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David Burnett

ISO 15189:2003 – Quality management, evaluation and continual improvement

Keywords: audit, continual improvement, management review, procedures, process, quality management

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, stressing the importance of evidence, document control, and control of records and clinical material. Examples are provided from the areas of resource management, and 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.

Clinical Chemical Laboratory Medicine, Walter de Gruyter

Print ISSN: 1434-6621
Volume: 44, 06/2006
Pages: 733 - 739

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