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ISO 13485:2016 Lead Auditor (TPECS)

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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. Additionally, it is highly recommended that inexperienced students take the BSI e-learning class "Essentials of 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, 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

Start/End Date and Time Location Fee Enroll
  • 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
  • Jul 20, 2017 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
  • 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
  • Jul 27, 2017 8:00 AM - 4:00 PM
Atlanta, GA
Holiday Inn Express-Buckhead
800 Sidney Marcus Boulevard
Atlanta, GA 30324
United States
(404) 949-4000
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USD $2250.00Enroll
  • 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
  • Aug 10, 2017 8:00 AM - 4:00 PM
Chicago, IL
Courtyard by Marriott Chicago Schaumburg
1311 American Lane
Schaumburg, IL 60173
United States
847/619-8100map this location
USD $2250.00Enroll
  • 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
  • Aug 17, 2017 8:00 AM - 4:00 PM
Boston, MA
Embassy Suites by Hilton Boston Waltham
550 Winter Street
Waltham, MA 02451
United States
1-781-890-6767
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USD $2250.00Enroll
  • 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
  • Aug 24, 2017 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
View Location Websitemap this location
USD $2250.00Enroll
  • 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
  • Aug 31, 2017 8:00 AM - 4:00 PM
Princeton, NJUSD $2150.00*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
  • Aug 31, 2017 8:00 AM - 4:00 PM
Minneapolis, MN
DoubleTree by Hilton-Minneapolis North
2200 Freeway Boulevard
Minneapolis, MN 55430
United States
(763) 566-8000
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USD $2150.00*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
  • Sep 14, 2017 8:00 AM - 4:00 PM
Atlanta, GAUSD $2150.00*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
  • Sep 21, 2017 8:00 AM - 4:00 PM
Raleigh, NCUSD $2150.00*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
  • Sep 28, 2017 8:00 AM - 4:00 PM
San Diego, CA
Country Inn and Suites by Carlson-San Diego North
5975 Lusk Boulevard
San Diego, CA 92121
United States
858/558-1818
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USD $2150.00*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
  • Sep 28, 2017 8:00 AM - 4:00 PM
Boston, MAUSD $2150.00*Enroll
  • Oct 10, 2017 8:00 AM - 5:30 PM
  • Oct 11, 2017 8:00 AM - 6:30 PM
  • Oct 12, 2017 8:00 AM - 6:00 PM
  • Oct 13, 2017 8:00 AM - 4:00 PM
Chicago, ILUSD $2150.00*Enroll
  • Oct 16, 2017 8:00 AM - 5:30 PM
  • Oct 17, 2017 8:00 AM - 6:30 PM
  • Oct 18, 2017 8:00 AM - 6:00 PM
  • Oct 19, 2017 8:00 AM - 4:00 PM
Boston, MAUSD $2150.00*Enroll
  • Nov 06, 2017 8:00 AM - 5:30 PM
  • Nov 07, 2017 8:00 AM - 6:30 PM
  • Nov 08, 2017 8:00 AM - 6:00 PM
  • Nov 09, 2017 8:00 AM - 4:00 PM
Memphis, TNUSD $2150.00*Enroll
  • Nov 13, 2017 8:00 AM - 5:30 PM
  • Nov 14, 2017 8:00 AM - 6:30 PM
  • Nov 15, 2017 8:00 AM - 6:00 PM
  • Nov 16, 2017 8:00 AM - 4:00 PM
San José, CAUSD $2150.00*Enroll
  • Nov 27, 2017 8:00 AM - 5:30 PM
  • Nov 28, 2017 8:00 AM - 6:30 PM
  • Nov 29, 2017 8:00 AM - 6:00 PM
  • Nov 30, 2017 8:00 AM - 4:00 PM
Atlanta, GAUSD $2150.00*Enroll
  • Nov 27, 2017 8:00 AM - 5:30 PM
  • Nov 28, 2017 8:00 AM - 6:30 PM
  • Nov 29, 2017 8:00 AM - 6:00 PM
  • Nov 30, 2017 8:00 AM - 4:00 PM
Princeton, NJUSD $2150.00*Enroll
  • Dec 04, 2017 8:00 AM - 5:30 PM
  • Dec 05, 2017 8:00 AM - 6:30 PM
  • Dec 06, 2017 8:00 AM - 6:00 PM
  • Dec 07, 2017 8:00 AM - 4:00 PM
Minneapolis, MNUSD $2150.00*Enroll