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Abstract(s)
A necessidade de manter sob controlo todos os instrumentos, equipamentos ou dispositivos de medição que possam ter efeito significativo sobre a exatidão ou validade de algum resultado é uma prática amplamente divulgada pelas organizações que possuem um sistema da qualidade formalmente reconhecido por algum organismo de certificação, designadamente pelo referencial ISO 9001. É necessário adotar medidas internas de organização que garantam que esses dispositivos médicos estejam permanentemente aptos para o serviço e contribuam assim para a garantia do cumprimento das especificações dos produtos. Neste sentido, revelou-se pertinente a preparação dos equipamentos de três serviços detentores de certificação ISO 9001:2015 para as auditorias externas que se iriam realizar. Esta preparação passou essencialmente pelo levantamento exaustivo dos equipamentos presentes nos serviços, inseri-los na plataforma de gestão de equipamentos, construção de dossiers individuais, inserir certificados de calibração para posterior elaboração dos Planos de Calibração de cada serviço, assim como analisar as não conformidades detetadas na auditoria interna. Foi necessário também otimizar a plataforma de gestão de equipamentos médicos, HM, para posterior implementação nos serviços piloto definidos pelo Gabinete da Qualidade de acordo com capacidade e maturidade que o Serviço apresenta. O trabalho realizado na ViGIE foi mais efémero, não sendo o objetivo principal do estágio, e passou por acrescentar sondas na plataforma HM que ainda não estavam inseridas. Esta ação foi realizada pela carência da ferramenta de gestão das calibrações dos sensores na plataforma ViGIE. Por fim, o objetivo principal do estágio foi cumprido, uma vez que os três serviços intervencionados não apresentaram falhas nas auditorias externas. Além disso, a plataforma HM beneficiou de todas as otimizações necessárias pelo que no final, foi proporcionado uma ação de formação aos GEL de cada serviço piloto para a utilização autónoma da plataforma.
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.
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.
Description
Keywords
Equipamentos Qualidade Certificação Calibração Plataformas Equipment Quality Certification Calibration Platforms