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Course Details

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

Course Area

Medical Devices

Course Duration

10 Days

Continuing Education Units

3.2

Course Fee

USD $2250.00

Upcoming Sessions
Aug 24 - Sep 3, 2020 - Live Online - Half DayEnroll
Sep 14-24, 2020 - Live Online - Half DayEnroll
Sep 28 - Oct 8, 2020 - Live Online - Half DayEnroll

View all sessions

* Subject to availability

Course Details

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

You will have the option to receive your course materials in either hard copy or soft copy:

  • Hard Copy option: You will receive a physical copy of the Student Handbook in the mail prior to the course.
  • Soft Copy option: You will receive an email prior to the course 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.

Course Logistics

  • Students need to connect to the class from any internet accessible location.
  • Webcam and Microphone are REQUIRED.
  • ALL course times shown are US EASTERN TIME.

*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 4, 6, and 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).

All Upcoming Course Dates

Date and Time Location Fees Enroll
Aug 24, 2020 2:00 PM - 6:00 PM ET
Aug 25, 2020 2:00 PM - 6:00 PM ET
Aug 26, 2020 2:00 PM - 6:00 PM ET
Aug 27, 2020 2:00 PM - 6:00 PM ET
Aug 31, 2020 2:00 PM - 6:00 PM ET
Sep 1, 2020 2:00 PM - 6:00 PM ET
Sep 2, 2020 2:00 PM - 6:00 PM ET
Sep 3, 2020 2:00 PM - 6:00 PM ET
Live Online - Half DayUSD $2350.00Enroll
Sep 14, 2020 2:30 PM - 6:30 PM ET
Sep 15, 2020 2:30 PM - 6:30 PM ET
Sep 16, 2020 2:30 PM - 6:30 PM ET
Sep 17, 2020 2:30 PM - 6:30 PM ET
Sep 21, 2020 2:30 PM - 6:30 PM ET
Sep 22, 2020 2:30 PM - 6:30 PM ET
Sep 23, 2020 2:30 PM - 6:30 PM ET
Sep 24, 2020 2:30 PM - 6:30 PM ET
Live Online - Half DayUSD $2250.00Enroll
Sep 28, 2020 9:00 AM - 1:30 PM ET
Sep 29, 2020 9:00 AM - 1:30 PM ET
Sep 30, 2020 9:00 AM - 1:30 PM ET
Oct 1, 2020 9:00 AM - 1:30 PM ET
Oct 5, 2020 9:00 AM - 1:30 PM ET
Oct 6, 2020 9:00 AM - 1:30 PM ET
Oct 7, 2020 9:00 AM - 1:30 PM ET
Oct 8, 2020 9:00 AM - 1:30 PM ET
Live Online - Half DayUSD $2350.00Enroll
Oct 19, 2020 9:00 AM - 12:00 PM ET
Oct 20, 2020 9:00 AM - 12:00 PM ET
Oct 21, 2020 9:00 AM - 12:00 PM ET
Oct 22, 2020 9:00 AM - 12:00 PM ET
Oct 23, 2020 9:00 AM - 12:00 PM ET
Oct 26, 2020 9:00 AM - 12:00 PM ET
Oct 27, 2020 9:00 AM - 12:00 PM ET
Oct 28, 2020 9:00 AM - 12:00 PM ET
Oct 29, 2020 9:00 AM - 12:00 PM ET
Oct 30, 2020 9:00 AM - 12:00 PM ET
Live Online - Half DayUSD $2350.00Enroll
Nov 9, 2020 9:00 AM - 12:00 PM ET
Nov 10, 2020 9:00 AM - 12:00 PM ET
Nov 11, 2020 9:00 AM - 12:00 PM ET
Nov 12, 2020 9:00 AM - 12:00 PM ET
Nov 13, 2020 9:00 AM - 12:00 PM ET
Nov 16, 2020 9:00 AM - 12:00 PM ET
Nov 17, 2020 9:00 AM - 12:00 PM ET
Nov 18, 2020 9:00 AM - 12:00 PM ET
Nov 19, 2020 9:00 AM - 12:00 PM ET
Nov 20, 2020 9:00 AM - 12:00 PM ET
Live Online - Half DayUSD $2350.00Enroll
Dec 7, 2020 2:00 PM - 5:00 PM ET
Dec 8, 2020 2:00 PM - 5:00 PM ET
Dec 9, 2020 2:00 PM - 5:00 PM ET
Dec 10, 2020 2:00 PM - 5:00 PM ET
Dec 11, 2020 2:00 PM - 5:00 PM ET
Dec 14, 2020 2:00 PM - 5:00 PM ET
Dec 15, 2020 2:00 PM - 5:00 PM ET
Dec 16, 2020 2:00 PM - 5:00 PM ET
Dec 17, 2020 2:00 PM - 5:00 PM ET
Dec 18, 2020 2:00 PM - 5:00 PM ET
Live Online - Half DayUSD $2350.00Enroll

The venues for scheduled courses are tentative until receipt of a course confirmation from BSI.

Live Online Classes

Certified, convenient, and interactive, with no travel costs.

Private Class

Interested in a private or customized version of this course? Request a quote.

Questions?

For questions regarding any of our courses, contact us or call 1.800.217.1390.

Questions?

For questions regarding any of our courses, contact us or call 1.800.217.1390

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