ISO 13485:2016 (MD QMS) Lead Auditor Course
The ISO 13485:2016 (MD QMS) Lead Auditor Course offered by OXQUAL develops professional competence in planning, conducting, reporting and managing audits of Medical Device Quality Management Systems. The programme covers ISO 13485 requirements, regulatory awareness, risk manageme...
About this qualification
The ISO 13485:2016 (MD QMS) Lead Auditor Course offered by OXQUAL develops professional competence in planning, conducting, reporting and managing audits of Medical Device Quality Management Systems. The programme covers ISO 13485 requirements, regulatory awareness, risk management, documentation, supplier controls and corrective actions.
Career-focused
Develop relevant skills and knowledge that can support your next professional step.
What you'll cover
Key topics covered in this OXQUAL programme include:
- ISO 13485:2016 Fundamentals
- Medical Device Quality Management
- ISO 13485 Clause Interpretation
- Medical Device Regulatory Awareness
- Risk-Based Quality Management
- Document and Record Control
- Product Traceability
- Supplier Evaluation
- Purchasing Controls
- Outsourced Process Monitoring
- Audit Planning
- Audit Scope and Checklists
- Audit Interviews
- Objective Evidence Collection
- Non-Conformity Reporting
- Root Cause Analysis
- Corrective-Action Verification
- Audit-Team Leadership
Who it's designed for
This OXQUAL programme is suitable for:
- Medical Device Quality-Assurance Professionals
- Medical Device Manufacturing Personnel
- Regulatory Affairs Personnel
- Compliance Officers
- Internal and External Auditors
What you'll gain
Successful completion of this OXQUAL programme can help learners to:
- Develop ISO 13485 auditing competence.
- Strengthen medical-device QMS knowledge.
- Improve regulatory-awareness skills.
- Develop supplier and documentation audit competence.
- Improve non-conformity reporting.
- Strengthen corrective-action verification.
How this qualification is assessed
The assessment pattern for this OXQUAL programme is outlined below.
- Duration: 3 hours.
- Total Marks: 100.
- Passing Criteria: Minimum 60%.
- Format: Multiple-choice questions, scenario-based audit questions, clause-interpretation exercises, non-conformity reporting tasks and practical audit case studies.
- Practical Assessment: Simulated audit planning, audit reporting and corrective-action evaluation activities may be included.
Have questions about this qualification?
Our team can help you understand the programme, assessment requirements and next steps.
Contact us