ISO 27032
Guidelines for Internet cybersecurity and stakeholder collaboration
ISO 13485
International standard for medical device quality management systems
Quick Verdict
ISO 27032 offers voluntary cybersecurity guidelines for internet ecosystems, fostering collaboration across stakeholders. ISO 13485 mandates certifiable QMS for medical devices, ensuring regulatory compliance and patient safety. Organizations adopt them for cyber resilience and market access respectively.
ISO 27032
ISO/IEC 27032:2023 Cybersecurity – Guidelines for Internet Security
Key Features
- Multi-stakeholder collaboration for cyberspace security
- Guidelines focused on Internet security threats
- Annex mapping to ISO 27002 controls
- Risk assessment for ecosystem dependencies
- Emphasis on incident response coordination
ISO 13485
ISO 13485:2016 Medical devices Quality management systems
Key Features
- Risk-based QMS processes and controls
- Design development verification and validation
- Post-market surveillance and complaint handling
- Supplier evaluation monitoring and auditing
- Process validation and product traceability
Detailed Analysis
A comprehensive look at the specific requirements, scope, and impact of each standard.
ISO 27032 Details
What It Is
ISO/IEC 27032:2023 is an international guidance standard titled Cybersecurity – Guidelines for Internet Security. It provides non-certifiable recommendations for managing Internet security risks in interconnected ecosystems, emphasizing multi-stakeholder collaboration. Its risk-based approach integrates with standards like ISO/IEC 27001.
Key Components
- Core pillars: stakeholder roles, risk assessment, incident management, technical/organizational controls.
- Annex A maps threats to ISO/IEC 27002's 93 controls.
- Built on PDCA cycle and cyberspace layers (technical, informational, human).
- No certification; voluntary integration into ISMS.
Why Organizations Use It
- Reduces ecosystem risks, shortens incident dwell time.
- Enhances regulatory alignment (e.g., NIS2, GDPR intersections).
- Builds trust, competitive edge via resilience.
- Streamlines audits, lowers costs through framework synergy.
Implementation Overview
- Phased: gap analysis, risk modeling, controls deployment, monitoring.
- Targets all sizes, especially online/ critical infrastructure operators.
- Cross-functional teams, training, exercises; ongoing audits for improvement.
ISO 13485 Details
What It Is
ISO 13485:2016 is the international standard titled Medical devices — Quality management systems — Requirements for regulatory purposes. It provides a certifiable framework for organizations to demonstrate consistent provision of safe medical devices meeting customer and regulatory requirements across the device lifecycle. Its risk-based approach emphasizes documented processes, validation, and traceability.
Key Components
- Organized into Clauses 4–8: QMS/documentation (4), management responsibility (5), resources (6), product realization (7), measurement/improvement (8).
- Core principles: process approach, regulatory integration, risk management (linked to ISO 14971), post-market surveillance.
- Certification via accredited bodies with stage 1/2 audits and surveillance.
Why Organizations Use It
- Enables market access (EU MDR, FDA QMSR alignment by 2026).
- Reduces risks like recalls via supplier controls, CAPA, validation.
- Builds stakeholder trust, operational efficiency, competitive edge.
Implementation Overview
- Phased: gap analysis, documentation, training, validation, audits.
- Applies to manufacturers, suppliers globally; scales by size.
- Involves eQMS, cross-functional teams; 9–18 months typical.
Key Differences
| Aspect | ISO 27032 | ISO 13485 |
|---|---|---|
| Scope | Internet security and cyberspace collaboration | Medical device QMS lifecycle and regulatory compliance |
| Industry | All organizations with online presence, global | Medical device manufacturers and suppliers, global |
| Nature | Non-certifiable guidance standard, voluntary | Certifiable QMS requirements standard, regulatory-oriented |
| Testing | Gap analysis, risk assessments, exercises | Internal audits, process validation, certification audits |
| Penalties | No direct penalties, loss of trust/competitiveness | Regulatory actions, market bans, certification loss |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about ISO 27032 and ISO 13485
ISO 27032 FAQ
ISO 13485 FAQ
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