Diseño de un Manual de Calidad basado en la norma ISO 15189 para el laboratorio clínico del Hospital Andino Alternativo de Chimborazo

Abstract

A quality manual based on the ISO 15189 standard was designed and developed for the laboratory of the Hospital Andino Alternativo de Chimborazo located in the city of Riobamba, Ciudadela 24 de Mayo, in order to become an accredited laboratory in the future. A study of the current situation of the laboratory under the NTE INEN-ISO 15189:2009 standard was carried out, analyzing the activities performed in relation to the quality of the service provided. A field investigation was applied to evaluate the requirements established in the standard, acquiring an approximation of compliance with the parameters, which determined that the laboratory complies with 49.84%. For the design of the quality manual, instruments, techniques and the international standard were used to determine the characteristics of the processes and standards used by the institution. A review of the documentation and information available in the clinical laboratory of the Hospital Andino Alternativo de Chimborazo was carried out and the manual was developed, which consists of procedures and records according to the requirements of the NTE INEN.ISO 15189:2009 standard. Applying the standard to the laboratory will achieve 100%, reflecting a good service and patient care; it is recommended the implementation of the quality manual under the INEN.ISO 15189:2009 standard to initiate a quality management system within the competitiveness with other laboratories.