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

You will have the option to receive your course materials in the following formats:

  • 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 available 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.

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).

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 TimeLocationFeeEnroll
  • 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
  • Apr 23, 2020 8:00 AM - 4:00 PM
Salt Lake City, UT
Hilton Garden Inn Salt Lake Downtown
250 West 600 South
Salt Lake City, UT 84101
United States
(801) 364-5200map this location
USD $2250.00Enroll
  • 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
  • Apr 30, 2020 8:00 AM - 4:00 PM
Dallas, TXUSD $2250.00Enroll
  • 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
  • May 07, 2020 8:00 AM - 4:00 PM
Minneapolis, MNUSD $2250.00Enroll
  • 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
  • May 07, 2020 8:00 AM - 4:00 PM
San Diego, CAUSD $2250.00Enroll
  • 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
  • May 14, 2020 8:00 AM - 4:00 PM
Princeton, NJUSD $2250.00Enroll
  • 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
  • May 21, 2020 8:00 AM - 4:00 PM
Chicago, ILUSD $2250.00Enroll
  • 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
  • May 21, 2020 8:00 AM - 4:00 PM
San José, CAUSD $2250.00Enroll
  • 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
  • May 22, 2020 8:00 AM - 4:00 PM
Princeton, NJUSD $2250.00Enroll
  • 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
  • Jun 04, 2020 8:00 AM - 4:00 PM
Dulles, VAUSD $2150.00*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
  • Jun 04, 2020 8:00 AM - 4:00 PM
San Diego, CAUSD $2150.00*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
  • Jun 11, 2020 8:00 AM - 4:00 PM
Atlanta, GAUSD $2150.00*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
  • Jun 11, 2020 8:00 AM - 4:00 PM
Seattle, WAUSD $2150.00*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
  • Jun 18, 2020 8:00 AM - 4:00 PM
Phoenix, AZUSD $2150.00*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
  • Jun 25, 2020 8:00 AM - 4:00 PM
Dallas, TXUSD $2150.00*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
  • Jun 25, 2020 8:00 AM - 4:00 PM
San José, CAUSD $2150.00*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
  • Jul 02, 2020 8:00 AM - 4:00 PM
Boston, MAUSD $2150.00*Enroll
  • Jul 06, 2020 8:00 AM - 5:30 PM
  • Jul 07, 2020 8:00 AM - 6:30 PM
  • Jul 08, 2020 8:00 AM - 6:00 PM
  • Jul 09, 2020 8:00 AM - 4:00 PM
San Diego, CAUSD $2150.00*Enroll
  • Jul 13, 2020 8:00 AM - 5:30 PM
  • Jul 14, 2020 8:00 AM - 6:30 PM
  • Jul 15, 2020 8:00 AM - 6:00 PM
  • Jul 16, 2020 8:00 AM - 4:00 PM
Minneapolis, MNUSD $2150.00*Enroll
  • Jul 13, 2020 8:00 AM - 5:30 PM
  • Jul 14, 2020 8:00 AM - 6:30 PM
  • Jul 15, 2020 8:00 AM - 6:00 PM
