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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 19011:2018 , "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).

Hard Copies: At the start of the course, a physical copy of the Student Handbook will be provided.

Soft Copies: Prior to the course, an email with instructions on how to access the online Student Handbook, which can be viewed, downloaded or printed, will be sent to students.

NOTE: Copies of the standards are not included in the class fee. BSI will make reasonable efforts to have loaner copies for use during the class, but students are encouraged to bring their own copy. Soft copies of the digital loaner standard cannot be printed or downloaded.

Online course option

This Course is also available as part of BSI’s Connected Learning Live service. A virtual instructor lead training course taught live online in a virtual classroom. Scheduled times and dates are available HERE

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
  • Dec 09, 2019 8:00 AM - 5:30 PM
  • Dec 10, 2019 8:00 AM - 6:30 PM
  • Dec 11, 2019 8:00 AM - 6:00 PM
Princeton, NJ
DoubleTree by Hilton - Princeton
4355 Route 1
Princeton, NJ 08540
United States
609-452-2400
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USD $1550.00Enroll
  • Dec 09, 2019 8:00 AM - 5:30 PM
  • Dec 10, 2019 8:00 AM - 6:30 PM
  • Dec 11, 2019 8:00 AM - 6:00 PM
Boston, MA
Courtyard Boston Downtown
275 Tremont Street
Boston, MA 02116
United States
(617) 426-1400
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USD $1550.00Enroll
  • Dec 16, 2019 8:00 AM - 5:30 PM
  • Dec 17, 2019 8:00 AM - 6:30 PM
  • Dec 18, 2019 8:00 AM - 6:00 PM
Dulles, VA
Monument II - Chesapeake Boardroom
12950 Worldgate Drive
Herndon, VA 20170
United States
(703) 347-9000map this location
USD $1550.00Enroll
  • Dec 16, 2019 8:00 AM - 5:30 PM
  • Dec 17, 2019 8:00 AM - 6:30 PM
  • Dec 18, 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
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USD $1550.00Enroll
  • Jan 06, 2020 8:00 AM - 5:30 PM
  • Jan 07, 2020 8:00 AM - 6:30 PM
  • Jan 08, 2020 8:00 AM - 6:00 PM
Boston, MAUSD $1550.00Enroll
  • Jan 06, 2020 8:00 AM - 5:30 PM
  • Jan 07, 2020 8:00 AM - 6:30 PM
  • Jan 08, 2020 8:00 AM - 6:00 PM
San Diego, CA
Courtyard Marriott San Diego Old Town
2435 Jefferson Street
San Diego, CA 92110
United States
(619) 260-8500map this location
USD $1550.00Enroll
  • Jan 13, 2020 8:00 AM - 5:30 PM
  • Jan 14, 2020 8:00 AM - 6:30 PM
  • Jan 15, 2020 8:00 AM - 6:00 PM
Atlanta, GAUSD $1550.00Enroll
  • Jan 13, 2020 8:00 AM - 5:30 PM
  • Jan 14, 2020 8:00 AM - 6:30 PM
