Course Area
Course Duration
3 Days
Continuing Education Units
2.4
Course Fee
CAD $1645.00
Early Bird Price*
CAD $1545.00
Course Details
BSI's “ISO 13485:2016 Internal Quality Systems Auditor” competency- based 3-day course teaches a general understanding of the concepts of the ISO 13485:2016 standard and the principles and practices of effective internal 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 internal audits that are required for a quality management system based on ISO 13485:2016. Our 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, practical role-playing, group workshops, and open forum discussions.
This course comprises the following two Exemplar Global TPECS Competency Units whose outcomes are certified by Exemplar Global:
- MD -Medical Device Systems
- AU - Management Systems Auditing
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
- Apply ISO 19011: 2018 concepts, new terminology and guidelines
- Understand the types of risks and opportunities associated with auditing
- Understand the roles and responsibilities of the auditor
- Conduct all phases of an internal audit adopting a risk-based approach
Who Should Attend?
Individuals interested in conducting, managing, or participating in first-party (internal) audits.
Prerequisite
A prior review of the ISO 13485:2016 standard is required and an understanding of auditing principles 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 3 eight hour sessions*, one per day. There are online exams at the end of each competency unit, which are in sessions 2 and 3. Exams range from is 120 -145 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 6 four hour sessions*, one per day. There are online exams at the end of each competency unit, which are in sessions 4 and 6. Exams range from is 120 - 145 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 4, 2023 9:00 AM - 5:30 PM ET Dec 5, 2023 9:00 AM - 5:30 PM ET Dec 6, 2023 9:00 AM - 5:30 PM ET | Live Online - Full Day | CAD $1645.00 | Enroll |
Dec 11, 2023 9:00 AM - 5:30 PM ET Dec 12, 2023 9:00 AM - 5:30 PM ET Dec 13, 2023 9:00 AM - 5:30 PM ET | Live Online - Full Day | CAD $1645.00 | Enroll |
Jan 3, 2024 9:00 AM - 5:30 PM ET Jan 4, 2024 9:00 AM - 5:30 PM ET Jan 5, 2024 9:00 AM - 5:30 PM ET | Live Online - Full Day | CAD $1645.00 | Enroll |
Jan 8, 2024 9:00 AM - 5:30 PM ET Jan 9, 2024 9:00 AM - 5:30 PM ET Jan 10, 2024 9:00 AM - 5:30 PM ET | Live Online - Full Day | CAD $1645.00 | Enroll |
Jan 15, 2024 11:00 AM - 8:30 PM ET Jan 16, 2024 11:00 AM - 8:30 PM ET Jan 17, 2024 11:00 AM - 8:30 PM ET | Live Online - Full Day | CAD $1645.00 | Enroll |
Jan 22, 2024 8:30 AM - 5:00 PM Jan 23, 2024 8:30 AM - 5:00 PM Jan 24, 2024 8:30 AM - 5:00 PM | Montréal, QC Novotel Montréal Centre 1180 rue de la Montagne Montreal, QC H3G 1Z1 Canada 514-861-6000 map location | CAD $1645.00 | Enroll |
Jan 22, 2024 9:00 AM - 5:30 PM ET Jan 23, 2024 9:00 AM - 5:30 PM ET Jan 24, 2024 9:00 AM - 5:30 PM ET | Live Online - Full Day | CAD $1645.00 | Enroll |
Jan 29, 2024 9:00 AM - 5:30 PM ET Jan 30, 2024 9:00 AM - 5:30 PM ET Jan 31, 2024 9:00 AM - 5:30 PM ET | Live Online - Full Day | CAD $1645.00 | Enroll |
Feb 6, 2024 11:00 AM - 8:30 PM ET Feb 7, 2024 11:00 AM - 8:30 PM ET Feb 8, 2024 11:00 AM - 8:30 PM ET | Live Online - Full Day | CAD $1645.00 | Enroll |
Feb 13, 2024 9:00 AM - 5:30 PM ET Feb 14, 2024 9:00 AM - 5:30 PM ET Feb 15, 2024 9:00 AM - 5:30 PM ET | Live Online - Full Day | CAD $1645.00 | Enroll |
Feb 19, 2024 9:00 AM - 1:00 PM ET Feb 20, 2024 9:00 AM - 1:00 PM ET Feb 21, 2024 9:00 AM - 1:00 PM ET Feb 22, 2024 9:00 AM - 1:00 PM ET Feb 26, 2024 9:00 AM - 1:00 PM ET Feb 27, 2024 9:00 AM - 1:00 PM ET | Live Online - Half Day | CAD $1645.00 | Enroll |
Feb 26, 2024 11:00 AM - 8:30 PM ET Feb 27, 2024 11:00 AM - 8:30 PM ET Feb 28, 2024 11:00 AM - 8:30 PM ET | Live Online - Full Day | CAD $1645.00 | Enroll |
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 | Live Online - Full Day | CAD $1645.00 | Enroll |
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 | Live Online - Full Day | CAD $1645.00 | Enroll |
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 | Live Online - Full Day | CAD $1645.00 | Enroll |
