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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 19011:2018, “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. 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, 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 19011:2018 concepts, new terminology and guidelines
  • Understand the types of risks and opportunities associated with auditing
  • Recognize the principles, practices, and types of audits
  • Conduct all phases of an audit adopting a risk-based approach, particularly in the section of audit planning
  • 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
  • Apply the latest auditor techniques and identify appropriate use
  • 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
  • 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, WI
Hyatt Place Milwaukee-Downtown
800 West Juneau Avenue
Milwaukee, WI 53233
United States
4148083814
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USD $2250.00Enroll
  • 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, GA
Courtyard Marriott Atlanta Downtown
133 Carnegie Way NW
Atlanta, GA 30303
United States
(404) 222-2416
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USD $2250.00Enroll
  • 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, TN
Hyatt Place-Primacy Parkway
1220 Primacy Parkway
Memphis, TN 38119
United States
(901) 680-9700map this location
USD $2250.00Enroll
  • 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, CA
Biltmore Hotel and Suites
2151 Laurelwood Road
Santa Clara, CA 95054
United States
408/988-8411
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USD $2250.00Enroll
  • 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, MA
Hilton Garden Inn Boston Logan Airport
100 Boardman Street
Boston, MA 02128
United States
(857) 256-2236map this location
USD $2250.00Enroll
  • 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 $2250.00Enroll
  • 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, MN
Hyatt Place Minneapolis Downtown
425 7th Street South
Minneapolis, MN 55415
United States
(912) 333 3111
View Location Websitemap this location
USD $2250.00Enroll
  • 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 $2250.00Enroll
  • Jan 07, 2019 8:00 AM - 5:30 PM
  • Jan 08, 2019 8:00 AM - 6:30 PM
  • Jan 09, 2019 8:00 AM - 6:00 PM
  • Jan 10, 2019 8:00 AM - 4:00 PM
San Diego, CAUSD $2150.00*Enroll
  • Jan 14, 2019 8:00 AM - 5:30 PM
  • Jan 15, 2019 8:00 AM - 6:30 PM
  • Jan 16, 2019 8:00 AM - 6:00 PM
  • Jan 17, 2019 8:00 AM - 4:00 PM
Atlanta, GAUSD $2150.00*Enroll
  • Jan 21, 2019 8:00 AM - 5:30 PM
  • Jan 22, 2019 8:00 AM - 6:30 PM
  • Jan 23, 2019 8:00 AM - 6:00 PM
  • Jan 24, 2019 8:00 AM - 4:00 PM
Chicago, ILUSD $2150.00*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
  • Feb 07, 2019 8:00 AM - 4:00 PM
San José, CAUSD $2150.00*Enroll
  • 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
  • Feb 14, 2019 8:00 AM - 4:00 PM
Houston, TXUSD $2150.00*Enroll
  • 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
  • Feb 21, 2019 8:00 AM - 4:00 PM
Orlando, FLUSD $2150.00*Enroll
  • 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
  • Feb 28, 2019 8:00 AM - 4:00 PM
Minneapolis, MNUSD $2150.00*Enroll
  • 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
  • Mar 21, 2019 8:00 AM - 4:00 PM
Atlanta, GAUSD $2150.00*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
  • Mar 28, 2019 8:00 AM - 4:00 PM
Chicago, ILUSD $2150.00*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
  • Apr 04, 2019 8:00 AM - 4:00 PM
Orlando, FLUSD $2150.00*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
  • Apr 11, 2019 8:00 AM - 4:00 PM
Seattle, WAUSD $2150.00*Enroll
  • Apr 22, 2019 8:00 AM - 5:30 PM
  • Apr 23, 2019 8:00 AM - 6:30 PM
  • Apr 24, 2019 8:00 AM - 6:00 PM
  • Apr 25, 2019 8:00 AM - 4:00 PM
Atlanta, GAUSD $2150.00*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
  • May 02, 2019 8:00 AM - 4:00 PM
Houston, TXUSD $2150.00*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
  • May 09, 2019 8:00 AM - 4:00 PM
San José, CAUSD $2150.00*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
  • May 16, 2019 8:00 AM - 4:00 PM
Princeton, NJUSD $2150.00*Enroll
  • May 27, 2019 8:00 AM - 5:30 PM
  • May 28, 2019 8:00 AM - 6:30 PM
  • May 29, 2019 8:00 AM - 6:00 PM
  • May 30, 2019 8:00 AM - 4:00 PM
Minneapolis, MNUSD $2150.00*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
  • Jun 06, 2019 8:00 AM - 4:00 PM
Atlanta, GAUSD $2150.00*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
  • Jun 13, 2019 8:00 AM - 4:00 PM
Houston, TXUSD $2150.00*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
  • Jun 20, 2019 8:00 AM - 4:00 PM
Orlando, FLUSD $2150.00*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
  • Jun 27, 2019 8:00 AM - 4:00 PM
Chicago, ILUSD $2150.00*Enroll