Conformity evaluation checklists of Panbio COVID-19 Ag Rapid Test Device for internal auditing: a quality compliance tool for ISO 15189:2012 accredited medical laboratories.
- Resource Type
- Academic Journal
- Authors
- Mok, Dennis; Eloyan, Naria; Chowdhury, Sharfuddin
- Source
- New Zealand Journal of Medical Laboratory Science (NZ J MED LAB SCI), Aug2021; 75(2): 110-114. (5p)
- Subject
- Language
- English
- ISSN
- 1171-0195
Objectives: The aim of this study was to develop a compliance tool that can be used by internal auditors to audit the conformity status of the use of Panbio COVID-19 Ag Rapid Test Device examination kit when ISO 15189:2012 accreditation is specified. The objectives include the identification of relevant conformance requirements in Clauses 4 (Management requirements) and 5 (Technical requirements) of ISO 15189:2012 and specific requirements for accreditation from accreditation bodies relating to areas of audit and the development of Panbio COVID-19 Ag Rapid Test Device examination kit conformity evaluation checklists for internal auditing. Methods: The relevant conformance requirements in Clauses 4 and 5 of ISO 15189:2012 and specific requirements for accreditation from 83/101 (82 %) accreditation bodies in 80/249 (32 %) countries were identified as specific audit criteria for Panbio COVID-19 Ag Rapid Test Device examination kit conformity evaluation checklists for reagents, test device and reference equipment. Results: A total of 22/1515 (1.5 %) conformance requirements relating to the use of Panbio COVID-19 Ag Rapid Test Device examination kit was identified in Clauses 4 and 5 of ISO 15189:2012, and specific accreditation requirements for calibration of reference equipment were identified and selected from 12/83 (14.4 %) accreditation bodies in 12/80 (15 %) countries; together these requirements were used to develop conformity evaluation of Panbio COVID-19 Ag Rapid Test Device examination kit checklists (n = 4) and an interpretation checklist. Conclusions: The present study has provided a practical contribution to existing knowledge of ISO 15189:2012 accreditation compliance management by providing internal auditors with a reasonably practicable approach to conduct comprehensive determination of conformity status of the use of Panbio COVID-19 Ag Rapid Test Device examination kit in accordance with ISO 15189:2012 and specific requirements for accreditation.