The Kenya Accreditation Services (KENAS) has suspended
standardisation accreditation for the National Public Health Laboratory Kenya
(NPHL).
KENAS cited non-compliance with updated ISO standards as the
reason for the decision.
In a letter to NPHL director Dr John Kiiru, KENAS Chief
Executive Officer Dr Walter Ongeti noted that the laboratory had not
transitioned from ISO 15189:2012 to ISO 15189:2022, as required under KENAS
Circular No. 2 of 2023.
“In view of the foregoing, KENAS was forced to proceed to
the accreditation [suspension], in accordance with the provisions of KENAS
Circular No. 2 of 2023, without further reference to you,” Ongeti stated.
He added, “Please be advised that your accreditation will
cease to be valid as of December 5, 2025, upon the expiry of ISO 15189:2012.
Consequently, your accreditation will be deemed technically invalid and
therefore withdrawn from that date.”
Ongeti further instructed the laboratory that during the
suspension period, it should not reference its accreditation in any materials
or claim to be accredited.
“All promotional materials bearing reference to
accreditation must be withheld until the suspension is lifted,” he said.
The National Public Health Laboratory Kenya, however,
emphasised that the KENAS suspension letter reflects a procedural stage within
the transition timeline, not a failure of quality systems.
The laboratory said it would continue engaging KENAS to
expedite the issuance of a formal clearance letter lifting the temporary
suspension.
“The temporary suspension communication reflects the standard
transition mechanism in the ISO 15189:2022 migration period. It is lifted once
final paperwork is issued,” the laboratory said in a statement.
ISO certification serves as a seal of approval from a
third-party body, indicating that a company or institution complies with
international standards developed by the International Organization for
Standardization (ISO).
It verifies that a management system, manufacturing process,
or service meets international best practices for quality, safety, and efficiency.
KENAS noted that the laboratory services wing of the health
ministry had been directed on March 15, 2023, through Circular No. 2 of 2023,
on how to transition from one standardisation level to the next.
The suspension comes in the wake of the Kenya National
Public Health Institute (KNPHI) stripping its Deputy Director for Laboratory
Services, Leonard Kingwara, of his roles.
In a letter dated January 19, 2026, the Ministry of Health
stated that Kingwara is not registered with the Kenya Medical Laboratory
Technicians and Technologists Board (KMLTTB).
According to the ministry, Kingwara is not authorised to
practice within KNPHI’s laboratory services unit because he lacks the mandatory
registration and licensing required under the law, raising concerns about
compliance within certain leadership roles in the public health sector.
The NPHL has reassured stakeholders that it remains
committed to maintaining high-quality laboratory standards while finalising the
administrative transition to ISO 15189:2022 accreditation.