title: ISO 15189:2003--quality management, evaluation and continual improvement.
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, 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.
authors.affiliation: Lindens Lodge, Bradford Place, Penarth, UK. davidburnett4@btinternet.com
authors.forename: David
authors.initials: D
authors.lastname: Burnett
mesh_terms: D019411:Clinical Laboratory Techniques / Q000592:standards*; D007753:Laboratories / Q000592:standards*; D008330:Management Audit; D019300:Medical Errors / Q000517:prevention & control; D011787:Quality of Health Care / Q000639:trends*; D017749:Total Quality Management; D006113:United Kingdom