Course Area
Course Duration
4 Days
Continuing Education Units
3.2
Course Fee
USD $2145.00
Early Bird Price*
USD $2045.00
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 |
---|---|---|---|
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 Day | USD $2145.00 | Enroll |
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 Day | USD $2145.00 | Enroll |
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 Day | USD $2145.00 | Enroll |
Nov 4, 2024 11:00 AM - 7:30 PM ET Nov 5, 2024 11:00 AM - 7:30 PM ET Nov 6, 2024 11:00 AM - 7:30 PM ET Nov 7, 2024 11:00 AM - 7:30 PM ET | Live Online - Full Day | USD $2145.00 | Enroll |
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 Day | USD $2145.00 | Enroll |
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, FL | USD $2145.00 | Enroll |
Dec 3, 2024 11:00 AM - 7:30 PM ET Dec 4, 2024 11:00 AM - 7:30 PM ET Dec 5, 2024 11:00 AM - 7:30 PM ET Dec 6, 2024 11:00 AM - 7:30 PM ET | Live Online - Full Day | USD $2145.00 | Enroll |
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 Day | USD $2145.00 | 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 Day | USD $2145.00 | Enroll |
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 Day | USD $2145.00 | Enroll |
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 Day | USD $2145.00 | Enroll |
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 Day | USD $2145.00 | Enroll |
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 Day | USD $2145.00 | Enroll |
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 Day | USD $2145.00 | Enroll |
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 Day | USD $2145.00 | Enroll |
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 Day | USD $2145.00 | Enroll |
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 Day | USD $2145.00 | Enroll |
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, MN | USD $2145.00 | Enroll |
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 Day | USD $2145.00 | Enroll |
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 Day | USD $2145.00 | Enroll |
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 Day | USD $2145.00 | Enroll |
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 | Live Online - Full Day | USD $2145.00 | Enroll |
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 | Live Online - Full Day | USD $2145.00 | Enroll |
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 | Live Online - Full Day | USD $2145.00 | Enroll |
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 Day | USD $2145.00 | Enroll |
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 | Live Online - Full Day | USD $2145.00 | Enroll |
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 May 8, 2025 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $2145.00 | Enroll |
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 | Live Online - Full Day | USD $2145.00 | Enroll |
May 20, 2025 9:00 AM - 1:00 PM ET May 21, 2025 9:00 AM - 1:00 PM ET May 22, 2025 9:00 AM - 1:00 PM ET May 23, 2025 9:00 AM - 1:00 PM ET May 27, 2025 9:00 AM - 1:00 PM ET 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 Day | USD $2145.00 | Enroll |
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, CA | USD $2145.00 | Enroll |
Jun 2, 2025 9:00 AM - 5:30 PM ET Jun 3, 2025 9:00 AM - 5:30 PM ET Jun 4, 2025 9:00 AM - 5:30 PM ET Jun 5, 2025 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $2145.00 | Enroll |
Jun 9, 2025 9:00 AM - 5:30 PM ET Jun 10, 2025 9:00 AM - 5:30 PM ET Jun 11, 2025 9:00 AM - 5:30 PM ET Jun 12, 2025 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $2145.00 | Enroll |
Jun 16, 2025 11:00 AM - 7:30 PM ET Jun 17, 2025 11:00 AM - 7:30 PM ET Jun 18, 2025 11:00 AM - 7:30 PM ET Jun 19, 2025 11:00 AM - 7:30 PM ET | Live Online - Full Day | USD $2145.00 | Enroll |
Jun 23, 2025 9:00 AM - 5:30 PM ET Jun 24, 2025 9:00 AM - 5:30 PM ET Jun 25, 2025 9:00 AM - 5:30 PM ET Jun 26, 2025 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $2145.00 | Enroll |
Jul 7, 2025 9:00 AM - 5:30 PM ET Jul 8, 2025 9:00 AM - 5:30 PM ET Jul 9, 2025 9:00 AM - 5:30 PM ET Jul 10, 2025 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $2145.00 | Enroll |