  • Jan 15, 2020 8:00 AM - 6:00 PM
Salt Lake City, UTUSD $1550.00Enroll
  • Jan 21, 2020 8:00 AM - 5:30 PM
  • Jan 22, 2020 8:00 AM - 6:30 PM
  • Jan 23, 2020 8:00 AM - 6:00 PM
Princeton, NJUSD $1550.00Enroll
  • Jan 21, 2020 8:00 AM - 5:30 PM
  • Jan 22, 2020 8:00 AM - 6:30 PM
  • Jan 23, 2020 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
  • Jan 27, 2020 8:00 AM - 5:30 PM
  • Jan 28, 2020 8:00 AM - 6:30 PM
  • Jan 29, 2020 8:00 AM - 6:00 PM
Chicago, IL
Hyatt Place Chicago Midway
6550 Cicero Avenue
Bedford Park, IL 60638
United States
(708) 594-1400map this location
USD $1550.00Enroll
  • Feb 03, 2020 8:00 AM - 5:30 PM
  • Feb 04, 2020 8:00 AM - 6:30 PM
  • Feb 05, 2020 8:00 AM - 6:00 PM
San Diego, CAUSD $1550.00Enroll
  • Feb 03, 2020 8:00 AM - 5:30 PM
  • Feb 04, 2020 8:00 AM - 6:30 PM
  • Feb 05, 2020 8:00 AM - 6:00 PM
Dallas, TXUSD $1550.00Enroll
  • Feb 10, 2020 8:00 AM - 5:30 PM
  • Feb 11, 2020 8:00 AM - 6:30 PM
  • Feb 12, 2020 8:00 AM - 6:00 PM
Minneapolis, MNUSD $1450.00*Enroll
  • Feb 10, 2020 8:00 AM - 5:30 PM
  • Feb 11, 2020 8:00 AM - 6:30 PM
  • Feb 12, 2020 8:00 AM - 6:00 PM
Phoenix, AZUSD $1450.00*Enroll
  • Feb 18, 2020 8:00 AM - 5:30 PM
  • Feb 19, 2020 8:00 AM - 6:30 PM
  • Feb 20, 2020 8:00 AM - 6:00 PM
Boston, MAUSD $1450.00*Enroll
  • Feb 24, 2020 8:00 AM - 5:30 PM
  • Feb 25, 2020 8:00 AM - 6:30 PM
  • Feb 26, 2020 8:00 AM - 6:00 PM
Atlanta, GAUSD $1450.00*Enroll
  • Feb 24, 2020 8:00 AM - 5:30 PM
  • Feb 25, 2020 8:00 AM - 6:30 PM
  • Feb 26, 2020 8:00 AM - 6:00 PM
San José, CAUSD $1450.00*Enroll
  • Mar 02, 2020 8:00 AM - 5:30 PM
  • Mar 03, 2020 8:00 AM - 6:30 PM
  • Mar 04, 2020 8:00 AM - 6:00 PM
Princeton, NJUSD $1450.00*Enroll
  • Mar 09, 2020 8:00 AM - 5:30 PM
  • Mar 10, 2020 8:00 AM - 6:30 PM
  • Mar 11, 2020 8:00 AM - 6:00 PM
Chicago, ILUSD $1450.00*Enroll
  • Mar 09, 2020 8:00 AM - 5:30 PM
  • Mar 10, 2020 8:00 AM - 6:30 PM
  • Mar 11, 2020 8:00 AM - 6:00 PM
San Diego, CAUSD $1450.00*Enroll
  • Mar 16, 2020 8:00 AM - 5:30 PM
  • Mar 17, 2020 8:00 AM - 6:30 PM
  • Mar 18, 2020 8:00 AM - 6:00 PM
Dulles, VAUSD $1450.00*Enroll
  • Mar 23, 2020 8:00 AM - 5:30 PM
  • Mar 24, 2020 8:00 AM - 6:30 PM
  • Mar 25, 2020 8:00 AM - 6:00 PM
Minneapolis, MNUSD $1450.00*Enroll
  • Mar 23, 2020 8:00 AM - 5:30 PM
  • Mar 24, 2020 8:00 AM - 6:30 PM
  • Mar 25, 2020 8:00 AM - 6:00 PM
San José, CAUSD $1450.00*Enroll
  • Mar 30, 2020 8:00 AM - 5:30 PM
  • Mar 31, 2020 8:00 AM - 6:30 PM
  • Apr 01, 2020 8:00 AM - 6:00 PM
Seattle, WAUSD $1450.00*Enroll
  • Apr 06, 2020 8:00 AM - 5:30 PM
  • Apr 07, 2020 8:00 AM - 6:30 PM
  • Apr 08, 2020 8:00 AM - 6:00 PM
