DNK International By Our Health Reporter,Nairobi.
The Ministry of Health (MoH) has suffered a major setback after the International Organization for Standardization (ISO), through the Kenya Accreditation Services (KENAS), suspended standardization accreditation for its laboratory services, raising concerns over Kenya’s compliance with international laboratory quality standards.
The suspension affects the laboratory services wing of the ministry and undermines efforts to position Kenya’s public health laboratories in line with globally accepted best practices.
In a letter authored by KENAS Chief Executive Officer Walter Ongeti and addressed to National Public Health Laboratory Director Dr. John Kiiru, the accreditation body cited failure by the ministry to transition from ISO 15189:2012 to the revised ISO 15189:2022 standards, as required under KENAS Circular No. 2 of 2023.
Ongeti noted that the transition guidelines were issued on March 15, 2023, and communicated through multiple platforms, including physical and virtual meetings, assessments, and official publications available on the KENAS website.
Despite this, KENAS stated that the ministry failed to respond adequately to the transition requirements.
“Transition Arrangements and Guidance on ISO 15189:2022 for Medical Laboratories (attached herein) outlines the transition timelines. This circular was communicated to you through various engagements, including meetings (both physical and virtual), assessments, and is also accessible on the KENAS website,” Ongeti said.
KENAS further stated that due to the failure to transition within the stipulated framework, it had proceeded to suspend the accreditation with immediate effect.
“In view of the foregoing, KENAS shall proceed to suspend your accreditation, effective from the date of this letter, in accordance with the provisions of KENAS Circular No. 2 of 2023, without further reference to you,” reads part of the letter.
The letter also warns that accreditation under ISO 15189:2012 will completely expire on December 5, 2025, after which it will be deemed technically invalid and withdrawn.
During the suspension period, KENAS directed that the affected laboratories must not make any reference to accreditation or present themselves as accredited, and all promotional materials bearing accreditation marks must be withheld until the suspension is lifted.
ISO 15189:2012 was revised and published in 2022, with all Conformity Assessment Bodies (CABs) and Accreditation Bodies granted a transition period ending December 5, 2025.
However, the Health Cabinet Secretary Aden Duale led administration has acknowledged receipt of the suspension notice but insists that the matter represents a procedural stage rather than a collapse of quality systems.
Through the Directorate of Public Health and Sanitation under the Division of National Laboratory Services (DNLS), the ministry maintained that all corrective actions have since been undertaken.
“The suspension notice issued in November 2025 represents the temporary compliance stage according to the timeline,not withdrawal—pending submission of transition actions and corrective documentation. All DNLS laboratories have since been compliant with ISO 15189:2012, operating under that accreditation during the transition period allowed by KENAS,” the ministry stated.
The accreditation controversy comes against the backdrop of internal changes at the Kenya National Public Health Institute (KNPHI), which recently stripped its Deputy Director for Laboratory Services, Leonard Kingwara, of his roles.
In a letter dated January 19, 2026, the Ministry of Health explained that Kingwara is not registered with the Kenya Medical Laboratory Technicians and Technologists Board (KMLTTB), a move that insiders describe as part of ongoing administrative restructuring within the health sector.
ISO certification serves as a third party assurance that an organization meets international standards for quality, safety, and efficiency.
Different ISO standards apply across sectors, including ISO 9001:2015 for quality management, ISO 14001:2015 for environmental sustainability, ISO 27001 for information security, and ISO 45001:2018 for occupational health and safety.
The International Organization for Standardization is an independent, non-governmental body headquartered in Geneva. Founded in 1947, ISO brings together 175 national standards bodies to develop voluntary, consensus-based standards that facilitate global trade and ensure reliability, safety, and efficiency across industries ranging from technology to healthcare.
[DNK-International@February 2,2026]
