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ISO 13485:2016 Internal Auditor (TPECS)

The class is not currently available.

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 also 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 Attainment 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

Course Materials:

You will have the option to receive your course materials in the following formats:

  • Hard Copies: At the start of the course, a physical copy of the Student Handbook will be provided.
  • Soft Copies: Prior to the course, an email with instructions on how to access the online Student Handbook, which can be viewed, downloaded or printed, will be sent to students.

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 bring their own copy. Soft copies of the digital loaner standard cannot be printed or downloaded.

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. 

Class Logistics:

There are written tests on each of the competency units in turn on Days 2 and 3. Detailed exam instructions will be provided. Certificates of Attainment in each competency unit will be provided for students who are deemed “Competent” for each competency unit. Certificates of attendance are provided to those who do not pass the competency test(s), and students will be given the opportunity to retake the test(s).

Online course option

This Course is also available as part of BSI’s Connected Learning Live service. A virtual instructor lead training course taught live online in a virtual classroom. Scheduled times and dates are available HERE

Upcoming Course Dates

The venues for scheduled courses are tentative until receipt of course confirmation from BSI.

Start/End Date and Time Location Fee Enroll
  • Feb 24, 2020 8:00 AM - 5:30 PM
  • Feb 25, 2020 8:00 AM - 6:30 PM
  • Feb 26, 2020 8:00 AM - 6:00 PM
Atlanta, GA
Four Points Atlanta Airport West
3520 North Desert Drive
Atlanta, GA 30344
United States
(404) 768-3100
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USD $1550.00Enroll
  • Feb 24, 2020 8:00 AM - 5:30 PM
  • Feb 25, 2020 8:00 AM - 6:30 PM
  • Feb 26, 2020 8:00 AM - 6:00 PM
San José, CA
Biltmore Hotel and Suites
2151 Laurelwood Road
Santa Clara, CA 95054
United States
408/988-8411
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USD $1550.00Enroll
  • Mar 02, 2020 8:00 AM - 5:30 PM
  • Mar 03, 2020 8:00 AM - 6:30 PM
  • Mar 04, 2020 8:00 AM - 6:00 PM
Princeton, NJUSD $1550.00Enroll
  • Mar 09, 2020 8:00 AM - 5:30 PM
  • Mar 10, 2020 8:00 AM - 6:30 PM
  • Mar 11, 2020 8:00 AM - 6:00 PM
Chicago, IL
Hyatt Place Chicago Midway
6550 Cicero Avenue
Bedford Park, IL 60638
United States
(708) 594-1400map this location
USD $1550.00Enroll
  • Mar 09, 2020 8:00 AM - 5:30 PM
  • Mar 10, 2020 8:00 AM - 6:30 PM
  • Mar 11, 2020 8:00 AM - 6:00 PM
San Diego, CA
Country Inn and Suites by Carlson-San Diego North
