ISO 13485:2016 Foundation Training

This is a high-quality course that gives learners a solid overview of ISO 13485, its requirements and benefits, and what steps organizations should take to achieve certification.


Reviewer Rating 4.3 Stars

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Duration: 4 hours

Aimed at organizations involved in the design, manufacture, storage, distribution, service, and commissioning or decommissioning of medical devices, this Foundation course introduces learners to ISO 13485:2016 and the requirements for a Quality Management System for Medical Devices (QMS for Medical Devices).

Though brief, the course is ideal for anyone whose organization is seeking to implement and maintain a QMS for Medical Devices, and get certified to ISO 13485:2016.

The ISO 13485 introductory training is online and on-demand. It can be taken anytime and on any device.

Learning Objectives

On completion of the course you will:

  • Be familiar with the concept of Quality Management Systems for Medical Devices and their benefits.
  • Understand the requirements of the ISO 13485:2016 standard.
  • Know about the documented information that's required when setting up an ISO 13485 system.
  • Understand the steps necessary to implement an ISO 13485 QMS for Medical Devices and achieve certification.

Course Content

The online course is interactive and combines videos with lectures and audio-visual presentations. PDF handouts are provided, which learners are encouraged to retain and refer back to.

Overview of ISO 13485:2016

This first part introduces ISO 13485, explaining what it is, how it's used, and the purpose and benefits of a QMS for Medical Devices.

ISO 13485:2016 Requirements

Next, the course takes a step-by-step look at the relevant clauses in the ISO 13485 standard in order to understand what they mean and what your company needs to do to comply with them.

Documented Information

Clear, well-written, and non-bureaucratic documentation is an important part of a QMS for Medical Devices.

A point worth noting here is that documents are used for storing and sharing information, while records are essentially hard copies of results (such as from an audit) or evidence of activities that have been performed. And while documents get revised from to time and are generally kept up-to-date, records are static and never revised.

Steps for Implementation & Certification

The final part explains how organizations can implement an ISO 13485 QMS for Medical Devices, ensure it complies with the standard's requirements, and achieve certification.

Who Should Take ISO 13485:2016 Foundation Training?

This course is ideal for:

  • Executives and other decision makers who need a deeper understanding of the ISO 13485 standard, its requirements and benefits, how to get started, and the steps leading to certification.
  • Executive who are unsure as to what their responsibilities are in the context of a 13485 system.
  • Department managers and team leaders who need a clear understanding of the ISO 13485 standard and what it requires of them, as well as how to benefit most from it.
  • Anyone wishing to learn more about Quality Management Systems for Medical Devices, their purpose and benefits, and best practices for compliance.

Certificate of Completion

Graduates of this ISO 13485:2016 Foundation Training course receive a Certificate of Completion. The certificate provides evidence of successfully passing the training program.

Certificate ISO 13485:2016 Foundation Training

To receive a Certificate of Completion, you need to pass the final exam. It's a multiple-choice assessment with a passing score of 60%. The exam can be re-taken unlimited times without additional charge.

What's Included

Login credentials for course dashboard, handouts and course materials, and course certificate.

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The course takes about 4 hours to complete (on-demand).

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Technical support and access to an instructor are available when needed.

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Buy without risk and get a full refund if you're not completely satisfied.

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Access to this course is available immediately after payment for 3 months.

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Works on PCs, tablets and smartphones. Windows, Mac, iOS and Android compatible.

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Average Rating: 4.3 (84 ratings)

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Sarah Jennings

Reviewer Rating 4 Stars23 February 2024

Absolutely loved the course! The overview of ISO 13485 and its requirements was laid out perfectly. The on-demand feature is a game-changer; could fit it ...

Paulo Binetti

Reviewer Rating 5 Stars21 November 2023

I would say this training is best for the learners who want to learn a little about many things connected to ISO 13485. It is not ...

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