ACCREDITATION TO ISO 15189

Medical laboratory accreditation to ISO 15189 standard is a recognition that the laboratory has implemented a reliable quality management system and has the appropriate technical competence to give out trustworthy and reliable test results. ISO 15189 specifies the requirements for quality and competence in medical laboratories. This ensures:

Quality improvement in internal operations;
Credibility of results of conformity assessment activities;
Improved market image which means a more competitive position;
Accessibility of attracting third-party work.

Medical laboratory accreditation seeks to promote quality in health care services in line with international, regional, and national goals. Medical laboratory services play a pivotal around the world, providing doctors and other healthcare workers with test results that help in the diagnosis of diseases hence giving guidance for appropriate and effective treatment significantly reducing the risk of misdiagnosis. These services contribute to improving the quality, efficiency, and cost-effectiveness of healthcare services.

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ACCREDITATION TO ISO 15189

KENAS accreditation with respect to this standard covers;

General medical/clinical laboratories
Research medical laboratories
Blood transfusion laboratories
Point of care testing
Medical imaging (Upcoming)

The medical laboratory accreditation to ISO 15189 is available to laboratories performing tests in the following various fields:

Human pathology including anatomical pathology (histology and cytology)
Chemical pathology
Microbiology
Hematology
Immunohematology
Cytogenetics
Molecular biology and immunology
Blood transfusion services and assisted reproductive technologies.

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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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