ISO 13485 sets out quality management system requirements for organizations involved in the life cycle of medical devices. Certification gives customers and partners independent evidence that your QMS controls design, production, suppliers and post-market activities.
What Is ISO 13485?
ISO 13485:2016 specifies QMS requirements for organizations that provide medical devices and related services. It is based on ISO 9001 but places more emphasis on regulatory requirements, risk management and documentation.
Regulatory Context
ISO 13485 certification by USGSR is not a regulatory approval. It does not replace FDA clearance or inspection, EU MDR/IVDR Notified Body certification, or MDSAP audits. Confirm what your target market and customers require before applying.
Key Requirements
| Clause | Topic | In practice |
|---|---|---|
| 4 | Quality management system | Documented QMS, medical device file, document and record control |
| 5 | Management responsibility | Quality policy, objectives, management review |
| 6 | Resource management | Competence, infrastructure, work environment, contamination control |
| 7 | Product realization | Risk management, design and development, purchasing, process validation, traceability |
| 8 | Measurement and improvement | Feedback, complaints, regulatory reporting, internal audit, CAPA |
The Certification Process
- Application: share your scope, sites and headcount; we confirm the route and audit time.
- Proposal and agreement: written proposal and certification agreement.
- Stage 1 audit: documentation and readiness review.
- Stage 2 audit: on-site evaluation of implementation and effectiveness.
- Certification decision: made by a competent reviewer who was not on the audit.
- Surveillance and recertification: annual surveillance, recertification every three years.
Auditors must be competent in the relevant device technical areas; we confirm availability before quoting.
What ISO 13485 Auditors Focus On
- The medical device file and links to design and risk management.
- Design controls, transfer and changes.
- Process validation, especially sterilization.
- Supplier controls, traceability, complaints and CAPA.
FAQs
What is the difference between ISO 13485 and ISO 9001?
ISO 13485 is specific to medical devices and emphasizes regulatory requirements, risk, validation and documentation.
Does ISO 13485 certification allow us to sell devices in the EU or US?
No. Market access depends on regulatory routes such as FDA requirements or EU MDR conformity assessment.
Is ISO 13485 part of MDSAP?
MDSAP audits are based on ISO 13485 plus country-specific requirements and are carried out by recognized auditing organizations. A USGSR certificate is not an MDSAP certificate.