ISO 13485:2016 Internal Auditor (TPECS)

BSI America
Training overview
Professional Course
3 days

Course description

ISO 13485:2016 Internal Auditor (TPECS)

BSI's “ISO 13485:2016 Internal Quality Systems Auditor” competency- based 3-day course teaches a general understanding of the concepts of the ISO 13485:2016 standard and the principles and practices of effective internal audits in accordance with ISO 19011:2018 , "Guidelines on Auditing Management Systems". Experienced instructors explain the clauses of ISO 13485:2016 in detail and guide students through internal audits that are required for a quality management system based on ISO 13485:2016. Our qualified instructors will also help you to boost your audit capabilities with the latest developments of the new 19011 standard. Students gain necessary auditing skills through a balance of formal classroom tutorials, practical role-playing, group workshops, and open forum discussions.

This course comprises the following two Exemplar Global TPECS Competency Units whose outcomes are certified by Exemplar Global:

  • MD -Medical DeviceSystems
  • AU - Management Systems Auditing

Attendees successfully completing this course receive a Certificate of Attainment for each of Exemplar Global Competency Units listed above.

Virtual delivery options may also be available for this course. Get in touch to learn more!

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COVID-19 Update

In light of COVID-19, this provider is now delivering some or all of their courses online. Contact them for more information!

Who should attend?

Who Should Attend

Individuals interested in conducting, managing, or participating in first-party (internal) audits.


A prior review of the ISO 13485:2016 standard is required and an understanding of auditing principles is suggested for this course. 

Training content

Learning Objectives

  • Understand quality management definitions, concepts, and guidelines
  • Understand the purpose of the ISO 9000 series
  • Understand the requirements of the ISO 13485:2016 standard
  • Apply ISO 19011: 2018 concepts, new terminology and guidelines
  • Understand the types of risks and opportunities associated with auditing.
  • Understand the roles and responsibilities of the auditor
  • Conduct all phases of an internal audit adopting a risk-based approach


The course fee is USD $1550 per person.

Early bird discounts are available for those booking in advance.

This course is offered at multiple locations. Contact BSI for details.

Continuing studies

Attendees who successfully complete the course will receive a Certificate of Attainment for these Exemplar Global knowledge competency units:

  • MD –Medical Device Systems
  • AU – Management Systems Auditing

Continuing Education Units: 2.4.

Why choose BSI?

Leading provider of business improvement solutions

Base of 65,000+ clients across the globe

Training services available in 150+ countries

About BSI

BSI America

With 58 offices serving over 65,000 clients across 150 countries, BSI is a leading global provider of business improvement solutions and training for organizations looking to embed excellence into their daily routines. Through local offices based in the US, BSI...

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