Title: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

Author:Dennis Mok, Naria Eloyan and Sharfuddin Chowdhury

Abstract: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.
Key words: compliance, conformity, ISO 15189:2012, quality management, SARS‑CoV‑2.
Supplementary information is available online at https://www.nzimls.org.nz/journals-recent
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