IEC 62443
International standard for IACS cybersecurity lifecycle security
ISO 13485
International standard for medical device quality management systems
Quick Verdict
IEC 62443 secures industrial control systems via zones, security levels, and certifications for OT resilience. ISO 13485 ensures medical device quality through lifecycle QMS, validation, and risk controls. Companies adopt them for compliance, risk reduction, and market access in regulated sectors.
IEC 62443
IEC 62443: Security for industrial automation systems
Key Features
- Zones/conduits model for risk-based segmentation
- Security levels SL-T/SL-C/SL-A triad
- Shared responsibility across stakeholders
- Seven foundational requirements FR1-FR7
- ISASecure modular certifications SDLA/CSA/SSA
ISO 13485
ISO 13485:2016 Medical devices Quality management systems
Key Features
- Risk-based QMS for device safety and regulatory compliance
- Lifecycle controls from design to post-market surveillance
- Mandatory process validation and software validation
- Supplier evaluation and outsourcing risk controls
- Traceability, CAPA, and continual improvement requirements
Detailed Analysis
A comprehensive look at the specific requirements, scope, and impact of each standard.
IEC 62443 Details
What It Is
IEC 62443 is the international consensus-based series of standards for securing Industrial Automation and Control Systems (IACS). It provides a risk-based framework spanning governance, risk assessment, system architecture, and component requirements tailored to OT environments with safety, availability, and long lifecycles.
Key Components
- Four groupings: General (-1), Policies (-2), System (-3), Components (-4).
- Seven Foundational Requirements (FR1-7) like authentication, integrity, data flow.
- Zones/conduits segmentation and security levels (SL0-4).
- ISASecure certifications: SDLA (4-1), CSA (4-2), SSA (3-3); maturity levels ML1-4.
Why Organizations Use It
- Mitigates OT cyber risks amid IIoT connectivity.
- Meets regulatory references (e.g., NIS-2) and supply chain demands.
- Enables measurable assurance via SL-T/SL-C/SL-A.
- Builds stakeholder trust through certified suppliers.
Implementation Overview
Phased: governance (2-1), risk/segmentation (3-2), controls (3-3/4-2), certification. Applies to critical infrastructure globally; multi-year for large orgs with audits.
ISO 13485 Details
What It Is
ISO 13485:2016, titled "Medical devices — Quality management systems — Requirements for regulatory purposes," is a certifiable international standard establishing a risk-based QMS framework for organizations in the medical device lifecycle, from design to post-market surveillance.
Key Components
- Core clauses (4–8): QMS/documentation, management responsibility, resources, product realization, measurement/improvement.
- Emphasizes documented procedures, validation, traceability, and risk controls per ISO 14971.
- Certification model involves accredited bodies with Stage 1/2 audits, surveillance, and recertification every 3 years.
Why Organizations Use It
- Aligns with EU MDR/IVDR, upcoming FDA QMSR (2026) for market access.
- Mitigates risks, reduces recalls, lowers quality costs.
- Builds stakeholder trust, enables supplier qualification, supports global scalability.
Implementation Overview
- Phased approach: gap analysis, documentation, training, validation, internal audits.
- Applies to manufacturers, suppliers, distributors; suits all sizes.
- Typical timeline 9–18 months to certification.
Key Differences
| Aspect | IEC 62443 | ISO 13485 |
|---|---|---|
| Scope | IACS cybersecurity lifecycle, zones/conduits, security levels | Medical device QMS, design/production, risk/validation, post-market |
| Industry | Industrial automation, critical infrastructure, cross-sector | Medical devices, healthcare supply chain, regulated manufacturers |
| Nature | Voluntary consensus standards series, ISASecure certification | Voluntary QMS standard for regulatory compliance, certification |
| Testing | SL-T/SL-C/SL-A assessments, ISASecure modular certification | Internal audits, process validation IQ/OQ/PQ, certification audits |
| Penalties | Loss of certification, supply chain exclusion, no legal fines | Certification loss, regulatory actions, market access denial |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about IEC 62443 and ISO 13485
IEC 62443 FAQ
ISO 13485 FAQ
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