ISO 13485:2016 Lead Auditor Training

Certified by Exemplar Global, this course will teach you to become an effective ISO 13485 Quality Management System (QMS) lead auditor, conduct solo audits and manage audit teams.


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Duration: 40 hours

This ISO 13485:2016 Lead Auditor Training course teaches everything you need to know to conduct effective audits, either as a solo auditor or head of an audit team.

Learning is enhanced by live, real-time video examples that enable course participants to experience opening and closing meetings, as well as an authentic audit.

Learners will also learn how to correctly interpret ISO 13485:2016 requirements and prepare documented information, understand the principles of the PDCA cycle, and know how to assess and manage risk.

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) Lead Auditor.

ISO 13485 lead auditor 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 requirements, benefits, and high-level structure (Annex SL).
  • Understand how to prepare and maintain documented information.
  • Know how to use the Plan Do Check Act cycle (PDCA) to create a sustainable Quality Management System for Medical Devices (QMS for Medical Devices) that fosters a culture of continuous improvement.
  • Be able to understand, identify, and communicate best practices.
  • Understand risk management and risk evaluation techniques.
  • Understand the processes involved in auditing, including the types of auditing and questioning techniques.
  • Have acquired the skills needed to conduct an internal audit, including preparation, and opening and closing meetings.
  • Know how to prepare and maintain lead audit reports.
  • Be able to set up and manage a team of lead auditors.
  • Have learned techniques to prepare you and your organization for the final certification audit.

Course Content

The online course is interactive and combines lectures with videos, presentations, and practical examples. Almost 200 pages of PDF handouts are provided, which learners are encouraged to retain and refer back to.

The course also provides a comprehensive set of Audit Checklists designed specifically for Quality Management Systems for Medical Devices. The set can be downloaded for future reference and used as a valuable tool when conducting internal audits.

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 an Quality Management System 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 an Quality Management System for Medical Devices (QMS 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.

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.

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.

Audit Process

This part introduces auditing techniques and includes a video tutorial that gives a practical "real-life" demonstration of an auditor conducting the opening meeting.

Audit Terms and Definitions, and Roles and Responsibilities

Terms and definitions are introduced and explained, as well as a discussion of the roles and responsibilities expected from a company's internal auditor.

Performing an Audit

This part includes a video tutorial that gives a practical "real-life" demonstration of audit questions and answers.

Nonconformities and Corrective Action

Nonconformities (also known as non-conformities or non-conformances) are the "gaps" in your QMS that don't fully comply with ISO 13485:2016 requirements. Corrective actions are actions taken to address these gaps. Keeping a record of all such nonconformities and corrective actions is a crucial part of auditing.

The lessons also include a video tutorial that gives a practical "real-life" demonstration of an auditor conducting the closing meeting.

Who Should Take ISO 13485:2016 Lead Auditor Training?

This course is ideal for:

  • Staff who've been appointed solo auditor or leader of the company's ISO 13485 audit team.
  • Medical device management professionals who need an in-depth understanding of ISO 13485 QMS audit practices.
  • Individuals who want to conduct third-party audits, work as a registrar auditor, or otherwise seek to expand their career opportunities as a Certified ISO 13485 Lead Auditor.

Certificate of Completion

Graduates of this ISO 13485:2016 Lead Auditor 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 Lead Auditor 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 40 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 (103 ratings)

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Karen Palmer

United Kingdom
Reviewer Rating 5 Stars9 March 2024

The interactive online course provided a great mix of lectures, videos, and practical examples. Plenty of handouts, though could do with better organization. The Audit ...

Daniel Bridges

United Kingdom
Reviewer Rating 5 Stars19 July 2023

It's a long course! The course isn't easy. It's very involved and covers the technical aspects quite well. My advice is this: stick with the course, and ...

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