Internal Auditing Risk Analysis for Medical Laboratories Seeking Accreditation through the Hong Kong Laboratory Accreditation Scheme (HOKLAS)

Objectives. The primary aim of this study was to determine quantitatively the extent coverage HongKong Laboratory Accreditation Scheme (HOKLAS 015) requirements by guidance checklists 016‑02 andHOKLAS 021).Methods. level conformance requirement HOKLAS 015 and 021was calculated an evaluation checklist based on in 015. A distributionanalysis relating International Standard ISO 15189:2012 process‑based quality management system model also performed elicit further information.Results. found provide 76% while 021 11%. have a distribution 78% model.Conclusion. results analysis should be value medical laboratories wishing maintain internal auditability required gaining awareness provided 021.