ISO 13485:2016 CertificationMedical Devices Quality Management
Demonstrate that your medical devices and related services consistently meet customer and regulatory requirements with ISO 13485 certification.
management system
What is ISO 13485:2016?
ISO 13485 sets quality management requirements for organisations involved in the design, production, installation, servicing and supply of medical devices. It places strong emphasis on risk management, traceability and regulatory compliance.
Who is it for?
- Medical device manufacturers
- Component and material suppliers
- Distributors and importers
- Sterilisation and service providers
Benefits of ISO 13485:2016
Patient safety
Consistent, controlled processes for safe devices.
Market access
Supports regulatory approvals in many markets.
Traceability
Clear records from design to delivery.
What ISO 13485:2016 Covers
Main areas assessed during the certification audit.
How to Get ISO 13485:2016 Certified
Application
Submit an application with details of your organisation, sites, scope and standard(s).
Quotation & agreement
We review the application, confirm audit duration and send a quotation and certification agreement.
Stage 1 audit
Review of your documentation and readiness for the Stage 2 audit.
Stage 2 audit
On‑site audit to evaluate the implementation and effectiveness of your management system.
Certification decision
Independent review of audit results and, once any non‑conformities are closed, certificate issue.
Surveillance audits
Periodic audits to confirm your system continues to meet the standard while you are certified.
Recertification
A recertification audit before your certificate expires to renew your certification.
Training for Your Team
Awareness, internal auditor and lead auditor courses for ISO 13485 and other standards.
View ISO coursesFrequently Asked Questions
It depends on your organisation’s size, complexity and readiness. After reviewing your application we will give you a clear timeline.
Certificate validity depends on the type of certification and the scheme requirements. The validity period is confirmed in your certification agreement and shown on your certificate, and certification is maintained through surveillance audits.
Yes. It can be audited together with other ISO management system standards in an integrated audit.