvement, and is considered affordable, sustainable, effective, and scalable.

Abstract

Few developing countries have established laboratory quality standards that are affordable and easy to implement and monitor. To address this challenge, the World Health Organization Regional Office for Africa (WHO AFRO) established a stepwise approach, using a 0- to 5-star scale, to the recognition of evolving fulfillment of the ISO 15189 standard rather than pass-fail grading. Laboratories that fail to achieve an assessment score of at least 55% will not be awarded a star ranking. Laboratories that achieve 95% or more will receive a 5-star rating. This stepwise approach acknowledges to laboratories where they stand, supports them with a series of evaluations to use to demonstrate improvement, and recognizes and rewards their progress. WHO AFRO's accreditation process is not intended to replace established ISO 15189 accreditation schemes, but rather to provide an interim pathway to the realization of international laboratory standards. Laboratories that demonstrate outstanding performance in the WHO-AFRO process will be strongly encouraged to enroll in an established ISO 15189 accreditation scheme. We believe that the WHO-AFRO approach for laboratory accreditation is affordable, sustainable, effective, and scalable.