CQI | IRCA Certified · Course Ref. No. PR369ISO 13485 Lead Auditor Certification Online
Aim of ISO 13485 Lead Auditor Training Online
ISO 13485 is a quality management system standard that specifies requirements for a medical device quality management system. It is based on the ISO 9001 standard but has been tailored specifically for the medical device industry. The aim of the ISO 13485 Lead Auditor Certification Online is to provide delegates with the knowledge and skills required to audit a medical device quality management system against the requirements of ISO 13485.
EAS offers this ISO 13485 Lead Auditor Course Online that provides an understanding of the principles of effective quality management system auditing. Upon successful completion of the course, delegates will be able to plan, conduct, report, and follow up on audits against ISO 13485.
Who Can Attend?
The ISO 13485 Lead Auditor Training online is designed for those who wish to become certified lead auditors or internal auditors of medical device quality management systems. This includes:
- Medical device manufacturers
- Medical device suppliers
- Medical device regulatory authorities
- Medical device auditors
- ISO 13485 Internal Auditors
Learning Benefits
After completing this ISO 13485 Lead Auditor Training online course, delegates will be able to:
- Understand the principles of effective quality management system auditing
- Plan, conduct, report, and follow up on audits against ISO 13485
- Apply a risk-based approach to auditing
- Communicate effectively with auditors and audit clients
- Understand the requirements of ISO 13485 for medical device quality management systems
- Improved confidence in your ability to manage and audit a medical device quality management system
Course Content
The ISO 13485 Lead Auditor Training online course covers the following topics:
- Introduction to quality management systems
- Auditing principles and practices
- Risk-based auditing
- Medical device quality management system requirements
- The audit process
- Audit reporting
- Closing an audit
Prerequisites
Delegates should have a good understanding of the principles of quality management systems and auditing. It is also recommended that delegates have some experience in the manufacture or assessment of medical devices. Candidates should also be aware of:
- Basic knowledge of ISO auditing principles based on ISO 19011:2018 requirements
- Knowledge of ISO standards and their application in businesses
- ISO 13485 requirements
EAS offers a tutor-led virtual ISO 13485 Internal Auditor Course Online available for those who are not much aware of the above requirements but wish to learn about ISO 13485. You can also check out our self-learning method of ISO 13485 Internal Auditor Training!
Course Duration and Learning Format
Duration of Course: 5 days, 40 hours
The ISO 13485 Lead Auditor Training online will be in the format of a Virtual Classroom. Participants will receive a link to attend a Zoom Video Conference to access the course entirely online. The features of this ISO 13485 Lead Auditor Training online include:
- Zoom Video lessons led by an expert instructor
- Join live, interactive discussions with the help of a collaborative learning platform
- Offline access to learning materials and reference papers that may be downloaded
- Interaction with participants from across the world
- Real-world examples from industry experts
- Group exercises and activities to apply the concepts learned after each topic
- After each session, quizzes are offered for continuous assessment
Course Evaluation
At the end of the ISO 13485 Lead Auditor course online, individuals will have the opportunity to take an examination. An ISO 13485 Lead Auditor Course Completion Certificate will be given to candidates who pass with a score of 70% or higher on the examination.
To learn more about the ISO 13485 Lead Auditor Certification Online, please refer to the frequently asked questions.
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