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Medical Laboratory Accreditation According to ISO 15189:2022: A Strategic Enabler for Global Health Tourism Development
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Fariba Shaygan   |
| Iranian Association of Clinical Laboratory Doctors |
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Abstract: (19 Views) |
The rapid expansion of global health tourism has intensified the need for internationally recognized quality assurance mechanisms across all components of healthcare delivery, including diagnostic services. Medical laboratories play a critical role in clinical decision-making, patient safety, and the overall quality of healthcare outcomes. Consequently, the reliability and international credibility of laboratory services have become essential determinants in attracting international patients and fostering trust among healthcare providers, insurers, and regulatory bodies.
ISO 15189:2022 is currently recognized as the most comprehensive international standard for assessing the quality and competence of medical laboratories. The revised edition adopts a risk-based approach and emphasizes patient-centered care, personnel competence, examination result validity, laboratory information management, and continual improvement throughout the pre-analytical, analytical, and post-analytical phases of testing. Beyond technical requirements, the standard promotes a sustainable culture of quality and organizational excellence.
This article examines the strategic role of ISO 15189:2022 accreditation in supporting the development of health tourism. Accredited laboratories provide internationally accepted evidence of competence, enhance patient confidence, facilitate collaboration with foreign healthcare institutions, improve diagnostic accuracy, and strengthen the international reputation of healthcare systems. Furthermore, accreditation contributes to reducing diagnostic errors, minimizing unnecessary healthcare costs, and improving the global acceptance and comparability of laboratory results.
The paper also highlights the opportunities and challenges facing Iranian medical laboratories in adopting ISO 15189:2022 as a tool for international integration and competitiveness. It is concluded that laboratory accreditation should be viewed not merely as a regulatory obligation but as a strategic investment in quality, credibility, and sustainable participation in the global health tourism market. Accreditation according to ISO 15189:2022 may therefore serve as a fundamental enabler of trust and a key driver for the advancement of health tourism.
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| Keywords: ISO 15189:2022, Medical Laboratory Accreditation, Health Tourism, Medical Tourism, Quality Management Systems, Laboratory Medicine, Patient Safety, Diagnostic Quality, International Standards, Healthcare Competitiveness, Quality Assurance, Risk-Based Thin |
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Full-Text [PDF 381 kb]
(11 Downloads)
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Type of Study: Review |
Subject:
Special
Received: 2026/09/28 | Accepted: 2026/09/29 | Published: 2026/09/29
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