+1 123 456 78 90
hello@monomo.com
hello@monomo.com
AI Risk Coverage Overview
We built our framework on a robust taxonomy that maps the landscape of AI-related risks across categories, domains, and sub-domains. This structure ensures comprehensive oversight and regulatory alignment.
Metric | Count |
Total Distinct AI Risks | 65 |
Total Risk Categories | 492 |
Total Risk Subcategories | 1,065 |
Total Risk Domains | 7 |
Total Risk Subdomains | 31 |
Technical documentation in Europe is no longer just operational material - it is regulatory evidence
We assess your documentation against EU regulations and ISO/IEC standards, and deliver a chapter-by-chapter gap report with clear corrective actions and audit-ready traceability.
Personalized Compliance Dashboard Wizard
Key EU Regulations and ISO Standards for Documentation
The main regulations and standards usually applicable to the documentation.
Regulation (EU) 2023/1230
Applies to machinery and embedded software.
Technical documentation must include:
Applies to machinery and embedded software.
Technical documentation must include:
- risk assessments
- safety instructions
- software behavior descriptions
Regulation (EU) 2023/988
Requires:
Requires:
- traceable technical documentation
- risk communication
- corrective action records
2014/35/EU & 2014/30/EU
Require:
Require:
- conformity documentation
- safety and installation instructions
Directive (EU) 2022/2555
Documentation must support:
Documentation must support:
- risk management
- incident handling
- security controls
Applies to software and digital products.
Documentation must include:
Documentation must include:
- security-by-design principles
- vulnerability handling processes
Defines best practices for:
- structure and clarity
- usability
- completeness of technical documentation
Information security documentation requirements.
Privacy information management aligned with GDPR.
Covers:
- AI governance
- lifecycle documentation
- accountability and risk management
Quality management requirements for:
- document control
- versioning
- change management
Requires documentation to be:
- accessible
- usable
- available in appropriate formats
Technical documentation must be provided in the official language(s) of the EU country where the product is marketed.
Compliance Dashboard Features
- Executive compliance summary (overall score + key risks)A high-level overview that shows the overall compliance status of the document, including a clear compliance score and the most significant regulatory risks, enabling quick understanding and decision-making by stakeholders.
- Chapter-by-chapter compliance assessmentA structured review of each document chapter, identifying how well individual sections align with applicable regulations and standards, so issues can be located and addressed precisely.
- Regulation/standard mapping for every findingDirect linkage of each compliance finding to the specific EU regulation or ISO/IEC standard it relates to, ensuring traceability and regulatory clarity.
- Compliance discrepancies list (what’s missing / incorrect)A consolidated list of all identified gaps and nonconformities, clearly describing what is missing, incomplete, or incorrect in the documentation.
- CAPA-ready recommendations (what to change, where, and why)Clear, actionable corrective and preventive actions that specify exactly what needs to be updated, where in the document the change should be made, and the regulatory rationale behind it.
- Evidence of compliance (what is already correct—no unnecessary edits)Identification of sections that already meet regulatory requirements, allowing teams to focus on real gaps and avoid unnecessary revisions or rework.
Start your self-assessment now to uncover risks, validate ethical safeguards, and prove your AI system is compliant with the European AI Act.