Medical Laboratories

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 those patients.  Such services include arrangements for requisition, patient preparation, patient identification, 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 the laboratory.

Medical laboratory accreditation requires conformance to the international standard EN ISO 15189 which defines particular requirements for the quality and competence of medical laboratories. Accredited medical examinations assure that clinical laboratories focus on maintaining patients’ healthcare, directly connected with improved patient safety, risk mitigation and operational efficiency.

Medical laboratories accredited to EN ISO 15189 (a sector-specific technical competence and management system standard) are recognized as meeting the management system principles of  ISO 9001:2015.

Information Documents

ISO 15189 and Medical Laboratories explained (NAB-MALTA publication)

ISO 15189 and Medical Laboratories Accreditation (ILAC publication)


Applying for accreditation

Application forms for the accreditation of your laboratory may be found in the publications section.