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EAS Accredited Foundation Training

ISO 13485:2016 Foundation · Self-Learning

ISO 13485 awareness training provides the knowledge for employees in the medical device manufacturing industry on how to implement an effective QMS.

ISO 13485 Awareness Training Online

Aim of the ISO 13485 Awareness Course

The online self-driven ISO 13485 awareness training course provided by EAS has been designed to help individuals learn and demonstrate commitment to quality and customer satisfaction, as well as continuously improve a quality management system for the medical device manufacturing industry. The objective of the training is to provide you with an overview of the requirements of ISO 13485 as a tool for business improvement.

Who can Attend this Course?

  • Individuals working in the quality control of medical equipment.
  • Individuals interested in learning more about the key procedures in medical device quality management systems.
  • Individuals who want to work in the field of medical device quality assurance.

There are no prerequisites for attending this course; therefore, anyone interested can register for ISO 13485 awareness training.

What are the Benefits of ISO 13485 Awareness Training?

The main benefits that candidates will get from ISO 13485 awareness training are:

  • Provides an overview of the International Organization for Standardization (ISO), including its structure, memberships, standard development process, and processes.
  • Obtain basic knowledge about the ISO 13485 standard, benefits, procedures, and audit details
  • Upon completion of the training, participants will be able to understand the purpose of ISO 13485 and ISO management systems
  • Become eligible to take the ISO 13485 internal auditor course

What is Covered?

  • History of ISO
  • Basic concepts of ISO 13485
  • The principles of ISO 13485
  • The requirements for the ISO 13485 standard
  • The benefits of implementing
  • The approach to implementation

Self-Learning Format for ISO 13485 Awareness Training

ISO 13485 awareness training is offered by EAS through online self-learning mode. This online course is suitable for individuals who are working professionals. You can complete this ISO 13485 awareness training course at your own pace and have online access to the course material for 30 days. The following course material and activities will be provided:

  • Online Learning Modules
  • Interactive activities to develop an understanding of key concepts
  • Quizzes at the end of learning modules for continuous assessment
  • Standard copies
  • Delegate course reference materials (downloadable for offline use)
  • You will receive a certification once you complete this course, and will be eligible for taking an internal auditor training course.
  • Online/Email support for any questions or clarifications

To learn more about ISO 13485 awareness training, please refer to the frequently asked questions.

Ready to enroll?Register for ISO 13485 awareness training!

Frequently asked questions

Everything you need to know about the ISO 13485:2016 Foundation.

How long is the ISO 13485:2016 Foundation course?
This is a self-paced foundation course with 30-day access to the online modules and quizzes — study anytime, at your own pace.
What are the prerequisites?
There are no prerequisites — this foundation/awareness course is open to anyone who wants to build a working understanding of ISO 13485.
Is there an exam?
There is no formal pass/fail exam — assessment is through short quizzes built into the self-paced modules. Completing the course earns your EAS Foundation completion certificate.
Is there a pass mark?
This is an awareness/foundation course — there's no pass/fail exam. You complete the online modules and quizzes and receive an EAS Foundation completion certificate.
Is the certificate accredited?
Yes — an EAS Foundation completion certificate, which also makes you eligible to take the Internal Auditor course.
How much does the course cost?
The course fee is USD 129. Group discounts are available on request.
Who should attend this course?
Anyone new to ISO 13485 — students, new team members and professionals who want a solid foundation before progressing to Internal Auditor or Lead Auditor training.
How do I enrol?
Click any "Enroll & Pay" button on this page, complete the short registration form, and pay securely online to reserve your seat.

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