ISO 13485:2016 - Quality Management Systems for Medical Devices

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.

In this free online course learn about the requirements of Quality Management Systems for Medical Device organizations and its regulatory aspects.

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Avg. Duration1.5-3 Hours
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Learning Outcomes

In this free course, you will learn how to:

Compare the revision of ISO 13485:2003 to ISO 13485:2016
List the main clauses of the ISO 13485:2016 standard along with the requirements
Define important terminologies about medical devices as per ISO 13485:2016
Explain the purpose of other international and regulatory standards like ISO 14971 and FDA 21 CFR Part 820
Compare ISO 13485 with FDA 21 CFR Part 820
Describe how to manage the requirements about medical device files
Illustrate how to assimilate work environment and contamination control requirements
Describe how to manage the requirements about design and development

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