Evaluating the success of implementing ISO 15189:2003 in a medical laboratory : peer reviewed original article

Abstract

The introduction of the ISO standard 15189:2003 in March 2005 implied that South African National Accreditation System would assess medical laboratories against this standard. This study evaluated the success with which the National Institute for Communicable Diseases Laboratories converted to ISO 15189:2003. The research traces the process from the comparison of the existing standard with the ISO 15189:2003 standard, to the adjustment of policies, procedures and practices, and finally the assessment of the effectiveness of the conversion through internal and external audits. Analyses of the internal audits identified what aspects were not yet effectively addressed. A subsequent assessment by the South African National Accreditation System also identified a few non-conformances. These results clearly indicated that aspects of management responsibility, such as monitoring, staff development and maintenance, and safety and health were key aspects that impact on the quality management system of an organization.