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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
  • Oct 22, 2018 8:00 AM - 5:30 PM
  • Oct 23, 2018 8:00 AM - 6:30 PM
  • Oct 24, 2018 8:00 AM - 6:00 PM
Milwaukee, WI
Hyatt Place Milwaukee-Downtown
800 West Juneau Avenue
Milwaukee, WI 53233
United States
4148083814
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USD $1550.00Enroll
  • Oct 29, 2018 8:00 AM - 5:30 PM
  • Oct 30, 2018 8:00 AM - 6:30 PM
  • Oct 31, 2018 8:00 AM - 6:00 PM
Atlanta, GA
Courtyard Marriott Atlanta Downtown
133 Carnegie Way NW
Atlanta, GA 30303
United States
(404) 222-2416
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USD $1550.00Enroll
  • Nov 05, 2018 8:00 AM - 5:30 PM
  • Nov 06, 2018 8:00 AM - 6:30 PM
  • Nov 07, 2018 8:00 AM - 6:00 PM
Memphis, TN
Hyatt Place-Primacy Parkway
1220 Primacy Parkway
Memphis, TN 38119
United States
(901) 680-9700map this location
USD $1550.00Enroll
  • Nov 12, 2018 8:00 AM - 5:30 PM
  • Nov 13, 2018 8:00 AM - 6:30 PM
  • Nov 14, 2018 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
  • Nov 12, 2018 8:00 AM - 5:30 PM
  • Nov 13, 2018 8:00 AM - 6:30 PM
  • Nov 14, 2018 8:00 AM - 6:00 PM
Boston, MA
Hilton Garden Inn Boston Logan Airport
100 Boardman Street
Boston, MA 02128
United States
(857) 256-2236map this location
USD $1550.00Enroll
  • Nov 26, 2018 8:00 AM - 5:30 PM
  • Nov 27, 2018 8:00 AM - 6:30 PM
  • Nov 28, 2018 8:00 AM - 6:00 PM
Princeton, NJUSD $1550.00Enroll
  • Dec 03, 2018 8:00 AM - 5:30 PM
  • Dec 04, 2018 8:00 AM - 6:30 PM
  • Dec 05, 2018 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
  • Dec 03, 2018 8:00 AM - 5:30 PM
  • Dec 04, 2018 8:00 AM - 6:30 PM
  • Dec 05, 2018 8:00 AM - 6:00 PM
San Diego, CAUSD $1550.00Enroll
  • Jan 07, 2019 8:00 AM - 5:30 PM
  • Jan 08, 2019 8:00 AM - 6:30 PM
  • Jan 09, 2019 8:00 AM - 6:00 PM
San Diego, CAUSD $1450.00*Enroll
  • Jan 14, 2019 8:00 AM - 5:30 PM
  • Jan 15, 2019 8:00 AM - 6:30 PM
  • Jan 16, 2019 8:00 AM - 6:00 PM
Atlanta, GAUSD $1450.00*Enroll
  • Jan 21, 2019 8:00 AM - 5:30 PM
  • Jan 22, 2019 8:00 AM - 6:30 PM
  • Jan 23, 2019 8:00 AM - 6:00 PM
Chicago, ILUSD $1450.00*Enroll
  • Feb 04, 2019 8:00 AM - 5:30 PM
  • Feb 05, 2019 8:00 AM - 6:30 PM
  • Feb 06, 2019 8:00 AM - 6:00 PM
San José, CAUSD $1450.00*Enroll
  • Feb 11, 2019 8:00 AM - 5:30 PM
  • Feb 12, 2019 8:00 AM - 6:30 PM
  • Feb 13, 2019 8:00 AM - 6:00 PM
Houston, TXUSD $1450.00*Enroll
  • Feb 18, 2019 8:00 AM - 5:30 PM
  • Feb 19, 2019 8:00 AM - 6:30 PM
  • Feb 20, 2019 8:00 AM - 6:00 PM
Orlando, FLUSD $1450.00*Enroll
  • Feb 25, 2019 8:00 AM - 5:30 PM
  • Feb 26, 2019 8:00 AM - 6:30 PM
  • Feb 27, 2019 8:00 AM - 6:00 PM
Minneapolis, MNUSD $1450.00*Enroll
  • Mar 18, 2019 8:00 AM - 5:30 PM
  • Mar 19, 2019 8:00 AM - 6:30 PM
  • Mar 20, 2019 8:00 AM - 6:00 PM
Atlanta, GAUSD $1450.00*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, ILUSD $1450.00*Enroll
  • 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, FLUSD $1450.00*Enroll
  • 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, WAUSD $1450.00*Enroll
  • Apr 22, 2019 8:00 AM - 5:30 PM
  • Apr 23, 2019 8:00 AM - 6:30 PM
  • Apr 24, 2019 8:00 AM - 6:00 PM
Atlanta, GAUSD $1450.00*Enroll
  • 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
Houston, TXUSD $1450.00*Enroll
  • 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, CAUSD $1450.00*Enroll
  • 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 $1450.00*Enroll
  • May 27, 2019 8:00 AM - 5:30 PM
  • May 28, 2019 8:00 AM - 6:30 PM
  • May 29, 2019 8:00 AM - 6:00 PM
Minneapolis, MNUSD $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
Houston, TXUSD $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