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Connected Learning Live ISO 13485:2016 Internal Auditor (TPECS)

BSI Connected Learning Live is a live, online training that combines premier skills development technologies with our expert instructors to deliver an engaging, interactive learning experience to you, regardless of location. This is an ideal alternative to the typical classroom setting for quality professionals who do not have the budget or time for travel, or just prefer the convenience of attending a class without having to leave their own personal environment.

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 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 Competency 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

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.

Course Materials:

Students will receive a BSI Connected Learning Live course Materials that will include comprehensive course manual with reference materials

Course Logistics:

Students can connect to the class from any internet-accessible location. Chrome is preferred. 

Students will require a Webcam and a Microphone. 

There are eight 3 hour sessions*, one per day. There are online exams at the end of each competency unit, which are in sessions 5, 8. Each exam is 90 minutes. Detailed exam instructions will be provided. Certificates of Attainment in each competency unit will be provided for students who are deemed "Competent" for each. Certificates of Attendance are provided to those who do not pass the competency exam(s), and students will be given the opportunity to retake the test(s).

*Session lengths could vary depending on amount of class discussion.

*****All course times shown are Eastern Time.*****

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
  • May 06, 2019 9:00 AM - 12:00 PM
  • May 07, 2019 9:00 AM - 12:00 PM
  • May 08, 2019 9:00 AM - 12:00 PM
  • May 09, 2019 9:00 AM - 12:00 PM
  • May 10, 2019 9:00 AM - 12:00 PM
  • May 13, 2019 9:00 AM - 12:00 PM
  • May 14, 2019 9:00 AM - 12:00 PM
  • May 15, 2019 9:00 AM - 12:00 PM
Live OnlineUSD $1650.00Enroll
  • Jun 03, 2019 2:00 PM - 5:00 PM
  • Jun 04, 2019 2:00 PM - 5:00 PM
  • Jun 05, 2019 2:00 PM - 5:00 PM
  • Jun 06, 2019 2:00 PM - 5:00 PM
  • Jun 07, 2019 2:00 PM - 5:00 PM
  • Jun 10, 2019 2:00 PM - 5:00 PM
  • Jun 11, 2019 2:00 PM - 5:00 PM
  • Jun 12, 2019 2:00 PM - 5:00 PM
Live OnlineUSD $1650.00Enroll
  • Jul 22, 2019 9:00 AM - 12:00 PM
  • Jul 23, 2019 9:00 AM - 12:00 PM
  • Jul 24, 2019 9:00 AM - 12:00 PM
  • Jul 25, 2019 9:00 AM - 12:00 PM
  • Jul 26, 2019 9:00 AM - 12:00 PM
  • Jul 29, 2019 9:00 AM - 12:00 PM
  • Jul 30, 2019 9:00 AM - 12:00 PM
  • Jul 31, 2019 9:00 AM - 12:00 PM
Live OnlineUSD $1650.00Enroll
  • Aug 19, 2019 2:00 PM - 5:00 PM
  • Aug 20, 2019 2:00 PM - 5:00 PM
  • Aug 21, 2019 2:00 PM - 5:00 PM
  • Aug 22, 2019 2:00 PM - 5:00 PM
  • Aug 23, 2019 2:00 PM - 5:00 PM
  • Aug 26, 2019 2:00 PM - 5:00 PM
  • Aug 27, 2019 2:00 PM - 5:00 PM
  • Aug 28, 2019 2:00 PM - 5:00 PM
Live OnlineUSD $1650.00Enroll
  • Oct 21, 2019 9:00 AM - 12:00 PM
  • Oct 22, 2019 9:00 AM - 12:00 PM
  • Oct 23, 2019 9:00 AM - 12:00 PM
  • Oct 24, 2019 9:00 AM - 12:00 PM
  • Oct 25, 2019 9:00 AM - 12:00 PM
  • Oct 28, 2019 9:00 AM - 12:00 PM
  • Oct 29, 2019 9:00 AM - 12:00 PM
  • Oct 30, 2019 9:00 AM - 12:00 PM
Live OnlineUSD $1650.00Enroll
  • Dec 09, 2019 2:00 PM - 5:00 PM
  • Dec 10, 2019 2:00 PM - 5:00 PM
  • Dec 11, 2019 2:00 PM - 5:00 PM
  • Dec 12, 2019 2:00 PM - 5:00 PM
  • Dec 13, 2019 2:00 PM - 5:00 PM
  • Dec 16, 2019 2:00 PM - 5:00 PM
  • Dec 17, 2019 2:00 PM - 5:00 PM
  • Dec 18, 2019 2:00 PM - 5:00 PM
Live OnlineUSD $1650.00Enroll