Sistema de gestión de calidad basado en estándar ISO 13485 para startup universitaria.
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Date
2024
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Universidad de Concepción
Abstract
Esta memoria busca crear protocolos que permitan facilitar a startups la creación, instauración y seguimiento de un sistema de gestión de calidad que permitan facilitar el proceso futuro de acreditación en ISO 13485. Para ello se analiza y resume el objetivo de la norma ISO 13485, se divide está en 5 secciones destinadas a facilitar su comprensión.
Se definen estas 5 secciones como: requisitos Generales, Responsabilidad de la dirección, Gestión de recursos, Realización del producto y Medición, analisis y mejora. Se crean protocolos que permitan orientar un sistema de gestión de calidad con consejos y requisitos de cada sección.
La empresa a orientar es una Startup universitaria que busca desarrollar y comercializar un producto de monitoreo pediátrico para 4 constantes vitales. Debido a su reciente creación, todavia no son aplicables secciones de la guía como la de producción y medición analisis y mejora. Se aplican los protocolos creados para iniciar con el sistema de gestión de calidad de Startup Universitaria.
Se concluye que la aplicación temprana de los protocolos creados permite facilitar el proceso futuro de acreditación.
This document aims to create protocols that facilitate startups in the creation, establishment, and monitoring of a quality management system, which will support the future process of ISO 13485 accreditation. To achieve this, the objective of the ISO 13485 standard is analyzed and summarized, dividing it into five sections designed to make it easier. These five sections are defined as: General Requirements, Management Responsibility, Resource Management, Product Realization, and Measurement, Analysis, and Improvement. Protocols are created to guide the quality management system, offering advice and requirements for each section The company to be guided is a university startup that aims to develop and market a pediatric monitoring product for four vital signs. Due to its recent establishment, sections of the guide such as production and measurement, analysis, and improvement are not yet applicable. The created protocols are applied to initiate the quality management system of the university Startup. It is concluded that the early implementation of the created protocols facilitates the future accreditation process. It also supports growth by controlling risk, as the required documentation ensures traceability and consistency in operations.
This document aims to create protocols that facilitate startups in the creation, establishment, and monitoring of a quality management system, which will support the future process of ISO 13485 accreditation. To achieve this, the objective of the ISO 13485 standard is analyzed and summarized, dividing it into five sections designed to make it easier. These five sections are defined as: General Requirements, Management Responsibility, Resource Management, Product Realization, and Measurement, Analysis, and Improvement. Protocols are created to guide the quality management system, offering advice and requirements for each section The company to be guided is a university startup that aims to develop and market a pediatric monitoring product for four vital signs. Due to its recent establishment, sections of the guide such as production and measurement, analysis, and improvement are not yet applicable. The created protocols are applied to initiate the quality management system of the university Startup. It is concluded that the early implementation of the created protocols facilitates the future accreditation process. It also supports growth by controlling risk, as the required documentation ensures traceability and consistency in operations.
Description
Tesis presentada para optar al grado académico de Ingeniero Civil Biomédico
Keywords
Control de calidad, Normalización, Acreditación (educación)