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Connected Learning Live ISO 13485:2016 Lead 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 Lead Auditor” competency-based 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. 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, 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 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
  • Understand the roles and responsibilities of the auditor
  • Apply ISO 19011:2018 concepts, new terminology and guidelines
  • Recognize the principles, practices, and types of audits
  • Conduct all phases of an audit adopting a risk-based approach
  • 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

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. 

Course Materials:

Students will receive a BSI Connected Learning Live course kit 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. 

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 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.

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

There are ten 3 hour sessions*, one per day. There are online exams at the end of each competency unit, which are in sessions 5, 8, and 10. 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).

*****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
  • 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
  • Dec 19, 2019 2:00 PM - 5:00 PM
  • Dec 20, 2019 2:00 PM - 5:00 PM
Live OnlineUSD $2350.00Enroll
  • Jan 06, 2020 2:00 PM - 5:00 PM
  • Jan 07, 2020 2:00 PM - 5:00 PM
  • Jan 08, 2020 2:00 PM - 5:00 PM
  • Jan 09, 2020 2:00 PM - 5:00 PM
  • Jan 10, 2020 2:00 PM - 5:00 PM
  • Jan 13, 2020 2:00 PM - 5:00 PM
  • Jan 14, 2020 2:00 PM - 5:00 PM
  • Jan 15, 2020 2:00 PM - 5:00 PM
  • Jan 16, 2020 2:00 PM - 5:00 PM
  • Jan 17, 2020 2:00 PM - 5:00 PM
Live OnlineUSD $2350.00Enroll
  • Feb 03, 2020 2:00 PM - 5:00 PM
  • Feb 04, 2020 2:00 PM - 5:00 PM
  • Feb 05, 2020 2:00 PM - 5:00 PM
  • Feb 06, 2020 2:00 PM - 5:00 PM
  • Feb 07, 2020 2:00 PM - 5:00 PM
  • Feb 10, 2020 2:00 PM - 5:00 PM
  • Feb 11, 2020 2:00 PM - 5:00 PM
  • Feb 12, 2020 2:00 PM - 5:00 PM
  • Feb 13, 2020 2:00 PM - 5:00 PM
  • Feb 14, 2020 2:00 PM - 5:00 PM
Live OnlineUSD $2350.00Enroll
  • Mar 02, 2020 2:00 PM - 5:00 PM
  • Mar 03, 2020 2:00 PM - 5:00 PM
  • Mar 04, 2020 2:00 PM - 5:00 PM
  • Mar 05, 2020 2:00 PM - 5:00 PM
  • Mar 06, 2020 2:00 PM - 5:00 PM
  • Mar 09, 2020 2:00 PM - 5:00 PM
  • Mar 10, 2020 2:00 PM - 5:00 PM
  • Mar 11, 2020 2:00 PM - 5:00 PM
  • Mar 12, 2020 2:00 PM - 5:00 PM
  • Mar 13, 2020 2:00 PM - 5:00 PM
Live OnlineUSD $2350.00Enroll
  • Mar 16, 2020 9:00 AM - 12:00 PM
