Standards Comparison

    DORA

    Mandatory
    2023

    EU regulation for digital operational resilience in financial sector

    VS

    ISO 9001

    Voluntary
    2015

    International standard for quality management systems

    Quick Verdict

    DORA mandates ICT resilience for EU finance against cyber threats via testing and reporting, while ISO 9001 offers voluntary global quality certification for process excellence. Finance firms adopt DORA for compliance; others choose ISO 9001 for efficiency and market trust.

    Digital Operational Resilience

    DORA

    Regulation (EU) 2022/2554, Digital Operational Resilience Act

    Cost
    €€€€
    Complexity
    High
    Implementation Time
    12-18 months

    Key Features

    • Comprehensive ICT risk management frameworks overseen by management
    • 4-hour initial reporting for major ICT incidents
    • Triennial threat-led penetration testing for critical entities
    • ESAs oversight of critical third-party ICT providers
    • Proportionality principle tailored to entity size and risk
    Quality Management

    ISO 9001

    ISO 9001:2015 Quality management systems – Requirements

    Cost
    €€€
    Complexity
    Medium
    Implementation Time
    6-12 months

    Key Features

    • Risk-based thinking throughout QMS processes
    • Process approach with PDCA cycle integration
    • Seven quality management principles foundation
    • Leadership commitment and top management accountability
    • High-Level Structure for multi-standard alignment

    Detailed Analysis

    A comprehensive look at the specific requirements, scope, and impact of each standard.

    DORA Details

    What It Is

    Digital Operational Resilience Act (DORA), Regulation (EU) 2022/2554, is an EU-wide regulation bolstering ICT resilience for the financial sector against disruptions like cyberattacks. Enacted December 2022, applicable January 2025, it targets 20 financial entity types and critical ICT third-party providers (CTPPs), using a risk-based, proportional approach to harmonize rules across 27 member states.

    Key Components

    DORA's pillars include:

    • **ICT Risk Management FrameworksIdentification, mitigation, annual reviews overseen by management.
    • **Incident Reporting4-hour alerts, 72-hour updates for major events (>5% users impacted).
    • **Resilience TestingAnnual vulnerability scans, triennial threat-led penetration testing (TLPT).
    • **Third-Party OversightDue diligence, monitoring, ESAs supervision of CTPPs. Compliance enforced via RTS/ITS, no certification but strict audits.

    Why Organizations Use It

    Mandatory for ~22,000 EU entities to avert 2% turnover fines. Drives resilience amid 74% ransomware rates, reduces systemic risks from third-parties (e.g., CrowdStrike outage), enhances trust and competitiveness.

    Implementation Overview

    Gap analyses, policy embedding, testing programs, vendor strategies. Proportional for SMEs/large firms; EU-focused, integrates EBA guidelines. Key: multi-year plans before 2025 deadline. (178 words)

    ISO 9001 Details

    What It Is

    ISO 9001:2015 is the international standard for Quality Management Systems (QMS), a certifiable framework ensuring organizations consistently meet customer and regulatory requirements through continual improvement. It uses a process-based, risk-thinking approach structured around the PDCA cycle.

    Key Components

    • 10 clauses (4-10 auditable): context, leadership, planning, support, operation, evaluation, improvement.
    • Built on **7 Quality Management Principlescustomer focus, leadership, engagement of people, process approach, improvement, evidence-based decisions, relationship management.
    • Voluntary certification via accredited bodies with audits every 3 years.

    Why Organizations Use It

    • Enhances customer satisfaction, efficiency, and competitiveness.
    • Meets market/contractual demands; manages risks proactively.
    • Builds trust, reduces costs, enables standard integrations (e.g., ISO 14001).

    Implementation Overview

    • Gap analysis, process mapping, training, internal audits, certification.
    • Applicable to all sizes/sectors; 6-12 months typical for medium organizations.

    Key Differences

    Scope

    DORA
    ICT risk, incidents, testing, third-party oversight in finance
    ISO 9001
    Quality management processes, continual improvement all sectors

    Industry

    DORA
    EU financial entities and critical ICT providers
    ISO 9001
    All industries globally, any organization size

    Nature

    DORA
    Mandatory EU regulation with enforcement
    ISO 9001
    Voluntary international certification standard

    Testing

    DORA
    Annual basic, triennial TLPT by authorities
    ISO 9001
    Internal audits, management reviews, certification audits

    Penalties

    DORA
    Up to 2% global turnover fines
    ISO 9001
    Loss of certification, no legal penalties

    Frequently Asked Questions

    Common questions about DORA and ISO 9001

    DORA FAQ

    ISO 9001 FAQ

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