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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 DeviceSystems
  • 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

Students receive comprehensive course manuals with reference materials.

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).

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
  • Mar 25, 2019 8:00 AM - 5:30 PM
  • Mar 26, 2019 8:00 AM - 6:30 PM
  • Mar 27, 2019 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 25, 2019 8:00 AM - 5:30 PM
  • Mar 26, 2019 8:00 AM - 6:30 PM
  • Mar 27, 2019 8:00 AM - 6:00 PM
San Diego, CA
Hilton Garden Inn San Diego Mission Valley/Stadium
3805 Murphy Canyon Road
San Diego, CA 92123
United States
(858) 278-9300map this location
USD $1550.00Enroll
  • Apr 01, 2019 8:00 AM - 5:30 PM
  • Apr 02, 2019 8:00 AM - 6:30 PM
  • Apr 03, 2019 8:00 AM - 6:00 PM
Orlando, FL
Crowne Plaza Orlando Universal
7800 Universal Blvd
Orlando, FL 32819
United States
407-355-0550map this location
USD $1550.00Enroll
  • Apr 08, 2019 8:00 AM - 5:30 PM
  • Apr 09, 2019 8:00 AM - 6:30 PM
  • Apr 10, 2019 8:00 AM - 6:00 PM
Seattle, WA
Crowne Plaza Seattle Airport
17338 International Boulevard
Seattle, WA 98188
United States
(206) 428-2123map this location
USD $1550.00Enroll
  • Apr 08, 2019 8:00 AM - 5:30 PM
  • Apr 09, 2019 8:00 AM - 6:30 PM
  • Apr 10, 2019 8:00 AM - 6:00 PM
Boston, MA
Courtyard Boston Logan Airport
225 William McClellan Highway
Boston, MA 02128
United States
(617) 933-1111map this location
USD $1550.00Enroll
  • Apr 23, 2019 8:00 AM - 5:30 PM
  • Apr 24, 2019 8:00 AM - 6:30 PM
  • Apr 25, 2019 8:00 AM - 6:00 PM
Atlanta, GAUSD $1550.00Enroll
  • Apr 29, 2019 8:00 AM - 5:30 PM
  • Apr 30, 2019 8:00 AM - 6:30 PM
  • May 01, 2019 8:00 AM - 6:00 PM
Dallas, TX
DoubleTree Dallas - Campbell Centre
8250 N. Central Expressway
Dallas, TX 75206-1888
United States
2146918700
View Location Websitemap this location
USD $1550.00Enroll
  • May 06, 2019 8:00 AM - 5:30 PM
  • May 07, 2019 8:00 AM - 6:30 PM
  • May 08, 2019 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
  • May 13, 2019 8:00 AM - 5:30 PM
  • May 14, 2019 8:00 AM - 6:30 PM
  • May 15, 2019 8:00 AM - 6:00 PM
Princeton, NJUSD $1550.00Enroll
  • May 13, 2019 8:00 AM - 5:30 PM
  • May 14, 2019 8:00 AM - 6:30 PM
  • May 15, 2019 8:00 AM - 6:00 PM
Boston, MAUSD $1550.00Enroll
  • May 28, 2019 8:00 AM - 5:30 PM
  • May 29, 2019 8:00 AM - 6:30 PM
  • May 30, 2019 8:00 AM - 6:00 PM
Minneapolis, MN
Hyatt Place Minneapolis Downtown
425 7th Street South
Minneapolis, MN 55415
United States
(912) 333 3111
View Location Websitemap this location
USD $1450.00*Enroll
  • Jun 03, 2019 8:00 AM - 5:30 PM
  • Jun 04, 2019 8:00 AM - 6:30 PM
  • Jun 05, 2019 8:00 AM - 6:00 PM
Atlanta, GAUSD $1450.00*Enroll
  • Jun 10, 2019 8:00 AM - 5:30 PM
  • Jun 11, 2019 8:00 AM - 6:30 PM
  • Jun 12, 2019 8:00 AM - 6:00 PM
Dallas, TXUSD $1450.00*Enroll
  • Jun 10, 2019 8:00 AM - 5:30 PM
  • Jun 11, 2019 8:00 AM - 6:30 PM
  • Jun 12, 2019 8:00 AM - 6:00 PM