Jul 14, 2025 9:00 AM - 5:30 PM ET Jul 15, 2025 9:00 AM - 5:30 PM ET Jul 16, 2025 9:00 AM - 5:30 PM ET Jul 17, 2025 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $2145.00 | Enroll |
Jul 21, 2025 11:00 AM - 7:30 PM ET Jul 22, 2025 11:00 AM - 7:30 PM ET Jul 23, 2025 11:00 AM - 7:30 PM ET Jul 24, 2025 11:00 AM - 7:30 PM ET | Live Online - Full Day | USD $2145.00 | Enroll |
Jul 28, 2025 9:00 AM - 5:30 PM ET Jul 29, 2025 9:00 AM - 5:30 PM ET Jul 30, 2025 9:00 AM - 5:30 PM ET Jul 31, 2025 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $2145.00 | Enroll |
Aug 5, 2025 8:00 AM - 5:30 PM Aug 6, 2025 8:00 AM - 5:30 PM Aug 7, 2025 8:00 AM - 6:00 PM Aug 8, 2025 8:00 AM - 4:00 PM | Boston, MA | USD $2145.00 | Enroll |
Aug 11, 2025 9:00 AM - 5:30 PM ET Aug 12, 2025 9:00 AM - 5:30 PM ET Aug 13, 2025 9:00 AM - 5:30 PM ET Aug 14, 2025 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $2145.00 | Enroll |
Aug 18, 2025 2:00 PM - 6:00 PM ET Aug 19, 2025 2:00 PM - 6:00 PM ET Aug 20, 2025 2:00 PM - 6:00 PM ET Aug 21, 2025 2:00 PM - 6:00 PM ET Aug 25, 2025 2:00 PM - 6:00 PM ET Aug 26, 2025 2:00 PM - 6:00 PM ET Aug 27, 2025 2:00 PM - 6:00 PM ET Aug 28, 2025 2:00 PM - 6:00 PM ET | Live Online - Half Day | USD $2145.00 | Enroll |
Aug 25, 2025 9:00 AM - 5:30 PM ET Aug 26, 2025 9:00 AM - 5:30 PM ET Aug 27, 2025 9:00 AM - 5:30 PM ET Aug 28, 2025 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $2145.00 | Enroll |
Sep 2, 2025 9:00 AM - 5:30 PM ET Sep 3, 2025 9:00 AM - 5:30 PM ET Sep 4, 2025 9:00 AM - 5:30 PM ET Sep 5, 2025 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $2145.00 | Enroll |
Sep 8, 2025 11:00 AM - 7:30 PM ET Sep 9, 2025 11:00 AM - 7:30 PM ET Sep 10, 2025 11:00 AM - 7:30 PM ET Sep 11, 2025 11:00 AM - 7:30 PM ET | Live Online - Full Day | USD $2145.00 | Enroll |
Sep 15, 2025 9:00 AM - 5:30 PM ET Sep 16, 2025 9:00 AM - 5:30 PM ET Sep 17, 2025 9:00 AM - 5:30 PM ET Sep 18, 2025 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $2145.00 | Enroll |
Sep 22, 2025 9:00 AM - 5:30 PM ET Sep 23, 2025 9:00 AM - 5:30 PM ET Sep 24, 2025 9:00 AM - 5:30 PM ET Sep 25, 2025 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $2145.00 | Enroll |
Sep 29, 2025 11:00 AM - 7:30 PM ET Sep 30, 2025 11:00 AM - 7:30 PM ET Oct 1, 2025 11:00 AM - 7:30 PM ET Oct 2, 2025 11:00 AM - 7:30 PM ET | Live Online - Full Day | USD $2145.00 | Enroll |
Oct 6, 2025 9:00 AM - 5:30 PM ET Oct 7, 2025 9:00 AM - 5:30 PM ET Oct 8, 2025 9:00 AM - 5:30 PM ET Oct 9, 2025 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $2145.00 | Enroll |
Oct 14, 2025 9:00 AM - 5:30 PM ET Oct 15, 2025 9:00 AM - 5:30 PM ET Oct 16, 2025 9:00 AM - 5:30 PM ET Oct 17, 2025 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $2145.00 | Enroll |
Oct 20, 2025 11:00 AM - 7:30 PM ET Oct 21, 2025 11:00 AM - 7:30 PM ET Oct 22, 2025 11:00 AM - 7:30 PM ET Oct 23, 2025 11:00 AM - 7:30 PM ET | Live Online - Full Day | USD $2145.00 | Enroll |
Oct 27, 2025 9:00 AM - 5:30 PM ET Oct 28, 2025 9:00 AM - 5:30 PM ET Oct 29, 2025 9:00 AM - 5:30 PM ET Oct 30, 2025 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $2145.00 | Enroll |
Nov 3, 2025 8:00 AM - 5:30 PM Nov 4, 2025 8:00 AM - 5:30 PM Nov 5, 2025 8:00 AM - 6:00 PM Nov 6, 2025 8:00 AM - 4:00 PM | Irvine, California | USD $2145.00 | Enroll |
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 Nov 18, 2025 9:00 AM - 1:00 PM ET Nov 19, 2025 9:00 AM - 1:00 PM ET Nov 20, 2025 9:00 AM - 1:00 PM ET | Live Online - Half Day | USD $2145.00 | Enroll |
Nov 10, 2025 11:00 AM - 7:30 PM ET Nov 11, 2025 11:00 AM - 7:30 PM ET Nov 12, 2025 11:00 AM - 7:30 PM ET Nov 13, 2025 11:00 AM - 7:30 PM ET | Live Online - Full Day | USD $2145.00 | Enroll |
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 Dec 4, 2025 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $2145.00 | Enroll |
Dec 8, 2025 9:00 AM - 5:30 PM ET Dec 9, 2025 9:00 AM - 5:30 PM ET Dec 10, 2025 9:00 AM - 5:30 PM ET Dec 11, 2025 9:00 AM - 5:30 PM ET | Live Online - Full Day | USD $2145.00 | Enroll |
Dec 15, 2025 11:00 AM - 7:30 PM ET Dec 16, 2025 11:00 AM - 7:30 PM ET Dec 17, 2025 11:00 AM - 7:30 PM ET Dec 18, 2025 11:00 AM - 7:30 PM ET | Live Online - Full Day | USD $2145.00 | Enroll |
The venues for scheduled courses are tentative until receipt of a course confirmation from BSI.