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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, "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
  • Jan 16, 2018 8:00 AM - 5:30 PM
  • Jan 17, 2018 8:00 AM - 6:30 PM
  • Jan 18, 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
  • Jan 22, 2018 8:00 AM - 5:30 PM
  • Jan 23, 2018 8:00 AM - 6:30 PM
  • Jan 24, 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
  • Jan 22, 2018 8:00 AM - 5:30 PM
  • Jan 23, 2018 8:00 AM - 6:30 PM
  • Jan 24, 2018 8:00 AM - 6:00 PM
San Diego, CAUSD $1550.00Enroll
  • Jan 29, 2018 8:00 AM - 5:30 PM
  • Jan 30, 2018 8:00 AM - 6:30 PM
  • Jan 31, 2018 8:00 AM - 6:00 PM
Princeton, NJ
Hampton Inn Princeton
4385 US 1 South
Princeton, NJ 08540
United States
609-951-0066map this location
USD $1550.00Enroll
  • Feb 05, 2018 8:00 AM - 5:30 PM
  • Feb 06, 2018 8:00 AM - 6:30 PM
  • Feb 07, 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
  • Feb 05, 2018 8:00 AM - 5:30 PM
  • Feb 06, 2018 8:00 AM - 6:30 PM
  • Feb 07, 2018 8:00 AM - 6:00 PM
Minneapolis, MNUSD $1550.00Enroll
  • Feb 12, 2018 8:00 AM - 5:30 PM
  • Feb 13, 2018 8:00 AM - 6:30 PM
  • Feb 14, 2018 8:00 AM - 6:00 PM
Houston, TXUSD $1550.00Enroll
  • Feb 20, 2018 8:00 AM - 5:30 PM
  • Feb 21, 2018 8:00 AM - 6:30 PM
  • Feb 22, 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 $1450.00*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, NJUSD $1450.00*Enroll
  • 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, WAUSD $1450.00*Enroll
  • 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, MAUSD $1450.00*Enroll
  • 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
View Location Websitemap this location
USD $1450.00*Enroll
  • 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 $1450.00*Enroll
  • 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, MNUSD $1450.00*Enroll