ISO 13485:2016 Lead Auditor (Live Online)

Course Area

Medical Devices

Course Duration

Continuing Education Units

3.2

Course Fee

USD $2250.00

Early Bird Price*

USD $2150.00

Upcoming Sessions
Dec 13-16, 2021 - Nashville, TNEnroll
Dec 13-23, 2021 - Live Online - Half DayEnroll
Dec 13-16, 2021 - Live Online - Full DayEnroll

View all sessions

* Subject to availability

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 13, 2021 8:00 AM - 5:30 PM
Dec 14, 2021 8:00 AM - 6:30 PM
Dec 15, 2021 8:00 AM - 6:00 PM
Dec 16, 2021 8:00 AM - 4:00 PM
Nashville, TN
Aloft Nashville West End
1719 West End Avenue
Nashville, TN 37203
United States
(615) 329-4200 map location
USD $2250.00 Enroll
Dec 13, 2021 8:30 AM - 1:00 PM ET
Dec 14, 2021 8:30 AM - 1:00 PM ET
Dec 15, 2021 8:30 AM - 1:00 PM ET
Dec 16, 2021 8:30 AM - 1:00 PM ET
Dec 20, 2021 8:30 AM - 1:00 PM ET
Dec 21, 2021 8:30 AM - 1:00 PM ET
Dec 22, 2021 8:30 AM - 1:00 PM ET
Dec 23, 2021 8:30 AM - 1:00 PM ET
Live Online - Half Day USD $2250.00 Enroll
Dec 13, 2021 9:00 AM - 5:30 PM ET
Dec 14, 2021 9:00 AM - 5:30 PM ET
Dec 15, 2021 9:00 AM - 5:30 PM ET
Dec 16, 2021 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $2250.00 Enroll
Dec 13, 2021 9:00 AM - 5:30 PM ET
Dec 14, 2021 9:00 AM - 5:30 PM ET
Dec 15, 2021 9:00 AM - 5:30 PM ET
Dec 16, 2021 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $2250.00 Enroll
Dec 20, 2021 11:00 AM - 8:30 PM ET
Dec 21, 2021 11:00 AM - 8:30 PM ET
Dec 22, 2021 11:00 AM - 8:30 PM ET
Dec 23, 2021 11:00 AM - 8:30 PM ET
Live Online - Full Day USD $2250.00 Enroll
Jan 4, 2022 11:00 AM - 8:30 PM ET
Jan 5, 2022 11:00 AM - 8:30 PM ET
Jan 6, 2022 11:00 AM - 8:30 PM ET
Jan 7, 2022 11:00 AM - 8:30 PM ET
Live Online - Full Day USD $2250.00 Enroll
Jan 10, 2022 8:00 AM - 5:30 PM
Jan 11, 2022 8:00 AM - 6:30 PM
Jan 12, 2022 8:00 AM - 6:00 PM
Jan 13, 2022 8:00 AM - 4:00 PM
Dulles, VA USD $2250.00 Enroll
Jan 10, 2022 9:00 AM - 5:30 PM ET
Jan 11, 2022 9:00 AM - 5:30 PM ET
Jan 12, 2022 9:00 AM - 5:30 PM ET
Jan 13, 2022 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $2250.00 Enroll
Jan 17, 2022 8:30 AM - 1:00 PM ET
Jan 18, 2022 8:30 AM - 1:00 PM ET
Jan 19, 2022 8:30 AM - 1:00 PM ET
Jan 20, 2022 8:30 AM - 1:00 PM ET
Jan 24, 2022 8:30 AM - 1:00 PM ET
Jan 25, 2022 8:30 AM - 1:00 PM ET
Jan 26, 2022 8:30 AM - 1:00 PM ET
Jan 27, 2022 8:30 AM - 1:00 PM ET
Live Online - Half Day USD $2250.00 Enroll
