BS EN ISO 13485:2016+A11:2021 Lead Auditor

This ON DEMAND 32-hour e-course teaches a detailed understanding of the concepts and requirements of the ISO 13485 Medical Quality Management standard and ISO 19011 Lead Auditing and includes a certified training Certificate of Competence. 3.2 CEUs.

Buy $700.00

Course curriculum

1. How to use this course
1. ISO 13485-Lesson-02
2. ISO 13485-Lesson-01 and 02-QUIZ
1. ISO 13485-Lesson-03
2. ISO 13485-Lesson-03-QUIZ
1. ISO 13485-Lesson-04a
2. ISO 13485-Lesson-04a-QUIZ
3. ISO 13485-Lesson-04b
4. ISO 13485-Lesson-04b_QUIZ
1. Video-Summary-Leadership requirements
2. ISO 13485-Lesson-05
3. ISO 13485-Lesson-05-QUIZ
1. Video-Summary-Support requirements
2. ISO 13485-Lesson-06
3. ISO 13485-Lesson-06-QUIZ
1. Video-Summary-Planning requirements
2. ISO 13485-Lesson-07a
3. ISO 13485-Lesson-07a-QUIZ
4. ISO 13485-Lesson-07b
5. ISO 13485-Lesson-07b-QUIZ
6. ISO 13485-Lesson-07c
7. ISO 13485-Lesson-07c-QUIZ
8. ISO 13485-Lesson-07d
9. ISO 13485-Lesson-07d-QUIZ
10. ISO 13485-Lesson-07e
11. ISO 13485-Lesson-07e-QUIZ
1. ISO 13485-Lesson-08a
2. ISO 13485-Lesson-08a-QUIZ
3. ISO 13485-Lesson-08b
4. ISO 13485-Lesson-08b-QUIZ
1. ISO 13485-Lesson-09-Annex
1. ISO 19011-Lesson-01 and 02
1. ISO 19011-Lesson-03
2. ISO 19011-Lesson-03-QUIZ
1. ISO 19011-Lesson-04
2. ISO 19011-Lesson-04-QUIZ
1. ISO 19011-Lesson-05a
2. ISO 19011-Lesson-05a-QUIZ
3. ISO 19011-Lesson-05b
4. ISO 19011-Lesson-05b-QUIZ
5. ISO 19011-Lesson-05c
6. ISO 19011-Lesson-05c-QUIZ
7. ISO 19011-Lesson-05d
8. ISO 19011-Lesson-05d-QUIZ
1. ISO 19011-Lesson-06a
2. ISO 19011-Lesson-06a-QUIZ
3. ISO 19011-Lesson-06b
4. ISO 19011-Lesson-06b-QUIZ
5. ISO 19011-Lesson-06c
6. ISO 19011-Lesson-06c-QUIZ
1. ISO 19011-Lesson-07a
2. ISO 19011-Lesson-07a-QUIZ
3. ISO 19011-Lesson-07b
4. ISO 19011-Lesson-07b-QUIZ
1. ISO 19011-Lesson-Annex
2. ISO 19011-Lesson-Annex-QUIZ
1. ISO 13485-Case Studies for Auditing
2. ISO 13485-Case Study Lead Auditor-QUIZ-1
3. ISO 13485-Case Study Lead Auditor-QUIZ-2
4. ISO 13485-Case Study Lead Auditor-QUIZ-3
5. ISO 13485-Case Study Lead Auditor-QUIZ-4
6. ISO 13485-Case Study Lead Auditor-QUIZ-5
1. Audit Reference ISO 19011:2018
2. Quick Reference ISO 13485:2016
1. Congratulations

About this course

$700.00
65 lessons
0 hours of video content

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Velocity 360 USA Training | UK

BS EN ISO 13485:2016+A11:2021 Lead Auditor

Course curriculum

Welcome to the course!

Overview | Clarification of Concepts | The Process Approach

Key Terms and definitions

Quality Management System

Management Responsibility

Resource Management

Product Realization

Measurement, Analysis and Improvement

ISO 13485 - Annex

ISO 19011 Auditing - Introduction | Scope

ISO 19011 Auditing - Terms and definitions

ISO 19011 Auditing - Principles of auditing

ISO 19011 Auditing - Managing an audit programme

ISO 19011 Auditing - Conducting the audit

ISO 19011 Auditing - Competence and evaluation of auditors

ISO 19011 Auditing - Annex A

ISO 13485 - Case Studies for Auditing

Student Handouts

Next steps

About this course

Discover your potential, starting today