Conformity evaluation of afinion 2 analyzer maintainability: Compliance practicality for Philippine National Standard PNS ISO 15189:2013 Accreditation
https://doi.org/10.47895/amp.vi0.6418
- Author:
Geraldine B. Dayrit
1
;
Dennis Mok
2
;
Rana Nabulsi
3
;
Naira Eloyan
4
,
5
;
Sharfuddin Chowdhury
6
;
Arisina Chung Yee Ma
7
Author Information
1. Department of Medical Microbiology, College of Public Health, University of the Philippines Manila, Manila, Philippines
2. Medical Management Consulting, Birkdale, Queensland, Australia
3. Dubai Health Authority, Dubai, Dubai, United Arab Emirates
4. Scientific Center of Drug and Medical Technology Expertise, Yerevan, Armenia
5. AMAS, Yerevan, Armenia
6. King Saud Medical City, Riyadh, Riyadh, Saudi Arabia
7. Queens Medical Centre, Nottingham University Hospitals NHS Trust, Nottingham, Nottinghamshire, United Kingdom
- Publication Type:Journal Article
- Keywords:
Afinion 2 Analyzer;
ISO 15189:2012;
Management review;
Quality compliance;
Quality conformity;
Quality management
- From:
Acta Medica Philippina
2023;57(11):72-91
- CountryPhilippines
- Language:English
-
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.
- Full text:6418-Article Text-133750-1-10-20231122.pdf
