Title:The strategic management stage of ISO 15189:2012 management system standard: an implementation update

Author:Dennis Mok and Sharfuddin Chowdhury

Abstract:Objectives: The primary aim of this paper is to provide an update on selected international standards, guidance documents and relevant literature at the application level that are associated with the implementation of the 'strategic management' stage of ISO 15189:2012.
Methods: Additional relevant international standards and guidance documents were identified from the Union of International Associations segmented organisations (Types A, B, C, D, E and F) and supplemented with additional literature.
Results: Selected international organisations (n = 14), inclusive of additional organisations (n = 6), were found to provide relevant international standards and guidance documents (n = 79), inclusive of additional documents (n = 47), in support of implementation of the strategic management stage of ISO 15189:2012. An updated list of literature (n = 49) was also provided for further reference.
Conclusions: The present study contributes to the medical laboratory's development of implementations of ISO 15189:2012 in areas of operations as targeted interventions using reasonably practical references to achieve an acceptable level of conformance.
Key words: clinical competence, conformity, ISO 15189:2012, quality control, quality improvement, total quality management.
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