Abstract

RAMIREZ BARRERA, A.F; MARTINEZ G, J.F  and  HIDALGO VAZQUEZ, E. MANAGEMENT MODEL FOR THE APPLICATION OF LEGAL METROLOGICAL CONTROL AND CONFORMITY ASSESSMENT IN BIOMEDICAL EQUIPMENT. Rev. ing. biomed. [online]. 2017, vol.11, n.21, pp.73-80. ISSN 1909-9762.

At present, the country faces major changes regarding regulations oriented toward technological management to be applied to biomedical equipment. In addition to those significant changes today, the National Quality System has introduced others regarding metrological control that need to be applied to some equipment in health services. As such, this paper aims to present a proposal based on a management model which integrates legal metrological controls applied to biomedical equipment, along with the application of measurement processes for activities associated to conformity evaluation. This model also uses a method of characterization of requirements established in different regulations aimed at ensuring equipment measurements also oriented toward conformity evaluation. The most significant expected result will be the proposal of a management structure enabling engineering units of health service providers to not only comply with said regulations, but also to offer high quality services based on trustworthiness, as support for activities aimed at patient safety.

Keywords : Metrological management; calibration; biomedical equipment; legal metrological control; patient safety.

        · abstract in Spanish | Portuguese     · text in Spanish     · Spanish ( pdf )