EU AI Act
EU regulation for risk-based AI safety and governance
ISO 30301
International standard for records management systems
Quick Verdict
EU AI Act mandates risk-based AI compliance for EU market access, with fines up to 7% turnover. ISO 30301 provides voluntary records management certification for governance. Companies adopt AI Act for legal survival, ISO 30301 for audit-ready evidence.
EU AI Act
Artificial Intelligence Act (Regulation (EU) 2024/1689)
Key Features
- Risk-based four-tier classification prohibiting unacceptable AI
- Conformity assessment and CE marking for high-risk systems
- Lifecycle requirements including risk management and data governance
- GPAI model transparency and systemic risk obligations
- Tiered fines up to 7% worldwide annual turnover
ISO 30301
ISO 30301:2019 Management systems for records
Key Features
- High-Level Structure for MSS integration
- Normative Annex A operational controls
- Explicit records requirements analysis (4.1.2)
- Flexible conformity pathways (self/third-party)
- Risk-based planning and measurable objectives
Detailed Analysis
A comprehensive look at the specific requirements, scope, and impact of each standard.
EU AI Act Details
What It Is
EU Artificial Intelligence Act (Regulation (EU) 2024/1689) is a comprehensive EU regulation establishing a risk-based framework for AI systems. It prohibits unacceptable-risk practices, regulates high-risk AI with lifecycle obligations, mandates transparency for limited-risk systems, and oversees general-purpose AI models, applicable across sectors with extraterritorial reach.
Key Components
- **Four risk tiersProhibited, high-risk (Annex I/III), limited-risk, minimal-risk.
- Core high-risk requirements: risk management (Article 9), data governance (Article 10), documentation, human oversight, cybersecurity (Article 15).
- Conformity assessment, CE marking, EU database registration.
- GPAI duties including systemic risk evaluations; hybrid enforcement via AI Office and national authorities.
Why Organizations Use It
Mandatory for EU market access; mitigates fines up to 7% global turnover. Enhances trust, ensures safety/fundamental rights protection, enables compliant innovation, and provides competitive edge in regulated sectors like healthcare, finance.
Implementation Overview
Phased rollout (6-36 months); involves AI inventory, classification, QMS integration, conformity assessments. Applies to providers/deployers globally; requires cross-functional governance, documentation, audits for high-risk systems.
ISO 30301 Details
What It Is
ISO 30301:2019 is an international standard specifying requirements for a Management System for Records (MSR). It provides a certifiable framework to establish, implement, maintain, and improve records processes, ensuring authoritative evidence of business activities. Applicable to any organization, it uses a risk-based, PDCA management system approach aligned with the High-Level Structure (HLS).
Key Components
- **Clauses 4–10Context, leadership, planning, support, operation, performance evaluation, improvement.
- **Clause 8 & Annex A (normative)Records lifecycle controls (creation, capture, access, retention, disposition).
- Built on ISO 15489 principles (authenticity, reliability, integrity, usability).
- Flexible conformity: self-declaration, external confirmation, or third-party certification.
Why Organizations Use It
- Enhances compliance, risk management, and business continuity.
- Provides auditability, transparency, and efficiency in information governance.
- Builds stakeholder trust via defensible evidence; integrates with ISO 9001, 27001.
Implementation Overview
- Phased: gap analysis, policy design, operational controls, audits.
- Suited for all sizes/industries; 12-18 months typical with cross-functional teams.
- Certification optional via accredited bodies.
Key Differences
| Aspect | EU AI Act | ISO 30301 |
|---|---|---|
| Scope | Risk-based AI systems, prohibitions, GPAI | Records management systems lifecycle |
| Industry | All sectors using AI in EU | Any organization worldwide |
| Nature | Mandatory EU regulation | Voluntary certification standard |
| Testing | Conformity assessments, notified bodies | Internal audits, management reviews |
| Penalties | Up to 7% global turnover fines | No legal penalties, certification loss |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about EU AI Act and ISO 30301
EU AI Act FAQ
ISO 30301 FAQ
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