ISO 13485:2016 Internal Auditor (Live Online)

Course Area

Medical Devices

Course Duration

3 Days

Continuing Education Units

2.4

Course Fee

USD $1550.00

Early Bird Price*

USD $1450.00

Upcoming Sessions
Dec 5-7, 2022 - San José, CAEnroll
Dec 12-14, 2022 - Live Online - Full DayEnroll
Dec 19-21, 2022 - Live Online - Full 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
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
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
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 9:00 AM - 5:30 PM ET
Dec 20, 2022 9:00 AM - 5:30 PM ET
Dec 21, 2022 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $1550.00 Enroll
Jan 3, 2023 8:00 AM - 5:30 PM
Jan 4, 2023 8:00 AM - 6:30 PM
Jan 5, 2023 8:00 AM - 6:00 PM
Atlanta, GA USD $1550.00 Enroll
Jan 9, 2023 9:00 AM - 5:30 PM ET
Jan 10, 2023 9:00 AM - 5:30 PM ET
Jan 11, 2023 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $1550.00 Enroll
Jan 16, 2023 11:00 AM - 8:30 PM ET
Jan 17, 2023 11:00 AM - 8:30 PM ET
Jan 18, 2023 11:00 AM - 8:30 PM ET
Live Online - Full Day USD $1550.00 Enroll
Jan 23, 2023 9:00 AM - 5:30 PM ET
Jan 24, 2023 9:00 AM - 5:30 PM ET
Jan 25, 2023 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $1550.00 Enroll
Jan 30, 2023 9:00 AM - 5:30 PM ET
Jan 31, 2023 9:00 AM - 5:30 PM ET
Feb 1, 2023 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $1550.00 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
San José, CA USD $1550.00 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
Live Online - Full Day USD $1550.00 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
Live Online - Full Day USD $1550.00 Enroll
Feb 27, 2023 9:00 AM - 5:30 PM ET
Feb 28, 2023 9:00 AM - 5:30 PM ET
Mar 1, 2023 9:00 AM - 5:30 PM ET
Live Online - Full Day USD $1550.00 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
Minneapolis, MN USD $1550.00 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
Live Online - Half Day USD $1550.00 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
Live Online - Full Day USD $1550.00 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
San Diego, CA USD $1550.00 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
Live Online - Full Day USD $1550.00 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
Live Online - Full Day USD $1550.00 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
Live Online - Full Day USD $1550.00 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
Boston, MA USD $1550.00 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
Live Online - Full Day USD $1550.00 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
Live Online - Full Day USD $1550.00 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
Live Online - Full Day USD $1550.00 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
Live Online - Full Day USD $1550.00 Enroll
Jun 5, 2023 2:30 PM - 6:30 PM ET
Jun 6, 2023 2:30 PM - 6:30 PM ET
Jun 7, 2023 2:30 PM - 6:30 PM ET
Jun 8, 2023 2:30 PM - 6:30 PM ET
Jun 12, 2023 2:30 PM - 6:30 PM ET
Jun 13, 2023 2:30 PM - 6:30 PM ET
Live Online - Half Day USD $1550.00 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
Orlando, FL USD $1550.00 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
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.