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Course Details

ISO 13485:2016 Internal Auditor (TPECS)

Course Area

Medical Devices

Course Duration

3 Days

Continuing Education Units

2.4

Course Fee

CAD $1450.00

Early Bird Price*

CAD $1350.00

Upcoming Sessions
Aug 17-19, 2020 - Live Online - Full DayEnroll
Aug 24-26, 2020 - Live Online - Full DayEnroll
Sep 8-10, 2020 - Live Online - Full DayEnroll

View all sessions

* Subject to availability

Course Details

BSI’s “ISO 13485:2016 Internal Quality Systems Auditor” competency-based 3-day course teaches a general understanding of the concepts of the ISO 13485:2016 standard and the principles and practices of effective internal 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 internal audits that are required for a quality management system based on ISO 13485:2016. Our instructors will help you to boost your audit capabilities with the latest development of the 19011 standard, Students gain necessary auditing skills through a balance of formal classroom tutorials, practical role-playing, group workshops, and open forum discussions.

This course comprises the following two Exemplar Global TPECS Competency Units whose outcomes are certified by Exemplar Global:

·         MD –Medical Device Systems

·         AU – Management Systems Auditing

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

          Apply ISO 19011:2018 concepts, new terminology and guidelines

          Understand the types of risks and opportunities associated with auditing

·         Understand the roles and responsibilities of the auditor

          Conduct all phases of an internal audit adopting a risk-based approach

Course Materials

Students receive comprehensive course manuals with reference materials.

Who Should Attend

·         Individuals interested in conducting, managing, or participating in first-party (internal) audits

Prerequisite

A prior review of the ISO 13485:2016 standard is required and an understanding of auditing principles is suggested for this course.

Class Logistics

There are written tests on each of the competency units in turn on Days 2 and 3. 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
Live Online - Full DayCAD $1550.00Enroll
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
Live Online - Full DayCAD $1550.00Enroll
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
Live Online - Full DayCAD $1450.00Enroll
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
Live Online - Full DayCAD $1450.00Enroll
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
Live Online - Full DayCAD $1450.00Enroll
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
Live Online - Full DayCAD $1450.00Enroll
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
Montréal, QuebecCAD $1450.00Enroll
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
Vancouver, BCCAD $1450.00Enroll
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
Toronto, ONCAD $1450.00Enroll
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
Ottawa, ONCAD $1450.00Enroll
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
Vancouver, BCCAD $1450.00Enroll
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
Toronto, ONCAD $1450.00Enroll
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
Montréal, QuebecCAD $1450.00Enroll

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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