Course Details

ISO 13485:2016 Lead Auditor (TPECS)

Student taking online training

Course Area

Medical Devices

Course Duration

4 Days

Continuing Education Units

3.2

Course Fee

USD $2145.00

Early Bird Price*

USD $2045.00

Upcoming Sessions

Dec 16-19, 2024 - Live Online - Full Day Enroll
Jan 6-9, 2025 - Live Online - Full Day Enroll
Jan 13-16, 2025 - Live Online - Full Day Enroll

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* 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
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 $2145.00Enroll
Jan 6, 2025 11:00 AM - 7:30 PM ET
Jan 7, 2025 11:00 AM - 7:30 PM ET
Jan 8, 2025 11:00 AM - 7:30 PM ET
Jan 9, 2025 11:00 AM - 7:30 PM ET
Live Online - Full DayUSD $2145.00Enroll
Jan 13, 2025 9:00 AM - 5:30 PM ET
Jan 14, 2025 9:00 AM - 5:30 PM ET
Jan 15, 2025 9:00 AM - 5:30 PM ET
Jan 16, 2025 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $2145.00Enroll
Jan 20, 2025 9:00 AM - 5:30 PM ET
Jan 21, 2025 9:00 AM - 5:30 PM ET
Jan 22, 2025 9:00 AM - 5:30 PM ET
Jan 23, 2025 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $2145.00Enroll
Jan 27, 2025 11:00 AM - 7:30 PM ET
Jan 28, 2025 11:00 AM - 7:30 PM ET
Jan 29, 2025 11:00 AM - 7:30 PM ET
Jan 30, 2025 11:00 AM - 7:30 PM ET
Live Online - Full DayUSD $2145.00Enroll
Feb 3, 2025 9:00 AM - 5:30 PM ET
Feb 4, 2025 9:00 AM - 5:30 PM ET
Feb 5, 2025 9:00 AM - 5:30 PM ET
Feb 6, 2025 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $2145.00Enroll
Feb 10, 2025 2:00 PM - 6:00 PM ET
Feb 11, 2025 2:00 PM - 6:00 PM ET
Feb 12, 2025 2:00 PM - 6:00 PM ET
Feb 13, 2025 2:00 PM - 6:00 PM ET
Feb 17, 2025 2:00 PM - 6:00 PM ET
Feb 18, 2025 2:00 PM - 6:00 PM ET
Feb 19, 2025 2:00 PM - 6:00 PM ET
Feb 20, 2025 2:00 PM - 6:00 PM ET
Live Online - Half DayUSD $2145.00Enroll
Feb 17, 2025 9:00 AM - 5:30 PM ET
Feb 18, 2025 9:00 AM - 5:30 PM ET
Feb 19, 2025 9:00 AM - 5:30 PM ET
Feb 20, 2025 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $2145.00Enroll
Feb 24, 2025 9:00 AM - 5:30 PM ET
Feb 25, 2025 9:00 AM - 5:30 PM ET
Feb 26, 2025 9:00 AM - 5:30 PM ET
Feb 27, 2025 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $2145.00Enroll
Mar 3, 2025 8:00 AM - 5:30 PM
Mar 4, 2025 8:00 AM - 5:30 PM
Mar 5, 2025 8:00 AM - 6:00 PM
Mar 6, 2025 8:00 AM - 4:00 PM
Minneapolis, MNUSD $2145.00Enroll
Mar 10, 2025 9:00 AM - 5:30 PM ET
Mar 11, 2025 9:00 AM - 5:30 PM ET
Mar 12, 2025 9:00 AM - 5:30 PM ET
Mar 13, 2025 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $2145.00Enroll
Mar 17, 2025 11:00 AM - 7:30 PM ET
Mar 18, 2025 11:00 AM - 7:30 PM ET
Mar 19, 2025 11:00 AM - 7:30 PM ET
Mar 20, 2025 11:00 AM - 7:30 PM ET
Live Online - Full DayUSD $2145.00Enroll
Mar 24, 2025 9:00 AM - 5:30 PM ET
Mar 25, 2025 9:00 AM - 5:30 PM ET
Mar 26, 2025 9:00 AM - 5:30 PM ET
Mar 27, 2025 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $2145.00Enroll
Mar 31, 2025 9:00 AM - 5:30 PM ET
Apr 1, 2025 9:00 AM - 5:30 PM ET
Apr 2, 2025 9:00 AM - 5:30 PM ET
Apr 3, 2025 9:00 AM - 5:30 PM ET
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Apr 7, 2025 11:00 AM - 7:30 PM ET
Apr 8, 2025 11:00 AM - 7:30 PM ET
Apr 9, 2025 11:00 AM - 7:30 PM ET
Apr 10, 2025 11:00 AM - 7:30 PM ET
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Apr 14, 2025 9:00 AM - 5:30 PM ET
Apr 15, 2025 9:00 AM - 5:30 PM ET
Apr 16, 2025 9:00 AM - 5:30 PM ET
Apr 17, 2025 9:00 AM - 5:30 PM ET
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Apr 21, 2025 9:00 AM - 5:30 PM ET
Apr 22, 2025 9:00 AM - 5:30 PM ET
Apr 23, 2025 9:00 AM - 5:30 PM ET
Apr 24, 2025 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $2145.00Enroll
Apr 28, 2025 11:00 AM - 7:30 PM ET
Apr 29, 2025 11:00 AM - 7:30 PM ET
Apr 30, 2025 11:00 AM - 7:30 PM ET
May 1, 2025 11:00 AM - 7:30 PM ET
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May 5, 2025 9:00 AM - 5:30 PM ET
May 6, 2025 9:00 AM - 5:30 PM ET
