Identification of ISO 15189: 2012 conformance requirements for medical laboratory internal auditing
The implementation of ISO 15189:2012 by medical laboratories is an ongoing challenge for the pathology services industry. The maintainability of the quality standard requires further logistic consideration in order to meet the specified productivity criteria. Accordingly, the critical requirements of ISO 15189:2012 require medical laboratories to commit substantial resources for ensuring conformity to the quality management system. A quantitative analysis of ISO 15189:2012 requirements for conformity management has been performed in order to determine the quantity of conformance requirements involved. A total of 1,515 conformance requirements were identified in Clauses 4 (management system requirements) and 5 (technical competence requirements) of ISO 15189:2012. This information has the potential to enhance the applicability and auditability of ISO 15189:2012 by using program and project management activities to support the implementation and internal audit processes.