Jan 17, 2022 11:00 AM - 8:30 PM ET
Jan 18, 2022 11:00 AM - 8:30 PM ET
Jan 19, 2022 11:00 AM - 8:30 PM ET
Jan 20, 2022 11:00 AM - 8:30 PM ET
Live Online - Full Day USD $2250.00 Enroll
Jan 24, 2022 9:00 AM - 5:30 PM ET
Jan 25, 2022 9:00 AM - 5:30 PM ET
Jan 26, 2022 9:00 AM - 5:30 PM ET
Jan 27, 2022 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $2250.00 Enroll
Jan 24, 2022 9:00 AM - 5:30 PM ET
Jan 25, 2022 9:00 AM - 5:30 PM ET
Jan 26, 2022 9:00 AM - 5:30 PM ET
Jan 27, 2022 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $2250.00 Enroll
Jan 31, 2022 8:00 AM - 5:30 PM
Feb 1, 2022 8:00 AM - 6:30 PM
Feb 2, 2022 8:00 AM - 6:00 PM
Feb 3, 2022 8:00 AM - 4:00 PM
Orlando, FL USD $2250.00 Enroll
Jan 31, 2022 9:00 AM - 5:30 PM ET
Feb 1, 2022 9:00 AM - 5:30 PM ET
Feb 2, 2022 9:00 AM - 5:30 PM ET
Feb 3, 2022 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $2250.00 Enroll
Feb 7, 2022 11:00 AM - 8:30 PM ET
Feb 8, 2022 11:00 AM - 8:30 PM ET
Feb 9, 2022 11:00 AM - 8:30 PM ET
Feb 10, 2022 11:00 AM - 8:30 PM ET
Live Online - Full Day USD $2250.00 Enroll
Feb 14, 2022 9:00 AM - 5:30 PM ET
Feb 15, 2022 9:00 AM - 5:30 PM ET
Feb 16, 2022 9:00 AM - 5:30 PM ET
Feb 17, 2022 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $2250.00 Enroll
Feb 14, 2022 2:30 PM - 6:30 PM ET
Feb 15, 2022 2:30 PM - 6:30 PM ET
Feb 16, 2022 2:30 PM - 6:30 PM ET
Feb 17, 2022 2:30 PM - 6:30 PM ET
Feb 21, 2022 2:30 PM - 6:30 PM ET
Feb 22, 2022 2:30 PM - 6:30 PM ET
Feb 23, 2022 2:30 PM - 6:30 PM ET
Feb 24, 2022 2:30 PM - 6:30 PM ET
Live Online - Half Day USD $2250.00 Enroll
Feb 21, 2022 9:00 AM - 5:30 PM ET
Feb 22, 2022 9:00 AM - 5:30 PM ET
Feb 23, 2022 9:00 AM - 5:30 PM ET
Feb 24, 2022 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $2250.00 Enroll
Feb 28, 2022 8:00 AM - 5:30 PM
Mar 1, 2022 8:00 AM - 6:30 PM
Mar 2, 2022 8:00 AM - 6:00 PM
Mar 3, 2022 8:00 AM - 4:00 PM
Salt Lake City, UT USD $2250.00 Enroll
Feb 28, 2022 9:00 AM - 5:30 PM ET
Mar 1, 2022 9:00 AM - 5:30 PM ET
Mar 2, 2022 9:00 AM - 5:30 PM ET
Mar 3, 2022 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $2250.00 Enroll
Mar 7, 2022 9:00 AM - 1:00 PM ET
Mar 8, 2022 9:00 AM - 1:00 PM ET
Mar 9, 2022 9:00 AM - 1:00 PM ET
Mar 10, 2022 9:00 AM - 1:00 PM ET
Mar 14, 2022 9:00 AM - 1:00 PM ET
Mar 15, 2022 9:00 AM - 1:00 PM ET
Mar 16, 2022 9:00 AM - 1:00 PM ET
Mar 17, 2022 9:00 AM - 1:00 PM ET
Live Online - Half Day USD $2250.00 Enroll