5975 Lusk Boulevard
San Diego, CA 92121
United States
858/558-1818
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USD $1550.00Enroll
  • Mar 16, 2020 8:00 AM - 5:30 PM
  • Mar 17, 2020 8:00 AM - 6:30 PM
  • Mar 18, 2020 8:00 AM - 6:00 PM
Dulles, VAUSD $1550.00Enroll
  • Mar 23, 2020 8:00 AM - 5:30 PM
  • Mar 24, 2020 8:00 AM - 6:30 PM
  • Mar 25, 2020 8:00 AM - 6:00 PM
Minneapolis, MN
Hyatt Place Minneapolis Downtown
425 7th Street South
Minneapolis, MN 55415
United States
(912) 333 3111
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USD $1550.00Enroll
  • Mar 23, 2020 8:00 AM - 5:30 PM
  • Mar 24, 2020 8:00 AM - 6:30 PM
  • Mar 25, 2020 8:00 AM - 6:00 PM
San José, CA
Biltmore Hotel and Suites
2151 Laurelwood Road
Santa Clara, CA 95054
United States
408/988-8411
View Location Websitemap this location
USD $1550.00Enroll
  • Mar 30, 2020 8:00 AM - 5:30 PM
  • Mar 31, 2020 8:00 AM - 6:30 PM
  • Apr 01, 2020 8:00 AM - 6:00 PM
Seattle, WAUSD $1550.00Enroll
  • Apr 06, 2020 8:00 AM - 5:30 PM
  • Apr 07, 2020 8:00 AM - 6:30 PM
  • Apr 08, 2020 8:00 AM - 6:00 PM
Boston, MAUSD $1550.00Enroll
  • Apr 14, 2020 8:00 AM - 5:30 PM
  • Apr 15, 2020 8:00 AM - 6:30 PM
  • Apr 16, 2020 8:00 AM - 6:00 PM
Atlanta, GAUSD $1550.00Enroll
  • Apr 14, 2020 8:00 AM - 5:30 PM
  • Apr 15, 2020 8:00 AM - 6:30 PM
  • Apr 16, 2020 8:00 AM - 6:00 PM
San Diego, CAUSD $1550.00Enroll
  • Apr 20, 2020 8:00 AM - 5:30 PM
  • Apr 21, 2020 8:00 AM - 6:30 PM
  • Apr 22, 2020 8:00 AM - 6:00 PM
Salt Lake City, UTUSD $1450.00*Enroll
  • Apr 27, 2020 8:00 AM - 5:30 PM
  • Apr 28, 2020 8:00 AM - 6:30 PM
  • Apr 29, 2020 8:00 AM - 6:00 PM
Dallas, TXUSD $1450.00*Enroll
  • Apr 27, 2020 8:00 AM - 5:30 PM
  • Apr 28, 2020 8:00 AM - 6:30 PM
  • Apr 29, 2020 8:00 AM - 6:00 PM
San José, CAUSD $1450.00*Enroll
  • May 04, 2020 8:00 AM - 5:30 PM
  • May 05, 2020 8:00 AM - 6:30 PM
  • May 06, 2020 8:00 AM - 6:00 PM
Minneapolis, MNUSD $1450.00*Enroll
  • May 04, 2020 8:00 AM - 5:30 PM
  • May 05, 2020 8:00 AM - 6:30 PM
  • May 06, 2020 8:00 AM - 6:00 PM
San Diego, CAUSD $1450.00*Enroll
  • May 11, 2020 8:00 AM - 5:30 PM
  • May 12, 2020 8:00 AM - 6:30 PM
  • May 13, 2020 8:00 AM - 6:00 PM
Princeton, NJUSD $1450.00*Enroll
  • May 18, 2020 8:00 AM - 5:30 PM
  • May 19, 2020 8:00 AM - 6:30 PM
  • May 20, 2020 8:00 AM - 6:00 PM
Chicago, ILUSD $1450.00*Enroll
  • May 18, 2020 8:00 AM - 5:30 PM
  • May 19, 2020 8:00 AM - 6:30 PM
  • May 20, 2020 8:00 AM - 6:00 PM
San José, CAUSD $1450.00*Enroll
  • May 19, 2020 8:00 AM - 5:30 PM
  • May 20, 2020 8:00 AM - 6:30 PM
  • May 21, 2020 8:00 AM - 6:00 PM
Princeton, NJUSD $1450.00*Enroll
  • Jun 01, 2020 8:00 AM - 5:30 PM
  • Jun 02, 2020 8:00 AM - 6:30 PM
  • Jun 03, 2020 8:00 AM - 6:00 PM
Dulles, VAUSD $1450.00*Enroll
  • Jun 01, 2020 8:00 AM - 5:30 PM
  • Jun 02, 2020 8:00 AM - 6:30 PM
  • Jun 03, 2020 8:00 AM - 6:00 PM
San Diego, CAUSD $1450.00*Enroll
