Course objective

ISO 13485 Internal Auditor Training course helps delegates to understand the basics of auditing to plan, conduct, and manage an internal audit of the Quality Management System (Medical device). This course also provides the key concepts of ISO 13485 requirements and auditing guidelines in accordance with ISO 19011. Moreover, the ISO 13485 Internal Auditor Course guides the delegates to become a successful internal auditor.

Also, Refer How to become ISO Auditor for more information

 What does the ISO 13485 internal auditor course cover?

  • Introduction to ISO 13485
  • Overview of ISO 13485:2016
  • ISO 13485 requirements
  • Audit definition, types, and concepts
  • Auditing guidelines (ISO 19011)
  • Audit report preparation and as well as checklist preparation
  • Follow-up procedures for internal audit
  • Roles and responsibilities of an internal auditor

Who should attend?

The ISO 13485 Internal Auditor Training course is perfect for the beginners who wish to gain the auditing knowledge and skills. But it is a must for quality managers, representatives, consultants, and also for the executives of quality assurance team (Medical devices and equipment).

Benefits of learning ISO 13485 Internal Auditor Training course

The delegates who completed the ISO 13485 Internal Auditor Course can be able to,

  • Understand the basics of the auditing process
  • Initiate, conduct and manage an audit and as well as prepare an effective audit report with necessary improvements
  • Learn the requirements of ISO 13485:2016
  • Improve the auditing knowledge and skills
  • Also, they can support the organization for the effective implementation of the laboratory management system

Why EAS?

EAS (Empowering Assurance Systems) is a third-party Conformity Assessment Body which is popular for providing management system certifications on various ISO standards and also for ISO training courses. We are a JAS ANZ (Joint Accreditation Systems of Australia and New Zealand) accredited certification body.

Professional tutors, practical guidance

We offer real-time auditors who have a vast industry background experience and are also lead auditors to train the candidates with practical examples for a better understanding of the concepts.

EAS – Training formats

EAS offers ISO 13485 Internal Auditor Training course in two different formats such as in-class training and online training. The classroom training is a 2 days training program (16 hours). It includes continuous assessments and also written examination at the end of the course. The online training is a 30 days training program. The candidates can access the course anywhere, at any time within these 30 days of a training program. Also, they should take the online examination to achieve the certificate.

However, if you want to improve your auditing knowledge and skills to perform a full audit of the Quality Management System against ISO 13485, then you can also consider taking EAS’ ISO 13485 lead auditor course.


EAS not only provides the professional certificate for the delegates who completed the ISO 13485 Internal Auditor Training Course but also issues the participation certificate for all who took the training program. The soft copy of the certificate will be sent to the registered email address to the candidates who attended the course online.

You can also check our certification status in our website.

Want to know more about the ISO 13485 Internal Auditor training? Kindly contact us. Our friendly training coordinators will assist you with detailed information.