Mar 7, 2022 11:00 AM - 8:30 PM ET
Mar 8, 2022 11:00 AM - 8:30 PM ET
Mar 9, 2022 11:00 AM - 8:30 PM ET
Mar 10, 2022 11:00 AM - 8:30 PM ET
Live Online - Full Day USD $2250.00 Enroll
Mar 14, 2022 9:00 AM - 5:30 PM ET
Mar 15, 2022 9:00 AM - 5:30 PM ET
Mar 16, 2022 9:00 AM - 5:30 PM ET
Mar 17, 2022 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $2250.00 Enroll
Mar 21, 2022 8:00 AM - 5:30 PM
Mar 22, 2022 8:00 AM - 6:30 PM
Mar 23, 2022 8:00 AM - 6:00 PM
Mar 24, 2022 8:00 AM - 4:00 PM
San José, CA USD $2250.00 Enroll
Mar 21, 2022 9:00 AM - 5:30 PM ET
Mar 22, 2022 9:00 AM - 5:30 PM ET
Mar 23, 2022 9:00 AM - 5:30 PM ET
Mar 24, 2022 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $2250.00 Enroll
Mar 28, 2022 11:00 AM - 8:30 PM ET
Mar 29, 2022 11:00 AM - 8:30 PM ET
Mar 30, 2022 11:00 AM - 8:30 PM ET
Mar 31, 2022 11:00 AM - 8:30 PM ET
Live Online - Full Day USD $2250.00 Enroll
Apr 4, 2022 9:00 AM - 5:30 PM ET
Apr 5, 2022 9:00 AM - 5:30 PM ET
Apr 6, 2022 9:00 AM - 5:30 PM ET
Apr 7, 2022 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $2250.00 Enroll
Apr 4, 2022 2:30 PM - 6:30 PM ET
Apr 5, 2022 2:30 PM - 6:30 PM ET
Apr 6, 2022 2:30 PM - 6:30 PM ET
Apr 7, 2022 2:30 PM - 6:30 PM ET
Apr 11, 2022 2:30 PM - 6:30 PM ET
Apr 12, 2022 2:30 PM - 6:30 PM ET
Apr 13, 2022 2:30 PM - 6:30 PM ET
Apr 14, 2022 2:30 PM - 6:30 PM ET
Live Online - Half Day USD $2250.00 Enroll
Apr 11, 2022 9:00 AM - 5:30 PM ET
Apr 12, 2022 9:00 AM - 5:30 PM ET
Apr 13, 2022 9:00 AM - 5:30 PM ET
Apr 14, 2022 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $2250.00 Enroll
Apr 18, 2022 8:00 AM - 5:30 PM
Apr 19, 2022 8:00 AM - 6:30 PM
Apr 20, 2022 8:00 AM - 6:00 PM
Apr 21, 2022 8:00 AM - 4:00 PM
Nashville, TN USD $2250.00 Enroll
Apr 18, 2022 9:00 AM - 5:30 PM ET
Apr 19, 2022 9:00 AM - 5:30 PM ET
Apr 20, 2022 9:00 AM - 5:30 PM ET
Apr 21, 2022 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $2250.00 Enroll
Apr 25, 2022 11:00 AM - 8:30 PM ET
Apr 26, 2022 11:00 AM - 8:30 PM ET
Apr 27, 2022 11:00 AM - 8:30 PM ET
Apr 28, 2022 11:00 AM - 8:30 PM ET
Live Online - Full Day USD $2250.00 Enroll
May 2, 2022 11:00 AM - 8:30 PM ET
May 3, 2022 11:00 AM - 8:30 PM ET
May 4, 2022 11:00 AM - 8:30 PM ET
May 5, 2022 11:00 AM - 8:30 PM ET
Live Online - Full Day USD $2250.00 Enroll
May 9, 2022 8:30 AM - 1:00 PM ET
May 10, 2022 8:30 AM - 1:00 PM ET
May 11, 2022 8:30 AM - 1:00 PM ET
