ISO 13485:2016 is the international standard for quality management systems in the design and manufacture of medical devices. GMI's quality management system is certified to ISO 13485:2016 by TÜV NORD Indonesia.
What the standard covers
ISO 13485 focuses on consistent, documented processes rather than on a single product. It covers:
- Document and record control
- Risk management across the product life cycle
- Supplier and material control
- Production and process validation
- Traceability, complaint handling and corrective action
Why it matters to buyers
Certification means an independent body has audited how products are designed, made and checked. For hospitals and distributors, it gives confidence that every batch follows the same controlled process.
Certification is about consistency: the same controlled process, batch after batch.
Certification is not a one-time event
Certified companies are audited regularly to keep their certificate. That ongoing review encourages continuous improvement on the production floor.
Quality at every stage
At GMI, checks are built into each step:
- Design and development
- Material selection
- In-process inspection
- Product testing
- Packaging integrity
- Safe delivery
