Diseño de un manual de calidad basado en la norma ISO 15189 para el laboratorio clínico del Hspital Cantonal de Colta Dr. Publio Escobar

Abstract

A Quality Manual was designed for the Clinical Laboratory of the Dr. Publio Escobar Hospital located in Cajabamba, in the Colta canton of the Province of Chimborazo, based on the requirements of ISO 15189 for the laboratory to achieve accreditation according to the applied standard. A study of the current situation of the laboratory under the NTE INEN ISO 15189:2009 standard was carried out, and an existing study between the activities developed and the quality of the service provided by the laboratory; a field research was applied to evaluate the requirements of the standard, acquiring an approximation of 35% compliance with the parameters through information and data obtained from the personnel working in the laboratory of the Hospital Dr. Publio Escobar, for the design of the laboratory. For the design of the Quality Manual, instruments, standards and techniques were applied to determine the characteristics of the processes and standards used by the institution. After analyzing the documentation and information available to the laboratory, the Quality Manual was developed, which consists of determining the roles and responsibilities of the personnel and the development of procedures and records according to the requirements of the standard. It is recommended the immediate application of the Quality Manual to initiate a Quality Management System within the competitiveness with other laboratories.