Conformity Evaluation of Afinion 2 Analyzer Maintainability: Compliance Practicality for Philippine National Standard PNS ISO 15189:2013 Accreditation

Authors

  • Geraldine B. Dayrit, RMT, MSc, DRDM Department of Medical Microbiology, College of Public Health, University of the Philippines Manila, Manila, Philippines https://orcid.org/0000-0001-6912-8596
  • Dennis Mok, BAppSc, BAppSc, MBA, MBA, MBA, MA Medical Management Consulting, Birkdale, Queensland, Australia
  • Rana Nabulsi, BSc, MSc, PhD Dubai Health Authority, Dubai, Dubai, United Arab Emirates
  • Naira Eloyan, BSc, MSc Scientific Center of Drug and Medical Technology Expertise, Yerevan, Armenia; AMAS, Yerevan, Armenia
  • Sharfuddin Chowdhury, MBBS, MMed, PhD King Saud Medical City, Riyadh, Riyadh, Saudi Arabia
  • Aristina Chung Yee Ma, BMedSci, MBChB Queen’s Medical Centre, Nottingham University Hospitals NHS Trust, Nottingham, Nottinghamshire, United Kingdom

DOI:

https://doi.org/10.47895/amp.vi0.6418

Keywords:

Afinion 2 Analyzer, ISO 15189:2012, management review, quality compliance, quality conformity, quality management

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.

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.

Results. This study identified a total of 44/1515 (2.9%) conformance requirements and 33/1515 (2.2%) conformance requirements was associated with the hardware and software component of Afinion 2 Analyzer, respectively in Clauses 4 and 5 of PNS ISO 15189:2013. In addition, manufacturer requirements (n = 5) were identified relating to preventive maintenance. Further, specific requirements for accreditation for maintenance of reference equipment were identified and selected from 13/75 (17%) accreditation bodies in 26/90 (29%) countries; together these requirements were used to develop conformity evaluation of Afinion 2 Analyzer checklists (n = 3) and an interpretation checklist.

Conclusion. The present study has offered a practical contribution to existing knowledge of PNS ISO 15189:2013 accreditation compliance management by providing the medical laboratory with a practicable tool to determine the conformity status of Afinion 2 Analyzer maintainability in accordance with PNS ISO 15189:2013 conformance requirements, manufacturer and specific requirements for accreditation.

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Published

2023-11-24

Issue

Vol. 57 No. 11 (2023)

Section

Articles

How to Cite

1.
Conformity Evaluation of Afinion 2 Analyzer Maintainability: Compliance Practicality for Philippine National Standard PNS ISO 15189:2013 Accreditation. Acta Med Philipp [Internet]. 2023 Nov. 24 [cited 2025 Apr. 24];57(11). Available from: https://actamedicaphilippina.upm.edu.ph/index.php/acta/article/view/6418

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