Boston, MAUSD $1450.00*Enroll
  • Apr 14, 2020 8:00 AM - 5:30 PM
  • Apr 15, 2020 8:00 AM - 6:30 PM
  • Apr 16, 2020 8:00 AM - 6:00 PM
Atlanta, GAUSD $1450.00*Enroll
  • Apr 14, 2020 8:00 AM - 5:30 PM
  • Apr 15, 2020 8:00 AM - 6:30 PM
  • Apr 16, 2020 8:00 AM - 6:00 PM
San Diego, CAUSD $1450.00*Enroll
  • Apr 20, 2020 8:00 AM - 5:30 PM
  • Apr 21, 2020 8:00 AM - 6:30 PM
  • Apr 22, 2020 8:00 AM - 6:00 PM
Salt Lake City, UTUSD $1450.00*Enroll
  • Apr 27, 2020 8:00 AM - 5:30 PM
  • Apr 28, 2020 8:00 AM - 6:30 PM
  • Apr 29, 2020 8:00 AM - 6:00 PM
Dallas, TXUSD $1450.00*Enroll
  • Apr 27, 2020 8:00 AM - 5:30 PM
  • Apr 28, 2020 8:00 AM - 6:30 PM
  • Apr 29, 2020 8:00 AM - 6:00 PM
San José, CAUSD $1450.00*Enroll
  • May 04, 2020 8:00 AM - 5:30 PM
  • May 05, 2020 8:00 AM - 6:30 PM
  • May 06, 2020 8:00 AM - 6:00 PM
Minneapolis, MNUSD $1450.00*Enroll
  • May 04, 2020 8:00 AM - 5:30 PM
  • May 05, 2020 8:00 AM - 6:30 PM
  • May 06, 2020 8:00 AM - 6:00 PM
San Diego, CAUSD $1450.00*Enroll
  • May 11, 2020 8:00 AM - 5:30 PM
  • May 12, 2020 8:00 AM - 6:30 PM
  • May 13, 2020 8:00 AM - 6:00 PM
Princeton, NJUSD $1450.00*Enroll
  • May 18, 2020 8:00 AM - 5:30 PM
  • May 19, 2020 8:00 AM - 6:30 PM
  • May 20, 2020 8:00 AM - 6:00 PM
Chicago, ILUSD $1450.00*Enroll
  • May 18, 2020 8:00 AM - 5:30 PM
  • May 19, 2020 8:00 AM - 6:30 PM
  • May 20, 2020 8:00 AM - 6:00 PM
San José, CAUSD $1450.00*Enroll
  • May 19, 2020 8:00 AM - 5:30 PM
  • May 20, 2020 8:00 AM - 6:30 PM
  • May 21, 2020 8:00 AM - 6:00 PM
Princeton, NJUSD $1450.00*Enroll
  • Jun 01, 2020 8:00 AM - 5:30 PM
  • Jun 02, 2020 8:00 AM - 6:30 PM
  • Jun 03, 2020 8:00 AM - 6:00 PM
Dulles, VAUSD $1450.00*Enroll
  • Jun 01, 2020 8:00 AM - 5:30 PM
  • Jun 02, 2020 8:00 AM - 6:30 PM
  • Jun 03, 2020 8:00 AM - 6:00 PM
San Diego, CAUSD $1450.00*Enroll
  • Jun 08, 2020 8:00 AM - 5:30 PM
  • Jun 09, 2020 8:00 AM - 6:30 PM
  • Jun 10, 2020 8:00 AM - 6:00 PM
Atlanta, GAUSD $1450.00*Enroll
  • Jun 08, 2020 8:00 AM - 5:30 PM
  • Jun 09, 2020 8:00 AM - 6:30 PM
  • Jun 10, 2020 8:00 AM - 6:00 PM
Seattle, WAUSD $1450.00*Enroll
  • Jun 15, 2020 8:00 AM - 5:30 PM
  • Jun 16, 2020 8:00 AM - 6:30 PM
  • Jun 17, 2020 8:00 AM - 6:00 PM
Phoenix, AZUSD $1450.00*Enroll
  • Jun 22, 2020 8:00 AM - 5:30 PM
  • Jun 23, 2020 8:00 AM - 6:30 PM
  • Jun 24, 2020 8:00 AM - 6:00 PM
Dallas, TXUSD $1450.00*Enroll
  • Jun 22, 2020 8:00 AM - 5:30 PM
  • Jun 23, 2020 8:00 AM - 6:30 PM
  • Jun 24, 2020 8:00 AM - 6:00 PM
San José, CAUSD $1450.00*Enroll
  • Jun 29, 2020 8:00 AM - 5:30 PM
  • Jun 30, 2020 8:00 AM - 6:30 PM
  • Jul 01, 2020 8:00 AM - 6:00 PM
Boston, MAUSD $1450.00*Enroll