Conformity evaluation checklists of API 20 E for ISO 15189:2012 internal auditing: An optimisation tool for medical laboratories

Objectives: The purpose of this study was to develop an applied tool based on conformance requirements identified in ISO 15189:2012, which can be used by internal auditors to audit the conformity status of the use of API 20 E. The objectives include the identification of relevant conformance requirements in Clauses 4 and 5 of ISO 15189:2012 relating to areas of audit and the development of API 20 E conformity evaluation checklists for internal auditing. Methods: The relevant conformance requirements were identified in Clauses 4 and 5 of ISO 15189:2012 by conducting content analysis. The conformance requirements were used as specific audit criteria for API 20 E conformity evaluation checklists for reagents, strip and reference equipment. Results: Selected conformance requirements (n = 22) in Clauses 4 and 5 of ISO 15189:2012 were used to develop API 20 E conformity evaluation checklists (n = 6) and an interpretation checklist. The main advantage internal auditors gain by using such tools is the ability to produce documented assurance that medical laboratories using API 20 E routinely are competently meeting the relevant conformance requirements specified in ISO 15189:2012. Conclusions: The present study contributes to existing knowledge of conformity management by providing internal auditors with a reasonably practical tool to conduct comprehensive and in-depth assessments of conformity status of the use of API 20 E in accordance with ISO 15189:2012 in the areas of acceptance testings as well as calibration and metrological traceability.