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
May 31 - Jun 2, 2022 - Live Online - Full DayEnroll
Jun 13-15, 2022 - Live Online - Full DayEnroll
Jun 20-22, 2022 - San José, CAEnroll

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
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
Live Online - Full Day USD $1550.00 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
Live Online - Full Day USD $1550.00 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
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 $1550.00 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
Live Online - Full Day USD $1550.00 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
Live Online - Full Day USD $1550.00 Enroll
Jul 11, 2022 8:00 AM - 5:30 PM
Jul 12, 2022 8:00 AM - 6:30 PM
Jul 13, 2022 8:00 AM - 6:00 PM
Dulles, VA USD $1550.00 Enroll
Jul 11, 2022 11:00 AM - 8:30 PM ET
Jul 12, 2022 11:00 AM - 8:30 PM ET
Jul 13, 2022 11:00 AM - 8:30 PM ET
Live Online - Full Day USD $1550.00 Enroll
Jul 18, 2022 9:00 AM - 5:30 PM ET
Jul 19, 2022 9:00 AM - 5:30 PM ET
Jul 20, 2022 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $1550.00 Enroll
Jul 25, 2022 8:00 AM - 5:30 PM
Jul 26, 2022 8:00 AM - 6:30 PM
Jul 27, 2022 8:00 AM - 6:00 PM
Orlando, FL USD $1550.00 Enroll
Aug 1, 2022 11:00 AM - 8:30 PM ET
Aug 2, 2022 11:00 AM - 8:30 PM ET
Aug 3, 2022 11:00 AM - 8:30 PM ET
Live Online - Full Day USD $1550.00 Enroll
Aug 1, 2022 2:30 PM - 6:30 PM ET
Aug 2, 2022 2:30 PM - 6:30 PM ET
Aug 3, 2022 2:30 PM - 6:30 PM ET
Aug 4, 2022 2:30 PM - 6:30 PM ET
Aug 8, 2022 2:30 PM - 6:30 PM ET
Aug 9, 2022 2:30 PM - 6:30 PM ET
Live Online - Half Day USD $1550.00 Enroll
Aug 8, 2022 8:00 AM - 5:30 PM
Aug 9, 2022 8:00 AM - 6:30 PM
Aug 10, 2022 8:00 AM - 6:00 PM
San José, CA USD $1550.00 Enroll
Aug 15, 2022 9:00 AM - 5:30 PM ET
Aug 16, 2022 9:00 AM - 5:30 PM ET
Aug 17, 2022 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $1550.00 Enroll
Aug 22, 2022 8:00 AM - 5:30 PM
Aug 23, 2022 8:00 AM - 6:30 PM
Aug 24, 2022 8:00 AM - 6:00 PM
Nashville, TN USD $1550.00 Enroll
Aug 29, 2022 11:00 AM - 8:30 PM ET
Aug 30, 2022 11:00 AM - 8:30 PM ET
Aug 31, 2022 11:00 AM - 8:30 PM ET
Live Online - Full Day USD $1550.00 Enroll
Sep 6, 2022 8:00 AM - 5:30 PM
Sep 7, 2022 8:00 AM - 6:30 PM
Sep 8, 2022 8:00 AM - 6:00 PM
Salt Lake City, UT USD $1550.00 Enroll
Sep 12, 2022 9:00 AM - 5:30 PM ET
Sep 13, 2022 9:00 AM - 5:30 PM ET
Sep 14, 2022 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $1550.00 Enroll
Sep 19, 2022 8:00 AM - 5:30 PM
Sep 20, 2022 8:00 AM - 6:30 PM
Sep 21, 2022 8:00 AM - 6:00 PM
Dulles, VA USD $1550.00 Enroll
Sep 19, 2022 9:00 AM - 1:00 PM ET
Sep 20, 2022 9:00 AM - 1:00 PM ET
Sep 21, 2022 9:00 AM - 1:00 PM ET
Sep 22, 2022 9:00 AM - 1:00 PM ET
Sep 26, 2022 9:00 AM - 1:00 PM ET
Sep 27, 2022 9:00 AM - 1:00 PM ET
Live Online - Half Day USD $1550.00 Enroll
Sep 26, 2022 11:00 AM - 8:30 PM ET
Sep 27, 2022 11:00 AM - 8:30 PM ET
Sep 28, 2022 11:00 AM - 8:30 PM ET
Live Online - Full Day USD $1550.00 Enroll
Oct 3, 2022 8:00 AM - 5:30 PM
Oct 4, 2022 8:00 AM - 6:30 PM
Oct 5, 2022 8:00 AM - 6:00 PM
San José, CA USD $1550.00 Enroll
Oct 11, 2022 9:00 AM - 5:30 PM ET
Oct 12, 2022 9:00 AM - 5:30 PM ET
Oct 13, 2022 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $1550.00 Enroll
Oct 17, 2022 8:00 AM - 5:30 PM
Oct 18, 2022 8:00 AM - 6:30 PM
Oct 19, 2022 8:00 AM - 6:00 PM
Orlando, FL USD $1550.00 Enroll
Oct 24, 2022 11:00 AM - 8:30 PM ET
Oct 25, 2022 11:00 AM - 8:30 PM ET
Oct 26, 2022 11:00 AM - 8:30 PM ET
Live Online - Full Day USD $1550.00 Enroll
Oct 31, 2022 8:00 AM - 5:30 PM
Nov 1, 2022 8:00 AM - 6:30 PM
Nov 2, 2022 8:00 AM - 6:00 PM
Salt Lake City, UT USD $1550.00 Enroll
Nov 7, 2022 9:00 AM - 5:30 PM ET
Nov 8, 2022 9:00 AM - 5:30 PM ET
Nov 9, 2022 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $1550.00 Enroll
Nov 14, 2022 8:00 AM - 5:30 PM
Nov 15, 2022 8:00 AM - 6:30 PM
Nov 16, 2022 8:00 AM - 6:00 PM
Nashville, TN USD $1550.00 Enroll
Nov 28, 2022 11:00 AM - 8:30 PM ET
Nov 29, 2022 11:00 AM - 8:30 PM ET
Nov 30, 2022 11:00 AM - 8:30 PM ET
Live Online - Full Day USD $1550.00 Enroll
Nov 28, 2022 2:30 PM - 6:30 PM ET
Nov 29, 2022 2:30 PM - 6:30 PM ET
Nov 30, 2022 2:30 PM - 6:30 PM ET
Dec 1, 2022 2:30 PM - 6:30 PM ET
Dec 5, 2022 2:30 PM - 6:30 PM ET
Dec 6, 2022 2:30 PM - 6:30 PM ET
Live Online - Half Day USD $1550.00 Enroll
Dec 5, 2022 8:00 AM - 5:30 PM
Dec 6, 2022 8:00 AM - 6:30 PM
Dec 7, 2022 8:00 AM - 6:00 PM
San José, CA USD $1550.00 Enroll
Dec 12, 2022 9:00 AM - 5:30 PM ET
Dec 13, 2022 9:00 AM - 5:30 PM ET
Dec 14, 2022 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $1550.00 Enroll
Dec 19, 2022 8:00 AM - 5:30 PM
Dec 20, 2022 8:00 AM - 6:30 PM
Dec 21, 2022 8:00 AM - 6:00 PM
Orlando, FL 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.