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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
  • 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, 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
  • 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
Dallas, TXUSD $1550.00Enroll
  • 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 $1550.00Enroll
  • 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
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
  • 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, MN
Hyatt Place Minneapolis Downtown
425 7th Street South
Minneapolis, MN 55415
United States
(912) 333 3111
View Location Websitemap this location
USD $1550.00Enroll
  • 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 $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
Chicago, ILUSD $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
San Diego, CAUSD $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 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, MAUSD $1450.00*Enroll
  • 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 $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
Dallas, 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 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, 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
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