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ISO 13485:2016 Internal Auditor (TPECS)

BSI America
Training overview
3 days
Classroom / Public

ISO 13485:2016 Internal Auditor (TPECS)

ISO 13485:2016 Internal Auditor (TPECS)

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.

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.

Training Locations

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

Provider: BSI America

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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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