ISO 13485:2016 Internal Auditor (Live Online)

Course Area

Medical Devices

Continuing Education Units

2.4

Course Fee

USD $1550.00

Early Bird Price*

USD $1450.00

Upcoming Sessions
Apr 26-28, 2021 - Live Online - Full DayEnroll
May 3-5, 2021 - Live Online - Full DayEnroll
May 3-11, 2021 - Live Online - Half DayEnroll

View all sessions

* Subject to availability

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
Apr 26, 2021 9:00 AM - 5:30 PM ET
Apr 27, 2021 9:00 AM - 5:30 PM ET
Apr 28, 2021 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $1550.00 Enroll
May 3, 2021 11:00 AM - 8:30 PM ET
May 4, 2021 11:00 AM - 8:30 PM ET
May 5, 2021 11:00 AM - 8:30 PM ET
Live Online - Full Day USD $1550.00 Enroll
May 3, 2021 2:30 PM - 6:30 PM ET
May 4, 2021 2:30 PM - 6:30 PM ET
May 5, 2021 2:30 PM - 6:30 PM ET
May 6, 2021 2:30 PM - 6:30 PM ET
May 10, 2021 2:30 PM - 6:30 PM ET
May 11, 2021 2:30 PM - 6:30 PM ET
Live Online - Half Day USD $1550.00 Enroll
May 10, 2021 9:00 AM - 5:30 PM ET
May 11, 2021 9:00 AM - 5:30 PM ET
May 12, 2021 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $1550.00 Enroll
May 17, 2021 11:00 AM - 8:30 PM ET
May 18, 2021 11:00 AM - 8:30 PM ET
May 19, 2021 11:00 AM - 8:30 PM ET
Live Online - Full Day USD $1550.00 Enroll
May 17, 2021 2:30 PM - 6:30 PM ET
May 18, 2021 2:30 PM - 6:30 PM ET
May 19, 2021 2:30 PM - 6:30 PM ET
May 20, 2021 2:30 PM - 6:30 PM ET
May 24, 2021 2:30 PM - 6:30 PM ET
May 25, 2021 2:30 PM - 6:30 PM ET
Live Online - Half Day USD $1550.00 Enroll
May 24, 2021 9:00 AM - 5:30 PM ET
May 25, 2021 9:00 AM - 5:30 PM ET
May 26, 2021 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $1550.00 Enroll
Jun 7, 2021 11:00 AM - 8:30 PM ET
Jun 8, 2021 11:00 AM - 8:30 PM ET
Jun 9, 2021 11:00 AM - 8:30 PM ET
Live Online - Full Day USD $1550.00 Enroll
Jun 7, 2021 2:30 PM - 6:30 PM ET
Jun 8, 2021 2:30 PM - 6:30 PM ET
Jun 9, 2021 2:30 PM - 6:30 PM ET
Jun 10, 2021 2:30 PM - 6:30 PM ET
Jun 14, 2021 2:30 PM - 6:30 PM ET
Jun 15, 2021 2:30 PM - 6:30 PM ET
Live Online - Half Day USD $1550.00 Enroll
Jun 14, 2021 9:00 AM - 5:30 PM ET
Jun 15, 2021 9:00 AM - 5:30 PM ET
Jun 16, 2021 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $1550.00 Enroll
Jun 21, 2021 11:00 AM - 8:30 PM ET
Jun 22, 2021 11:00 AM - 8:30 PM ET
Jun 23, 2021 11:00 AM - 8:30 PM ET
Live Online - Full Day USD $1550.00 Enroll
Jun 21, 2021 2:30 PM - 6:30 PM ET
Jun 22, 2021 2:30 PM - 6:30 PM ET
Jun 23, 2021 2:30 PM - 6:30 PM ET
Jun 24, 2021 2:30 PM - 6:30 PM ET
Jun 28, 2021 2:30 PM - 6:30 PM ET
Jun 29, 2021 2:30 PM - 6:30 PM ET
Live Online - Half Day USD $1550.00 Enroll
Jun 28, 2021 9:00 AM - 5:30 PM ET
Jun 29, 2021 9:00 AM - 5:30 PM ET
Jun 30, 2021 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $1550.00 Enroll
Jul 6, 2021 9:00 AM - 5:30 PM ET
Jul 7, 2021 9:00 AM - 5:30 PM ET
Jul 8, 2021 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $1550.00 Enroll
Jul 12, 2021 11:00 AM - 8:30 PM ET
Jul 13, 2021 11:00 AM - 8:30 PM ET
Jul 14, 2021 11:00 AM - 8:30 PM ET
Live Online - Full Day USD $1550.00 Enroll
Jul 12, 2021 9:00 AM - 1:00 PM ET
Jul 13, 2021 9:00 AM - 1:00 PM ET
Jul 14, 2021 9:00 AM - 1:00 PM ET
Jul 15, 2021 9:00 AM - 1:00 PM ET
Jul 19, 2021 9:00 AM - 1:00 PM ET
