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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 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, “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. 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 definitions, concepts, and guidelines
  • Recognize the principles, practices, and types of audits
  • Conduct all phases of an internal audit
  • 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
  • Conduct on-site activities
  • Prepare audit conclusions
  • Conduct closing meetings
  • Report audit results

Course Materials:

Students receive comprehensive course manuals with reference materials.

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:

  • Course kit instructions
  • LogitechTM headphone set with microphone
  • LogitechTM high-definition web cam
  • Comprehensive course manual with reference materials
  • Contact information for technical support

Course Logistics:

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

*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 10, 2018 2:00 PM - 5:00 PM
  • Sep 11, 2018 2:00 PM - 5:00 PM
  • Sep 12, 2018 2:00 PM - 5:00 PM
  • Sep 13, 2018 2:00 PM - 5:00 PM
  • Sep 14, 2018 2:00 PM - 5:00 PM
  • Sep 17, 2018 2:00 PM - 5:00 PM
  • Sep 18, 2018 2:00 PM - 5:00 PM
  • Sep 19, 2018 2:00 PM - 5:00 PM
  • Sep 20, 2018 2:00 PM - 5:00 PM
  • Sep 21, 2018 2:00 PM - 5:00 PM
Live OnlineUSD $2350.00Enroll
  • Oct 15, 2018 9:00 AM - 12:00 PM
  • Oct 16, 2018 9:00 AM - 12:00 PM
  • Oct 17, 2018 9:00 AM - 12:00 PM
  • Oct 18, 2018 9:00 AM - 12:00 PM
  • Oct 19, 2018 9:00 AM - 12:00 PM
  • Oct 22, 2018 9:00 AM - 12:00 PM
  • Oct 23, 2018 9:00 AM - 12:00 PM
  • Oct 24, 2018 9:00 AM - 12:00 PM
  • Oct 25, 2018 9:00 AM - 12:00 PM
  • Oct 26, 2018 9:00 AM - 12:00 PM
Live OnlineUSD $2350.00Enroll
  • Oct 29, 2018 9:00 AM - 12:00 PM
  • Oct 30, 2018 9:00 AM - 12:00 PM
  • Oct 31, 2018 9:00 AM - 12:00 PM
  • Nov 01, 2018 9:00 AM - 12:00 PM
  • Nov 02, 2018 9:00 AM - 12:00 PM
  • Nov 05, 2018 9:00 AM - 12:00 PM
  • Nov 06, 2018 9:00 AM - 12:00 PM
  • Nov 07, 2018 9:00 AM - 12:00 PM
  • Nov 08, 2018 9:00 AM - 12:00 PM
  • Nov 09, 2018 9:00 AM - 12:00 PM
Live OnlineUSD $2350.00Enroll
  • Nov 26, 2018 2:00 PM - 5:00 PM
  • Nov 27, 2018 2:00 PM - 5:00 PM
  • Nov 28, 2018 2:00 PM - 5:00 PM
  • Nov 29, 2018 2:00 PM - 5:00 PM
  • Nov 30, 2018 2:00 PM - 5:00 PM
  • Dec 03, 2018 2:00 PM - 5:00 PM
  • Dec 04, 2018 2:00 PM - 5:00 PM
  • Dec 05, 2018 2:00 PM - 5:00 PM
  • Dec 06, 2018 2:00 PM - 5:00 PM
  • Dec 07, 2018 2:00 PM - 5:00 PM
Live OnlineUSD $2350.00Enroll