ISO 13485:2016 - LEAD AUDITOR - MEDICAL DEVICES

About Course

The ISO 13485:2016 Lead Auditor course is a specialized training program designed for professionals in the medical device industry who want to become proficient in auditing quality management systems for medical devices.

The course helps participants develop advanced auditing skills based on ISO 13485:2016 requirements, focusing on:

1. Audit planning
2. Risk assessment
3. Compliance verification
4. Quality and safety enhancement of medical devices

Learning Outcomes

After successful completion, participants will be able to:

1. Understand ISO 13485:2016 quality management principles for medical devices
2. Lead all phases of audits from planning to reporting
3. Apply auditing techniques specific to medical devices
4. Conduct risk-based audits effectively
5. Evaluate compliance of medical device quality systems
6. Communicate audit findings and recommendations
7. Support continual improvement in medical device quality management

What Will You Learn?

The course includes:

1. Introduction to ISO 13485:2016 and medical device QMS
2. Roles and responsibilities of a Lead Auditor
3. Understanding ISO 13485:2016 requirements
4. Audit planning and preparation
5. Conducting effective on-site audits
6. Risk-based audit planning
7. Documentation of audit findings
8. Non-conformity identification and root cause analysis
9. Corrective and preventive action planning
10. Audit reporting and improvement recommendations
11. Managing audit teams and audit programs
12. Continuous improvement in medical device quality audits

Evaluation Criteria

Assessment may include:

1. Written exams and assignments
2. Participation in discussions and case studies
3. Practical exercises and role-play scenarios
4. Performance in written assessments

Entry Criteria

Participants should have:

1. Good understanding of quality management principles
2. Knowledge of auditing practices and standards
3. Prior experience in quality management, auditing, or medical devices is recommended

Duration

1. Recommended Study Duration: 7 Days

Organization Information

IRBA states that it is a non-profit organization supporting:

1. Auditors
2. Trainers
3. Certification bodies
4. Educational institutions