Explore our catalog for On-demand training.

Explore

Course Details

ISO 13485:2016 Internal Auditor (TPECS)

Course Area

Medical Devices

Course Duration

3 Days

Continuing Education Units

2.4

Course Fee

USD $1645.00

Early Bird Price*

USD $1545.00

Upcoming Sessions
Mar 11-13, 2024 - Minneapolis, MNEnroll
Mar 18-20, 2024 - Live Online - Full DayEnroll
Mar 25-27, 2024 - Live Online - Full DayEnroll

View all sessions

* Subject to availability

See also

Course Details

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 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 Device Systems
  • AU - Management Systems Auditing

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

New to TPECS?

For more information, please see our Understanding the TPECS Course Structure page.

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

Who Should Attend?

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

Prerequisite

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

Course Materials

Soft Copy: You will receive an email prior to the course with instructions on how to access the online Student Handbook, which can be viewed, downloaded or printed.

NOTE: Copies of the standards are not included in the class fee.

BSI will make reasonable efforts to have loaner copies available for use during the class, but students are encouraged to have their own copy. Soft copies of the digital loaner standard cannot be printed or downloaded.

Course Logistics

If your class is Live Online:

  • Students need to connect to the class from any internet accessible location.
  • Webcam and Microphone are REQUIRED.
  • ALL course times shown are US EASTERN TIME.

If your class is In-person :

  • You are encouraged to bring a laptop with you to class.
  • Please bring a picture ID such as a driver's license, passport, or work badge to class for verification purposes.

*Session lengths could vary depending on amount of class discussion.

Full Day Classes - (Live Online and In-person) There are 3 eight hour sessions*, one per day. There are online exams at the end of each competency unit, which are in sessions 2 and 3. Exams range from is 120 -145 minutes. Detailed exam instructions will be provided. Certificates of Attainment in each competency unit will be provided for students who are deemed "Competent" for each. Certificates of Attendance are provided to those who do not pass the competency exam(s), and students will be given the opportunity to retake the test(s).

Half Day Classes - (Live Online) There are 6 four hour sessions*, one per day. There are online exams at the end of each competency unit, which are in sessions 4 and 6. Exams range from is 120 - 145 minutes. Detailed exam instructions will be provided. Certificates of Attainment in each competency unit will be provided for students who are deemed "Competent" for each. Certificates of Attendance are provided to those who do not pass the competency exam(s), and students will be given the opportunity to retake the test(s).

