ISO 13485:2016 Lead Auditor

Description

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 TimeLocationFeeEnroll
  • 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
San Diego, CA
Hilton Garden Inn San Diego Mission Valley/Stadium
3805 Murphy Canyon Road
San Diego, CA 92123
United States
(858) 278-9300map this location
USD $2250.00Enroll
  • 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, 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
  • 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 $2250.00Enroll
  • 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 $2250.00Enroll
  • 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
San Diego, CA
Hilton Garden Inn San Diego Mission Valley/Stadium
3805 Murphy Canyon Road
San Diego, CA 92123
United States
(858) 278-9300map this location
USD $2250.00Enroll
  • 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 $2250.00Enroll
  • 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 $2250.00Enroll
  • 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
Boston, MA
Courtyard Boston Logan Airport
225 William McClellan Highway
Boston, MA 02128
United States
(617) 933-1111map this location
USD $2250.00Enroll
  • Apr 23, 2019 8:00 AM - 5:30 PM
  • Apr 24, 2019 8:00 AM - 6:30 PM
  • Apr 25, 2019 8:00 AM - 6:00 PM
  • Apr 26, 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
Dallas, 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 28, 2019 8:00 AM - 5:30 PM
  • May 29, 2019 8:00 AM - 6:30 PM
  • May 30, 2019 8:00 AM - 6:00 PM
  • May 31, 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
Dallas, TXUSD $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
San Diego, CAUSD $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
  • Jul 08, 2019 8:00 AM - 5:30 PM
  • Jul 09, 2019 8:00 AM - 6:30 PM
  • Jul 10, 2019 8:00 AM - 6:00 PM
  • Jul 11, 2019 8:00 AM - 4:00 PM
Boston, MAUSD $2150.00*Enroll
  • Jul 15, 2019 8:00 AM - 5:30 PM
  • Jul 16, 2019 8:00 AM - 6:30 PM
  • Jul 17, 2019 8:00 AM - 6:00 PM
  • Jul 18, 2019 8:00 AM - 4:00 PM
San Diego, CAUSD $2150.00*Enroll
  • Jul 22, 2019 8:00 AM - 5:30 PM
  • Jul 23, 2019 8:00 AM - 6:30 PM
  • Jul 24, 2019 8:00 AM - 6:00 PM
  • Jul 25, 2019 8:00 AM - 4:00 PM
Dulles, VAUSD $2150.00*Enroll
  • Jul 29, 2019 8:00 AM - 5:30 PM
  • Jul 30, 2019 8:00 AM - 6:30 PM
  • Jul 31, 2019 8:00 AM - 6:00 PM
  • Aug 01, 2019 8:00 AM - 4:00 PM
Seattle, WAUSD $2150.00*Enroll
  • Aug 05, 2019 8:00 AM - 5:30 PM
  • Aug 06, 2019 8:00 AM - 6:30 PM
  • Aug 07, 2019 8:00 AM - 6:00 PM
  • Aug 08, 2019 8:00 AM - 4:00 PM
Atlanta, GAUSD $2150.00*Enroll
  • Aug 19, 2019 8:00 AM - 5:30 PM
  • Aug 20, 2019 8:00 AM - 6:30 PM
  • Aug 21, 2019 8:00 AM - 6:00 PM
  • Aug 22, 2019 8:00 AM - 4:00 PM
Minneapolis, MNUSD $2150.00*Enroll
  • Aug 26, 2019 8:00 AM - 5:30 PM
  • Aug 27, 2019 8:00 AM - 6:30 PM
  • Aug 28, 2019 8:00 AM - 6:00 PM
  • Aug 29, 2019 8:00 AM - 4:00 PM
Princeton, NJUSD $2150.00*Enroll
  • Sep 16, 2019 8:00 AM - 5:30 PM
  • Sep 17, 2019 8:00 AM - 6:30 PM
  • Sep 18, 2019 8:00 AM - 6:00 PM
  • Sep 19, 2019 8:00 AM - 4:00 PM
San Diego, CAUSD $2150.00*Enroll
  • Sep 23, 2019 8:00 AM - 5:30 PM
  • Sep 24, 2019 8:00 AM - 6:30 PM
  • Sep 25, 2019 8:00 AM - 6:00 PM
  • Sep 26, 2019 8:00 AM - 4:00 PM
Dallas, TXUSD $2150.00*Enroll
  • Sep 30, 2019 8:00 AM - 5:30 PM
  • Oct 01, 2019 8:00 AM - 6:30 PM
  • Oct 02, 2019 8:00 AM - 6:00 PM
  • Oct 03, 2019 8:00 AM - 4:00 PM
Atlanta, GAUSD $2150.00*Enroll
  • Sep 30, 2019 8:00 AM - 5:30 PM
  • Oct 01, 2019 8:00 AM - 6:30 PM
  • Oct 02, 2019 8:00 AM - 6:00 PM
  • Oct 03, 2019 8:00 AM - 4:00 PM
San José, CAUSD $2150.00*Enroll
  • Oct 07, 2019 8:00 AM - 5:30 PM
  • Oct 08, 2019 8:00 AM - 6:30 PM
  • Oct 09, 2019 8:00 AM - 6:00 PM
  • Oct 10, 2019 8:00 AM - 4:00 PM
Chicago, ILUSD $2150.00*Enroll
  • Oct 21, 2019 8:00 AM - 5:30 PM
  • Oct 22, 2019 8:00 AM - 6:30 PM
  • Oct 23, 2019 8:00 AM - 6:00 PM
  • Oct 24, 2019 8:00 AM - 4:00 PM
Orlando, FLUSD $2150.00*Enroll
  • Oct 21, 2019 8:00 AM - 5:30 PM
  • Oct 22, 2019 8:00 AM - 6:30 PM
  • Oct 23, 2019 8:00 AM - 6:00 PM
  • Oct 24, 2019 8:00 AM - 4:00 PM
Seattle, WAUSD $2150.00*Enroll
  • Nov 04, 2019 8:00 AM - 5:30 PM
  • Nov 05, 2019 8:00 AM - 6:30 PM
  • Nov 06, 2019 8:00 AM - 6:00 PM
  • Nov 07, 2019 8:00 AM - 4:00 PM
San Diego, CAUSD $2150.00*Enroll
  • Nov 18, 2019 8:00 AM - 5:30 PM
  • Nov 19, 2019 8:00 AM - 6:30 PM
  • Nov 20, 2019 8:00 AM - 6:00 PM
  • Nov 21, 2019 8:00 AM - 4:00 PM
Boston, MAUSD $2150.00*Enroll
  • Dec 02, 2019 8:00 AM - 5:30 PM
  • Dec 03, 2019 8:00 AM - 6:30 PM
  • Dec 04, 2019 8:00 AM - 6:00 PM
  • Dec 05, 2019 8:00 AM - 4:00 PM
Atlanta, GAUSD $2150.00*Enroll
  • 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
  • Dec 19, 2019 8:00 AM - 4:00 PM
Dulles, VAUSD $2150.00*Enroll

Whittington & Associates

We are committed to providing expert training, effective consulting, and valuable auditing. If you have any questions about our services, please contact us at 770-862-1766, or Larry@WhittingtonAssociates.com.