Description
Why should you attend?
This ISO 13485:2016 Lead Auditor course equips professionals with the expertise to assess and improve medical device Quality Management Systems (QMS) while ensuring compliance with global regulatory standards like FDA and EU MDR. Participants gain advanced auditing skills, enabling them to identify risks, address non-conformities, and drive continual improvement. This certification enhances career opportunities, establishes credibility, and supports organizational growth by ensuring consistent product quality and safety. Globally recognized, this course fosters efficient processes, effective risk management, and alignment with industry best practices, making it invaluable for professionals in the medical device sector.
This training course has been officially recognized by Exemplar Global as fully meeting the training requirements for ISO 13485:2016 Lead Auditor personnel certification.
Who should attend?
This training course is intended for:
- Quality managers and engineers
- Regulatory Affairs professionals
- Internal and external auditors
- Consultants
- Medical device manufacturers
- Aspiring auditors
- Suppliers to medical device companies
Learning objectives
This course enables you to:
- Gain a comprehensive understanding of the ISO 13485:2016 standard and its application in medical device Quality Management Systems.
- Master auditing principles and techniques including audit planning, execution, reporting, and follow-up.
- Acquire the skills to lead, manage, and coordinate internal and external audit teams.
- Learn how to establish audit objectives, determine scope, and manage audit programs.
- Develop the ability to identify non-conformities, assess risks, and provide effective corrective action recommendations.
- Understand how to assess risk as part of the audit process and ensure it is effectively addressed in the QMS.
- Learn to evaluate and audit risk management processes critical to medical device manufacturing and compliance.
- Enhance communication and reporting skills.
- Drive continual improvement by learning how to align audit findings with organizational goals for improved quality and compliance.
- Meet certification requirements.
Educational approach
This training course:
- Utilizes varied teaching methods, including role-playing.
- Emphasizes active listening, to ensure that participants have the opportunity to engage in meaningful dialogue and actively absorb the information provided.
- Facilitates interaction between participants and with the instructor.
- Incorporates a major concept focus, presenting essential terminology in order to facilitate a clear and concise understanding of the subject matter.
Class Format(s)
Instructor-led (live in-person, virtual)
Certification(s)
Upon successful completion of This trainer’s ISO 13485:2016 Lead Auditor training, including the accompanying examinations, participants are awarded an Exemplar Global Certification for the corresponding This trainer training units.
Content Style
Lecture and Workshop
Project/Actual Training Days
4 days
Provider Additional Information
Participants who successfully complete this course can use these certifications as credits towards ISO 14001 Auditor qualifications and other similar standards.
