Medical Laboratories Accreditation

ACCREDITATION TO ISO 15189

Medical Laboratories are responsible for delivering numerous tests every working day in support of health services around the world. Medical laboratories provide vital test results that inform proper diagnosis, treatment decisions, and desired health outcomes.

ISO 15189 accreditation provides confidence in the quality of medical laboratories through a process that verifies their integrity, impartiality and competence.

The KENAS ISO 15189 accreditation covers the following disciplines:

  • Clinical chemistry including Toxicology – Endocrinology
  • Haematology
  • Blood Transfusion and blood banking
  • Microbiology
    • Bacteriology
    • Mycobacteriology
    • Virology
    • Parasitology
    • Mycology
    • Molecular biology
  • Histopathology and Cytology
  • Immunology (Serology)
  • Genetics
  • Andrology

Diagnostic Imaging Accreditation

Medical imaging provides information for the diagnosis, prevention and treatment of disease or assessment of health and includes conventional diagnostic radiology as well as a wide variety of specialised techniques.

KENAS accreditation is applicable to all organisations providing diangostic imaging. These include private medical imaging services and those in the public system.

The scopes of accreditation for Diagnostic imaging services are, in general, classified according to imaging modalities wich include:

  • X-rays
  • Bone Mineral Densitometry
  • CT Scanning
  • DSA/Interventional Radiology
  • General Radiography
  • MR Imaging
  • Mammography
  • Nuclear Medicine
  • Ultrasound
  • PET-CT Scanning

Point-of-care testing Accreditation

Point-of-care testing (POCT) refers to any testing conducted outside a medical laboratory, in a hospital, in a clinic or by a health care organization providing ambulatory care.

Healthcare professionals delivering POCT usually use test kits, which may include hand-held devices to read blood, saliva, or urine samples The Point-of-Care Testing Standards apply to organizations that provide point-of-care testing

The fourth edition of ISO15189 published in 2022 brings POCT into this widely adopted standard and it is expected that medical laboratory services will extend their accreditation to include POCT.

Public Notice
Deadline: 27 March 2025
Mandatory Exemption Application for Foreign-Accredited Conformity Assessment Bodies
The Kenya Accreditation Service (KENAS) informs all conformity assessment bodies in Kenya accredited by foreign bodies to apply for exemption from KENAS accreditation. This requirement, effective from 27th December 2024, mandates compliance by 27th March 2025. Apply through the Exemption Application Application Form .

Please submit the completed application and documents to the e-mail: [email protected]. For any enquiries, please reach us on +254 20 484 0000
Note: The exemption agreement will only be signed by the CAB after acceptance of the application and evaluation of the fees payable.

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