ISO 13485 Internal Auditor Course Online

About the ISO 13485 Internal Auditor Course Online

ISO 13485 Internal Auditor Training helps individuals acquire the knowledge and skills to conduct an internal audit of a quality management system for medical devices according to ISO 13485 requirements. An ISO 13485 internal auditor can help organizations ensure that their quality management systems comply with ISO 13485 requirements. Individuals may now take this course online at a very affordable rate!

Aim of the Course

Optimize your internal auditing skills with the internationally recognized ISO I3485 internal auditor course online provided by EAS. Gain confidence in planning and performing an effective internal audit, as well as reporting and taking corrective action where necessary. An ineffective audit can lead to severe consequences, thus resulting in process failure, patient dissatisfaction, and regulatory noncompliance.

This online training course is intended for medical device quality professionals wishing to build on their current knowledge of ISO 13485:2016 and evaluate the effectiveness of their QMS. It teaches the principles and practices of effective audits following ISO 13485:2016. The ISO 13485 internal auditor course online has been designed to give you the necessary skills to perform internal audits of an organization's Quality Management Systems (QMS) for Medical Devices to the requirements of ISO 13485 and to contribute to their continual improvement.

Who Can Attend this Course?

  • Medical device professionals
  • Management representatives/Top management
  • ISO Consultants
  • Healthcare Consultants
  • Those who wish to become internal auditors for ISO 13485

Benefits of ISO 13485 Internal Auditor Course Online

  • Maintain compliance with ISO 13485:2016
  • Help organizations meet a global benchmark in quality standards
  • Increase your career opportunities
  • Write factual audit reports and suggest corrective actions
  • Assist organizations in achieving ISO 13485 Certification

Overview of ISO 13485 Internal Auditor Course Online

  • ISO standard terminology & PDCA Cycle
  • Overview of 13485 with explanations and examples
  • Roles and Responsibilities of auditors
  • Planning & Conducting of Internal Audit
  • Writing, reporting, and follow-up of non-conformities

What Prior Knowledge Should I Have?

It is highly recommended that you have prior knowledge of the following concepts before attending the ISO 13485 Training Course online:

  • The Plan-Do-Check-Act (PDCA) Cycle
  • Basic knowledge of the ISO 13485 standard
  • Commonly used terms and definitions

Individuals who would like a beginner-level course on the ISO 13485 standard can check out our ISO 13485 Foundation Course Online.

Self-Learning ISO 13485 Internal Auditor Training Online (30 days)

Individuals who are working professionals will benefit from this form of learning. You receive 30 days of online access to the course materials and can complete the course at your own speed.

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)
  • Online examination at the end of the course to achieve internal auditor certification
  • Online/Email support for any questions or clarifications

The lessons are laid out in a step-by-step order, guiding you through each topic so that you can grasp all concepts. You can simply comprehend complex ideas by utilizing the numerous real-world auditing scenarios that are provided throughout the course.

Assessment and Certification

The ISO 13485 Internal Auditor course online assesses the candidate at the end of the training session through an Online Examination.

Final Exam

The final exam will have 3 sections:

  • Section A: 10 objective questions carrying one mark each.
  • Section B: 4 short answer questions, each carrying five marks.
  • Section C: Two audit scenario case studies carrying ten marks each.

Criteria for successful completion: The evaluation of this course will be based on the scores obtained on the final examination. A minimum score of 70% should be achieved on the final exam to receive a course completion certificate.

To learn more about the ISO 13485 Internal Auditor Course Online, please refer to the frequently asked questions.

Ready to enroll? Click here to register for ISO 13485 Internal Auditor Training!

ISO 13485:2016 Internal Auditor - Self Learning

QMS for Medical Devices | MDQMS-IA-SL

USD 275

Course Duration : 30 Days