ISO 15189:2012 Certification for Medical laboratories
This International Standard, based upon ISO/IEC 17025 and ISO 9001, specifies requirements for competence and quality that are particular to medical laboratories1. It is acknowledged that a country could have its own specific regulations or requirements applicable to some or all its professional personnel and their activities and responsibilities in this domain.
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 examination requests, patient preparation, patient identification, collection of samples, transportation, storage, processing and examination of clinical samples, together with subsequent interpretation, reporting and advice, in addition to the considerations of safety and ethics in medical laboratory work.
Whenever allowed by national, regional or local regulations and requirements, it is desirable that medical laboratory services include the examination of patients in consultation cases, and that those services actively participate in the prevention of disease in addition to diagnosis and patient management. Each laboratory should also provide suitable educational and scientific opportunities for professional staff working with it.
While this International Standard is intended for use throughout the currently recognized disciplines of medical laboratory services, those working in other services and disciplines such as clinical physiology, medical imaging and medical physics could also find it useful and appropriate. In addition, bodies engaged in the recognition of the competence of medical laboratories will be able to use this International Standard as the basis for their activities. If a laboratory seeks accreditation, it should select an accrediting body which operates in accordance with ISO/IEC 17011 and which takes into account the particular requirements of medical laboratories.
This International Standard is not intended to be used for the purposes of certification, however a medical laboratory’s fulfilment of the requirements of this International Standard means the laboratory meets both the technical competence requirements and the management system requirements that are necessary for it to consistently deliver technically valid results. The management system requirements in Clause 4 are written in a language relevant to a medical laboratory’s operations and meet the principles of ISO 9001:2008, Quality management systems — Requirements, and are aligned with its pertinent requirements