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ISO 13485:2016 Internal Auditor (TPECS)

BSI's “ISO 13485:2016 Internal Quality Systems Auditor” competency- based 3-day course teaches a general understanding of the concepts of the ISO 13485:2016 standard and the principles and practices of effective internal 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 internal audits that are required for a quality management system based on ISO 13485:2016. 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, practical role-playing, group workshops, and open forum discussions.

This course comprises the following two Exemplar Global TPECS Competency Units whose outcomes are certified by Exemplar Global:

  • MD -Medical Device Systems
  • AU - Management Systems Auditing

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
  • Apply ISO 19011: 2018 concepts, new terminology and guidelines
  • Understand the types of risks and opportunities associated with auditing.
  • Understand the roles and responsibilities of the auditor
  • Conduct all phases of an internal audit adopting a risk-based approach

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, managing, or participating in first-party (internal) audits.

Prerequisite

A prior review of the ISO 13485:2016 standard is required and an understanding of auditing principles is suggested for this course. 

Class Logistics

There are written tests on each of the competency units in turn on Days 2 and 3. 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
  • Jun 01, 2020 11:30 AM - 8:30 PM
  • Jun 02, 2020 11:30 AM - 8:30 PM
  • Jun 03, 2020 11:30 AM - 8:30 PM
Live Online - Full DayUSD $1650.00Enroll
  • Jun 08, 2020 8:30 AM - 5:30 PM
  • Jun 09, 2020 8:30 AM - 6:30 PM
  • Jun 10, 2020 8:30 AM - 6:00 PM
Live Online - Full DayUSD $1650.00Enroll
  • Jun 29, 2020 8:30 AM - 5:30 PM
  • Jun 30, 2020 8:30 AM - 6:30 PM
  • Jul 01, 2020 8:30 AM - 6:00 PM
Live Online - Full DayUSD $1650.00Enroll
  • Jul 06, 2020 11:00 AM - 5:30 PM
  • Jul 07, 2020 11:00 AM - 6:30 PM
  • Jul 08, 2020 11:00 AM - 6:00 PM
Live Online - Full DayUSD $1650.00Enroll
  • 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
Live Online - Full DayUSD $1650.00Enroll
  • 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
Live Online - Full DayUSD $1650.00Enroll
  • Jul 20, 2020 9:00 AM - 5:30 PM
  • Jul 21, 2020 9:00 AM - 5:30 PM
  • Jul 22, 2020 9:00 AM - 5:30 PM
Live Online - Full DayUSD $1650.00Enroll
  • 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
Live Online - Full DayUSD $1650.00Enroll
  • 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
Live Online - Full DayUSD $1550.00*Enroll
  • 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
Live Online - Full DayUSD $1550.00*Enroll
  • 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
Live Online - Full DayUSD $1550.00*Enroll
  • 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
Live Online - Full DayUSD $1550.00*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
Dallas, TXUSD $1450.00*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
Atlanta, GAUSD $1450.00*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
San Diego, CAUSD $1450.00*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
Phoenix, AZUSD $1450.00*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
Nashville, TNUSD $1450.00*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
San José, CAUSD $1450.00*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
Minneapolis, MNUSD $1450.00*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
San Diego, CAUSD $1450.00*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
Princeton, NJUSD $1450.00*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
Salt Lake City, UTUSD $1450.00*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
Dulles, VAUSD $1450.00*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
San José, CAUSD $1450.00*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
Denver, COUSD $1450.00*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
Nashville, TNUSD $1450.00*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
Phoenix, AZUSD $1450.00*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
Seattle, WAUSD $1450.00*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
Boston, MAUSD $1450.00*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
Dallas, TXUSD $1450.00*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
San José, CAUSD $1450.00*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
Atlanta, GAUSD $1450.00*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
Salt Lake City, UTUSD $1450.00*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
Chicago, ILUSD $1450.00*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
San Diego, CAUSD $1450.00*Enroll