Diseño, implementación y certificación del sistema de gestión de la calidad bajo los requisitos de la Norma NTC-ISO 9001:2015 para el laboratorio de Ciencias Básicas de la Universidad Santiago de Cali

Abstract

The Laboratory of Basic Sciences, as part of its strategic development, decides to initiate the implementation and documentation of a Quality Management System under the requirements of the International Standard ISO 9001: 2015, with the objective of guaranteeing the continuous improvement of its processes, Increase customer satisfaction and be competitively located in the local and regional market by offering a timely service and ensuring the validity and traceability of the reported data. To establish a work route aimed at achieving certification, a work plan was defined that began with the diagnosis of the Laboratory in terms of compliance with standard requirements, for this, the entire existing document base was compiled. With the information obtained, the methodology based on the PHVA cycle was designed, which resulted in the study of the context of the Laboratory, the identification of the needs and expectations of the interested parties, the definition of the process quality objectives, the scope , the identification, evaluation, analysis and map of risks associated with the process, all this to finally structure the quality manual and facilitate the revision of the Quality Management System implemented, first by an internal quality audit that delivered a favorable concept for the presentation to external quality audit, which certified compliance with the requirements of the audited standard, ISO 9001: 2015, and granted the extension of the scope for the Subsystem to which the Basic Sciences Laboratory belongs.