Methodological improvement for risk and opportunity analysis under ISO 9001:2015 in a higher education institution

Abstract

ISO 9001:2015 introduced risk-based thinking as a cross-cutting element of quality management systems, requiring organizations to identify, evaluate, and address risks and opportunities that may affect their objectives. In higher education institutions undergoing organizational transitions, operationalizing this requirement may present systemic gaps that lead to auditable nonconformities. This paper documents the diagnosis, design, and implementation of a process-based risk and opportunity analysis methodology within the Integrated Management System (SGI) of the School of Mechanical and Electrical Engineering (FIME) at the Autonomous University of Nuevo León (UANL), in response to findings identified during internal and external audits conducted in 2021. Using a qualitative research approach, the Five Whys and One How tool was applied to determine the root cause of the nonconformity, identifying that the absence of a clear and comprehensible methodology for the new organizational structure —which had renewed 80% of its process owners— constituted the origin of the problem. A four-activity Corrective Action Plan was designed and a standardized Risk Analysis Matrix was developed for all SGI processes. Results show that all four activities were completed at 100%, the finding was closed during Internal Audit No. 40, and the research hypothesis was confirmed. The study provides evidence on the relevance of participatory and structured methodologies for strengthening quality management system maturity in university contexts with high staff turnover.