  • Jun 08, 2020 8:00 AM - 5:30 PM
  • Jun 09, 2020 8:00 AM - 6:30 PM
  • Jun 10, 2020 8:00 AM - 6:00 PM
Atlanta, GAUSD $1450.00*Enroll
  • Jun 08, 2020 8:00 AM - 5:30 PM
  • Jun 09, 2020 8:00 AM - 6:30 PM
  • Jun 10, 2020 8:00 AM - 6:00 PM
Seattle, WAUSD $1450.00*Enroll
  • Jun 15, 2020 8:00 AM - 5:30 PM
  • Jun 16, 2020 8:00 AM - 6:30 PM
  • Jun 17, 2020 8:00 AM - 6:00 PM
Phoenix, AZUSD $1450.00*Enroll
  • Jun 22, 2020 8:00 AM - 5:30 PM
  • Jun 23, 2020 8:00 AM - 6:30 PM
  • Jun 24, 2020 8:00 AM - 6:00 PM
Dallas, TXUSD $1450.00*Enroll
  • Jun 22, 2020 8:00 AM - 5:30 PM
  • Jun 23, 2020 8:00 AM - 6:30 PM
  • Jun 24, 2020 8:00 AM - 6:00 PM
San José, CAUSD $1450.00*Enroll
  • Jun 29, 2020 8:00 AM - 5:30 PM
  • Jun 30, 2020 8:00 AM - 6:30 PM
  • Jul 01, 2020 8:00 AM - 6:00 PM
Boston, MAUSD $1450.00*Enroll
  • Jul 06, 2020 8:00 AM - 5:30 PM
  • Jul 07, 2020 8:00 AM - 6:30 PM
  • Jul 08, 2020 8:00 AM - 6:00 PM
San Diego, CAUSD $1450.00*Enroll
  • Jul 13, 2020 8:00 AM - 5:30 PM
  • Jul 14, 2020 8:00 AM - 6:30 PM
  • Jul 15, 2020 8:00 AM - 6:00 PM
Minneapolis, MNUSD $1450.00*Enroll
  • Jul 13, 2020 8:00 AM - 5:30 PM
  • Jul 14, 2020 8:00 AM - 6:30 PM
  • Jul 15, 2020 8:00 AM - 6:00 PM
Salt Lake City, UTUSD $1450.00*Enroll
  • Jul 20, 2020 8:00 AM - 5:30 PM
  • Jul 21, 2020 8:00 AM - 6:30 PM
  • Jul 22, 2020 8:00 AM - 6:00 PM
Princeton, NJUSD $1450.00*Enroll
  • Jul 27, 2020 8:00 AM - 5:30 PM
  • Jul 28, 2020 8:00 AM - 6:30 PM
  • Jul 29, 2020 8:00 AM - 6:00 PM
Atlanta, GAUSD $1450.00*Enroll
  • Jul 27, 2020 8:00 AM - 5:30 PM
  • Jul 28, 2020 8:00 AM - 6:30 PM
  • Jul 29, 2020 8:00 AM - 6:00 PM
San José, CAUSD $1450.00*Enroll
  • Aug 03, 2020 8:00 AM - 5:30 PM
  • Aug 04, 2020 8:00 AM - 6:30 PM
  • Aug 05, 2020 8:00 AM - 6:00 PM
Boston, MAUSD $1450.00*Enroll
  • Aug 10, 2020 8:00 AM - 5:30 PM
  • Aug 11, 2020 8:00 AM - 6:30 PM
  • Aug 12, 2020 8:00 AM - 6:00 PM
Chicago, ILUSD $1450.00*Enroll
  • Aug 10, 2020 8:00 AM - 5:30 PM
  • Aug 11, 2020 8:00 AM - 6:30 PM
  • Aug 12, 2020 8:00 AM - 6:00 PM
San Diego, CAUSD $1450.00*Enroll
  • Aug 17, 2020 8:00 AM - 5:30 PM
  • Aug 18, 2020 8:00 AM - 6:30 PM
  • Aug 19, 2020 8:00 AM - 6:00 PM
Dulles, VAUSD $1450.00*Enroll
  • Aug 24, 2020 8:00 AM - 5:30 PM
  • Aug 25, 2020 8:00 AM - 6:30 PM
  • Aug 26, 2020 8:00 AM - 6:00 PM
Nashville, TNUSD $1450.00*Enroll
  • Aug 24, 2020 8:00 AM - 5:30 PM
  • Aug 25, 2020 8:00 AM - 6:30 PM
  • Aug 26, 2020 8:00 AM - 6:00 PM
San José, CAUSD $1450.00*Enroll
  • Aug 31, 2020 8:00 AM - 5:30 PM
  • Sep 01, 2020 8:00 AM - 6:30 PM
  • Sep 02, 2020 8:00 AM - 6:00 PM
Seattle, WAUSD $1450.00*Enroll
  • Sep 08, 2020 8:00 AM - 5:30 PM
  • Sep 09, 2020 8:00 AM - 6:30 PM
  • Sep 10, 2020 8:00 AM - 6:00 PM
Dallas, TXUSD $1450.00*Enroll
  • Sep 14, 2020 8:00 AM - 5:30 PM
  • Sep 15, 2020 8:00 AM - 6:30 PM
  • Sep 16, 2020 8:00 AM - 6:00 PM
Atlanta, GAUSD $1450.00*Enroll
