ISO 13485 Internal Auditor Training Program

Based on ISO 13485:2016 Standard - Medical Device Quality Management Systems

virtual classes schedule

23rd - 24th Jan 2021: ISO 13485 Internal auditor Training | Duration: 2 Days

What you'll gain by enrolling for this course?

The key deliverables for the ISO 13485 Certification Program are stated as below:

  • Training material and end-to-end guidance on Medical Device Quality Management System Requirements – Context, Leadership, Support, Operation, Performance & Improvement
  • At TÜV SÜD, you'll be taught by academics who are leaders in the field of Medical Device Quality Management System. Get access to our community of experts for strategic guidance and continuous improvement
  • Get access to our ISO 13485 Training Kit and Pre-study material that is focused, practical and engaging, preparing professionals to make an immediate impact with their newly-gained skills
  • To create a more realistic training situation and to enhance students' involvement we use practical role-playing and open forum discussion as a medium of interaction
  • We connect organizations to our curated network of expert professionals for successful and timely training execution
  • We develop post-training learning solutions that are in line with the required learning outcomes
  • On course completion you will be awarded with our internationally accepted ISO 13485 Internal Auditor Training Certificate

About the course

The ISO 13485:2016 Internal Auditor Training Course aims to provide knowledge about all the requirements of 13485:2016 standard to help you implement, audit a Medical Device Quality Management System. Professions who complete this course will be able to successfully perform internal audit activities and use the knowledge gained to offer corrective measures for Medical Device Quality Management processes.

Training Duration

2 Days

Please Note: Virtual Classroom training available

Who should attend?

This course is designed for:

  • Medical Device Manufacturers.
  • Quality Professionals
  • Regulatory Professionals
  • Internal and external Auditors
  • Consultants and anyone involved with the implementation of the standard

Learning and Career Benefits

Our course provides an opportunity for participants to learn and implement the following:

  • Understand the requirements of ISO 13485:2016, a standalone Quality Management Systems standard for Medical Device manufacturers that is mandatory while fulfilling the regulatory compliance
  • Learn to perform internal auditor activities and evaluate your organization’s Medical Device Quality Management System
  • Learn about the Guidelines of Medical Device Quality Management System auditing according to ISO 13485:2016


Having prior knowledge and understanding of the Quality Management System - ISO 13485 Standards and/or experience in medical device operations.

Examination and Certification

Written examination(Open Book) will be conducted at the end of the course. Participants who score 70% and above will be issued a Certificate of Achievement, while the others will be issued a Certificate of Attendance.

Fill-in the adjacent form to download brochure.

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Discuss your ISO 13485 Internal Auditor training requirement with us.

Phone   :  +91 20 6684 1212

Email    :   [email protected]



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