ISO 13485:2016 Awareness & Internal Audit Online
| Location | : Arrowhead Consulting |
| Date | : 3-4 August 2026 |
| Duration | : 2 Days |
| Investment | : IDR. 1,500,000 / person |
Objective
To provide delegates with a thorough understanding of:
- Implementation Methodology & Requirements of ISO 13485:2016
- Documentation Required by ISO 13485:2016
Course Description
- Medical Devices Quality Management Concept
- Background & Benefits of ISO 13485
- Risk Management (based on ISO 14971)
- Implementation Methodology
- Regulation and Legal compliance
- Quality Policy
- Responsibility and Authority
- Management Review
- Advisory Notice and Technical File
- DMR (Device Master Record)
- Installation and Servicing Activities
- Cleanliness of Product
- Identification and Traceability
- Sterile Medical Devices
- Customer Property and Preservation of Product
- Work environment and Infrastructure
- Non-conformity Product and Complain Handling
- Feedback, Identification and Traceability
- Data Analysis and Continual Improvement
- Inspection and Test
- Training and Servicing
- Internal Audit
- Corrective and Preventive Action
- Continual Improvement
