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Abstract(s)
A Norma 13485:2016 especifica os requisitos para um sistema de gestão da qualidade que possa
ser usado por uma organização envolvida em uma ou mais etapas de ciclo de vida de um
dispositivo médico, incluindo conceção e desenvolvimento, produção, armazenamento e
distribuição, instalação, assistência, desativação final e eliminação de dispositivos médicos.
Também é usada como referência para conceção e desenvolvimento ou provisão de atividades
associadas, como por exemplo, apoio técnico.
Esta norma, baseia-se na Norma 9001:2008 cujo objetivo é documentar processos,
procedimentos e responsabilidades envolvidos no cumprimento de políticas e objetivos de
qualidade.
O objetivo deste trabalho é realizar uma análise do processo de implementação da Norma
13485:2016 na empresa Nimco Portugal Lda, que produz calçado ortopédico por medida, e
pretende certificar os seus produtos como dispositivos médicos.
Esta dissertação representa uma visão geral da Norma e a sua aplicabilidade na área de IT,
levantamento de requisitos na estrutura atual da organização, análise de risco à infraestrutura
e sistemas, implementação de procedimentos e documentos necessários para atender os
requisitos. Além disso, também é desenvolvida uma análise de valor para mencionar os
benefícios da aplicação da Norma à organização e à definição da sua proposta de valor.
Durante a realização desta dissertação e após auditoria por parte da Associação Portuguesa de
Certificação (APCER), foram enumeradas algumas não conformidades que são analisadas e
atribuídas ações para resolução ou mitigação do risco, como por exemplo, relacionada com
validação de software. Para solução deste problema, são estudadas diversas metodologias de
testes agile com o intuito da empresa utilizar no desenvolvimento de software.
A solução para a validação de software é desenhada, descrita e implementada nesta dissertação,
utilizando uma das metodologias de testes analisadas.
Por fim, é efetuado um levantamento ao estado da sua implementação e efetuado um inquérito
interno para avaliação da solução
The International standard 13485:2016 specifies the requirements for a quality management system that can be used by an organization involved in the production of one or more stages of the life cycle of a medical device. These stages can include from design and development to production, storage and distribution, installation, servicing and final decommissioning and disposal of medical devices. It can also be applied to design, development or provision of associated activities, such as technical support. This standard is based on the ISO 9001:2008, whose objective is to document processes, procedures and responsibilities involved in meeting with quality policies and objectives. The objective of this work is to carry out an analysis of the implementation process of the ISO 13485:2016 in the company Nimco Portugal Lda, which produces made-to-measure orthopedic footwear, and intends to certify its products as medical devices. This dissertation represents an overview of the Standard and its applicability in the IT area, requirements survey in the current structure of the organization, risk analysis to the infrastructure and systems, implementation of procedures and documents needed to meet the requirements. In addition, a value analysis is also developed to mention the benefits of applying the Standard to the organization and the definition of its value proposition. During the realization of this dissertation and after the Associação Portuguesa de Certificação (APCER) audit, some non-conformities were listed that are analyzed and assigned actions for resolution or risk mitigation, such as related to software validation. To solve this problem, several agile testing methodologies are studied with the intent of the company to use them in software development. The solution for software validation is designed, described and implemented in this dissertation, using one of the analyzed testing methodologies. Finally, a status of its implementation is assessed, and an internal survey is conducted to evaluate the solution
The International standard 13485:2016 specifies the requirements for a quality management system that can be used by an organization involved in the production of one or more stages of the life cycle of a medical device. These stages can include from design and development to production, storage and distribution, installation, servicing and final decommissioning and disposal of medical devices. It can also be applied to design, development or provision of associated activities, such as technical support. This standard is based on the ISO 9001:2008, whose objective is to document processes, procedures and responsibilities involved in meeting with quality policies and objectives. The objective of this work is to carry out an analysis of the implementation process of the ISO 13485:2016 in the company Nimco Portugal Lda, which produces made-to-measure orthopedic footwear, and intends to certify its products as medical devices. This dissertation represents an overview of the Standard and its applicability in the IT area, requirements survey in the current structure of the organization, risk analysis to the infrastructure and systems, implementation of procedures and documents needed to meet the requirements. In addition, a value analysis is also developed to mention the benefits of applying the Standard to the organization and the definition of its value proposition. During the realization of this dissertation and after the Associação Portuguesa de Certificação (APCER) audit, some non-conformities were listed that are analyzed and assigned actions for resolution or risk mitigation, such as related to software validation. To solve this problem, several agile testing methodologies are studied with the intent of the company to use them in software development. The solution for software validation is designed, described and implemented in this dissertation, using one of the analyzed testing methodologies. Finally, a status of its implementation is assessed, and an internal survey is conducted to evaluate the solution
Description
Keywords
Dispositivos médicos Sistemas de gestão de qualidade ISO 13485:2016 Medical devices Quality management systems