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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

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 Time Location Fee Enroll
  • Jul 13, 2020 9:00 AM - 5:30 PM
  • Jul 14, 2020 9:00 AM - 5:30 PM
  • Jul 15, 2020 9:00 AM - 5:30 PM
  • Jul 16, 2020 9:00 AM - 5:30 PM
Live Online - Full DayUSD $2350.00Enroll
  • Jul 13, 2020 11:00 AM - 8:30 PM
  • Jul 14, 2020 11:00 AM - 9:30 PM
  • Jul 15, 2020 11:00 AM - 9:00 PM
  • Jul 16, 2020 11:00 AM - 7:00 PM
Live Online - Full DayUSD $2350.00Enroll
  • Jul 27, 2020 11:00 AM - 8:30 PM
  • Jul 28, 2020 11:00 AM - 8:30 PM
  • Jul 29, 2020 11:00 AM - 8:30 PM
  • Jul 30, 2020 11:00 AM - 8:30 PM
Live Online - Full DayUSD $2350.00Enroll
  • Aug 03, 2020 9:00 AM - 5:30 PM
  • Aug 04, 2020 9:00 AM - 5:30 PM
  • Aug 05, 2020 9:00 AM - 5:30 PM
  • Aug 06, 2020 9:00 AM - 5:30 PM
Live Online - Full DayUSD $2350.00Enroll
  • Aug 10, 2020 11:00 AM - 8:30 PM
  • Aug 11, 2020 11:00 AM - 8:30 PM
  • Aug 12, 2020 11:00 AM - 8:30 PM
  • Aug 13, 2020 11:00 AM - 8:30 PM
Live Online - Full DayUSD $2350.00Enroll
  • Aug 17, 2020 9:00 AM - 5:30 PM
  • Aug 18, 2020 9:00 AM - 5:30 PM
  • Aug 19, 2020 9:00 AM - 5:30 PM
  • Aug 20, 2020 9:00 AM - 5:30 PM
Live Online - Full DayUSD $2350.00Enroll
  • Aug 24, 2020 11:00 AM - 8:30 PM
  • Aug 25, 2020 11:00 AM - 8:30 PM
  • Aug 26, 2020 11:00 AM - 8:30 PM
  • Aug 27, 2020 11:00 AM - 8:30 PM
Live Online - Full DayUSD $2350.00Enroll
  • 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