San Diego, CAUSD $1450.00*Enroll
  • Jun 17, 2019 8:00 AM - 5:30 PM
  • Jun 18, 2019 8:00 AM - 6:30 PM
  • Jun 19, 2019 8:00 AM - 6:00 PM
Orlando, FLUSD $1450.00*Enroll
  • Jun 24, 2019 8:00 AM - 5:30 PM
  • Jun 25, 2019 8:00 AM - 6:30 PM
  • Jun 26, 2019 8:00 AM - 6:00 PM
Chicago, ILUSD $1450.00*Enroll
  • Jul 08, 2019 8:00 AM - 5:30 PM
  • Jul 09, 2019 8:00 AM - 6:30 PM
  • Jul 10, 2019 8:00 AM - 6:00 PM
Boston, MAUSD $1450.00*Enroll
  • Jul 15, 2019 8:00 AM - 5:30 PM
  • Jul 16, 2019 8:00 AM - 6:30 PM
  • Jul 17, 2019 8:00 AM - 6:00 PM
San Diego, CAUSD $1450.00*Enroll
  • Jul 22, 2019 8:00 AM - 5:30 PM
  • Jul 23, 2019 8:00 AM - 6:30 PM
  • Jul 24, 2019 8:00 AM - 6:00 PM
Dulles, VAUSD $1450.00*Enroll
  • Jul 29, 2019 8:00 AM - 5:30 PM
  • Jul 30, 2019 8:00 AM - 6:30 PM
  • Jul 31, 2019 8:00 AM - 6:00 PM
Seattle, WAUSD $1450.00*Enroll
  • Aug 05, 2019 8:00 AM - 5:30 PM
  • Aug 06, 2019 8:00 AM - 6:30 PM
  • Aug 07, 2019 8:00 AM - 6:00 PM
Atlanta, GAUSD $1450.00*Enroll
  • Aug 19, 2019 8:00 AM - 5:30 PM
  • Aug 20, 2019 8:00 AM - 6:30 PM
  • Aug 21, 2019 8:00 AM - 6:00 PM
Minneapolis, MNUSD $1450.00*Enroll
  • Aug 19, 2019 8:00 AM - 5:30 PM
  • Aug 20, 2019 8:00 AM - 6:30 PM
  • Aug 21, 2019 8:00 AM - 6:00 PM
San José, CAUSD $1450.00*Enroll
  • Aug 26, 2019 8:00 AM - 5:30 PM
  • Aug 27, 2019 8:00 AM - 6:30 PM
  • Aug 28, 2019 8:00 AM - 6:00 PM
Princeton, NJUSD $1450.00*Enroll
  • Sep 16, 2019 8:00 AM - 5:30 PM
  • Sep 17, 2019 8:00 AM - 6:30 PM
  • Sep 18, 2019 8:00 AM - 6:00 PM
San Diego, CAUSD $1450.00*Enroll
  • Sep 23, 2019 8:00 AM - 5:30 PM
  • Sep 24, 2019 8:00 AM - 6:30 PM
  • Sep 25, 2019 8:00 AM - 6:00 PM
Dallas, TXUSD $1450.00*Enroll
  • Sep 30, 2019 8:00 AM - 5:30 PM
  • Oct 01, 2019 8:00 AM - 6:30 PM
  • Oct 02, 2019 8:00 AM - 6:00 PM
Atlanta, GAUSD $1450.00*Enroll
  • Oct 07, 2019 8:00 AM - 5:30 PM
  • Oct 08, 2019 8:00 AM - 6:30 PM
  • Oct 09, 2019 8:00 AM - 6:00 PM
Chicago, ILUSD $1450.00*Enroll
  • Oct 21, 2019 8:00 AM - 5:30 PM
  • Oct 22, 2019 8:00 AM - 6:30 PM
  • Oct 23, 2019 8:00 AM - 6:00 PM
Orlando, FLUSD $1450.00*Enroll
  • Oct 21, 2019 8:00 AM - 5:30 PM
  • Oct 22, 2019 8:00 AM - 6:30 PM
  • Oct 23, 2019 8:00 AM - 6:00 PM
Seattle, WAUSD $1450.00*Enroll
  • Oct 21, 2019 8:00 AM - 5:30 PM
  • Oct 22, 2019 8:00 AM - 6:30 PM
  • Oct 23, 2019 8:00 AM - 6:00 PM
San José, CAUSD $1450.00*Enroll
  • Nov 04, 2019 8:00 AM - 5:30 PM
  • Nov 05, 2019 8:00 AM - 6:30 PM
  • Nov 06, 2019 8:00 AM - 6:00 PM
San Diego, CAUSD $1450.00*Enroll
  • Nov 18, 2019 8:00 AM - 5:30 PM
  • Nov 19, 2019 8:00 AM - 6:30 PM
  • Nov 20, 2019 8:00 AM - 6:00 PM
Boston, MAUSD $1450.00*Enroll
  • Dec 02, 2019 8:00 AM - 5:30 PM
  • Dec 03, 2019 8:00 AM - 6:30 PM
  • Dec 04, 2019 8:00 AM - 6:00 PM
Atlanta, GAUSD $1450.00*Enroll
  • Dec 02, 2019 8:00 AM - 5:30 PM
  • Dec 03, 2019 8:00 AM - 6:30 PM
  • Dec 04, 2019 8:00 AM - 6:00 PM
San José, CAUSD $1450.00*Enroll
  • Dec 16, 2019 8:00 AM - 5:30 PM
  • Dec 17, 2019 8:00 AM - 6:30 PM
  • Dec 18, 2019 8:00 AM - 6:00 PM
Dulles, VAUSD $1450.00*Enroll