Implementation of an ISO quality management system in medical diagnostic laboratories: a case study


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International Hellenic University
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2017 (EN)
Implementation of an ISO quality management system in medical diagnostic laboratories: a case study (EN)

Hatzibougias, Dimitris (EN)

School of Economics, Business Administration and Legal Studies, MSc in Management (EN)
Katsaliaki, Korina (EN)

This dissertation was written as part of the MSc in Management at the International Hellenic University. Demand for laboratory medical services is growing rapidly and is happening at a time of financial pressure , consequently, laboratory medicine specialists face the growing challenge of delivering a modern service of high quality. Better clinical laboratory tests, cancer screening tests, surgical pathology and cytopathology services, are especially important for cancer treatment, thus a Quality Management System (QMS) becomes a substantial component to guarantee constant improvement, quality assurance, repeatability, verification, and reproducibility, especially if we consider the fact that most of these tests involve several testing steps, that harbor the risk of multiple error mishaps . The objective of this study is to evaluate the impact of a QMS in a laboratory ’s performance , by monitoring the change of pre - specified quality objectives before and after the implementation. A general description of ISO15189, a dedicated medical laboratory QMS, is preceded and definition of Quality and Quality Assurance is attempted. QMS evaluation method was based on the fulfillment of questionnaires by the employees, since all of them were engaged in the process, and no Laboratory Information System (LIS) was installed in the past, to access quantitative data. Preparation period, pre-assessment results, main assessment results are described and explained . Moreover, the study captures employees’ experience and perspectives of the QMS implementation, comparing the results with literature findings. Interestingly the rate of most pre-analytical, analytical and post-analytical errors was significantly reduced after the QMS implementation, while at the same time personnel found it difficult to adjust to the new conditions, especially in the initial part of the process. Most of the findings seem to be consistent with those published in the literature. (EN)


Quality (EN)
Quality control (EN)
Microdiagnostics (EN)
ISO15189 (EN)
Organizational effectiveness--Measurement (EN)

Διεθνές Πανεπιστήμιο της Ελλάδος (EL)
International Hellenic University (EN)



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