NIST 800-53
U.S. catalog of security and privacy controls
ISO 13485
International standard for medical device quality management systems
Quick Verdict
NIST 800-53 provides flexible security/privacy controls for federal systems and adopters managing CIA risks, while ISO 13485 mandates rigorous QMS for medical devices ensuring lifecycle safety. Organizations adopt NIST for risk management, ISO for regulatory certification.
NIST 800-53
NIST SP 800-53 Rev. 5 Security and Privacy Controls
Key Features
- 20 control families with 1,100+ security/privacy controls
- Tailorable Low/Moderate/High baselines in SP 800-53B
- Outcome-based statements for flexible, role-neutral implementation
- Integrated privacy baseline irrespective of impact level
- OSCAL machine-readable formats enabling automation
ISO 13485
ISO 13485:2016 Medical devices Quality management systems
Key Features
- Risk-based QMS controls for device lifecycle
- Design development verification and validation
- Supplier evaluation and outsourcing controls
- Post-market surveillance and complaint handling
- Process validation and traceability requirements
Detailed Analysis
A comprehensive look at the specific requirements, scope, and impact of each standard.
NIST 800-53 Details
What It Is
NIST SP 800-53 Rev. 5, titled Security and Privacy Controls for Information Systems and Organizations, is a U.S. federal control catalog framework. It provides a comprehensive, risk-based set of safeguards to protect confidentiality, integrity, availability (CIA) and manage privacy risks for systems and organizations. The outcome-based approach emphasizes flexible, customizable implementation via the Risk Management Framework (RMF).
Key Components
- 20 control families (e.g., AC Access Control, SR Supply Chain Risk Management) with over 1,100 base controls and enhancements.
- Baselines in SP 800-53B: Low/Moderate/High security plus privacy baseline.
- Parameters, tailoring, overlays for customization; SP 800-53A assessment procedures.
- OSCAL for machine-readable automation; integrated with RMF lifecycle.
Why Organizations Use It
- Mandatory for federal agencies/contractors under FISMA/OMB A-130; voluntary benchmark for others.
- Enhances risk management, operational resilience, supply chain security.
- Builds stakeholder trust, enables FedRAMP, reciprocity; maps to ISO 27001, CSF.
Implementation Overview
Follow **RMFcategorize (FIPS 199), select/tailor baselines, implement, assess (SP 800-53A), authorize, monitor. Suits all sizes/industries; requires governance, automation, audits. No formal certification but ATO/continuous monitoring essential. (178 words)
ISO 13485 Details
What It Is
ISO 13485:2016—Medical devices—Quality management systems—Requirements for regulatory purposes—is an international certification standard for QMS in medical devices. It ensures organizations consistently meet customer and regulatory requirements across the device lifecycle using a risk-based process approach.
Key Components
- Eight clauses, with 4–8 substantive: QMS/documentation, management responsibility, resources, product realization, measurement/improvement.
- Emphasizes design controls, validation, traceability, post-market surveillance.
- Builds on ISO 9001 but adds device-specific regulatory focus.
- Third-party certification model via accredited bodies.
Why Organizations Use It
- Enables market access (EU MDR, FDA QMSR alignment 2026).
- Mitigates risks, reduces recalls, ensures compliance.
- Drives efficiency, supplier control, stakeholder trust.
Implementation Overview
- Phased: gap analysis, documentation, training, validation, audits.
- Applies to manufacturers/suppliers globally; scales by size.
- Stage 1/2 audits lead to certification, surveillance follows.
Key Differences
| Aspect | NIST 800-53 | ISO 13485 |
|---|---|---|
| Scope | Security/privacy controls for info systems | QMS for medical device lifecycle |
| Industry | Federal, critical infrastructure, all sectors | Medical devices and suppliers |
| Nature | Voluntary catalog, risk management framework | Certification standard for regulatory compliance |
| Testing | SP 800-53A procedures, continuous monitoring | Internal audits, process validation, certification |
| Penalties | No legal penalties, FISMA contract risks | Certification loss, regulatory enforcement |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about NIST 800-53 and ISO 13485
NIST 800-53 FAQ
ISO 13485 FAQ
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