  • Sep 14, 2020 8:00 AM - 5:30 PM
  • Sep 15, 2020 8:00 AM - 6:30 PM
  • Sep 16, 2020 8:00 AM - 6:00 PM
San Diego, CAUSD $1450.00*Enroll
  • Sep 21, 2020 8:00 AM - 5:30 PM
  • Sep 22, 2020 8:00 AM - 6:30 PM
  • Sep 23, 2020 8:00 AM - 6:00 PM
Phoenix, AZUSD $1450.00*Enroll
  • Sep 28, 2020 8:00 AM - 5:30 PM
  • Sep 29, 2020 8:00 AM - 6:30 PM
  • Sep 30, 2020 8:00 AM - 6:00 PM
Nashville, TNUSD $1450.00*Enroll
  • Sep 28, 2020 8:00 AM - 5:30 PM
  • Sep 29, 2020 8:00 AM - 6:30 PM
  • Sep 30, 2020 8:00 AM - 6:00 PM
San José, CAUSD $1450.00*Enroll
  • Oct 05, 2020 8:00 AM - 5:30 PM
  • Oct 06, 2020 8:00 AM - 6:30 PM
  • Oct 07, 2020 8:00 AM - 6:00 PM
Minneapolis, MNUSD $1450.00*Enroll
  • Oct 05, 2020 8:00 AM - 5:30 PM
  • Oct 06, 2020 8:00 AM - 6:30 PM
  • Oct 07, 2020 8:00 AM - 6:00 PM
San Diego, CAUSD $1450.00*Enroll
  • Oct 12, 2020 8:00 AM - 5:30 PM
  • Oct 13, 2020 8:00 AM - 6:30 PM
  • Oct 14, 2020 8:00 AM - 6:00 PM
Princeton, NJUSD $1450.00*Enroll
  • Oct 12, 2020 8:00 AM - 5:30 PM
  • Oct 13, 2020 8:00 AM - 6:30 PM
  • Oct 14, 2020 8:00 AM - 6:00 PM
Salt Lake City, UTUSD $1450.00*Enroll
  • Oct 19, 2020 8:00 AM - 5:30 PM
  • Oct 20, 2020 8:00 AM - 6:30 PM
  • Oct 21, 2020 8:00 AM - 6:00 PM
Dulles, VAUSD $1450.00*Enroll
  • Oct 19, 2020 8:00 AM - 5:30 PM
  • Oct 20, 2020 8:00 AM - 6:30 PM
  • Oct 21, 2020 8:00 AM - 6:00 PM
San José, CAUSD $1450.00*Enroll
  • Oct 26, 2020 8:00 AM - 5:30 PM
  • Oct 27, 2020 8:00 AM - 6:30 PM
  • Oct 28, 2020 8:00 AM - 6:00 PM
Denver, COUSD $1450.00*Enroll
  • Nov 02, 2020 8:00 AM - 5:30 PM
  • Nov 03, 2020 8:00 AM - 6:30 PM
  • Nov 04, 2020 8:00 AM - 6:00 PM
Nashville, TNUSD $1450.00*Enroll
  • Nov 02, 2020 8:00 AM - 5:30 PM
  • Nov 03, 2020 8:00 AM - 6:30 PM
  • Nov 04, 2020 8:00 AM - 6:00 PM
Phoenix, AZUSD $1450.00*Enroll
  • Nov 09, 2020 8:00 AM - 5:30 PM
  • Nov 10, 2020 8:00 AM - 6:30 PM
  • Nov 11, 2020 8:00 AM - 6:00 PM
Seattle, WAUSD $1450.00*Enroll
  • Nov 16, 2020 8:00 AM - 5:30 PM
  • Nov 17, 2020 8:00 AM - 6:30 PM
  • Nov 18, 2020 8:00 AM - 6:00 PM
Boston, MAUSD $1450.00*Enroll
  • Nov 30, 2020 8:00 AM - 5:30 PM
  • Dec 01, 2020 8:00 AM - 6:30 PM
  • Dec 02, 2020 8:00 AM - 6:00 PM
Dallas, TXUSD $1450.00*Enroll
  • Nov 30, 2020 8:00 AM - 5:30 PM
  • Dec 01, 2020 8:00 AM - 6:30 PM
  • Dec 02, 2020 8:00 AM - 6:00 PM
San José, CAUSD $1450.00*Enroll
  • Dec 07, 2020 8:00 AM - 5:30 PM
  • Dec 08, 2020 8:00 AM - 6:30 PM
  • Dec 09, 2020 8:00 AM - 6:00 PM
Atlanta, GAUSD $1450.00*Enroll
  • Dec 07, 2020 8:00 AM - 5:30 PM
  • Dec 08, 2020 8:00 AM - 6:30 PM
  • Dec 09, 2020 8:00 AM - 6:00 PM
Salt Lake City, UTUSD $1450.00*Enroll
  • Dec 14, 2020 8:00 AM - 5:30 PM
  • Dec 15, 2020 8:00 AM - 6:30 PM
  • Dec 16, 2020 8:00 AM - 6:00 PM
Chicago, ILUSD $1450.00*Enroll
  • Dec 14, 2020 8:00 AM - 5:30 PM
  • Dec 15, 2020 8:00 AM - 6:30 PM
  • Dec 16, 2020 8:00 AM - 6:00 PM
San Diego, CAUSD $1450.00*Enroll