ISO Standard for Medical Laboratories

ISO 15189:2003 has been published for medical laboratories to implement quality management systems based on ISO 9001:2000.

“The new standard will help medical laboratories to organize their operation efficiently”, said John Zlockie, Secretary of the technical committee which developed the new standard. “It will help them 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 their operation, from patient preparation and identification, to the collection and examination of clinical samples.

According to John Zlockie, ISO 15189 will also prove useful to accreditation bodies engaged in the recognition of the competence of medical laboratories as a basis for their activities. “ISO 15189 will be an important template for assessing and recognizing the competence of medical laboratories in their technical capacity and the effective quality management of a professional service and its staff – with or without the aim of accreditation.”

ISO 15189:2003 is available from the ANSI Electronic Standards Store for $97.
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