July 11, 2003—ISO (International Organization for Standardization) has published a standard for medical laboratories for implementing quality management systems based on ISO 9001:2000. ISO says that the new standard will help medical laboratories “to organize their operation efficiently, to comply with regulatory requirements, to meet the expectations of their clients and, most importantly, to improve or maintain their service to patients.”
ISO 15189:2003, Medical laboratories—Particular requirements for quality and competence, provides a framework for the design and improvement of process-based quality management systems by medical laboratories. It is based on ISO 17025:1999, General requirements for the competence of testing and calibration laboratories, but provides specific requirements for its implementation in medical laboratories.
The new standard is intended to promote a common approach to the quality management of medical laboratories and to all aspects of its operation, from patient preparation and identification to the collection and examination of clinical samples.
The standard costs 126 Swiss francs and is available from ISO national member institutes and from ISO Central Secretariat. To order, e-mail Sonia Rosas or call 41/ 22 749 03 36.
