ISO 13485:2016-Sistemas de Gestão da Qualidade para Dispositivos Médicos

Q: What is the ISO 13485 quality management system (QMS)?

The ISO 13485 QMS is an international standard and guideline developed for quality management systems in the medical device industry. This guideline provides quality assurance for your product’s life cycle.

Q: What is a medical device quality management system?

A medical device quality management system (QMS) is a set of procedures and processes that cover the different aspects of the design, manufacturing, handling, supplier management, risk management, distribution, labeling, storage, and more of medical devices. You can study it free in the course ISO 13485:2016 - Quality Management Systems for Medical Devices .

Q: What is the difference between the ISO 9001 and ISO 13485 systems?

The main difference between the ISO 9001 and ISO 13485 systems is that the former is an international standard of processes and procedures that can be applied to any industry and organisation. The ISO 13485 is a comprehensive system that is specific to the manufacturing of medical devices.

Q: Which is the best quality management systems for medical devices course?

Alison offers training in ISO 13485:2016 - Quality Management Systems for Medical Devices . This free online ISO 13485 certification training course will teach you about quality management systems for medical devices. You will study the ISO 13485:2016 standard, learn how it was developed, and look into the practical steps to achieve certification in the standard. You will cover the types of personal certifications available and look closely at standard terminologies related to stakeholders, product, QMS, risk and sterilization, and more.

Neste curso online gratuito aprenda sobre os requisitos dos Sistemas de Gestão da Qualidade para as organizações de Dispositivos Médicos e seus aspectos regulatórios.

Este curso de formação de certificação ISO 13485 gratuito online irá ensiná-lo ... Este curso de formação de certificação ISO 13485 gratuito online irá ensiná-lo sobre sistemas de gestão de qualidade para dispositivos médicos. Você estudará o padrão ISO 13485:2016, aprenderá como foi desenvolvido, e analisará as etapas práticas para a certificação da empresa na ISO 13485. Você cobrirá os tipos de certificações pessoais disponíveis e observará atentamente as terminologias padrão relacionadas aos stakeholders, produto, QMS, Risco e Esterilização, e muito mais!

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