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ISO 13485:2016 Lead Auditor (TPECS)

BSI's “ISO 13485:2016 Lead Auditor” competency-based 4-day course teaches a general understanding of the concepts of the ISO 13485:2016 standard and the principles and practices of leading management systems and process 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 the entire audit process, from managing an audit program to reporting on audit results. Students gain necessary auditing skills through a balance of formal classroom tutorials, role playing, group workshops, and open forum discussions.

This course comprises the following three Exemplar Global TPECS Competency Units whose outcomes are certified by Exemplar Global:

  • MD - Medical Device Systems
  • AU - Management Systems Auditing
  • TL - Leading Management Systems Audit Teams

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
  • Apply ISO 19011 definitions, concepts, and guidelines
  • Recognize the principles, practices, and types of audits
  • Conduct all phases of an internal audit
  • Prepare and present effective reports
  • Understand Exemplar Global's certification scheme
  • Understand the role of objectives, scope and criteria in the audit process
  • How to plan audits
  • Conduct audit team selection
  • Initiate the audit and conducting opening meetings
  • Understand audit team leader responsibilities
  • Communicate effectively during the audit
  • Conduct on-site activities
  • Prepare audit conclusions
  • Conduct closing meetings
  • Report audit results

Course Materials

Students receive comprehensive course manuals with reference materials.

Who Should Attend

  • Individuals interested in conducting first-party, second-party, and third-party audits
  • Management Representatives
  • Quality Directors in Medical Device
  • Managers
  • Engineers
  • Consultants

Prerequisite

A prior review of the ISO 13485:2016 standard is required and internal audit experience is suggested for this course. 

