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Course Details

ISO 13485:2016 Internal Auditor (TPECS)

Course Area

Medical Devices

Course Duration

3 Days

Continuing Education Units

2.4

Course Fee

CAD $1645.00

Early Bird Price*

CAD $1545.00

Upcoming Sessions
Dec 4-6, 2023 - Live Online - Full DayEnroll
Dec 11-13, 2023 - Live Online - Full DayEnroll
Jan 3-5, 2024 - Live Online - Full DayEnroll

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* Subject to availability

See also

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 DayCAD $1645.00Enroll
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 DayCAD $1645.00Enroll
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 DayCAD $1645.00Enroll
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 DayCAD $1645.00Enroll
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 DayCAD $1645.00Enroll
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 $1645.00Enroll
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 DayCAD $1645.00Enroll
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
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Feb 6, 2024 11:00 AM - 8:30 PM ET
Feb 7, 2024 11:00 AM - 8:30 PM ET
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Feb 13, 2024 9:00 AM - 5:30 PM ET
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Feb 19, 2024 9:00 AM - 1:00 PM ET
Feb 20, 2024 9:00 AM - 1:00 PM ET
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Mar 18, 2024 9:00 AM - 5:30 PM ET
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Apr 29, 2024 9:00 AM - 5:30 PM ET
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Sep 16, 2024 2:30 PM - 6:30 PM ET
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Oct 28, 2024 9:00 AM - 5:30 PM ET
Oct 29, 2024 9:00 AM - 5:30 PM ET
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Nov 4, 2024 11:00 AM - 8:30 PM ET
Nov 5, 2024 11:00 AM - 8:30 PM ET
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Nov 11, 2024 9:00 AM - 1:00 PM ET
Nov 12, 2024 9:00 AM - 1:00 PM ET
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Nov 25, 2024 9:00 AM - 5:30 PM ET
Nov 26, 2024 9:00 AM - 5:30 PM ET
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Dec 3, 2024 11:00 AM - 8:30 PM ET
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Dec 9, 2024 9:00 AM - 5:30 PM ET
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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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For questions regarding any of our courses, contact us or call 800.217.1390 (USA) 800.862.6752 (Canada)

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