ISO 14971:2019 Lead Auditor [English] Exemplar Global Certif

ISO 14971:2019 Lead Auditor

This 32-hour On Demand training course teaches a detailed understanding of the concepts and requirements of the ISO 14971:2019 Medical Devices — Application of risk management to medical devices standard and the principles and practices of leading management systems audits in accordance with ISO 19011:2026 Guidelines for Auditing Management Systems. Includes a certified training Certificate of Competence. 3.2 CEUs. Language: English.

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Course curriculum

1. 1 - How to use this course
1. ISO 14971:2019 Sample Risk Management Plan
2. ISO 14971:2019 Sample Risk Management Analysis Report
1. ISO 14971_Lesson-02
2. ISO 14971_Lesson-02-QUIZ
1. ISO 14971_Lesson-03
2. ISO 14971_Lesson-03-QUIZ
1. ISO 14971_Lesson-04
2. ISO 14971_Lesson-04-QUIZ
1. ISO 14971_Lesson-05a
2. ISO 14971_Lesson-05a-QUIZ
3. ISO 14971_Lesson-05b
4. ISO 14971_Lesson-05b-QUIZ
5. ISO 14971_Lesson-05c
6. ISO 14971_Lesson-05c-QUIZ
1. ISO 14971_Lesson-06
2. ISO 14971_Lesson-06-QUIZ
1. ISO 14971_Lesson-07
2. ISO 14971_Lesson-07-QUIZ
1. ISO 14971_Lesson-08
2. ISO 14971_Lesson-08-QUIZ
1. ISO 14971_Lesson-09
2. ISO 14971_Lesson-09-QUIZ
1. ISO 14971_Lesson-10
2. ISO 14971_Lesson-10-QUIZ
1. ISO 19011:2026 Lesson 1 - Overview Video
1. ISO 19011:2026 Lesson 2 - Overview Video
2. ISO 19011:2026 Lesson 2 - Slides
3. ISO 19011:2026 Lesson 2 - Quiz
1. ISO 19011:2026 Lesson 3 - Overview Video
2. ISO 19011:2026 Lesson 3 - Slides
3. ISO 19011:2026 Lesson 3 - Quiz
1. ISO 19011:2026 Lesson 4 - Overview Video
2. ISO 19011:2026 Lesson 4 - Slides
3. ISO 19011:2026 Lesson 4 - Quiz
1. ISO 19011:2026 Lesson 5a - Overview Video
2. ISO 19011:2026 Lesson 5a - Slides
3. ISO 19011:2026 Lesson 5a - Quiz
4. ISO 19011:2026 Lesson 5b - Overview Video
5. ISO 19011:2026 Lesson 5b - Slides
6. ISO 19011:2026 Lesson 5b - Quiz
1. ISO 19011:2026 Lesson 6a - Overview Video
2. ISO 19011:2026 Lesson 6a - Slides
3. ISO 19011:2026 Lesson 6a - Quiz
4. ISO 19011:2026 Lesson 6b - Overview Video
5. ISO 19011:2026 Lesson 6b - Slides
6. ISO 19011:2026 Lesson 6b - Quiz
1. ISO 19011:2026 Lesson 7 - Overview Video
2. ISO 19011:2026 Lesson 7 - Slides
3. ISO 19011:2026 Lesson 7 - Quiz
1. ISO 19011:2026 Lesson 8 - Overview Video
2. ISO 19011:2026 Lesson 8 - Slides
3. ISO 19011:2026 Lesson 8 - Quiz
1. Exemplar Global Registration Information
1. Course Wrap-Up & Next Steps

ISO 14971:2019 Lead Auditor Exemplar Global Certified

$2,200.00
On Demand / Student-Paced
32 hours / 3.2 CEUs
English
Exemplar Global Certified

Learning Objectives

Understand quality management definitions, concepts, and guidelines for ISO 14971:2019
Know the requirements of the ISO 14971:2019 standard
Understand the process approach
Know the records required for internal and external audits
Understand audit team leader responsibilities and how to communicate effectively during the audit
Possess the skills to evaluate the competence and skills of auditors and select the audit team members
Realize the roles and responsibilities of the auditor
Be capable of conducting all phases of an audit using a risk-based approach and identifying nonconformances
Understand the requirements for planning the audit and conducting the opening and closing meetings
Know methods to prepare audit conclusions and the audit report

Certified Training

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Our certificates are secure, digitally issued, and verifiable online by any third-party, registrar, or certification body. You can easily add your credential to your LinkedIn or other social media profile.

Enroll Now $2200 CAD