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.