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Course Details

ISO 13485:2016 Lead Auditor (TPECS)

Course Area

Medical Devices

Course Duration

4 Days

Continuing Education Units

3.2

Course Fee

USD $2385.00

Early Bird Price*

USD $2285.00

Upcoming Sessions
Feb 26-29, 2024 - Irvine, CAEnroll
Feb 26-29, 2024 - Live Online - Full DayEnroll
Mar 4-7, 2024 - Live Online - Full DayEnroll

View all sessions

* Subject to availability

See also

Course Details

BSI's “ISO 13485:2016 Lead Auditor” competency-based course teaches a general understanding of the concepts of the ISO 13485:2016 standard and the principles and practices of leading management systems and process 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 the entire audit process, from managing an audit program to reporting on audit results. 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, role playing, group workshops, and open forum discussions.

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

  • MD - Medical Device Systems
  • AU - Management Systems Auditing
  • TL - Leading Management Systems Audit Teams

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
  • Understand the roles and responsibilities of the auditor
  • Apply ISO 19011:2018 concepts, new terminology and guidelines
  • Recognize the principles, practices, and types of audits
  • Conduct all phases of an audit adopting a risk-based approach
  • Prepare and present effective reports
  • Understand Exemplar Global's certification scheme
  • Understand the role of objectives, scope and criteria in the audit process
  • How to plan audits
  • Conduct audit team selection
  • Initiate the audit and conducting opening meetings
  • Understand audit team leader responsibilities
  • Communicate effectively during the audit
  • Apply the latest auditor techniques and identify appropriate use
  • Conduct on-site activities
  • Prepare audit conclusions
  • Conduct closing meetings
  • Report audit results

Who Should Attend?

  • Individuals interested in conducting first-party, second-party, and third-party audits
  • Management Representatives
  • Quality Directors in Medical Device
  • Managers
  • Engineers
  • Consultants

