ISO 13485
International standard for medical device quality management systems
Basel III
Global framework for bank capital, leverage and liquidity standards
Quick Verdict
ISO 13485 provides QMS certification for medical device makers ensuring regulatory compliance and patient safety, while Basel III mandates capital and liquidity rules for banks to enhance financial stability and prevent crises. Organizations adopt them for market access and resilience.
ISO 13485
Medical devices — Quality management systems — Requirements for regulatory purposes
Key Features
- Risk-based QMS for medical device lifecycle
- Mandatory medical device files per product family
- Explicit process and software validation requirements
- Integrated post-market surveillance and complaints handling
- Tailored exclusions with documented justifications
Basel III
Basel III: Finalising post-crisis reforms
Key Features
- Strengthened CET1 capital requirements and buffers
- Non-risk-based leverage ratio backstop
- Liquidity Coverage Ratio for 30-day stress
- Net Stable Funding Ratio for funding stability
- Enhanced Pillar 3 RWA comparability disclosures
Detailed Analysis
A comprehensive look at the specific requirements, scope, and impact of each standard.
ISO 13485 Details
What It Is
ISO 13485:2016 is an international certification standard specifying requirements for quality management systems (QMS) in medical device organizations. It ensures consistent provision of safe devices meeting customer and regulatory requirements across the lifecycle, from design to post-market. Adopts a risk-based process approach emphasizing documentation, validation, and traceability.
Key Components
- Clauses 4–8 cover QMS, management responsibility, resources, product realization, measurement/improvement.
- Includes medical device files, supplier controls, design validation, sterile processes, CAPA.
- Built on process interactions, risk management (ISO 14971), continual improvement.
- Third-party certification via staged audits.
Why Organizations Use It
Facilitates market access (EU MDR, FDA QMSR alignment 2026), reduces risks/recalls, ensures supply chain control. Builds regulatory maturity, stakeholder trust; competitive edge via certification.
Implementation Overview
Phased: gap analysis, documentation, training, validation, audits. Applies to manufacturers/suppliers globally; 9–18 months typical, high complexity/cost for eQMS, consulting.
Basel III Details
What It Is
Basel III is the global regulatory framework issued by the Basel Committee on Banking Supervision (BCBS) for bank prudential standards. It addresses post-financial crisis weaknesses in capital quality, leverage, and liquidity through a risk-based, multi-metric approach combining risk-weighted assets (RWA), non-risk-based measures, and standardized liquidity ratios.
Key Components
- **Three PillarsPillar 1 (capital, leverage, LCR, NSFR requirements); Pillar 2 (supervisory review/ICAAP); Pillar 3 (disclosures for comparability).
- Core elements: CET1 (4.5%), buffers (2.5% CCB + others), 3% leverage ratio, LCR/NSFR ≥100%.
- Built on revised RWA methods, output floor (72.5%), and enhanced risk coverage.
- Compliance via national implementation, no central certification.
Why Organizations Use It
- Mandatory for internationally active banks to ensure resilience.
- Mitigates systemic risks, improves funding costs, enhances market confidence.
- Strategic benefits: optimized balance sheets, reduced model risk, competitive positioning.
Implementation Overview
- Phased enterprise transformation: governance, data/IT upgrades, parallel testing.
- Applies to large banks globally; varies by jurisdiction (e.g., EU CRR3, US Endgame).
- Involves QIS, stress testing, Pillar 3 reporting; audited by supervisors.
Key Differences
| Aspect | ISO 13485 | Basel III |
|---|---|---|
| Scope | Medical device lifecycle QMS | Bank capital, liquidity, leverage |
| Industry | Medical devices, suppliers globally | Banking, financial institutions |
| Nature | Voluntary certification standard | Mandatory prudential regulation |
| Testing | Certification body audits, internal audits | Supervisory reviews, stress tests |
| Penalties | Loss of certification, market access | Fines, asset caps, enforcement |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about ISO 13485 and Basel III
ISO 13485 FAQ
Basel III FAQ
You Might also be Interested in These Articles...
The 'Black Box' Risk: Why Human-in-the-Loop is the Ultimate Fail-Safe for 2026 Security Operations
Uncover the black box AI risk in security ops. Learn why human-in-the-loop auditing is crucial for 2026. Upskill analysts to ensure data privacy and robust secu
The Tool Landscape for Reaching and Maintaining ISO 27001 Compliance
Discover top ISO 27001 compliance tools, their pros/cons, implementation steps, costs, and benefits. Streamline your path to certification and ongoing complianc
What is DORA and which Requirements does the Standard define?
Discover DORA requirements for info security, strict authority monitoring, and steps to achieve compliance. Build a resilient organization with our detailed gui
Run Maturity Assessments with GRADUM
Transform your compliance journey with our AI-powered assessment platform
Assess your organization's maturity across multiple standards and regulations including ISO 27001, DORA, NIS2, NIST, GDPR, and hundreds more. Get actionable insights and track your progress with collaborative, AI-powered evaluations.
Check out these other Gradum.io Standards Comparison Pages
GRI vs ISO 27701
Unlock GRI vs ISO 27701: GRI drives impact-focused sustainability & HES reporting; ISO 27701 builds certifiable privacy management. Compare, comply, excel—discover now!
ITIL vs WCAG
ITIL vs WCAG: Compare ITSM best practices with web accessibility standards. Align ITIL 4's SVS & 34 practices with WCAG POUR principles for compliant, value-driven IT services now!
PCI DSS vs EN 1090
Compare PCI DSS vs EN 1090: payment security meets steel/aluminum execution standards. Uncover key differences, compliance paths & execution classes. Choose wisely now!