May 12, 2022 8:30 AM - 1:00 PM ET
May 16, 2022 8:30 AM - 1:00 PM ET
May 17, 2022 8:30 AM - 1:00 PM ET
May 18, 2022 8:30 AM - 1:00 PM ET
May 19, 2022 8:30 AM - 1:00 PM ET
Live Online - Half Day USD $2250.00 Enroll
May 9, 2022 9:00 AM - 5:30 PM ET
May 10, 2022 9:00 AM - 5:30 PM ET
May 11, 2022 9:00 AM - 5:30 PM ET
May 12, 2022 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $2250.00 Enroll
May 16, 2022 9:00 AM - 5:30 PM ET
May 17, 2022 9:00 AM - 5:30 PM ET
May 18, 2022 9:00 AM - 5:30 PM ET
May 19, 2022 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $2250.00 Enroll
May 23, 2022 8:00 AM - 5:30 PM
May 24, 2022 8:00 AM - 6:30 PM
May 25, 2022 8:00 AM - 6:00 PM
May 26, 2022 8:00 AM - 4:00 PM
Dulles, VA USD $2250.00 Enroll
May 24, 2022 11:00 AM - 8:30 PM ET
May 25, 2022 11:00 AM - 8:30 PM ET
May 26, 2022 11:00 AM - 8:30 PM ET
May 27, 2022 11:00 AM - 8:30 PM ET
Live Online - Full Day USD $2250.00 Enroll
May 31, 2022 11:00 AM - 8:30 PM ET
Jun 1, 2022 11:00 AM - 8:30 PM ET
Jun 2, 2022 11:00 AM - 8:30 PM ET
Jun 3, 2022 11:00 AM - 8:30 PM ET
Live Online - Full Day USD $2250.00 Enroll
Jun 6, 2022 2:30 PM - 6:30 PM ET
Jun 7, 2022 2:30 PM - 6:30 PM ET
Jun 8, 2022 2:30 PM - 6:30 PM ET
Jun 9, 2022 2:30 PM - 6:30 PM ET
Jun 13, 2022 2:30 PM - 6:30 PM ET
Jun 14, 2022 2:30 PM - 6:30 PM ET
Jun 15, 2022 2:30 PM - 6:30 PM ET
Jun 16, 2022 2:30 PM - 6:30 PM ET
Live Online - Half Day USD $2250.00 Enroll
Jun 13, 2022 9:00 AM - 5:30 PM ET
Jun 14, 2022 9:00 AM - 5:30 PM ET
Jun 15, 2022 9:00 AM - 5:30 PM ET
Jun 16, 2022 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $2250.00 Enroll
Jun 20, 2022 8:00 AM - 5:30 PM
Jun 21, 2022 8:00 AM - 6:30 PM
Jun 22, 2022 8:00 AM - 6:00 PM
Jun 23, 2022 8:00 AM - 4:00 PM
San José, CA USD $2250.00 Enroll
Jun 20, 2022 9:00 AM - 5:30 PM ET
Jun 21, 2022 9:00 AM - 5:30 PM ET
Jun 22, 2022 9:00 AM - 5:30 PM ET
Jun 23, 2022 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $2250.00 Enroll
Jun 27, 2022 11:00 AM - 8:30 PM ET
Jun 28, 2022 11:00 AM - 8:30 PM ET
Jun 29, 2022 11:00 AM - 8:30 PM ET
Jun 30, 2022 11:00 AM - 8:30 PM ET
Live Online - Full Day USD $2250.00 Enroll

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

Whittington & Associates

We are committed to providing expert training, effective consulting, and valuable auditing. If you have any questions about our services, please contact us at 770-862-1766, or Larry@WhittingtonAssociates.com.