ISO 13485:2016 Implementer Training

Certified by Exemplar Global, this high-quality training course teaches you how to implement an efficient ISO 13485 Quality Management System for Medical Devices and achieve certification.


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Duration: 24 hours

This Implementer course gives learners a detailed understanding of ISO 13485:2016 and how to achieve certification. Topics covered include the requirements of a Quality Management System for Medical Devices (QMS for Medical Devices), its benefits, documented information, implementation techniques, and preparation for the certification audit.

The course is ideal for anyone who needs a thorough understanding of ISO 13485:2016, will be playing a key role in implementing and maintaining a QMS for Medical Devices at your company, and needs to know the steps required to achieve certification.

The ISO 13485 course includes an examination. Upon successful completion, graduates have the option to seek registration as an Exemplar Global Certified Medical Device Management System (ISO 13485) Specialist.

ISO 13485 implementer training and exam are online and on-demand. Both can be taken anytime and on any device.

Learning Objectives

On completion of the course you will:

  • Have a detailed understanding of the ISO 13485:2016 standard, along with its high-level structure (Annex SL) and the benefits typically gained from certification.
  • Understand the clause-by-clause requirements of ISO 13485.
  • Know how to prepare and maintain documented information.
  • Understand the steps required to implement a QMS for Medical Devices at your company.
  • Know how to use the Plan Do Check Act cycle (PDCA) to create a sustainable QMS for Medical Devices that fosters a culture of continuous improvement.
  • Be aware of the steps needed to appoint a third-party registrar to undertake the certification audit.

Course Content

The online course is interactive and combines videos with lectures, presentations, and practical examples. More than 200 pages of 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.

Principles of ISO 13485

The ISO 13485:2016 standard embraces 8 core principles: customer focus, the engagement of people (staff and managers) within the organization, strong leadership, continual improvement, evidence-based decision making, a process approach, a system approach to management, and relationship management.

Requirements of a Quality Management System for Medical Devices

This part takes a step-by-step look at the relevant clauses in the ISO 13485:2016 standard in order to understand what they mean and what your company needs to do to comply with them.

Control of Documents & Records

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

While documents are used for storing and sharing information, 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.

Risk Management

The ISO 13485 standard requires that risk-based thinking be a part of your Quality Management System's processes, and risk management be a key consideration with regards to patient and/or end-user safety when using a medical device.

Steps for Implementation & Certification

The final part examines the steps necessary to implement an ISO 13485 QMS for Medical Devices and achieve certification.

Who Should Take ISO 13485:2016 Implementer Training?

This course is ideal for:

  • Staff responsible for managing the company's implementation project, setting up a sustainable QMS for Medical Devices that meets ISO 13485 requirements, and achieving certification.
  • Experienced implementers who need the additional knowledge and skill sets to integrate ISO 13485 with an existing management system.
  • Consultants who want to learn how to implement ISO 13485 Quality Management Systems and gain the associated professional certification.

Certificate of Completion

Graduates of this ISO 13485:2016 Implementer Training course receive a Certificate of Completion with the Exemplar Global accreditation mark. The certificate provides evidence of successfully passing the training program.

Certificate ISO 13485:2016 Implementer 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 24 hours to complete (on-demand).

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

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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: 4.4 (49 ratings)

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Stephan Wald

Reviewer Rating 4 Stars26 September 2023

Overall it is a course I will strongly recommend. I would say there are small inconsistencies with the course structure, but these are minor and will ...

Keith Lim

Reviewer Rating 4 Stars26 February 2024

I am happy to give my feedback for this ISO 13485 training program for company implementers. I am the implementer for my company because senior ...

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