  • Jul 16, 2020 8:00 AM - 4:00 PM
Salt Lake City, UTUSD $2150.00*Enroll
  • Jul 20, 2020 8:00 AM - 5:30 PM
  • Jul 21, 2020 8:00 AM - 6:30 PM
  • Jul 22, 2020 8:00 AM - 6:00 PM
  • Jul 23, 2020 8:00 AM - 4:00 PM
Princeton, NJUSD $2150.00*Enroll
  • Jul 27, 2020 8:00 AM - 5:30 PM
  • Jul 28, 2020 8:00 AM - 6:30 PM
  • Jul 29, 2020 8:00 AM - 6:00 PM
  • Jul 30, 2020 8:00 AM - 4:00 PM
Atlanta, GAUSD $2150.00*Enroll
  • Jul 27, 2020 8:00 AM - 5:30 PM
  • Jul 28, 2020 8:00 AM - 6:30 PM
  • Jul 29, 2020 8:00 AM - 6:00 PM
  • Jul 30, 2020 8:00 AM - 4:00 PM
San José, CAUSD $2150.00*Enroll
  • Aug 03, 2020 8:00 AM - 5:30 PM
  • Aug 04, 2020 8:00 AM - 6:30 PM
  • Aug 05, 2020 8:00 AM - 6:00 PM
  • Aug 06, 2020 8:00 AM - 4:00 PM
Boston, MAUSD $2150.00*Enroll
  • Aug 10, 2020 8:00 AM - 5:30 PM
  • Aug 11, 2020 8:00 AM - 6:30 PM
  • Aug 12, 2020 8:00 AM - 6:00 PM
  • Aug 13, 2020 8:00 AM - 4:00 PM
Chicago, ILUSD $2150.00*Enroll
  • Aug 10, 2020 8:00 AM - 5:30 PM
  • Aug 11, 2020 8:00 AM - 6:30 PM
  • Aug 12, 2020 8:00 AM - 6:00 PM
  • Aug 13, 2020 8:00 AM - 4:00 PM
San Diego, CAUSD $2150.00*Enroll
  • Aug 17, 2020 8:00 AM - 5:30 PM
  • Aug 18, 2020 8:00 AM - 6:30 PM
  • Aug 19, 2020 8:00 AM - 6:00 PM
  • Aug 20, 2020 8:00 AM - 4:00 PM
Dulles, VAUSD $2150.00*Enroll
  • Aug 24, 2020 8:00 AM - 5:30 PM
  • Aug 25, 2020 8:00 AM - 6:30 PM
  • Aug 26, 2020 8:00 AM - 6:00 PM
  • Aug 27, 2020 8:00 AM - 4:00 PM
Nashville, TNUSD $2150.00*Enroll
  • Aug 24, 2020 8:00 AM - 5:30 PM
  • Aug 25, 2020 8:00 AM - 6:30 PM
  • Aug 26, 2020 8:00 AM - 6:00 PM
  • Aug 27, 2020 8:00 AM - 4:00 PM
San José, CAUSD $2150.00*Enroll
  • Aug 31, 2020 8:00 AM - 5:30 PM
  • Sep 01, 2020 8:00 AM - 6:30 PM
  • Sep 02, 2020 8:00 AM - 6:00 PM
  • Sep 03, 2020 8:00 AM - 4:00 PM
Seattle, WAUSD $2150.00*Enroll
  • Sep 08, 2020 8:00 AM - 5:30 PM
  • Sep 09, 2020 8:00 AM - 6:30 PM
  • Sep 10, 2020 8:00 AM - 6:00 PM
  • Sep 11, 2020 8:00 AM - 4:00 PM
Dallas, TXUSD $2150.00*Enroll
  • Sep 14, 2020 8:00 AM - 5:30 PM
  • Sep 15, 2020 8:00 AM - 6:30 PM
  • Sep 16, 2020 8:00 AM - 6:00 PM
  • Sep 17, 2020 8:00 AM - 4:00 PM
Atlanta, GAUSD $2150.00*Enroll
  • Sep 14, 2020 8:00 AM - 5:30 PM
  • Sep 15, 2020 8:00 AM - 6:30 PM
  • Sep 16, 2020 8:00 AM - 6:00 PM
  • Sep 17, 2020 8:00 AM - 4:00 PM
San Diego, CAUSD $2150.00*Enroll
  • Sep 21, 2020 8:00 AM - 5:30 PM
  • Sep 22, 2020 8:00 AM - 6:30 PM
  • Sep 23, 2020 8:00 AM - 6:00 PM
  • Sep 24, 2020 8:00 AM - 4:00 PM
Phoenix, AZUSD $2150.00*Enroll
  • Sep 28, 2020 8:00 AM - 5:30 PM
  • Sep 29, 2020 8:00 AM - 6:30 PM
  • Sep 30, 2020 8:00 AM - 6:00 PM
  • Oct 01, 2020 8:00 AM - 4:00 PM
Nashville, TNUSD $2150.00*Enroll
  • Sep 28, 2020 8:00 AM - 5:30 PM
  • Sep 29, 2020 8:00 AM - 6:30 PM
  • Sep 30, 2020 8:00 AM - 6:00 PM
  • Oct 01, 2020 8:00 AM - 4:00 PM
San José, CAUSD $2150.00*Enroll
  • Oct 05, 2020 8:00 AM - 5:30 PM
  • Oct 06, 2020 8:00 AM - 6:30 PM