  • Mar 17, 2020 9:00 AM - 12:00 PM
  • Mar 18, 2020 9:00 AM - 12:00 PM
  • Mar 19, 2020 9:00 AM - 12:00 PM
  • Mar 20, 2020 9:00 AM - 12:00 PM
  • Mar 23, 2020 9:00 AM - 12:00 PM
  • Mar 24, 2020 9:00 AM - 12:00 PM
  • Mar 25, 2020 9:00 AM - 12:00 PM
  • Mar 26, 2020 9:00 AM - 12:00 PM
  • Mar 27, 2020 9:00 AM - 12:00 PM
Live OnlineUSD $2350.00Enroll
  • Mar 30, 2020 2:00 PM - 5:00 PM
  • Mar 31, 2020 2:00 PM - 5:00 PM
  • Apr 01, 2020 2:00 PM - 5:00 PM
  • Apr 02, 2020 2:00 PM - 5:00 PM
  • Apr 03, 2020 2:00 PM - 5:00 PM
  • Apr 06, 2020 2:00 PM - 5:00 PM
  • Apr 07, 2020 2:00 PM - 5:00 PM
  • Apr 08, 2020 2:00 PM - 5:00 PM
  • Apr 09, 2020 2:00 PM - 5:00 PM
  • Apr 10, 2020 2:00 PM - 5:00 PM
Live OnlineUSD $2350.00Enroll
  • Apr 20, 2020 2:00 PM - 5:00 PM
  • Apr 21, 2020 2:00 PM - 5:00 PM
  • Apr 22, 2020 2:00 PM - 5:00 PM
  • Apr 23, 2020 2:00 PM - 5:00 PM
  • Apr 24, 2020 2:00 PM - 5:00 PM
  • Apr 27, 2020 2:00 PM - 5:00 PM
  • Apr 28, 2020 2:00 PM - 5:00 PM
  • Apr 29, 2020 2:00 PM - 5:00 PM
  • Apr 30, 2020 2:00 PM - 5:00 PM
  • May 01, 2020 2:00 PM - 5:00 PM
Live OnlineUSD $2350.00Enroll
  • May 04, 2020 9:00 AM - 12:00 PM
  • May 05, 2020 9:00 AM - 12:00 PM
  • May 06, 2020 9:00 AM - 12:00 PM
  • May 07, 2020 9:00 AM - 12:00 PM
  • May 08, 2020 9:00 AM - 12:00 PM
  • May 11, 2020 9:00 AM - 12:00 PM
  • May 12, 2020 9:00 AM - 12:00 PM
  • May 13, 2020 9:00 AM - 12:00 PM
  • May 14, 2020 9:00 AM - 12:00 PM
  • May 15, 2020 9:00 AM - 12:00 PM
Live OnlineUSD $2350.00Enroll
  • May 18, 2020 9:00 AM - 12:00 PM
  • May 19, 2020 9:00 AM - 12:00 PM
  • May 20, 2020 9:00 AM - 12:00 PM
  • May 21, 2020 9:00 AM - 12:00 PM
  • May 22, 2020 9:00 AM - 12:00 PM
  • May 25, 2020 9:00 AM - 12:00 PM
  • May 26, 2020 9:00 AM - 12:00 PM
  • May 27, 2020 9:00 AM - 12:00 PM
  • May 28, 2020 9:00 AM - 12:00 PM
  • May 29, 2020 9:00 AM - 12:00 PM
Live OnlineUSD $2350.00Enroll
  • Jun 01, 2020 2:00 PM - 5:00 PM
  • Jun 02, 2020 2:00 PM - 5:00 PM
  • Jun 03, 2020 2:00 PM - 5:00 PM
  • Jun 04, 2020 2:00 PM - 5:00 PM
  • Jun 05, 2020 2:00 PM - 5:00 PM
  • Jun 08, 2020 2:00 PM - 5:00 PM
  • Jun 09, 2020 2:00 PM - 5:00 PM
  • Jun 10, 2020 2:00 PM - 5:00 PM
  • Jun 11, 2020 2:00 PM - 5:00 PM
  • Jun 12, 2020 2:00 PM - 5:00 PM
Live OnlineUSD $2350.00Enroll
  • Jun 15, 2020 2:00 PM - 5:00 PM
  • Jun 16, 2020 2:00 PM - 5:00 PM
  • Jun 17, 2020 2:00 PM - 5:00 PM
  • Jun 18, 2020 2:00 PM - 5:00 PM
  • Jun 19, 2020 2:00 PM - 5:00 PM
  • Jun 22, 2020 2:00 PM - 5:00 PM
  • Jun 23, 2020 2:00 PM - 5:00 PM
  • Jun 24, 2020 2:00 PM - 5:00 PM
  • Jun 25, 2020 2:00 PM - 5:00 PM
  • Jun 26, 2020 2:00 PM - 5:00 PM
Live OnlineUSD $2350.00Enroll