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

The class is not currently available.

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. 

*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
  • Sep 23, 2019 2:00 PM - 5:00 PM
  • Sep 24, 2019 2:00 PM - 5:00 PM
  • Sep 25, 2019 2:00 PM - 5:00 PM
  • Sep 26, 2019 2:00 PM - 5:00 PM
  • Sep 27, 2019 2:00 PM - 5:00 PM
  • Sep 30, 2019 2:00 PM - 5:00 PM
  • Oct 01, 2019 2:00 PM - 5:00 PM
  • Oct 02, 2019 2:00 PM - 5:00 PM
  • Oct 03, 2019 2:00 PM - 5:00 PM
  • Oct 04, 2019 2:00 PM - 5:00 PM
Live OnlineUSD $2350.00Enroll
  • 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
  • Oct 31, 2019 9:00 AM - 12:00 PM
  • Nov 01, 2019 9:00 AM - 12:00 PM
Live OnlineUSD $2350.00Enroll
  • Nov 11, 2019 2:00 PM - 5:00 PM
  • Nov 12, 2019 2:00 PM - 5:00 PM
  • Nov 13, 2019 2:00 PM - 5:00 PM
  • Nov 14, 2019 2:00 PM - 5:00 PM
  • Nov 15, 2019 2:00 PM - 5:00 PM
  • Nov 18, 2019 2:00 PM - 5:00 PM
  • Nov 19, 2019 2:00 PM - 5:00 PM
  • Nov 20, 2019 2:00 PM - 5:00 PM
  • Nov 21, 2019 2:00 PM - 5:00 PM
  • Nov 22, 2019 2:00 PM - 5:00 PM
Live OnlineUSD $2350.00Enroll
  • 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
  • Dec 19, 2019 2:00 PM - 5:00 PM
  • Dec 20, 2019 2:00 PM - 5:00 PM
Live OnlineUSD $2350.00Enroll