Jul 20, 2021 9:00 AM - 1:00 PM ET
Live Online - Half Day USD $1550.00 Enroll
Jul 12, 2021 8:00 AM - 5:30 PM
Jul 13, 2021 8:00 AM - 6:30 PM
Jul 14, 2021 8:00 AM - 6:00 PM
Salt Lake City, UT USD $1550.00 Enroll
Jul 19, 2021 9:00 AM - 5:30 PM ET
Jul 20, 2021 9:00 AM - 5:30 PM ET
Jul 21, 2021 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $1550.00 Enroll
Jul 26, 2021 9:00 AM - 5:30 PM ET
Jul 27, 2021 9:00 AM - 5:30 PM ET
Jul 28, 2021 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $1550.00 Enroll
Jul 26, 2021 2:30 PM - 6:30 PM ET
Jul 27, 2021 2:30 PM - 6:30 PM ET
Jul 28, 2021 2:30 PM - 6:30 PM ET
Jul 29, 2021 2:30 PM - 6:30 PM ET
Aug 2, 2021 2:30 PM - 6:30 PM ET
Aug 3, 2021 2:30 PM - 6:30 PM ET
Live Online - Half Day USD $1550.00 Enroll
Aug 2, 2021 9:00 AM - 5:30 PM ET
Aug 3, 2021 9:00 AM - 5:30 PM ET
Aug 4, 2021 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $1550.00 Enroll
Aug 9, 2021 11:00 AM - 8:30 PM ET
Aug 10, 2021 11:00 AM - 8:30 PM ET
Aug 11, 2021 11:00 AM - 8:30 PM ET
Live Online - Full Day USD $1550.00 Enroll
Aug 9, 2021 9:00 AM - 1:00 PM ET
Aug 10, 2021 9:00 AM - 1:00 PM ET
Aug 11, 2021 9:00 AM - 1:00 PM ET
Aug 12, 2021 9:00 AM - 1:00 PM ET
Aug 16, 2021 9:00 AM - 1:00 PM ET
Aug 17, 2021 9:00 AM - 1:00 PM ET
Live Online - Half Day USD $1550.00 Enroll
Aug 16, 2021 9:00 AM - 5:30 PM ET
Aug 17, 2021 9:00 AM - 5:30 PM ET
Aug 18, 2021 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $1550.00 Enroll
Aug 16, 2021 8:00 AM - 5:30 PM
Aug 17, 2021 8:00 AM - 6:30 PM
Aug 18, 2021 8:00 AM - 6:00 PM
Nashville, TN USD $1550.00 Enroll
Aug 23, 2021 9:00 AM - 5:30 PM ET
Aug 24, 2021 9:00 AM - 5:30 PM ET
Aug 25, 2021 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $1550.00 Enroll
Aug 23, 2021 2:30 PM - 6:30 PM ET
Aug 24, 2021 2:30 PM - 6:30 PM ET
Aug 25, 2021 2:30 PM - 6:30 PM ET
Aug 26, 2021 2:30 PM - 6:30 PM ET
Aug 30, 2021 2:30 PM - 6:30 PM ET
Aug 31, 2021 2:30 PM - 6:30 PM ET
Live Online - Half Day USD $1550.00 Enroll
Aug 30, 2021 9:00 AM - 5:30 PM ET
Aug 31, 2021 9:00 AM - 5:30 PM ET
Sep 1, 2021 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $1550.00 Enroll
Sep 7, 2021 11:00 AM - 8:30 PM ET
Sep 8, 2021 11:00 AM - 8:30 PM ET
Sep 9, 2021 11:00 AM - 8:30 PM ET
Live Online - Full Day USD $1550.00 Enroll
Sep 13, 2021 9:00 AM - 5:30 PM ET
Sep 14, 2021 9:00 AM - 5:30 PM ET
Sep 15, 2021 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $1550.00 Enroll
Sep 13, 2021 2:30 PM - 6:30 PM ET
Sep 14, 2021 2:30 PM - 6:30 PM ET
Sep 15, 2021 2:30 PM - 6:30 PM ET
Sep 16, 2021 2:30 PM - 6:30 PM ET
Sep 20, 2021 2:30 PM - 6:30 PM ET
Sep 21, 2021 2:30 PM - 6:30 PM ET
Live Online - Half Day USD $1550.00 Enroll
Sep 13, 2021 8:00 AM - 5:30 PM
Sep 14, 2021 8:00 AM - 6:30 PM
Sep 15, 2021 8:00 AM - 6:00 PM
Dulles, VA USD $1550.00 Enroll
Sep 20, 2021 9:00 AM - 5:30 PM ET
Sep 21, 2021 9:00 AM - 5:30 PM ET
Sep 22, 2021 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $1550.00 Enroll
Sep 27, 2021 11:00 AM - 8:30 PM ET
Sep 28, 2021 11:00 AM - 8:30 PM ET
Sep 29, 2021 11:00 AM - 8:30 PM ET
Live Online - Full Day USD $1550.00 Enroll
Sep 27, 2021 9:00 AM - 1:00 PM ET
Sep 28, 2021 9:00 AM - 1:00 PM ET
Sep 29, 2021 9:00 AM - 1:00 PM ET
Sep 30, 2021 9:00 AM - 1:00 PM ET
