Internal Auditor
3 Days
ISO 13485 Internal Auditor
A training programme building internal audit capacity for medical device manufacturers.
Duration
3 Days
Certificate
Exemplar Global
Format
Classroom / Online
Modules
3 Modules
Who Is This Course For?
Quality assurance officers
Production managers
Internal auditors
Regulatory affairs teams
Course Content
A comprehensive, modular curriculum designed for practical application
Module 1: ISO 13485 Requirements
- Design controls
- Production validation
- CAPA management
Module 2: Internal Audit
- Audit planning
- Clean room auditing
- Documentation control
Module 3: Reporting
- Finding classification
- Regulatory compliance reporting
- Improvement tracking
Certification
The ISO 13485 Internal Auditor certificate qualifies you to independently audit your medical device quality system.
Medical device internal audit competence
Regulatory requirements knowledge
Risk management
Patient safety contribution
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