Elejalde Alvarez, Olga Lucía2012-08-092012-08-0920091909-0455http://hdl.handle.net/10567/585Risk management as a tool to secure the administration of the integral system, is one of the best strategies organizations have to make the process network dynamic, implementing actions that aim to guarantee the quality of the products, the prevention of pollution and the health of the workers. The risk identification was made for products with the ISO 14971:2007, “Risk Management for Medical Devices” and for processes, the norm NTC 5254:2006, “Risk Management”. The result of such analysis, allowed the detection of the failure modes of the process that generate hazards for the product, the patient, the environment and the worker. The quantitative results allowed in a first stage, to say that the control and risk treatment actions for a 90.7% of the risks in the company are located below a 125 risk potential level. By consolidating the risk analysis, the organizations can manage the processes in a safe way and stay active in a every day more competitive market.esCorporación Universitaria LasallistaGestión de riesgoÁrea Metropolitana del Valle de AburráNTC-ISO 13485ISO 2007NTC 5254Gestión de riesgo - NormasAdministración integralBuenas prácticas de manufactura (BPM)Article