Diseño de un sistema de gestión de calidad en laboratorios de biotecnología

Abstract

Biotechnology laboratories play a fundamental role in academic training and scientific research, requiring structured documentation and operational management to ensure the quality of their processes. ISO standards provide an internationally recognized framework for quality and efficiency across various sectors, including laboratories. This research aims to design a Quality Management System (QMS) aligned with ISO 9001:2015, which establishes requirements to ensure process quality, emphasizing resource control, operational planning, and continuous improvement. Through an initial diagnostic assessment, which involved the use of tools such as checklists, surveys, interviews, SWOT analysis, and Pareto diagrams, the main non-conformities in management were identified. The results indicate that the limited availability of reagents and materials (17 mentions) is the most recurrent issue, followed by deficiencies in planning and process management (12 mentions) and inconsistencies in document management (10 mentions). Based on these findings, a Quality Manual was developed, establishing guidelines and procedures to enhance laboratory management in accordance with ISO 9001:2015 requirements. Additionally, a Non-Conformity Log, Corrective Actions, and Preventive Measures were implemented, aiming to adapt the proposed documentation system to laboratory needs, improving operational efficiency and compliance within the academic sector.