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ISO 13485:2016 Internal Auditor (TPECS)

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, "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. 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
  • Understand the roles and responsibilities of the auditor

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

Start/End Date and Time Location Fee Enroll
  • Mar 05, 2018 8:00 AM - 5:30 PM
  • Mar 06, 2018 8:00 AM - 6:30 PM
  • Mar 07, 2018 8:00 AM - 6:00 PM
Princeton, NJ
Courtyard by Marriott Princeton
3815 U.S. Highway 1
@ Mapleton Princeton
Princeton, NJ 08540
United States
(609)436-8964
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USD $1550.00Enroll
  • Mar 12, 2018 8:00 AM - 5:30 PM
  • Mar 13, 2018 8:00 AM - 6:30 PM
  • Mar 14, 2018 8:00 AM - 6:00 PM
Seattle, WA
Hilton Seattle Airport & Conference Center
17620 International Boulevard
Seattle, WA 98188
United States
(206) 901-5910
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USD $1550.00Enroll
  • Mar 12, 2018 8:00 AM - 5:30 PM
  • Mar 13, 2018 8:00 AM - 6:30 PM
  • Mar 14, 2018 8:00 AM - 6:00 PM
Boston, MA
Embassy Suites by Hilton Boston Waltham
550 Winter Street
Waltham, MA 02451
United States
1-781-890-6767
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USD $1550.00Enroll
  • Mar 19, 2018 8:00 AM - 5:30 PM
  • Mar 20, 2018 8:00 AM - 6:30 PM
  • Mar 21, 2018 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 19, 2018 8:00 AM - 5:30 PM
  • Mar 20, 2018 8:00 AM - 6:30 PM
  • Mar 21, 2018 8:00 AM - 6:00 PM
Atlanta, GA
Holiday Inn Express-Buckhead
800 Sidney Marcus Boulevard
Atlanta, GA 30324
United States
(404) 949-4000
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USD $1550.00Enroll
  • Mar 19, 2018 8:00 AM - 5:30 PM
  • Mar 20, 2018 8:00 AM - 6:30 PM
  • Mar 21, 2018 8:00 AM - 6:00 PM
Memphis, TNUSD $1550.00Enroll
  • Mar 26, 2018 8:00 AM - 5:30 PM
  • Mar 27, 2018 8:00 AM - 6:30 PM
  • Mar 28, 2018 8:00 AM - 6:00 PM
Minneapolis, MN
DoubleTree by Hilton-Minneapolis North
2200 Freeway Boulevard
Minneapolis, MN 55430
United States
(763) 566-8000
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USD $1550.00Enroll
  • Apr 02, 2018 8:00 AM - 5:30 PM
  • Apr 03, 2018 8:00 AM - 6:30 PM
  • Apr 04, 2018 8:00 AM - 6:00 PM
Minneapolis, MNUSD $1550.00Enroll
  • Apr 16, 2018 8:00 AM - 5:30 PM
  • Apr 17, 2018 8:00 AM - 6:30 PM
  • Apr 18, 2018 8:00 AM - 6:00 PM
San Diego, CAUSD $1550.00Enroll
  • May 01, 2018 8:00 AM - 5:30 PM
  • May 02, 2018 8:00 AM - 6:30 PM
  • May 03, 2018 8:00 AM - 6:00 PM
San Diego, CAUSD $1450.00*Enroll
  • May 01, 2018 8:00 AM - 5:30 PM
  • May 02, 2018 8:00 AM - 6:30 PM
  • May 03, 2018 8:00 AM - 6:00 PM
Chicago, ILUSD $1450.00*Enroll
  • May 07, 2018 8:00 AM - 5:30 PM
  • May 08, 2018 8:00 AM - 6:30 PM
  • May 09, 2018 8:00 AM - 6:00 PM
Raleigh, NCUSD $1450.00*Enroll
  • May 14, 2018 8:00 AM - 5:30 PM
  • May 15, 2018 8:00 AM - 6:30 PM
  • May 16, 2018 8:00 AM - 6:00 PM
San José, CAUSD $1450.00*Enroll
  • May 21, 2018 8:00 AM - 5:30 PM
  • May 22, 2018 8:00 AM - 6:30 PM
  • May 23, 2018 8:00 AM - 6:00 PM
Boston, MAUSD $1450.00*Enroll
  • Jun 04, 2018 8:00 AM - 5:30 PM
  • Jun 05, 2018 8:00 AM - 6:30 PM
  • Jun 06, 2018 8:00 AM - 6:00 PM
Atlanta, GAUSD $1450.00*Enroll
  • Jun 11, 2018 8:00 AM - 5:30 PM
  • Jun 12, 2018 8:00 AM - 6:30 PM
  • Jun 13, 2018 8:00 AM - 6:00 PM
Minneapolis, MNUSD $1450.00*Enroll
  • Jun 11, 2018 8:00 AM - 5:30 PM
  • Jun 12, 2018 8:00 AM - 6:30 PM
  • Jun 13, 2018 8:00 AM - 6:00 PM
Seattle, WAUSD $1450.00*Enroll
  • Jun 11, 2018 8:00 AM - 5:30 PM
  • Jun 12, 2018 8:00 AM - 6:30 PM
  • Jun 13, 2018 8:00 AM - 6:00 PM
Memphis, TNUSD $1450.00*Enroll
  • Jun 19, 2018 8:00 AM - 5:30 PM
  • Jun 20, 2018 8:00 AM - 6:30 PM
  • Jun 21, 2018 8:00 AM - 6:00 PM
Orlando, FLUSD $1450.00*Enroll
  • Jun 25, 2018 8:00 AM - 5:30 PM
  • Jun 26, 2018 8:00 AM - 6:30 PM
  • Jun 27, 2018 8:00 AM - 6:00 PM
Princeton, NJUSD $1450.00*Enroll