Browsing by Author "Prado Franco, Valeria"
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Item Desarrollo de un manual de calidad para una empresa de metrología biomédica(Universidad Santiago de Cali, 2021) Prado Franco, Valeria; Vargas Vásquez, Jhon Edwar (Director)The biomedical metrology laboratories provide their services to health care institutions with respect to medical equipment/devices in order to ensure patient safety, for this reason the laboratories every day seek continuous improvement of their procedures and to monitor them through an official document such as a quality manual. According to the above, this work addressed the development of a manual for a biomedical metrology company, since its processes are of great importance in health care institutions because they provide calibration and validation services to medical devices used in the diagnosis,support and monitoring of patients;for this purpose a literature review was conducted finding some international standards ISO 9001: 2015 and ISO/IEC 17025:2017 that helped to obtain information on the requirements and mandatory documents that are relevant for the development of the manual, giving focus on quality and the main characteristics that a metrology company must have. Additionally, a survey was applied to health care institutions in Valle del Cauca, to know their perception about the characteristics that a quality metrology service should have, concluding that it is too important that a metrology company has disposition, quality, benefits towards the client, known patterns in the market and is accredited; this document plays a relevant role when starting the course of an accreditation of its calibration and validation processes in a certain time. Finally,a document was consolidated that presents the organization of the company through a process map and a characterization of the PHVA cycle required by the international standard, the quality indicators were built with their respective life sheets,in order to have a measurement of these and to know which is the traceability of the performance obtained in a period of time established by the process leader.