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 | Live Online - Full Day | CAD $1645.00 | Enroll |
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 | Live Online - Full Day | CAD $1645.00 | Enroll |
Apr 15, 2024 11:00 AM - 8:30 PM ET Apr 16, 2024 11:00 AM - 8:30 PM ET Apr 17, 2024 11:00 AM - 8:30 PM ET | Live Online - Full Day | CAD $1645.00 | Enroll |
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 | Live Online - Full Day | CAD $1645.00 | Enroll |
Apr 29, 2024 8:30 AM - 5:00 PM Apr 30, 2024 8:30 AM - 5:00 PM May 1, 2024 8:30 AM - 5:00 PM | Vancouver, BC | CAD $1645.00 | Enroll |
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 | Live Online - Full Day | CAD $1645.00 | Enroll |
May 6, 2024 11:00 AM - 8:30 PM ET May 7, 2024 11:00 AM - 8:30 PM ET May 8, 2024 11:00 AM - 8:30 PM ET | Live Online - Full Day | CAD $1645.00 | Enroll |
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 | Live Online - Full Day | CAD $1645.00 | Enroll |
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 | Live Online - Half Day | CAD $1645.00 | Enroll |
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 | Live Online - Full Day | CAD $1645.00 | Enroll |
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 | Live Online - Full Day | CAD $1645.00 | Enroll |
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 | Live Online - Full Day | CAD $1645.00 | Enroll |
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 | Live Online - Full Day | CAD $1645.00 | Enroll |
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 | Live Online - Full Day | CAD $1645.00 | Enroll |
Jul 15, 2024 11:00 AM - 8:30 PM ET Jul 16, 2024 11:00 AM - 8:30 PM ET Jul 17, 2024 11:00 AM - 8:30 PM ET | Live Online - Full Day | CAD $1645.00 | Enroll |
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 | Live Online - Full Day | CAD $1645.00 | Enroll |
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 | Live Online - Full Day | CAD $1645.00 | Enroll |
Aug 6, 2024 11:00 AM - 8:30 PM ET Aug 7, 2024 11:00 AM - 8:30 PM ET Aug 8, 2024 11:00 AM - 8:30 PM ET | Live Online - Full Day | CAD $1645.00 | Enroll |
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 Day | CAD $1645.00 | Enroll |
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 | Live Online - Full Day | CAD $1645.00 | Enroll |
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 | Live Online - Full Day | CAD $1645.00 | Enroll |
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 | Live Online - Full Day | CAD $1645.00 | Enroll |
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 Sep 23, 2024 2:30 PM - 6:30 PM ET Sep 24, 2024 2:30 PM - 6:30 PM ET | Live Online - Half Day | CAD $1645.00 | Enroll |
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 | Live Online - Full Day | CAD $1645.00 | Enroll |
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 | Live Online - Full Day | CAD $1645.00 | Enroll |
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 | Live Online - Full Day | CAD $1645.00 | Enroll |
Oct 15, 2024 11:00 AM - 8:30 PM ET Oct 16, 2024 11:00 AM - 8:30 PM ET Oct 17, 2024 11:00 AM - 8:30 PM ET | Live Online - Full Day | CAD $1645.00 | 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 | Live Online - Full Day | CAD $1645.00 | 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 | Live Online - Full Day | CAD $1645.00 | Enroll |
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 | Live Online - Full Day | CAD $1645.00 | 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 | Live Online - Half Day | CAD $1645.00 | Enroll |
Nov 25, 2024 9:00 AM - 5:30 PM ET Nov 26, 2024 9:00 AM - 5:30 PM ET Nov 27, 2024 9:00 AM - 5:30 PM ET | Live Online - Full Day | CAD $1645.00 | Enroll |
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 | Live Online - Full Day | CAD $1645.00 | 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 | Live Online - Full Day | CAD $1645.00 | 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 | Live Online - Full Day | CAD $1645.00 | Enroll |
The venues for scheduled courses are tentative until receipt of a course confirmation from BSI.
Recommended Qualification Pathways
ISO 13485:2016 Internal Auditor (TPECS) puts you on the pathway for the following qualifications.





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