ISO 9001:2015 Certification in a Nursing Clinical Simulation Center: Development, Implementation, and Results.
DOI:
https://doi.org/10.22201/fm.30617243e.2026.6.126Keywords:
Certificación ISO:9001, Gestión de calidad, Simulación clínica, Certificación, Educación en saludAbstract
ABSTRACT.
Introduction. Simulation centers have become established as strategic environments in health sciences education; however, their effectiveness depends largely on standardization and quality assurance through certification and accreditation processes, which constitute solid frameworks for guarantee, efficiency, and reliability. The objective of this work is to describe the experience of implementing a Quality Management System (QMS) for certification under the ISO 9001:2015 standard in a university clinical simulation center, analyzing the benefits, challenges, and results obtained.
Materials and methods. Descriptive case study of the certification process in a university simulation center for nursing training. A deductive analysis was applied in the diagnostic phase. An inductive analysis was used for the planning and development of procedures, with monitoring of compliance with requirements based on the standard.
Results. In 2023, the standardization of procedures began with the analysis phase, followed by awareness-raising and dissemination. In 2024, the system was formally implemented, along with a document audit and consulting services. In 2025, an internal audit was conducted, resulting in a corrective action plan. Subsequently, an external audit was scheduled by a certifying body.
Discussion and conclusion: Certification enabled the standardization of key processes, such as academic planning, materials control, the maintenance program, and results evaluation. ISO 9001:2015 certification in clinical simulation centers contributes to strengthening the reliability of processes, fosters a culture of quality, and positions the center as an academic and institutional leader. Its implementation requires a team responsible for operating the system, the appointment of a Quality Management System (QMS) leader, specialized consulting services, audit training, and ensuring institutional and senior management support.
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