Diseño de un Manual de Calidad basado en la norma ISO 15189 para el laboratorio clínico del Hospital Básico de Guamote

Abstract

A quality manual was designed and prepared for the clinical laboratory of the Hospital Básico de Guamote, located on Avenida Simón Bolívar y Guayaquil in the Guamote canton, province of Chimborazo, with the aim of accrediting the laboratory in the future. A field investigation was carried out to collect information from the personnel working in the clinical laboratory. A study was made of the current situation of the clinical laboratory of the Hospital Básico de Guamote, of the relationship between the activities they develop and the quality of the service they provide, which allowed evaluating the requirements established by the ISO 15189:2009 standard, acquiring an approximation of compliance with the parameters, which determined a percentage of compliance of 37%. For the design of the quality manual, instruments, techniques and international standards were applied to determine the characteristics of the processes and identify the standards used by the institution. After analyzing the documentation and information available to the laboratory, the quality manual was prepared, which consists of compiling procedures and records in accordance with the requirements of ISO 15189:2009. With the application of the quality manual, the laboratory will reach the 100% evaluation parameters, reflecting a better service and attention to its users. Therefore, it is recommended the immediate application of the quality manual to start a Quality Management System within the competitiveness with other laboratories.