Class Logistics

There are written tests on each of the competency units in turn on Days 2, 3 and 4. 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
  • Jul 23, 2018 8:00 AM - 5:30 PM
  • Jul 24, 2018 8:00 AM - 6:30 PM
  • Jul 25, 2018 8:00 AM - 6:00 PM
  • Jul 26, 2018 8:00 AM - 4:00 PM
Atlanta, GA
Courtyard Marriott Atlanta Downtown
133 Carnegie Way NW
Atlanta, GA 30303
United States
(404) 222-2416
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USD $2250.00Enroll
  • Jul 23, 2018 8:00 AM - 5:30 PM
  • Jul 24, 2018 8:00 AM - 6:30 PM
  • Jul 25, 2018 8:00 AM - 6:00 PM
  • Jul 26, 2018 8:00 AM - 4:00 PM
Minneapolis, MN
Hyatt Place Minneapolis Downtown
425 7th Street South
Minneapolis, MN 55415
United States
(912) 333 3111
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USD $2250.00Enroll
  • Aug 06, 2018 8:00 AM - 5:30 PM
  • Aug 07, 2018 8:00 AM - 6:30 PM
  • Aug 08, 2018 8:00 AM - 6:00 PM
  • Aug 09, 2018 8:00 AM - 4:00 PM
Memphis, TNUSD $2250.00Enroll
  • Aug 06, 2018 8:00 AM - 5:30 PM
  • Aug 07, 2018 8:00 AM - 6:30 PM
  • Aug 08, 2018 8:00 AM - 6:00 PM
  • Aug 09, 2018 8:00 AM - 4:00 PM
Chicago, IL
Hyatt Place Chicago Midway
6550 Cicero Avenue
Bedford Park, IL 60638
United States
(708) 594-1400map this location
USD $2250.00Enroll
  • Aug 13, 2018 8:00 AM - 5:30 PM
  • Aug 14, 2018 8:00 AM - 6:30 PM
  • Aug 15, 2018 8:00 AM - 6:00 PM
  • Aug 16, 2018 8:00 AM - 4:00 PM
Boston, MA
DoubleTree by Hilton Hotel Boston - Downtown
821 Washington Street
Boston, MA 02111
United States
617.956.7900
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USD $2250.00Enroll
  • Aug 20, 2018 8:00 AM - 5:30 PM
  • Aug 21, 2018 8:00 AM - 6:30 PM
  • Aug 22, 2018 8:00 AM - 6:00 PM
  • Aug 23, 2018 8:00 AM - 4:00 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 $2250.00Enroll
  • Aug 27, 2018 8:00 AM - 5:30 PM
  • Aug 28, 2018 8:00 AM - 6:30 PM
  • Aug 29, 2018 8:00 AM - 6:00 PM
  • Aug 30, 2018 8:00 AM - 4:00 PM
Minneapolis, MNUSD $2250.00Enroll
  • Aug 27, 2018 8:00 AM - 5:30 PM
  • Aug 28, 2018 8:00 AM - 6:30 PM
  • Aug 29, 2018 8:00 AM - 6:00 PM
  • Aug 30, 2018 8:00 AM - 4:00 PM
Princeton, NJ
Courtyard by Marriott Princeton
3815 U.S. Highway 1
@ Mapleton Princeton
Princeton, NJ 08540
United States
(609)436-8964
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USD $2250.00Enroll
  • Sep 17, 2018 8:00 AM - 5:30 PM
  • Sep 18, 2018 8:00 AM - 6:30 PM
  • Sep 19, 2018 8:00 AM - 6:00 PM
  • Sep 20, 2018 8:00 AM - 4:00 PM
Portland, ORUSD $2150.00*Enroll
  • Sep 17, 2018 8:00 AM - 5:30 PM
  • Sep 18, 2018 8:00 AM - 6:30 PM
  • Sep 19, 2018 8:00 AM - 6:00 PM
  • Sep 20, 2018 8:00 AM - 4:00 PM
Raleigh, NCUSD $2150.00*Enroll
  • Sep 24, 2018 8:00 AM - 5:30 PM
  • Sep 25, 2018 8:00 AM - 6:30 PM
  • Sep 26, 2018 8:00 AM - 6:00 PM
  • Sep 27, 2018 8:00 AM - 4:00 PM
Boston, MAUSD $2150.00*Enroll
  • Sep 24, 2018 8:00 AM - 5:30 PM
  • Sep 25, 2018 8:00 AM - 6:30 PM
  • Sep 26, 2018 8:00 AM - 6:00 PM
  • Sep 27, 2018 8:00 AM - 4:00 PM
San Diego, CAUSD $2150.00*Enroll
  • Oct 08, 2018 8:00 AM - 5:30 PM
  • Oct 09, 2018 8:00 AM - 6:30 PM
  • Oct 10, 2018 8:00 AM - 6:00 PM
  • Oct 11, 2018 8:00 AM - 4:00 PM
Chicago, ILUSD $2150.00*Enroll
  • Oct 22, 2018 8:00 AM - 5:30 PM
  • Oct 23, 2018 8:00 AM - 6:30 PM
  • Oct 24, 2018 8:00 AM - 6:00 PM
  • Oct 25, 2018 8:00 AM - 4:00 PM
Milwaukee, WIUSD $2150.00*Enroll
  • Oct 29, 2018 8:00 AM - 5:30 PM
  • Oct 30, 2018 8:00 AM - 6:30 PM
  • Oct 31, 2018 8:00 AM - 6:00 PM
  • Nov 01, 2018 8:00 AM - 4:00 PM
Atlanta, GAUSD $2150.00*Enroll
  • Nov 05, 2018 8:00 AM - 5:30 PM
  • Nov 06, 2018 8:00 AM - 6:30 PM
  • Nov 07, 2018 8:00 AM - 6:00 PM
  • Nov 08, 2018 8:00 AM - 4:00 PM
Memphis, TNUSD $2150.00*Enroll
  • Nov 12, 2018 8:00 AM - 5:30 PM
  • Nov 13, 2018 8:00 AM - 6:30 PM
  • Nov 14, 2018 8:00 AM - 6:00 PM
  • Nov 15, 2018 8:00 AM - 4:00 PM
San José, CAUSD $2150.00*Enroll
  • Nov 12, 2018 8:00 AM - 5:30 PM
  • Nov 13, 2018 8:00 AM - 6:30 PM
  • Nov 14, 2018 8:00 AM - 6:00 PM
  • Nov 15, 2018 8:00 AM - 4:00 PM
Boston, MAUSD $2150.00*Enroll
  • Nov 26, 2018 8:00 AM - 5:30 PM
  • Nov 27, 2018 8:00 AM - 6:30 PM
  • Nov 28, 2018 8:00 AM - 6:00 PM
  • Nov 29, 2018 8:00 AM - 4:00 PM
Princeton, NJUSD $2150.00*Enroll
  • Dec 03, 2018 8:00 AM - 5:30 PM
  • Dec 04, 2018 8:00 AM - 6:30 PM
  • Dec 05, 2018 8:00 AM - 6:00 PM
  • Dec 06, 2018 8:00 AM - 4:00 PM
Minneapolis, MNUSD $2150.00*Enroll
  • Dec 03, 2018 8:00 AM - 5:30 PM
  • Dec 04, 2018 8:00 AM - 6:30 PM
  • Dec 05, 2018 8:00 AM - 6:00 PM
  • Dec 06, 2018 8:00 AM - 4:00 PM
San Diego, CAUSD $2150.00*Enroll