Medical Laboratory Accreditation Consultancy UNI EN ISO 15189

Medical laboratories - Quality and competence requirements

UNI EN ISO 15189:2013

Medical laboratories — Requirements for quality and competence
1 Scope
2 Normative references
3 Terms and definitions
4 Management requirements
4.1 Organization and management responsibility
4.2 Quality management system
4.3 Document control
4.4 Service agreements
4.5 Examination by referral laboratories
4.6 External services and supplies
4.7 Advisory services
4.8 Resolution of complaints
4.9 Identification and control of nonconformities
4.10 Corrective action
4.11 Preventive action
4.12 Continual improvement
4.13 Control of records
4.14 Evaluation and audits
4.15 Management review
5 Technical requirements
5.1 Personnel
5.2 Accommodation and environmental conditions
5.3 Laboratory equipment, reagents, and consumables
5.4 Pre-examination processes
5.5 Examination processes
5.6 Ensuring quality of examination results
5.7 Post-examination processes
5.8 Reporting of results
5.9 Release of results
5.10 Laboratory information management

This International Standard, based upon ISO/IEC 17025 and ISO 9001, specifies requirements for competence and quality that are particular to medical laboratories. 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.

Regulation for the accreditation of Testing and Medical Laboratories