ISO 13485:2016 Internal Auditor

Description

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 TimeLocationFeeEnroll
  • Jun 05, 2017 8:00 AM - 5:30 PM
  • Jun 06, 2017 8:00 AM - 6:30 PM
  • Jun 07, 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
  • Jun 12, 2017 8:00 AM - 5:30 PM
  • Jun 13, 2017 8:00 AM - 6:30 PM
  • Jun 14, 2017 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
  • Jun 12, 2017 8:00 AM - 5:30 PM
  • Jun 13, 2017 8:00 AM - 6:30 PM
  • Jun 14, 2017 8:00 AM - 6:00 PM
Seattle, WAUSD $1550.00Enroll
  • Jun 19, 2017 8:00 AM - 5:30 PM
  • Jun 20, 2017 8:00 AM - 6:30 PM
  • Jun 21, 2017 8:00 AM - 6:00 PM
Orlando, FLUSD $1550.00Enroll
  • Jun 26, 2017 8:00 AM - 5:30 PM
  • Jun 27, 2017 8:00 AM - 6:30 PM
  • Jun 28, 2017 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
  • Jul 17, 2017 8:00 AM - 5:30 PM
  • Jul 18, 2017 8:00 AM - 6:30 PM
  • Jul 19, 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
  • Jul 24, 2017 8:00 AM - 5:30 PM
  • Jul 25, 2017 8:00 AM - 6:30 PM
  • Jul 26, 2017 8:00 AM - 6:00 PM
Atlanta, GAUSD $1450.00*Enroll
  • Aug 07, 2017 8:00 AM - 5:30 PM
  • Aug 08, 2017 8:00 AM - 6:30 PM
  • Aug 09, 2017 8:00 AM - 6:00 PM
Chicago, ILUSD $1450.00*Enroll
  • Aug 14, 2017 8:00 AM - 5:30 PM
  • Aug 15, 2017 8:00 AM - 6:30 PM
  • Aug 16, 2017 8:00 AM - 6:00 PM
Boston, MAUSD $1450.00*Enroll
  • Aug 21, 2017 8:00 AM - 5:30 PM
  • Aug 22, 2017 8:00 AM - 6:30 PM
  • Aug 23, 2017 8:00 AM - 6:00 PM
San José, CAUSD $1450.00*Enroll
  • Aug 28, 2017 8:00 AM - 5:30 PM
  • Aug 29, 2017 8:00 AM - 6:30 PM
  • Aug 30, 2017 8:00 AM - 6:00 PM
Minneapolis, MNUSD $1450.00*Enroll
  • Aug 28, 2017 8:00 AM - 5:30 PM
  • Aug 29, 2017 8:00 AM - 6:30 PM
  • Aug 30, 2017 8:00 AM - 6:00 PM
Princeton, NJUSD $1450.00*Enroll
  • Sep 11, 2017 8:00 AM - 5:30 PM
  • Sep 12, 2017 8:00 AM - 6:30 PM
  • Sep 13, 2017 8:00 AM - 6:00 PM
Atlanta, GAUSD $1450.00*Enroll
  • Sep 18, 2017 8:00 AM - 5:30 PM
  • Sep 19, 2017 8:00 AM - 6:30 PM
  • Sep 20, 2017 8:00 AM - 6:00 PM
Raleigh, NCUSD $1450.00*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
San Diego, CAUSD $1450.00*Enroll