May 7, 2025 9:00 AM - 5:30 PM ET
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Live Online - Full DayUSD $2145.00Enroll
May 12, 2025 9:00 AM - 5:30 PM ET
May 13, 2025 9:00 AM - 5:30 PM ET
May 14, 2025 9:00 AM - 5:30 PM ET
May 15, 2025 9:00 AM - 5:30 PM ET
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May 20, 2025 9:00 AM - 1:00 PM ET
May 21, 2025 9:00 AM - 1:00 PM ET
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May 28, 2025 9:00 AM - 1:00 PM ET
May 29, 2025 9:00 AM - 1:00 PM ET
May 30, 2025 9:00 AM - 1:00 PM ET
Live Online - Half DayUSD $2145.00Enroll
May 27, 2025 8:00 AM - 5:30 PM
May 28, 2025 8:00 AM - 5:30 PM
May 29, 2025 8:00 AM - 6:00 PM
May 30, 2025 8:00 AM - 4:00 PM
San José, CAUSD $2145.00Enroll
Jun 2, 2025 9:00 AM - 5:30 PM ET
Jun 3, 2025 9:00 AM - 5:30 PM ET
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Live Online - Full DayUSD $2145.00Enroll
Jun 9, 2025 9:00 AM - 5:30 PM ET
Jun 10, 2025 9:00 AM - 5:30 PM ET
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Jun 16, 2025 11:00 AM - 7:30 PM ET
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Jun 23, 2025 9:00 AM - 5:30 PM ET
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Jul 7, 2025 9:00 AM - 5:30 PM ET
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Jul 14, 2025 9:00 AM - 5:30 PM ET
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Jul 21, 2025 11:00 AM - 7:30 PM ET
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Jul 28, 2025 9:00 AM - 5:30 PM ET
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Aug 5, 2025 8:00 AM - 5:30 PM
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Boston, MAUSD $2145.00Enroll
Aug 11, 2025 9:00 AM - 5:30 PM ET
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Aug 18, 2025 2:00 PM - 6:00 PM ET
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Aug 25, 2025 9:00 AM - 5:30 PM ET
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Sep 2, 2025 9:00 AM - 5:30 PM ET
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Sep 8, 2025 11:00 AM - 7:30 PM ET
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Sep 29, 2025 11:00 AM - 7:30 PM ET
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Oct 6, 2025 9:00 AM - 5:30 PM ET
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Oct 14, 2025 9:00 AM - 5:30 PM ET
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Oct 20, 2025 11:00 AM - 7:30 PM ET
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Oct 27, 2025 9:00 AM - 5:30 PM ET
Oct 28, 2025 9:00 AM - 5:30 PM ET
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Oct 30, 2025 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $2145.00Enroll
Nov 3, 2025 8:00 AM - 5:30 PM
Nov 4, 2025 8:00 AM - 5:30 PM
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Nov 10, 2025 9:00 AM - 1:00 PM ET
Nov 11, 2025 9:00 AM - 1:00 PM ET
Nov 12, 2025 9:00 AM - 1:00 PM ET
Nov 13, 2025 9:00 AM - 1:00 PM ET
Nov 17, 2025 9:00 AM - 1:00 PM ET
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Nov 10, 2025 11:00 AM - 7:30 PM ET
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Nov 12, 2025 11:00 AM - 7:30 PM ET
Nov 13, 2025 11:00 AM - 7:30 PM ET
Live Online - Full DayUSD $2145.00Enroll
Dec 1, 2025 9:00 AM - 5:30 PM ET
Dec 2, 2025 9:00 AM - 5:30 PM ET
Dec 3, 2025 9:00 AM - 5:30 PM ET
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Live Online - Full DayUSD $2145.00Enroll
Dec 8, 2025 9:00 AM - 5:30 PM ET
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Dec 15, 2025 11:00 AM - 7:30 PM ET
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Dec 17, 2025 11:00 AM - 7:30 PM ET
Dec 18, 2025 11:00 AM - 7:30 PM ET
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The venues for scheduled courses are tentative until receipt of a course confirmation from BSI.

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

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