ISO 13485:2016 Lead Auditor (Live Online)

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 6-9, 2023 - San José, CAEnroll
Feb 13-16, 2023 - Live Online - Full DayEnroll
Feb 20-23, 2023 - 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
Feb 6, 2023 8:00 AM - 5:30 PM
Feb 7, 2023 8:00 AM - 6:30 PM
Feb 8, 2023 8:00 AM - 6:00 PM
Feb 9, 2023 8:00 AM - 4:00 PM
San José, CA
Delta Hotels by Marriot-Santa Clara/Silicon Valley
2151 Laurelwood Road
Santa Clara, CA 95054
United States
408/988-8411
View Location Website
map location
USD $2385.00 Enroll
Feb 13, 2023 9:00 AM - 5:30 PM ET
Feb 14, 2023 9:00 AM - 5:30 PM ET
Feb 15, 2023 9:00 AM - 5:30 PM ET
Feb 16, 2023 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $2385.00 Enroll
Feb 20, 2023 9:00 AM - 5:30 PM ET
Feb 21, 2023 9:00 AM - 5:30 PM ET
Feb 22, 2023 9:00 AM - 5:30 PM ET
Feb 23, 2023 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $2385.00 Enroll
Mar 6, 2023 8:00 AM - 5:30 PM
Mar 7, 2023 8:00 AM - 6:30 PM
Mar 8, 2023 8:00 AM - 6:00 PM
Mar 9, 2023 8:00 AM - 4:00 PM
Minneapolis, MN
Hyatt Place Minneapolis Downtown
425 7th Street South
Minneapolis, MN 55415
United States
612 333 3111
View Location Website
map location
USD $2385.00 Enroll
Mar 6, 2023 9:00 AM - 1:00 PM ET
Mar 7, 2023 9:00 AM - 1:00 PM ET
Mar 8, 2023 9:00 AM - 1:00 PM ET
Mar 9, 2023 9:00 AM - 1:00 PM ET
Mar 13, 2023 9:00 AM - 1:00 PM ET
Mar 14, 2023 9:00 AM - 1:00 PM ET
Mar 15, 2023 9:00 AM - 1:00 PM ET
Mar 16, 2023 9:00 AM - 1:00 PM ET
Live Online - Half Day USD $2385.00 Enroll
Mar 27, 2023 9:00 AM - 5:30 PM ET
Mar 28, 2023 9:00 AM - 5:30 PM ET
Mar 29, 2023 9:00 AM - 5:30 PM ET
Mar 30, 2023 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $2385.00 Enroll
Apr 3, 2023 8:00 AM - 5:30 PM
Apr 4, 2023 8:00 AM - 6:30 PM
Apr 5, 2023 8:00 AM - 6:00 PM
Apr 6, 2023 8:00 AM - 4:00 PM
San Diego, CA USD $2385.00 Enroll
Apr 10, 2023 11:00 AM - 8:30 PM ET
Apr 11, 2023 11:00 AM - 8:30 PM ET
Apr 12, 2023 11:00 AM - 8:30 PM ET
Apr 13, 2023 11:00 AM - 8:30 PM ET
Live Online - Full Day USD $2385.00 Enroll
Apr 17, 2023 9:00 AM - 5:30 PM ET
Apr 18, 2023 9:00 AM - 5:30 PM ET
Apr 19, 2023 9:00 AM - 5:30 PM ET
Apr 20, 2023 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $2385.00 Enroll
Apr 24, 2023 9:00 AM - 5:30 PM ET
Apr 25, 2023 9:00 AM - 5:30 PM ET
Apr 26, 2023 9:00 AM - 5:30 PM ET
Apr 27, 2023 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $2385.00 Enroll
May 1, 2023 8:00 AM - 5:30 PM
May 2, 2023 8:00 AM - 6:30 PM
May 3, 2023 8:00 AM - 6:00 PM
May 4, 2023 8:00 AM - 4:00 PM
Boston, MA USD $2385.00 Enroll
May 8, 2023 9:00 AM - 5:30 PM ET
May 9, 2023 9:00 AM - 5:30 PM ET
May 10, 2023 9:00 AM - 5:30 PM ET
May 11, 2023 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $2385.00 Enroll
May 15, 2023 9:00 AM - 5:30 PM ET
May 16, 2023 9:00 AM - 5:30 PM ET
May 17, 2023 9:00 AM - 5:30 PM ET
May 18, 2023 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $2385.00 Enroll
May 23, 2023 9:00 AM - 5:30 PM ET
May 24, 2023 9:00 AM - 5:30 PM ET
May 25, 2023 9:00 AM - 5:30 PM ET
May 26, 2023 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $2385.00 Enroll
May 30, 2023 11:00 AM - 8:30 PM ET
May 31, 2023 11:00 AM - 8:30 PM ET
Jun 1, 2023 11:00 AM - 8:30 PM ET
Jun 2, 2023 11:00 AM - 8:30 PM ET
Live Online - Full Day USD $2385.00 Enroll
Jun 5, 2023 2:30 PM - 7:00 PM ET
Jun 6, 2023 2:30 PM - 7:00 PM ET
Jun 7, 2023 2:30 PM - 7:00 PM ET
Jun 8, 2023 2:30 PM - 7:00 PM ET
Jun 12, 2023 2:30 PM - 7:00 PM ET
Jun 13, 2023 2:30 PM - 7:00 PM ET
Jun 14, 2023 2:30 PM - 7:00 PM ET
Jun 15, 2023 2:30 PM - 7:00 PM ET
Live Online - Half Day USD $2385.00 Enroll
Jun 19, 2023 8:00 AM - 5:30 PM
Jun 20, 2023 8:00 AM - 6:30 PM
Jun 21, 2023 8:00 AM - 6:00 PM
Jun 22, 2023 8:00 AM - 4:00 PM
Orlando, FL USD $2385.00 Enroll
Jun 26, 2023 9:00 AM - 5:30 PM ET
Jun 27, 2023 9:00 AM - 5:30 PM ET
Jun 28, 2023 9:00 AM - 5:30 PM ET
Jun 29, 2023 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $2385.00 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.