Prerequisite

A prior review of the ISO 13485:2016 standard is required and internal audit experience 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 4 eight hour sessions*, one per day. There are online exams at the end of each competency unit, which are in sessions 2, 3, and 4. Exams range from is 90-120 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 8 four hour sessions*, one per day. There are online exams at the end of each competency unit, which are in sessions 4, 6, and 8. Exams range from is 90-120 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
Feb 26, 2024 9:00 AM - 5:30 PM
Feb 27, 2024 9:00 AM - 5:30 PM
Feb 28, 2024 9:00 AM - 5:30 PM
Feb 29, 2024 9:00 AM - 5:30 PM
Irvine, CA
Embassy Suites- Orange County Airport
2120 Main Street
Irvine, CA 92614
United States
1-949-553-8332
map location
USD $2385.00Enroll
Feb 26, 2024 11:00 AM - 7:30 PM ET
Feb 27, 2024 11:00 AM - 7:30 PM ET
Feb 28, 2024 11:00 AM - 7:30 PM ET
Feb 29, 2024 11:00 AM - 7:30 PM ET
Live Online - Full DayUSD $2385.00Enroll
Mar 4, 2024 9:00 AM - 5:30 PM ET
Mar 5, 2024 9:00 AM - 5:30 PM ET
Mar 6, 2024 9:00 AM - 5:30 PM ET
Mar 7, 2024 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $2385.00Enroll
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
Mar 14, 2024 8:00 AM - 4:00 PM
Minneapolis, MN
Crowne Plaza Minneapolis West
3131 Campus Drive
Plymouth, MN 55441
United States
map location
USD $2385.00Enroll
Mar 11, 2024 3:00 PM - 11:00 PM PT
Mar 12, 2024 3:00 PM - 11:00 PM PT
Mar 13, 2024 3:00 PM - 11:00 PM PT
Mar 14, 2024 3:00 PM - 11:00 PM PT
Live Online - Full DayUSD $2385.00Enroll
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
Mar 21, 2024 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $2385.00Enroll
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
Mar 28, 2024 11:00 AM - 8:30 PM ET
Live Online - Full DayUSD $2385.00Enroll
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
Apr 5, 2024 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $2385.00Enroll
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
Apr 12, 2024 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $2385.00Enroll
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
Apr 18, 2024 11:00 AM - 7:30 PM ET
Live Online - Full DayUSD $2385.00Enroll
Apr 22, 2024 7:00 AM - 3:00 PM ET
Apr 23, 2024 7:00 AM - 3:00 PM ET
Apr 24, 2024 7:00 AM - 3:00 PM ET
Apr 25, 2024 7:00 AM - 3:00 PM ET
Live Online - Full DayUSD $2385.00Enroll
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
Apr 25, 2024 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $2385.00Enroll
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
May 2, 2024 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $2385.00Enroll
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
May 9, 2024 11:00 AM - 7:30 PM ET
Live Online - Full DayUSD $2385.00Enroll
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
May 16, 2024 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $2385.00Enroll
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
May 30, 2024 9:00 AM - 1:00 PM ET
May 31, 2024 9:00 AM - 1:00 PM ET
Live Online - Half DayUSD $2385.00Enroll
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
May 31, 2024 8:00 AM - 4:00 PM
Irvine, CAUSD $2385.00Enroll
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
Jun 6, 2024 11:00 AM - 8:30 PM ET
Live Online - Full DayUSD $2385.00Enroll
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
Jun 14, 2024 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $2385.00Enroll
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
Jun 20, 2024 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $2385.00Enroll
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
Jun 27, 2024 11:00 AM - 8:30 PM ET
Live Online - Full DayUSD $2385.00Enroll
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
Jul 11, 2024 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $2385.00Enroll
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
Jul 18, 2024 11:00 AM - 7:30 PM ET
Live Online - Full DayUSD $2385.00Enroll
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
Jul 25, 2024 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $2385.00Enroll
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
Aug 1, 2024 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $2385.00Enroll
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
Aug 9, 2024 11:00 AM - 7:30 PM ET
Live Online - Full DayUSD $2385.00Enroll
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
Aug 15, 2024 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $2385.00Enroll
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
Aug 22, 2024 8:00 AM - 4:00 PM
Boston, MAUSD $2385.00Enroll
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
Aug 29, 2024 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $2385.00Enroll
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
Sep 6, 2024 11:00 AM - 8:30 PM ET
Live Online - Full DayUSD $2385.00Enroll
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
Sep 12, 2024 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $2385.00Enroll
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
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Sep 24, 2024 2:30 PM - 6:30 PM ET
Sep 25, 2024 2:30 PM - 6:30 PM ET
Sep 26, 2024 2:30 PM - 6:30 PM ET
Live Online - Half DayUSD $2385.00Enroll
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
Sep 26, 2024 11:00 AM - 8:30 PM ET
Live Online - Full DayUSD $2385.00Enroll
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
Oct 3, 2024 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $2385.00Enroll
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
Oct 10, 2024 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $2385.00Enroll
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
Oct 18, 2024 11:00 AM - 7:30 PM ET
Live Online - Full DayUSD $2385.00Enroll
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
Oct 25, 2024 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $2385.00Enroll
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
Oct 31, 2024 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $2385.00Enroll
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
Nov 7, 2024 11:00 AM - 8:30 PM ET
Live Online - Full DayUSD $2385.00Enroll
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
Nov 20, 2024 9:00 AM - 1:00 PM ET
Nov 21, 2024 9:00 AM - 1:00 PM ET
Live Online - Half DayUSD $2385.00Enroll
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
Nov 21, 2024 8:00 AM - 4:00 PM
Orlando, FLUSD $2385.00Enroll
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
Dec 6, 2024 11:00 AM - 8:30 PM ET
Live Online - Full DayUSD $2385.00Enroll
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
Dec 12, 2024 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $2385.00Enroll
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
Dec 19, 2024 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $2385.00Enroll

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

Recommended Qualification Pathways

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

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