ISO 13485:2016 — Medical Devices Quality Management Systems
ISO 13485 is the international standard for a quality management system specific to medical devices. It sets requirements for organizations that design, produce, install, or service medical devices, with a strong focus on regulatory compliance and risk management.
Who needs ISO 13485?
Medical device manufacturers and their suppliers, plus organizations providing design, sterilization, distribution, or servicing for medical devices.
How does ISO 13485 certification work?
A Stage 1 and Stage 2 initial audit, a three-year certificate, annual surveillance audits, and recertification in year three.
The structure of ISO 13485
- Clause 4 — Quality management system
- Clause 5 — Management responsibility
- Clause 6 — Resource management
- Clause 7 — Product realization (design, production, traceability)
- Clause 8 — Measurement, analysis, and improvement
How SWC CRM helps you manage ISO 13485 certification
Centralize device documentation
Store quality records, design and production evidence, and traceability documents in one version-controlled project workspace.
Audit to ISO 13485 requirements
Run internal and certification audits with a configurable ISO 13485 checklist, capturing evidence against each clause and requirement.
Manage CAPA with discipline
Track corrective and preventive actions (CAPA) from identification through verification and closure, with owners and reminders at every stage.
Keep certification current
Automated surveillance and recertification scheduling keeps your device QMS audit-ready throughout the three-year cycle.
Manage ISO 13485 certification in one platform
Run ISO 13485 projects, clause-by-clause audits, evidence, and renewals in SWC CRM — fully customizable to your team's workflow.
ISO 13485 certification: frequently asked questions
What is the difference between ISO 9001 and ISO 13485?
Both are quality management standards, but ISO 13485 is tailored to medical devices and regulatory requirements. Unlike ISO 9001, it places less emphasis on continual improvement and more on maintaining effective processes, documentation, and risk management for device safety.
Is ISO 13485 required for medical devices?
In most major markets, an ISO 13485-compliant quality management system is effectively required to place medical devices on the market, as it underpins regulatory approvals such as the EU MDR and is recognized by many regulators worldwide.
How long is ISO 13485 certification valid?
An ISO 13485 certificate is valid for three years, with annual surveillance audits and a recertification audit at the end of the cycle.
Related standards
New to certification? Start with our step-by-step certification guide or browse the ISO glossary.