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Course Details

ISO 13485:2016 Lead Auditor (TPECS)

Course Area

Medical Devices

Course Duration

4 Days

Continuing Education Units

3.2

Course Fee

CAD $2150.00

Early Bird Price*

CAD $2050.00

Upcoming Sessions
Aug 17-20, 2020 - Live Online - Full DayEnroll
Aug 24-27, 2020 - Live Online - Full DayEnroll
Sep 8-11, 2020 - Live Online - Full DayEnroll

View all sessions

* Subject to availability

Course Details

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 19011:2018, “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. Our instructors will also help you to boost your audit capabilities with the lates 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 Attainment for each of Exemplar Global Competency Units listed above.

New to TPECS? For more information, please see ourUnderstanding the TPECS Course Structure page.

Learning Objectives

·         Understand quality management definitions, concepts, and guidelines        

·         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

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. 

Class Logistics

There are written tests on each of the competency units in turn on Days 2, 3 and 4. Detailed exam instructions will be provided. Certificates of Attainment in each competency unit will be provided for students who are deemed “Competent” for each competency unit. Certificates of attendance are provided to those who do not pass the competency test(s), and students will be given the opportunity to retake the test(s).

All Upcoming Course Dates

Date and Time Location Fees Enroll
Aug 17, 2020 9:00 AM - 5:30 PM ET
Aug 18, 2020 9:00 AM - 5:30 PM ET
Aug 19, 2020 9:00 AM - 5:30 PM ET
Aug 20, 2020 9:00 AM - 5:30 PM ET
Live Online - Full DayCAD $2250.00Enroll
Aug 24, 2020 11:00 AM - 8:30 PM ET
Aug 25, 2020 11:00 AM - 8:30 PM ET
Aug 26, 2020 11:00 AM - 8:30 PM ET
Aug 27, 2020 11:00 AM - 8:30 PM ET
Live Online - Full DayCAD $2250.00Enroll
Sep 8, 2020 9:00 AM - 5:30 PM ET
Sep 9, 2020 9:00 AM - 5:30 PM ET
Sep 10, 2020 9:00 AM - 5:30 PM ET
Sep 11, 2020 9:00 AM - 5:30 PM ET
Live Online - Full DayCAD $2150.00Enroll
Sep 14, 2020 11:00 AM - 8:30 PM ET
Sep 15, 2020 11:00 AM - 8:30 PM ET
Sep 16, 2020 11:00 AM - 8:30 PM ET
Sep 17, 2020 11:00 AM - 8:30 PM ET
Live Online - Full DayCAD $2150.00Enroll
Sep 21, 2020 9:00 AM - 5:30 PM ET
Sep 22, 2020 9:00 AM - 5:30 PM ET
Sep 23, 2020 9:00 AM - 5:30 PM ET
Sep 24, 2020 9:00 AM - 5:30 PM ET
Live Online - Full DayCAD $2150.00Enroll
Sep 28, 2020 11:00 AM - 8:30 PM ET
Sep 29, 2020 11:00 AM - 8:30 PM ET
Sep 30, 2020 11:00 AM - 8:30 PM ET
Oct 1, 2020 11:00 AM - 8:30 PM ET
Live Online - Full DayCAD $2150.00Enroll
Oct 13, 2020 8:00 AM - 5:30 PM
Oct 14, 2020 8:00 AM - 6:30 PM
Oct 15, 2020 8:00 AM - 6:00 PM
Oct 16, 2020 8:00 AM - 4:00 PM
Montréal, QuebecCAD $2150.00Enroll
Oct 19, 2020 8:00 AM - 5:30 PM
Oct 20, 2020 8:00 AM - 6:30 PM
Oct 21, 2020 8:00 AM - 6:00 PM
Oct 22, 2020 8:00 AM - 4:00 PM
Vancouver, BCCAD $2150.00Enroll
Nov 2, 2020 8:00 AM - 5:30 PM
Nov 3, 2020 8:00 AM - 6:30 PM
Nov 4, 2020 8:00 AM - 6:00 PM
Nov 5, 2020 8:00 AM - 4:00 PM
Toronto, ONCAD $2150.00Enroll
Nov 9, 2020 8:00 AM - 5:30 PM
Nov 10, 2020 8:00 AM - 6:30 PM
Nov 11, 2020 8:00 AM - 6:00 PM
Nov 12, 2020 8:00 AM - 4:00 PM
Ottawa, ONCAD $2150.00Enroll
Nov 16, 2020 8:00 AM - 5:30 PM
Nov 17, 2020 8:00 AM - 6:30 PM
Nov 18, 2020 8:00 AM - 6:00 PM
Nov 19, 2020 8:00 AM - 4:00 PM
Vancouver, BCCAD $2150.00Enroll
Dec 7, 2020 8:00 AM - 5:30 PM
Dec 8, 2020 8:00 AM - 6:30 PM
Dec 9, 2020 8:00 AM - 6:00 PM
Dec 10, 2020 8:00 AM - 4:00 PM
Toronto, ONCAD $2150.00Enroll
Dec 14, 2020 8:00 AM - 5:30 PM
Dec 15, 2020 8:00 AM - 6:30 PM
Dec 16, 2020 8:00 AM - 6:00 PM
Dec 17, 2020 8:00 AM - 4:00 PM
Montréal, QuebecCAD $2150.00Enroll

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

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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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