ABSTRACT
Objectives@#The primary aim of this study was to determine quantitatively the extent of coverage of the Hong Kong Laboratory Accreditation Scheme (HOKLAS 015) requirements by guidance checklists (HOKLAS 016‑02 and HOKLAS 021). @*Methods@#The level of conformance requirement coverage of HOKLAS 015 by HOKLAS 016‑02 and HOKLAS 021 was calculated by an evaluation checklist based on conformance requirements in HOKLAS 015. A distribution analysis of conformance requirements relating to the International Standard ISO 15189:2012 process‑based quality management system model was also performed to elicit further coverage information. @*Results@#HOKLAS 016‑02 was found to provide coverage of 76% while HOKLAS 021 was found to provide coverage of 11%. HOKLAS 015 was also found to have a distribution coverage of 78% relating to the International Standard ISO 15189:2012 process‑based quality management system model.@*Conclusion@#The results of this analysis should be of value to medical laboratories wishing to maintain the internal auditability required by HOKLAS 015 by gaining an awareness of the extent of coverage provided by HOKLAS 016‑02 and HOKLAS 021.
Subject(s)
Accreditation , Management AuditABSTRACT
Objectives@#The implementation of Philippine National Standard PNS ISO 15189:2013 to support the medical laboratory to produce competent results is a recognised challenge. It is apparent that the approach of ensuring the equipment availability can be specifically optimised. No known research has focused on exploring on the conduct of conformity evaluation of Afinion 2 Analyzer maintainability for the PNS ISO 15189:2013 accredited medical laboratory. The aim of the current study was to develop a practical tool for the medical laboratory to support the internal audit process by determining the compliance status of Afinion 2 Analyzer maintainability. @*Methods@#The relevant conformance requirements in Clauses 4 (Management requirements) and 5 (Technical requirements) of PNS ISO 15189:2013, manufacturer requirements and specific requirements for accreditation from 70/101 (69%) accreditation bodies in 80/249 (32%) countries were identified as specific audit criteria for Afinion 2 Analyzer conformity evaluation checklists for the maintenance and reference equipment.
ABSTRACT
Objectives@#The implementation of Philippine National Standard PNS ISO 15189:2013 to support the medical laboratory to produce competent results is a recognised challenge. It is apparent that the approach of ensuring the equipment availability can be specifically optimised. No known research has focused on exploring on the conduct of conformity evaluation of Afinion 2 Analyzer maintainability for the PNS ISO 15189:2013 accredited medical laboratory. The aim of the current study was to develop a practical tool for the medical laboratory to support the internal audit process by determining the compliance status of Afinion 2 Analyzer maintainability.