Integration Of Biomedical Equipment Maintenance And Laboratory Quality Management To Enhance Diagnostic Accuracy: A Systematic Review
Abstract
Background: Ensuring diagnostic accuracy in clinical laboratories requires not only robust analytical protocols but also an integrated approach to equipment maintenance within the laboratory quality management system (QMS). International standards like ISO 15189 emphasize equipment management as a core element of laboratory accreditation, yet the degree to which integrating maintenance programs with QMS enhances diagnostic reliability has varied in practice. We conducted a systematic review of recent literature (2015–2025) to evaluate how the integration of biomedical equipment maintenance with laboratory QMS contributes to improved diagnostic accuracy, reduced error rates, higher equipment uptime, and patient safety.
Methods: Following PRISMA guidelines, we searched PubMed, Scopus, Web of Science, and IEEE Xplore for peer-reviewed studies published from 2010 to October 2025. Search terms combined concepts of laboratory equipment maintenance, quality management (including ISO 15189, WHO-LQMS), and diagnostic accuracy or errors. We included studies that explicitly addressed equipment maintenance within a laboratory QMS and reported impacts on diagnostic performance or related outcomes. Two reviewers screened titles/abstracts and full texts against inclusion criteria. Data were extracted and synthesized qualitatively from 12 selected studies. A PRISMA flow diagram depicts the selection process.
Results: The 12 included studies encompassed diverse settings (including hospitals…
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