Successful Transition of Accredited Medical Laboratories to ISO 15189:2022 Standard

Mutetei Mutisya

— 2 min read
Successful Transition of Accredited Medical Laboratories to ISO 15189:2022 Standard

Medical laboratories accredited by Kenya Accreditation Service under ISO 15189 have successfully transitioned to the updated ISO 15189:2022 standard. This achievement marks a significant milestone in enhancing the quality, reliability, and patient-centred approach of diagnostic services across Kenya.

The transition followed the roadmap shared in Circular No. 02 of 2023 – Transition Arrangements and Guidance on ISO 15189:2022 for Medical Laboratories, which outlined a three-year period based on guidance from the International Laboratory Accreditation Cooperation (ILAC). With the transition period now officially concluded, all accredited medical laboratories are required to maintain continuous compliance with the new standard.

What ISO 15189:2022 Means for Accredited Medical Laboratories

The revised standard introduces several key improvements to ensure safer and more reliable laboratory services:

  • A stronger focus on clinical risk, emphasising the impact of test results on patient care.
  • Integration of Point-of-Care Testing (POCT) requirements into the main standard.
  • Alignment with the ISO/IEC 17000 series, ensuring global consistency in conformity assessment practices.
  • Clearer expectations for quality management and staff competence.

These updates bring accredited laboratories in line with current medical practices and international benchmarks for diagnostic accuracy.

Why Accreditation to ISO 15189:2022 Matters

Being accredited under ISO 15189:2022 benefits Kenya’s healthcare system and patients by:

  • Ensuring accuracy and reliability of test results for diagnosis and treatment.
  • Enhancing public confidence in accredited laboratories.
  • Reducing risks associated with diagnostic errors.
  • Supporting research collaboration, insurance partnerships, and cross-border healthcare services.

For patients, this means their samples are handled by laboratories that meet internationally recognised standards.

Celebrating the Achievement

KENAS wishes to acknowledge the dedication of all laboratories that successfully transitioned. Ms. Doris Mueni, Manager of the Medical Laboratories Scheme, expressed:

"We sincerely thank the over 100 accredited medical laboratories that have successfully transitioned to ISO 15189:2022. Your commitment to maintaining the highest standards of quality and competence is a major step forward for Kenya’s healthcare system. This transition strengthens the credibility of medical test results and enhances patient safety nationwide."

This milestone comes alongside national reforms under the Business Laws Amendment Act (2024), which requires all conformity assessment bodies (CABs)—including testing laboratories, inspection bodies, and certification bodies—to be accredited.

KENAS CEO, Dr. Walter Juma Ongeti, highlights the importance of this development:

"Accreditation is now a statutory requirement for all conformity assessment bodies in Kenya. This protects consumers by ensuring that testing, inspection, and certification services meet trusted and internationally recognised standards. KENAS is ready to guide any medical laboratory on its journey to accreditation, including through our specialised training programmes."

KENAS Continues to Support Quality in Healthcare

KENAS remains committed to providing technical guidance, capacity building, and ISO 15189:2022-focused training to accredited laboratories and those seeking accreditation. Laboratories looking to strengthen their systems or start the accreditation journey are encouraged to engage with KENAS.

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