ISO 15189:2003 - A practical tool for the management of quality in the medical laboratory

Abstract

The requirements of ISO 15189:2003 are discussed in the context of a process and outcome based quality management model in which the user's needs are the central focus. The requirements of ISO 15189:2003 are examined in terms of organisation and a quality management system and stress the importance of evidence, document control and control of records and clinical material. Examples are provided from the areas of resource management, pre examination, examination and post examination processes. In the final section the importance of evaluation and continual improvement is presented in relation to internal audit and external assessment, non-conformity, corrective and preventative action and management review.