Gestão dos equipamentos usados na área da saúde com função de medição

: plataformas de gestão

Abstract

The need to keep under control all instruments, equipment or measuring devices that may have a significant effect on the accuracy or validity of any result is a practice widely disseminated by organizations that have a quality system formally recognized by a certification body, namely by the ISO 9001 standard. It is necessary to adopt internal organizational measures to ensure that these medical devices are permanently fit for service and thus contribute to ensuring compliance with product specifications. In this sense, it was relevant to prepare the equipment of three services holding ISO 9001:2015 certification for the external audits that would be carried out. This preparation essentially involved an exhaustive survey of the equipment present in the services, inserting them into the equipment management platform, construction of individual files, inserting calibration certificates for later elaboration of the Calibration Plans for each service, as well as analyzing the non-conformities detected. in internal audit. It was also necessary to optimize the medical equipment management platform, HM, for later implementation in the pilot services defined by the Quality Office according to the capacity and maturity that the Service presents. The work carried out at ViGIE was more ephemeral, not being the main objective of the internship, and involved adding probes to the HM platform that were not yet inserted. This action was carried out due to the lack of a sensor calibration management tool on the ViGIE platform. Finally, the main objective of the internship was fulfilled, since the three services involved did not present failures in the external audits. In addition, the HM platform benefited from all the necessary optimizations, so in the end, was provided a training session to the GELs of each pilot service for the autonomous use of the platform.

Date of Award	14 Oct 2022
Original language	Portuguese
Awarding Institution	Universidade Católica Portuguesa
Supervisor	Sílvia Maria de Jesus Moutinho Riedstra (Supervisor) & Margarida Isabel Marques da Silva Alves Cardoso (Co-Supervisor)