ISO 13485 Certification
Demonstrate a quality management system fit for medical-device regulation.
Service overview
ISO 13485 specifies requirements for a quality management system where an organisation must demonstrate its ability to provide medical devices that meet customer and regulatory requirements.
AXIOS assessors with medical-device competence review your design controls, risk management and regulatory alignment across the product lifecycle.
Who needs this service
- Medical-device manufacturers and designers
- Suppliers and service providers to the device industry
- Organisations entering regulated healthcare markets
Benefits
- Evidence of a regulation-ready quality system
- Smoother access to regulated markets
- Stronger control of design and production risk
- Confidence for regulators and healthcare customers
What is ISO 13485?
ISO 13485 specifies the requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements.
It is the globally recognised QMS standard for the medical-device sector and underpins regulatory approval in many markets.
Official standard: iso.org →
Benefits of certification
- ✓A recognised basis for medical-device regulatory compliance
- ✓Stronger control of risk across the product lifecycle
- ✓Confidence for customers, partners and regulators
- ✓Improved traceability and documentation discipline
- ✓Easier market access in regulated jurisdictions
Steps to certification
- 1
Application & proposal
You complete a quote request so AXIOS can understand your organisation and define the scope of assessment, then receive a tailored certification proposal.
- 2
Two-stage initial audit
A Stage 1 readiness review is followed by a Stage 2 assessment of your management system in operation. Your system should have run for at least three months with a management review and a full internal-audit cycle.
- 3
Decision & certification
After a successful Stage 2 and an independent certification decision, AXIOS issues your certificate — valid for three years and maintained through annual surveillance audits and a recertification audit in year three.
Frequently asked questions
How is it different from ISO 9001?
ISO 13485 is tailored to medical devices, with greater emphasis on regulatory requirements, risk management, traceability and documentation; it does not follow the Annex SL structure.
Who needs ISO 13485?
Manufacturers and suppliers across the medical-device lifecycle, including design, production, storage, distribution and servicing.
Does it guarantee regulatory approval?
No, but it provides the QMS foundation that most medical-device regulations require.
How long is it valid?
Three years, with annual surveillance and a year-three recertification audit.
Official reference
Read the full ISO 13485 article and buy the standard on the International Organization for Standardization (ISO) website.
View ISO 13485 on iso.org →Talk to AXIOS about ISO 13485 Certification
Our specialists will help you choose the right scope and plan a clear path to certification or assessment.