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Abstract

The clinical laboratory of FIBUSPAM hospital is a private company that provides specialized medical care and clinical laboratory services, which did not have a Quality Manual to serve as a guide and tool for the staff to perform their activities. That is why, in some cases, systematic errors occur in the stages of analysis, resulting in delays in the delivery of results. For these reasons, the objective of this research was to design a Quality Manual based on the 15189 ISO standard for the clinical laboratory at FIBUSPAM hospital. The methodology implemented had a qualitative-quantitative approach; a descriptive non-experimental design was used because there was no manipulation of data; and a cross-sectional approach was used since it was developed in a given time. The development of the study consisted of evaluating the initial situation of the laboratory through the application of the SAE checklist that considers the requirements described by ISO 15189:2012. Then the Quality Manual and necessary documentation were designed and created according to the deficiencies found in the evaluation. Finally, the Quality Manual and documentation were implemented for all personnel in the laboratory area, and a final evaluation was conducted to check if there was a change in compliance with requirements. The implementation of the quality manual allowed the laboratory to achieve 89.70% compliance with the requirements concerning the initial score of 30.82%. In conclusion, the design and implementation of the Quality Manual resulted in an improvement in terms of compliance with regulatory requirements, which allowed satisfying patients' needs through the delivery of valid and reliable results.