ISO 15189 covers the essential elements for medical laboratories to demonstrate the quality and competence of their services, as well as to consistently deliver technically valid test or 'examination' results as they are known in the standard. Medical laboratory services are essential in the diagnosis and assessment of the health of patients. Their services encompass arrangements for requisition, patient preparation, patient identification, collection of samples, transportation, storage, processing and examination of clinical samples, together with subsequent result validation, interpretation, reporting and advice. Medical laboratory services should therefore meet the needs of all patients, clinical personnel responsible for patient care and any other interested parties.
The laboratory's aim is not only to provide accurate results, but to do so on the right patient within a meaningful time frame as regards clinical Management, using appropriate laboratory procedures and with a respect for ethics, confidentiality and the safety of the patient.
To demonstrate the quality and reliability of their services, medical laboratories can seek accreditation to ISO 15189.