  • Oct 07, 2020 8:00 AM - 6:00 PM
  • Oct 08, 2020 8:00 AM - 4:00 PM
Minneapolis, MNUSD $2150.00*Enroll
  • Oct 05, 2020 8:00 AM - 5:30 PM
  • Oct 06, 2020 8:00 AM - 6:30 PM
  • Oct 07, 2020 8:00 AM - 6:00 PM
  • Oct 08, 2020 8:00 AM - 4:00 PM
San Diego, CAUSD $2150.00*Enroll
  • Oct 12, 2020 8:00 AM - 5:30 PM
  • Oct 13, 2020 8:00 AM - 6:30 PM
  • Oct 14, 2020 8:00 AM - 6:00 PM
  • Oct 15, 2020 8:00 AM - 4:00 PM
Princeton, NJUSD $2150.00*Enroll
  • Oct 12, 2020 8:00 AM - 5:30 PM
  • Oct 13, 2020 8:00 AM - 6:30 PM
  • Oct 14, 2020 8:00 AM - 6:00 PM
  • Oct 15, 2020 8:00 AM - 4:00 PM
Salt Lake City, UTUSD $2150.00*Enroll
  • Oct 19, 2020 8:00 AM - 5:30 PM
  • Oct 20, 2020 8:00 AM - 6:30 PM
  • Oct 21, 2020 8:00 AM - 6:00 PM
  • Oct 22, 2020 8:00 AM - 4:00 PM
Dulles, VAUSD $2150.00*Enroll
  • Oct 19, 2020 8:00 AM - 5:30 PM
  • Oct 20, 2020 8:00 AM - 6:30 PM
  • Oct 21, 2020 8:00 AM - 6:00 PM
  • Oct 22, 2020 8:00 AM - 4:00 PM
San José, CAUSD $2150.00*Enroll
  • Oct 26, 2020 8:00 AM - 5:30 PM
  • Oct 27, 2020 8:00 AM - 6:30 PM
  • Oct 28, 2020 8:00 AM - 6:00 PM
  • Oct 29, 2020 8:00 AM - 4:00 PM
Denver, COUSD $2150.00*Enroll
  • Nov 02, 2020 8:00 AM - 5:30 PM
  • Nov 03, 2020 8:00 AM - 6:30 PM
  • Nov 04, 2020 8:00 AM - 6:00 PM
  • Nov 05, 2020 8:00 AM - 4:00 PM
Nashville, TNUSD $2150.00*Enroll
  • Nov 02, 2020 8:00 AM - 5:30 PM
  • Nov 03, 2020 8:00 AM - 6:30 PM
  • Nov 04, 2020 8:00 AM - 6:00 PM
  • Nov 05, 2020 8:00 AM - 4:00 PM
Phoenix, AZUSD $2150.00*Enroll
  • Nov 09, 2020 8:00 AM - 5:30 PM
  • Nov 10, 2020 8:00 AM - 6:30 PM
  • Nov 11, 2020 8:00 AM - 6:00 PM
  • Nov 12, 2020 8:00 AM - 4:00 PM
Seattle, WAUSD $2150.00*Enroll
  • Nov 16, 2020 8:00 AM - 5:30 PM
  • Nov 17, 2020 8:00 AM - 6:30 PM
  • Nov 18, 2020 8:00 AM - 6:00 PM
  • Nov 19, 2020 8:00 AM - 4:00 PM
Boston, MAUSD $2150.00*Enroll
  • Nov 30, 2020 8:00 AM - 5:30 PM
  • Dec 01, 2020 8:00 AM - 6:30 PM
  • Dec 02, 2020 8:00 AM - 6:00 PM
  • Dec 03, 2020 8:00 AM - 4:00 PM
Dallas, TXUSD $2150.00*Enroll
  • Nov 30, 2020 8:00 AM - 5:30 PM
  • Dec 01, 2020 8:00 AM - 6:30 PM
  • Dec 02, 2020 8:00 AM - 6:00 PM
  • Dec 03, 2020 8:00 AM - 4:00 PM
San José, CAUSD $2150.00*Enroll
  • Dec 07, 2020 8:00 AM - 5:30 PM
  • Dec 08, 2020 8:00 AM - 6:30 PM
  • Dec 09, 2020 8:00 AM - 6:00 PM
  • Dec 10, 2020 8:00 AM - 4:00 PM
Atlanta, GAUSD $2150.00*Enroll
  • Dec 07, 2020 8:00 AM - 5:30 PM
  • Dec 08, 2020 8:00 AM - 6:30 PM
  • Dec 09, 2020 8:00 AM - 6:00 PM
  • Dec 10, 2020 8:00 AM - 4:00 PM
Salt Lake City, UTUSD $2150.00*Enroll
  • Dec 14, 2020 8:00 AM - 5:30 PM
  • Dec 15, 2020 8:00 AM - 6:30 PM
  • Dec 16, 2020 8:00 AM - 6:00 PM
  • Dec 17, 2020 8:00 AM - 4:00 PM
Chicago, ILUSD $2150.00*Enroll
  • Dec 14, 2020 8:00 AM - 5:30 PM
  • Dec 15, 2020 8:00 AM - 6:30 PM
  • Dec 16, 2020 8:00 AM - 6:00 PM
  • Dec 17, 2020 8:00 AM - 4:00 PM
San Diego, CAUSD $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.