Course Reviews

Amazing content | 100% online | Exceptional value

5 star rating

ISO 13485:2016 Lead Auditor

Deborah Walsh

5 star rating

easy to understand and knowledge based training program with flexibility of schedule

Ibad Tirmizi

5 star rating

ISO 13485:2016 Lead Auditor

George Gargarella

4 star rating

CFR820 GMP Requirements

rodolfo valenzuela

Great Course!

Great Course!

Read Less
5 star rating

Risk Management course review

Srirama Bhairi

4 star rating

Great Overview

Crystal Jones

Course curriculum

  • 1

    Welcome to the course!

    • How to use this course

  • 2

    Overview, Clarification of Concepts, and The Process Approach

    • ISO 13485-Lesson-02

    • ISO 13485-Lesson-01 and 02-QUIZ

  • 3

    Key Terms and definitions

    • ISO 13485-Lesson-03

    • ISO 13485-Lesson-03-QUIZ

  • 4

    Quality Management System

    • ISO 13485-Lesson-04a

    • ISO 13485-Lesson-04a-QUIZ

    • ISO 13485-Lesson-04b

    • ISO 13485-Lesson-04b_QUIZ

  • 5

    Management Responsibility

    • ISO 13485-Lesson-05

    • ISO 13485-Lesson-05-QUIZ

  • 6

    Resource Management

    • ISO 13485-Lesson-06

    • ISO 13485-Lesson-06-QUIZ

  • 7

    Product Realization

    • ISO 13485-Lesson-07a

    • ISO 13485-Lesson-07a-QUIZ

    • ISO 13485-Lesson-07b

    • ISO 13485-Lesson-07b-QUIZ

    • ISO 13485-Lesson-07c

    • ISO 13485-Lesson-07c-QUIZ

    • ISO 13485-Lesson-07d

    • ISO 13485-Lesson-07d-QUIZ

    • ISO 13485-Lesson-07e

    • ISO 13485-Lesson-07e-QUIZ

  • 8

    Measurement, Analysis and Improvement

    • ISO 13485-Lesson-08a

    • ISO 13485-Lesson-08a-QUIZ

    • ISO 13485-Lesson-08b

    • ISO 13485-Lesson-08b-QUIZ

  • 9

    ISO 19011 Auditing - Welcome, Introduction and Scope

    • ISO 19011-Lesson-01 and 02

  • 10

    ISO 19011 Auditing - Terms and definitions

    • ISO 19011-Lesson-03

    • ISO 19011-Lesson-03-QUIZ

  • 11

    ISO 19011 Auditing - Principles of auditing

    • ISO 19011-Lesson-04

    • ISO 19011-Lesson-04-QUIZ

  • 12

    ISO 19011 Auditing - Managing an audit programme

    • ISO 19011-Lesson-05a

    • ISO 19011-Lesson-05a-QUIZ

    • ISO 19011-Lesson-05b

    • ISO 19011-Lesson-05b-QUIZ

    • ISO 19011-Lesson-05c

    • ISO 19011-Lesson-05c-QUIZ

    • ISO 19011-Lesson-05d

    • ISO 19011-Lesson-05d-QUIZ

  • 13

    ISO 19011: Auditing - Conducting the audit

    • ISO 19011-Lesson-06a

    • ISO 19011-Lesson-06a-QUIZ

    • ISO 19011-Lesson-06b

    • ISO 19011-Lesson-06b-QUIZ

    • ISO 19011-Lesson-06c

    • ISO 19011-Lesson-06c-QUIZ

  • 14

    ISO 19011 Auditing - Competence and evaluation of auditors

    • ISO 19011-Lesson-07a

    • ISO 19011-Lesson-07a-QUIZ

    • ISO 19011-Lesson-07b

    • ISO 19011-Lesson-07b-QUIZ

  • 15

    ISO 19011 Auditing - Annex A

    • ISO 19011-Lesson-Annex

    • ISO 19011-Lesson-Annex-QUIZ

  • 16

    ISO 13485-Case Studies for Auditing

    • ISO 13485-Case Studies for Auditing

    • ISO 13485-Case Study Lead Auditor-QUIZ

  • 17

    Student Handouts

    • Student Handouts

  • 18

    Next steps

    • Congratulations

Learning Objectives

Upon completion of this training, students will be able to:

  • Understand medical device 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 the role of objectives, scope and criteria in the audit process

  • How to plan audits and conduct audit team selection

  • Initiate the audit and conducting opening meetings

e-Course Benefits

Amazing content | 100% online | Exceptional value

  • Eliminate travel and lodging expenses

  • Save time by attending course On Demand, anytime, anywhere, with any device

  • Learn through exercises and case study

  • Receive a globally-recognized certificate for successfully completing the course

Who should attend?

  • Quality managers and engineers or implementers within an organization seeking or maintaining registration to ISO 13485

  • Design Engineers, Process Engineers and Manufacturing Engineers

  • Lead auditors and internal auditors

ISO 13485 Lead Auditor

Get your CERTIFICATE OF COMPETENCE today!

Additional products

Training On Demand™