Title:ISO 15189:2012 implementation checklists for conformity assessment by accreditation bodies: a comparative analysis

Author:D. Mok.

Abstract:Objectives: The aim of this research was to determine the extent of conformance requirement coverage provided by ISO 15189:2012 guidance checklists produced by accreditation bodies. The contributing objectives include the identification of conformance requirements in ISO 15189:2012 for the development of evaluation checklists and determination of the level of conformance requirement coverage by quantitative analysis.
Methods: The conformance requirements were identified and located in Clauses 4 and 5 of ISO 15189:2012 by content analysis. The identified conformance requirements were used to develop evaluation checklists for further evaluability assessment. The distribution of conformance requirement coverage was allocated to the ISO 15189:2012 process-based quality management system framework for comparative analysis.
Results: A total of 51/109 (47 %) accreditation bodies offered ISO 15189:2012 accreditation to medical laboratories and 6/51 (12 %) of these accreditation bodies have published guidance checklists for use in preparation for accreditation assessment. An evaluability assessment of the checklists published by these 6/51 (12 %) accreditation bodies was conducted and the extent of coverage by the evaluand checklists was classified into four major stages based on the ISO 15189:2012 process-based quality management system framework. The overall conformance requirement coverage by the checklists was analysed with the following results: ‘orange status’ coverage (≤ 50 %) was provided by the Finnish Accreditation Service, the South African National Accreditation System and the National Association of Testing Authorities, Australia; ‘yellow-green status’ coverage (51 % to 84 %) was provided by the Danish Accreditation Fund; and, ‘green status’ coverage (85 % to 100 %) was provided by the Hong Kong Accreditation Service and the Singapore Accreditation Council. Three selected compliance management issues
were also identified in areas with limited coverage (0 %); these include Subclauses 4.11, 5.6.1 and 5.9.1 of ISO 15189:2012. The implications of identified issues for the management of risk mitigation are highlighted and recommendations made.
Conclusions: Medical laboratories planning to conduct gap analysis in preparation for accreditation should take into account that the guidance checklists recommended by accreditation bodies are not intended to identify all relevant conformance requirements, and they need to conduct their own initial internal audits to support the implementation process.
Key words: continuous quality management, quality control, quality improvement, total quality management.
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