Oct 4, 2021 9:00 AM - 1:00 PM ET
Oct 5, 2021 9:00 AM - 1:00 PM ET
Live Online - Half Day USD $1550.00 Enroll
Oct 4, 2021 9:00 AM - 5:30 PM ET
Oct 5, 2021 9:00 AM - 5:30 PM ET
Oct 6, 2021 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $1550.00 Enroll
Oct 11, 2021 9:00 AM - 5:30 PM ET
Oct 12, 2021 9:00 AM - 5:30 PM ET
Oct 13, 2021 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $1550.00 Enroll
Oct 11, 2021 2:30 PM - 6:30 PM ET
Oct 12, 2021 2:30 PM - 6:30 PM ET
Oct 13, 2021 2:30 PM - 6:30 PM ET
Oct 14, 2021 2:30 PM - 6:30 PM ET
Oct 18, 2021 2:30 PM - 6:30 PM ET
Oct 19, 2021 2:30 PM - 6:30 PM ET
Live Online - Half Day USD $1550.00 Enroll
Oct 11, 2021 8:00 AM - 5:30 PM
Oct 12, 2021 8:00 AM - 6:30 PM
Oct 13, 2021 8:00 AM - 6:00 PM
Orlando, FL USD $1550.00 Enroll
Oct 18, 2021 11:00 AM - 8:30 PM ET
Oct 19, 2021 11:00 AM - 8:30 PM ET
Oct 20, 2021 11:00 AM - 8:30 PM ET
Live Online - Full Day USD $1550.00 Enroll
Oct 25, 2021 9:00 AM - 5:30 PM ET
Oct 26, 2021 9:00 AM - 5:30 PM ET
Oct 27, 2021 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $1550.00 Enroll
Oct 25, 2021 9:00 AM - 1:00 PM ET
Oct 26, 2021 9:00 AM - 1:00 PM ET
Oct 27, 2021 9:00 AM - 1:00 PM ET
Oct 28, 2021 9:00 AM - 1:00 PM ET
Nov 1, 2021 9:00 AM - 1:00 PM ET
Nov 2, 2021 9:00 AM - 1:00 PM ET
Live Online - Half Day USD $1550.00 Enroll
Nov 1, 2021 9:00 AM - 5:30 PM ET
Nov 2, 2021 9:00 AM - 5:30 PM ET
Nov 3, 2021 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $1550.00 Enroll
Nov 1, 2021 8:00 AM - 5:30 PM
Nov 2, 2021 8:00 AM - 6:30 PM
Nov 3, 2021 8:00 AM - 6:00 PM
Salt Lake City, UT USD $1550.00 Enroll
Nov 8, 2021 9:00 AM - 5:30 PM ET
Nov 9, 2021 9:00 AM - 5:30 PM ET
Nov 10, 2021 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $1550.00 Enroll
Nov 8, 2021 9:00 AM - 1:00 PM ET
Nov 9, 2021 9:00 AM - 1:00 PM ET
Nov 10, 2021 9:00 AM - 1:00 PM ET
Nov 11, 2021 9:00 AM - 1:00 PM ET
Nov 15, 2021 9:00 AM - 1:00 PM ET
Nov 16, 2021 9:00 AM - 1:00 PM ET
Live Online - Half Day USD $1550.00 Enroll
Nov 15, 2021 11:00 AM - 8:30 PM ET
Nov 16, 2021 11:00 AM - 8:30 PM ET
Nov 17, 2021 11:00 AM - 8:30 PM ET
Live Online - Full Day USD $1550.00 Enroll
Nov 29, 2021 9:00 AM - 5:30 PM ET
Nov 30, 2021 9:00 AM - 5:30 PM ET
Dec 1, 2021 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $1550.00 Enroll
Nov 29, 2021 2:30 PM - 6:30 PM ET
Nov 30, 2021 2:30 PM - 6:30 PM ET
Dec 1, 2021 2:30 PM - 6:30 PM ET
Dec 2, 2021 2:30 PM - 6:30 PM ET
Dec 6, 2021 2:30 PM - 6:30 PM ET
Dec 7, 2021 2:30 PM - 6:30 PM ET
Live Online - Half Day USD $1550.00 Enroll
Dec 6, 2021 9:00 AM - 5:30 PM ET
Dec 7, 2021 9:00 AM - 5:30 PM ET
Dec 8, 2021 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $1550.00 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
Live Online - Full Day USD $1550.00 Enroll
Dec 13, 2021 9:00 AM - 1:00 PM ET
Dec 14, 2021 9:00 AM - 1:00 PM ET
Dec 15, 2021 9:00 AM - 1:00 PM ET
Dec 16, 2021 9:00 AM - 1:00 PM ET
Dec 20, 2021 9:00 AM - 1:00 PM ET
Dec 21, 2021 9:00 AM - 1:00 PM ET
Live Online - Half Day USD $1550.00 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
Nashville, TN USD $1550.00 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
Live Online - Full Day USD $1550.00 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.