ISO 13485:2016 Auditor Training

Certified by Exemplar Global, this course will teach you to become a highly-efficient internal auditor with a broad understanding of the processes expected from an ISO 13485 Quality Management System for Medical Devices.


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Duration: 16 hours

The ISO 13485:2016 Auditor Training course gives you the skill set needed to take part in the internal audit program at your company.

The course will ensure that you thoroughly understand your role as an auditor and have the expertise needed to conduct effective audits, identify and report non-conformances, and complete follow-up activities. The course will also explain risk management techniques, implementation steps, and how to prepare for the certification audit.

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) Auditor.

ISO 13485 internal 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 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.
  • 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 steps required to implement ISO 13485:2016.
  • Have acquired the skills needed to conduct an internal audit, including preparation, opening and closing meetings, and writing audit reports.
  • Have learned techniques to prepare you for the final certification audit.

Course Content

The online course is interactive and combines lectures with presentations and practical examples. More than 160 pages of PDF handouts are provided, which learners are encouraged to retain and refer back to.

The course also provides a free Audit Checklist. It contains more than 200 audit questions and can be 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 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 an Quality Management System for Medical Devices

This module 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 an ISO 13485 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.

Internal Auditing

This part introduces auditing techniques, including the fundamentals (audit methodologies), and the roles and responsibilities expected from a company's internal auditor.

  • Internal Auditing Basics
  • Audit Types
  • Roles and Responsibilities

Audit Records

Audit proceedings and findings must be documented according to ISO's specific requirements. The reports you compile (which show nonconformities and the corrective actions taken to address them) must be retained as they will be reviewed during the certification audit and subsequent surveillance audits. Points covered in this module include:

  • Audit Preparation
  • Conducting an Audit
  • Audit Reporting
  • Audit Completion and Follow-Up

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 Auditor Training?

The course is ideal for:

  • Staff who've been appointed members of their company's ISO 13485 internal audit team.
  • Quality Management professionals who need a broader understanding of ISO 13485 audit practices.
  • Consultants who want to learn how to audit ISO 13485 Quality Management Systems and gain the associated professional certification.

Certificate of Completion

Graduates of this ISO 13485:2016 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 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 16 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: 4.6 (122 ratings)

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Emma Watson

South Korea
Reviewer Rating 4 Stars11 January 2024

I found the content comprehensive, the audit checklist was very helpful. The 3 months access, however, felt a bit rushed with my work schedule. Perhaps ...

Seok Park

South Korea
Reviewer Rating 5 Stars8 March 2024

I usually do not trust online courses too much. I think they are covering too many needs for people in different sectors with needs that ...

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