DORA
EU regulation for digital operational resilience in financial sector
ISO 37301
Certifiable international standard for compliance management systems.
Quick Verdict
DORA mandates ICT resilience for EU financial firms against cyber threats, while ISO 37301 offers voluntary certification for comprehensive compliance systems across sectors. Financial entities adopt DORA for regulatory survival; others choose ISO 37301 for governance excellence and stakeholder trust.
DORA
Regulation (EU) 2022/2554, Digital Operational Resilience Act
Key Features
- Mandates comprehensive ICT risk management frameworks
- Requires 4-hour incident reporting for major incidents
- Mandates threat-led penetration testing every 3 years
- Oversees critical third-party ICT service providers
- Harmonizes resilience standards across EU financial sector
ISO 37301
ISO 37301:2021 Compliance management systems – Requirements
Key Features
- Certifiable CMS requirements replacing ISO 19600 guidance
- HLS alignment for integration with other ISO standards
- Risk-based planning for obligations and opportunities
- Mandatory whistleblowing channels and anti-retaliation protections
- Leadership-driven culture and continual improvement PDCA
Detailed Analysis
A comprehensive look at the specific requirements, scope, and impact of each standard.
DORA Details
What It Is
DORA, formally Regulation (EU) 2022/2554, is a transformative EU regulation enhancing digital operational resilience for the financial sector against ICT risks like cyberattacks and outages. It targets 20 financial entity types and critical third-party providers across 27 member states, using a proactive, risk-based, proportional approach.
Key Components
- **ICT Risk ManagementFrameworks for identification, mitigation, and annual reviews.
- **Incident Reporting4-hour notifications, 72-hour updates for major incidents.
- **Resilience TestingAnnual scans and triennial TLPT.
- **Third-Party OversightDue diligence, monitoring of CTPPs. Enforced via ESAs with fines up to 2% global turnover; no formal certification but mandatory compliance.
Why Organizations Use It
- Meets legal mandate effective January 2025.
- Counters threats (74% ransomware hit rate).
- Prevents systemic disruptions like CrowdStrike outage.
- Boosts trust, resilience, and cybersecurity investments.
Implementation Overview
Gap analyses, framework development, testing programs, vendor reviews. Applies EU-wide to all sizes proportionally; involves reporting, audits by authorities.
ISO 37301 Details
What It Is
ISO 37301:2021, officially Compliance management systems – Requirements with guidance for use, is a certifiable international standard for Compliance Management Systems (CMS). It provides auditable requirements to establish, implement, maintain, and improve CMS across all organization sizes and sectors. Built on the ISO High-Level Structure (HLS) and Plan-Do-Check-Act (PDCA) cycle, it adopts a risk-based approach to identify obligations, risks, and controls.
Key Components
- Leadership commitment, policy, roles, and culture.
- **Planningrisk assessment, objectives, actions.
- **Supportresources, competence (per ISO 37303), awareness, communication (whistleblowing).
- **Operationcontrols, third-party management.
- **Performance evaluationmonitoring, audits, reviews.
- **Improvementnonconformities, continual enhancement. Follows HLS (10 clauses); companion standards like ISO 37302 for metrics.
Why Organizations Use It
- Reduces regulatory risks, fines, reputational harm.
- Builds stakeholder trust via certification.
- Integrates with ISO 9001/14001/27001.
- Drives integrity culture, ESG alignment.
- Meets investor, partner demands.
Implementation Overview
Phased: gap analysis, register building, training, audits, certification (3-year cycle via ANAB-accredited bodies). Scalable for SMEs to enterprises; universal applicability.
Key Differences
| Aspect | DORA | ISO 37301 |
|---|---|---|
| Scope | ICT/digital operational resilience in finance | All compliance obligations across sectors |
| Industry | EU financial entities and CTPPs | All industries, global applicability |
| Nature | Mandatory EU regulation | Voluntary certifiable standard |
| Testing | Annual basic + triennial TLPT | Internal audits + certification audits |
| Penalties | Up to 2% global turnover fines | Loss of certification, no fines |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about DORA and ISO 37301
DORA FAQ
ISO 37301 FAQ
You Might also be Interested in These Articles...

Top 5 Reasons NIST SP 800-53 Rev 5 Overlays Unlock AI Risk Management for Private Sector Enterprises in 2025
Top 5 reasons NIST SP 800-53 Rev 5 AI overlays unlock risk management for private enterprises. Tailorable controls combat model poisoning & data leakage. CISO i

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

NIST CSF 2.0 Plain English Decoder: Translating Govern, Supply Chain, and Core Functions from Jargon to Actionable Insights
Demystify NIST CSF 2.0 jargon with plain English tables for Govern, Supply Chain & Core Functions. Actionable steps for risk oversight & vendor management. Empo
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
ISO 20000 vs ISO 28000
Compare ISO 20000 vs ISO 28000: IT service mgmt excellence meets supply chain security resilience. Key differences, benefits & integration for robust operations—choose wisely now.
AEO vs EU AI Act
AEO vs EU AI Act: Compare customs security certification with AI risk regulation. Key differences in compliance, benefits & strategies for global success. Dive in!
CSL (Cyber Security Law of China) vs UL Certification
Compare CSL (Cyber Security Law of China) vs UL Certification: Navigate data localization, security pillars & global safety standards. Gain strategies for China-US compliance success now.