Online ISO 13485 Internal Auditor Training #separator_sa #site_title

Online ISO 13485 Internal Auditor Training | Exemplar Global Certified

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Online ISO 13485 Internal Auditor Training (Exemplar Global Certified) for anyone that wants to gain an internationally recognized qualification to be part of the team that performs internal audits of part of their Quality Management System (QMS) based on ISO 13485 and it can be attended from anywhere in the world.

Our 16hr eLearning course is a highly interactive way to learn at a time & a pace that works best for you, making it easier to get the training you need while balancing a busy home or work life.

Subject Area
Medical Devices
16 Hours
USD $ 995.00  per person
Team Pricing
USD $ 3,980.00
Exemplar Global

This ISO 13485 Internal Auditor Training course is available via eLearning (24/7) offering you the most convenient & flexible way to learn online, anytime, anywhere. It is important to note that the exact time it takes to complete the eLearning modules will vary based on current knowledge, experience, and learning style.

Learning Objectives

On completion of this Online ISO 13485 Internal Auditor Training, successful Learners will have the knowledge needed to:

  1. Explain the purpose of a medical device quality management system, of medical device quality management systems standards, and the business benefits of improved performance given by an effectively implemented medical device quality management system
  2. Outline the structure and content of ISO 13485 and its relationship with ISO 9001 and IMDRF individual country regulatory documents
  3. Explain the specific quality management-related requirements of ISO 13485
  4. With reference to the PDCA cycle, explain the process-based QMS Model for ISO 13485 and the role of an internal auditor in the maintenance and improvement of Quality Management Systems
  5. Explain the role and responsibilities of an auditor to plan, conduct, report, and follow up an internal audit in accordance with ISO 19011

Course Content

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Entry Requirements

Before completing this course, each Learner should have the following prior knowledge:

Work Experience

  • It is recommended that anyone wishing to attend this course has some work-based experience in Quality Management (based on ISO 13485)

Management Systems

  • The Plan, Do Check, Act (PDCA) Cycle
  • The core elements of a management system and the interrelationship between top management responsibility, policy, objectives, planning, implementation, measurement, review, and continual improvement.

Fluency in written and spoken English

  • For participants whose first language is not English, we recommend a minimum English language competency of IELTS 5.5 (or equivalent) for successful completion of the program. This is not assessed by Comply Guru in advance & each participant must self-assess their competency.

Copy of ISO 13485 (International Standard)

  • It is recommended that each Learner should have a copy of ISO 13485:2016 (International Standard) to reference while completing this course. This is not provided by Comply Guru and without it, this course will be challenging to complete successfully.

Assessment & Certification

Assessment Methodology

In order to successfully complete this course, each Learner will need to:

  • Complete the eLearning modules and obtain 70% or higher in the final assessments (MCQ-based) by the required deadline set in advance of the given workshop dates you are registered for
  • Fully attend the Instructor Workshop as 100% attendance is required
  • Obtain 70% or higher in the graded assessments during the Instructor Workshops


Exemplar Global accreditation is offered with our Online ISO 13485 Internal Auditor Training. Successful completion will entitle each Learner to receive a digital Certificate of Achievement.