Standard
ISO 13485:2016
Medical Devices Quality
The QMS standard for medical devices — aligned to global regulator expectations.
Benefits
- Regulatory alignment (FDA, MDR, IVDR)
- Product-safety assurance
- Design-controls discipline
- Supplier control
- Post-market surveillance
Requirements
- Design & development controls
- Sterile & clean products
- Risk management (ISO 14971)
- Complaint handling
- Regulatory reporting
- Corrective & preventive action
Certification process
- 01Application & scope
- 02Auto eligibility & mandays
- 03Documented information review
- 04Stage 1 readiness audit
- 05Corrective actions
- 06Stage 2 audit
- 07Independent decision
- 08Certificate issued
- 09Annual surveillance
- 10Recertification (Year 3)
Frequently asked questions
- How long does certification take?Typically 6–12 weeks depending on scope, sites and readiness.
- Is the certificate globally recognised?Yes — under the IAF Multilateral Recognition Arrangement.
- Can we transfer an existing certificate?Yes — see /certification/transfer-certification.
- Do you provide the standard document?No — IREA does not distribute ISO standards; buy from ISO/national body.