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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. Additionally, it is highly recommended that inexperienced students take the BSI e-learning class “Essentials of ISO 13485:2003"prior to attending the classroom training.

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
  • Sep 25, 2017 8:00 AM - 5:30 PM
  • Sep 26, 2017 8:00 AM - 6:30 PM
  • Sep 27, 2017 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
  • Sep 25, 2017 8:00 AM - 5:30 PM
  • Sep 26, 2017 8:00 AM - 6:30 PM
  • Sep 27, 2017 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
  • Oct 10, 2017 8:00 AM - 5:30 PM
  • Oct 11, 2017 8:00 AM - 6:30 PM
  • Oct 12, 2017 8:00 AM - 6:00 PM
Chicago, IL
Residence Inn Chicago Schaumburg
1610 McConnor Parkway
Schaumburg, IL 60173
United States
847.517.9200
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USD $1550.00Enroll
  • Oct 16, 2017 8:00 AM - 5:30 PM
  • Oct 17, 2017 8:00 AM - 6:30 PM
  • Oct 18, 2017 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
View Location Websitemap this location
USD $1550.00Enroll
  • Oct 23, 2017 8:00 AM - 5:30 PM
  • Oct 24, 2017 8:00 AM - 6:30 PM
  • Oct 25, 2017 8:00 AM - 6:00 PM
Milwaukee, WIUSD $1550.00Enroll
  • Oct 30, 2017 8:00 AM - 5:30 PM
  • Oct 31, 2017 8:00 AM - 6:30 PM
  • Nov 01, 2017 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
  • Nov 06, 2017 8:00 AM - 5:30 PM
  • Nov 07, 2017 8:00 AM - 6:30 PM
  • Nov 08, 2017 8:00 AM - 6:00 PM
Memphis, TNUSD $1550.00Enroll
  • Nov 13, 2017 8:00 AM - 5:30 PM
  • Nov 14, 2017 8:00 AM - 6:30 PM
  • Nov 15, 2017 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 27, 2017 8:00 AM - 5:30 PM
  • Nov 28, 2017 8:00 AM - 6:30 PM
  • Nov 29, 2017 8:00 AM - 6:00 PM
Atlanta, GAUSD $1450.00*Enroll
  • Nov 27, 2017 8:00 AM - 5:30 PM
  • Nov 28, 2017 8:00 AM - 6:30 PM
  • Nov 29, 2017 8:00 AM - 6:00 PM
Princeton, NJ
Hyatt Place Princeton
3565 US Highway 1
Princeton, NJ 08540
United States
(609) 720.0200
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USD $1450.00*Enroll
  • Dec 04, 2017 8:00 AM - 5:30 PM
  • Dec 05, 2017 8:00 AM - 6:30 PM
  • Dec 06, 2017 8:00 AM - 6:00 PM
Minneapolis, MNUSD $1450.00*Enroll
  • Dec 18, 2017 8:00 AM - 5:30 PM
  • Dec 19, 2017 8:00 AM - 6:30 PM
  • Dec 20, 2017 8:00 AM - 6:00 PM
San Diego, CAUSD $1450.00*Enroll