Medical Laboratory Accreditation

Medical Laboratory Accreditation


The general criteria for accreditation of medical laboratories are contained within the ISO 15189:2012 Medical Laboratories- Particular Requirements for quality and competence.

Medical laboratory accreditation is a means of determining the technical competence of a medical laboratory to perform specific types of testing, measurement, and calibration of equipment. Medical laboratory accreditation also provides a formal recognition to competent laboratories, thus providing a ready means for customers to identify and select reliable testing and measurement services able to meet the customers’ needs.

Medical laboratory services are essential to patient care and therefore have to be available to meet the needs of all patients and the clinical personnel responsible for the care of these patients. These services include arrangements for requisition, patient preparation, patient identification, the collection of samples, transportation, storage, processing, and examination of clinical samples together with subsequent validation, interpretation, reporting, and advice, in addition to the considerations of safety and ethics in medical laboratory work.

Currently, KENAS is offering accreditation to the following medical laboratories:

  • General medical/clinical laboratory accreditation
  • Research medical laboratory accreditation
  • Forensic medical laboratory accreditation
  • Blood transfusion laboratories
  • X-ray laboratory accreditation

Click to open the listed documents

KENAS Guide to implementing ISO 15189
KENAS Guide to medical Laboratory accreditation
KENAS ISO 15189 checklist

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