All Upcoming Course Dates

Date and Time Location Fees Enroll
Mar 11, 2024 8:00 AM - 5:30 PM
Mar 12, 2024 8:00 AM - 6:30 PM
Mar 13, 2024 8:00 AM - 6:00 PM
Minneapolis, MN
Crowne Plaza Minneapolis West
3131 Campus Drive
Plymouth, MN 55441
United States
map location
USD $1645.00Enroll
Mar 18, 2024 9:00 AM - 5:30 PM ET
Mar 19, 2024 9:00 AM - 5:30 PM ET
Mar 20, 2024 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1645.00Enroll
Mar 25, 2024 11:00 AM - 8:30 PM ET
Mar 26, 2024 11:00 AM - 8:30 PM ET
Mar 27, 2024 11:00 AM - 8:30 PM ET
Live Online - Full DayUSD $1645.00Enroll
Apr 2, 2024 9:00 AM - 5:30 PM ET
Apr 3, 2024 9:00 AM - 5:30 PM ET
Apr 4, 2024 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1645.00Enroll
Apr 9, 2024 9:00 AM - 5:30 PM ET
Apr 10, 2024 9:00 AM - 5:30 PM ET
Apr 11, 2024 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1645.00Enroll
Apr 15, 2024 11:00 AM - 7:30 PM ET
Apr 16, 2024 11:00 AM - 7:30 PM ET
Apr 17, 2024 11:00 AM - 7:30 PM ET
Live Online - Full DayUSD $1645.00Enroll
Apr 22, 2024 9:00 AM - 5:30 PM ET
Apr 23, 2024 9:00 AM - 5:30 PM ET
Apr 24, 2024 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1645.00Enroll
Apr 29, 2024 9:00 AM - 5:30 PM ET
Apr 30, 2024 9:00 AM - 5:30 PM ET
May 1, 2024 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1645.00Enroll
May 6, 2024 11:00 AM - 7:30 PM ET
May 7, 2024 11:00 AM - 7:30 PM ET
May 8, 2024 11:00 AM - 7:30 PM ET
Live Online - Full DayUSD $1645.00Enroll
May 13, 2024 9:00 AM - 5:30 PM ET
May 14, 2024 9:00 AM - 5:30 PM ET
May 15, 2024 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1645.00Enroll
May 21, 2024 9:00 AM - 1:00 PM ET
May 22, 2024 9:00 AM - 1:00 PM ET
May 23, 2024 9:00 AM - 1:00 PM ET
May 24, 2024 9:00 AM - 1:00 PM ET
May 28, 2024 9:00 AM - 1:00 PM ET
May 29, 2024 9:00 AM - 1:00 PM ET
Live Online - Half DayUSD $1645.00Enroll
May 28, 2024 8:00 AM - 5:30 PM
May 29, 2024 8:00 AM - 6:30 PM
May 30, 2024 8:00 AM - 6:00 PM
Irvine, CAUSD $1645.00Enroll
Jun 3, 2024 11:00 AM - 8:30 PM ET
Jun 4, 2024 11:00 AM - 8:30 PM ET
Jun 5, 2024 11:00 AM - 8:30 PM ET
Live Online - Full DayUSD $1645.00Enroll
Jun 11, 2024 9:00 AM - 5:30 PM ET
Jun 12, 2024 9:00 AM - 5:30 PM ET
Jun 13, 2024 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1645.00Enroll
Jun 17, 2024 9:00 AM - 5:30 PM ET
Jun 18, 2024 9:00 AM - 5:30 PM ET
Jun 19, 2024 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1645.00Enroll
Jun 24, 2024 11:00 AM - 8:30 PM ET
Jun 25, 2024 11:00 AM - 8:30 PM ET
Jun 26, 2024 11:00 AM - 8:30 PM ET
Live Online - Full DayUSD $1645.00Enroll
Jul 8, 2024 9:00 AM - 5:30 PM ET
Jul 9, 2024 9:00 AM - 5:30 PM ET
Jul 10, 2024 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1645.00Enroll
Jul 15, 2024 11:00 AM - 7:30 PM ET
Jul 16, 2024 11:00 AM - 7:30 PM ET
Jul 17, 2024 11:00 AM - 7:30 PM ET
Live Online - Full DayUSD $1645.00Enroll
Jul 22, 2024 9:00 AM - 5:30 PM ET
Jul 23, 2024 9:00 AM - 5:30 PM ET
Jul 24, 2024 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1645.00Enroll
Jul 29, 2024 9:00 AM - 5:30 PM ET
Jul 30, 2024 9:00 AM - 5:30 PM ET
Jul 31, 2024 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1645.00Enroll
Aug 6, 2024 11:00 AM - 7:30 PM ET
Aug 7, 2024 11:00 AM - 7:30 PM ET
Aug 8, 2024 11:00 AM - 7:30 PM ET
Live Online - Full DayUSD $1645.00Enroll
Aug 12, 2024 9:00 AM - 5:30 PM ET
Aug 13, 2024 9:00 AM - 5:30 PM ET
Aug 14, 2024 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1645.00Enroll
Aug 19, 2024 8:00 AM - 5:30 PM
