ISO Auditor Training by Standard
ISO 13485 Auditor Training
Medical devices - Quality management systems
Overview
A standard to ensure the quality and safety of medical devices in their design, manufacture, and distribution, compatible with regulatory (GMP) standards.
Target Industries
Medical device manufacturing/design, hospitals, etc.
Common Information
- Target Audience: Experienced auditors, new auditors, certification body personnel, internal auditors, consultants, etc.
- Course Structure: Theoretical lectures + Case-based workshops + Examination
- Industry Classification: Classified according to IAF codes
Course Content
- Understanding of GMP and the medical device lifecycle
- Requirements for risk management and design verification
- Case study analysis
Training Effects
- The medical device industry requires a high level of documentation, risk management, and traceability.
- Auditors must have an understanding of special processes such as design and development, sterilization, and cleanroom management.
- Requires understanding of international standards as it is a certification directly linked to entering overseas markets like CE and FDA.
