ISO 13485
Medical devices - Quality management systems
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Framework Domains (5)
ISO 13485: Administrative Safeguards
Organizational security management (ISO 13485)
| Code | Title |
|---|---|
| ISO13485-06 | Security management process and risk analysis |
| ISO13485-07 | Workforce security and clearance procedures |
| ISO13485-08 | Information access management |
| ISO13485-09 | Security awareness and training program |
| ISO13485-10 | Contingency planning for ePHI |
| ISO13485-11 | Business associate management |
ISO 13485: Organizational Requirements
Policies, procedures, and documentation (ISO 13485)
| Code | Title |
|---|---|
| ISO13485-21 | Security and privacy policies |
| ISO13485-22 | Documentation and record retention |
| ISO13485-23 | Compliance evaluation and review |
| ISO13485-24 | Incident reporting procedures |
ISO 13485: Patient Data Protection
Safeguarding protected health information (ISO 13485)
| Code | Title |
|---|---|
| ISO13485-01 | ePHI access controls and authorization |
| ISO13485-02 | ePHI encryption at rest and in transit |
| ISO13485-03 | Minimum necessary standard enforcement |
| ISO13485-04 | Patient data de-identification procedures |
| ISO13485-05 | Audit trail for ePHI access |
ISO 13485: Physical Safeguards
Physical security for systems with ePHI (ISO 13485)
| Code | Title |
|---|---|
| ISO13485-17 | Facility access controls |
| ISO13485-18 | Workstation security and use policies |
| ISO13485-19 | Device and media controls |
| ISO13485-20 | Disposal and re-use procedures |
ISO 13485: Technical Safeguards
Technical measures for ePHI protection (ISO 13485)
| Code | Title |
|---|---|
| ISO13485-12 | Unique user identification and authentication |
| ISO13485-13 | Automatic logoff and session management |
| ISO13485-14 | Audit controls and monitoring |
| ISO13485-15 | Integrity controls for ePHI |
| ISO13485-16 | Transmission security and encryption |
Maps to 547 other frameworks
Frequently Asked Questions
What is ISO 13485?
ISO 13485 is a compliance framework from International with 5 domains and 24 controls. Medical devices - Quality management systems It is used by organisations to establish and maintain compliance with industry standards and regulatory requirements.
How many controls does ISO 13485 have?
ISO 13485 has 24 controls organised across 5 domains. The largest domains are ISO 13485: Administrative Safeguards (6 controls), ISO 13485: Patient Data Protection (5 controls), ISO 13485: Technical Safeguards (5 controls). Each control defines specific requirements that organisations must implement to achieve compliance.
What frameworks does ISO 13485 map to?
ISO 13485 maps to 547 other compliance frameworks. The top mapping partners are FDA 21 CFR Part 11 (50% coverage), NIS2 Directive Implementing Acts (50% coverage), UK Telecommunications (Security) Act 2021 (50% coverage). Use our comparison tool to explore control-level mappings between frameworks.
How do I get started with ISO 13485 compliance?
Start your ISO 13485 compliance journey by running a self-assessment on our platform to identify your current compliance posture. Our AI advisory can answer specific questions about ISO 13485 requirements, and cross-framework mapping helps you leverage existing controls from other frameworks you may already comply with. Create a free account to access all 24 controls and track your progress.
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