Aug 20, 2024 8:00 AM - 6:30 PM
Aug 21, 2024 8:00 AM - 6:00 PM
Boston, MAUSD $1645.00Enroll
Aug 26, 2024 9:00 AM - 5:30 PM ET
Aug 27, 2024 9:00 AM - 5:30 PM ET
Aug 28, 2024 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1645.00Enroll
Sep 3, 2024 11:00 AM - 8:30 PM ET
Sep 4, 2024 11:00 AM - 8:30 PM ET
Sep 5, 2024 11:00 AM - 8:30 PM ET
Live Online - Full DayUSD $1645.00Enroll
Sep 9, 2024 9:00 AM - 5:30 PM ET
Sep 10, 2024 9:00 AM - 5:30 PM ET
Sep 11, 2024 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1645.00Enroll
Sep 16, 2024 2:30 PM - 6:30 PM ET
Sep 17, 2024 2:30 PM - 6:30 PM ET
Sep 18, 2024 2:30 PM - 6:30 PM ET
Sep 19, 2024 2:30 PM - 6:30 PM ET
Sep 23, 2024 2:30 PM - 6:30 PM ET
Sep 24, 2024 2:30 PM - 6:30 PM ET
Live Online - Half DayUSD $1645.00Enroll
Sep 23, 2024 11:00 AM - 8:30 PM ET
Sep 24, 2024 11:00 AM - 8:30 PM ET
Sep 25, 2024 11:00 AM - 8:30 PM ET
Live Online - Full DayUSD $1645.00Enroll
Sep 30, 2024 9:00 AM - 5:30 PM ET
Oct 1, 2024 9:00 AM - 5:30 PM ET
Oct 2, 2024 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1645.00Enroll
Oct 7, 2024 9:00 AM - 5:30 PM ET
Oct 8, 2024 9:00 AM - 5:30 PM ET
Oct 9, 2024 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1645.00Enroll
Oct 15, 2024 11:00 AM - 7:30 PM ET
Oct 16, 2024 11:00 AM - 7:30 PM ET
Oct 17, 2024 11:00 AM - 7:30 PM ET
Live Online - Full DayUSD $1645.00Enroll
Oct 22, 2024 9:00 AM - 5:30 PM ET
Oct 23, 2024 9:00 AM - 5:30 PM ET
Oct 24, 2024 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1645.00Enroll
Oct 28, 2024 9:00 AM - 5:30 PM ET
Oct 29, 2024 9:00 AM - 5:30 PM ET
Oct 30, 2024 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1645.00Enroll
Nov 4, 2024 11:00 AM - 8:30 PM ET
Nov 5, 2024 11:00 AM - 8:30 PM ET
Nov 6, 2024 11:00 AM - 8:30 PM ET
Live Online - Full DayUSD $1645.00Enroll
Nov 11, 2024 9:00 AM - 1:00 PM ET
Nov 12, 2024 9:00 AM - 1:00 PM ET
Nov 13, 2024 9:00 AM - 1:00 PM ET
Nov 14, 2024 9:00 AM - 1:00 PM ET
Nov 18, 2024 9:00 AM - 1:00 PM ET
Nov 19, 2024 9:00 AM - 1:00 PM ET
Live Online - Half DayUSD $1645.00Enroll
Nov 18, 2024 8:00 AM - 5:30 PM
Nov 19, 2024 8:00 AM - 6:30 PM
Nov 20, 2024 8:00 AM - 6:00 PM
Orlando, FLUSD $1645.00Enroll
Nov 25, 2024 9:00 AM - 5:30 PM ET
Nov 26, 2024 9:00 AM - 5:30 PM ET
Nov 27, 2024 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1645.00Enroll
Dec 3, 2024 11:00 AM - 8:30 PM ET
Dec 4, 2024 11:00 AM - 8:30 PM ET
Dec 5, 2024 11:00 AM - 8:30 PM ET
Live Online - Full DayUSD $1645.00Enroll
Dec 9, 2024 9:00 AM - 5:30 PM ET
Dec 10, 2024 9:00 AM - 5:30 PM ET
Dec 11, 2024 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1645.00Enroll
Dec 16, 2024 9:00 AM - 5:30 PM ET
Dec 17, 2024 9:00 AM - 5:30 PM ET
Dec 18, 2024 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1645.00Enroll

The venues for scheduled courses are tentative until receipt of a course confirmation from BSI.

Recommended Qualification Pathways

ISO 13485:2016 Internal Auditor (TPECS) puts you on the pathway for the following qualifications.

Recommended Courses

You may also be interested in these related courses.

Live Online Classes

Certified, convenient, and interactive, with no travel costs.

Private Class

Interested in a private or customized version of this course? Request a quote.

Questions?

For questions regarding any of our courses, contact us or call 1.800.217.1390.

Questions?

For questions regarding any of our courses, contact us or call 800.217.1390 (USA) 800.862.6752 (Canada)

Stay Connected