AI IMPACT ASSESSMENT
Comprehensive AI Risk & Governance Evaluation for Regulated INDUSTRIES
The AI Impact Assessment delivers a structured analysis of your AI system’s risks, regulatory exposure, and governance maturity. Built specifically for European organisations working in highly regulated sectors, this assessment supports legal, technical, and executive stakeholders in meeting obligations under the EU AI Act, ISO/IEC 42001:2023, ISO/IEC 23894:2023, ISO/IEC 42006:2025, ISO/IEC 42005:2025, GDPR, NIS2, NIST AI RMF, and other critical compliance frameworks.
You receive a complete documentation and implementation roadmap, with practical, audit-ready outputs that align with business needs and regulatory expectations. When a controlled environment is needed to run or examine your AI system, we provide a dedicated secure workspace enclave in Quantiti ∞, Niskaa’s secure AWS cloud platform and managed services suite. This enclave is isolated, EU-resident, encrypted, access-controlled, and centrally logged for full audit traceability.
Use Case Scoping & Risk Classification
Clarify how your AI systems fall under EU AI Act requirements.
This initial step documents system purpose, deployment context, and role mapping (provider, deployer, etc.). It helps confirm whether your AI is classified as “high-risk” or otherwise regulated under the EU AI Act, and defines what actions are required before and after deployment.
Key outputs include:
- Role and responsibility mapping across stakeholders
- Use case classification against AI Act Annexes
- High-risk system identification and summary
- Record of compliance obligations linked to risk level
This foundational classification supports internal decisions, procurement processes, and regulator queries.
AI Governance & Control Design
Establish internal accountability for safe, legal, and monitored AI use.
Based on ISO/IEC 42001:2023 and NIST AI RMF, this phase defines how your organisation oversees AI development, deployment, and updates. It structures roles, policies, escalation paths, and operational controls across departments.
We support you with:
- Governance operating model (roles, committees, escalation)
- Policy and SOP review and development
- Human oversight and intervention mechanisms
- Change management and supplier assurance
This ensures your team can document and defend decisions throughout the AI lifecycle.
ISO/IEC 42001 AIMS Implementation
Build a complete AI management system aligned with ISO standards.
This section formalises your internal governance and control structure for AI in line with ISO/IEC 42001:2023. It gives you the building blocks to achieve and maintain a certified AI Management System (AIMS), aligned with EU regulatory expectations and best practices from ISO and NIST.
We help you:
- Define your AIMS scope, boundaries, and stakeholders
- Develop policies, procedures, and operating controls required by ISO/IEC 42001
- Map lifecycle activities (design, development, deployment, monitoring) to control objectives
- Align your system to support GDPR, NIS2, and EU AI Act requirements
- Integrate with existing ISO/IEC 27001 systems where relevant
- Prepare internal audit and management review structures
This gives you the foundation to pursue ISO/IEC 42001 certification or operate at the required level of maturity for procurement and oversight.
Data & Model Risk Assessment
Identify and reduce risks in your training data, input sources, model behaviour, and system performance.
This part of the assessment follows ISO/IEC 23894:2023 guidelines for AI-specific risk. It targets the core components of your AI system: the datasets used to train and validate your models, the real-world inputs your system receives during operation, and the models themselves, including architecture, behaviour, and robustness. The goal is to uncover risks such as bias (unfair decisions from skewed data), drift (performance drop as real-world data changes), low explainability (decisions no one can clearly explain), and vulnerability to adversarial attacks (inputs designed to trick the AI).
Focus areas include:
- Dataset quality, representativeness, and labeling
- Model testing, explainability, and robustness
- Monitoring for drift and performance degradation
- Known attack vectors and mitigation strategy
Outputs feed directly into technical and compliance documentation.
Fundamental Rights Risk Evaluation
Analyse and document the impact of AI systems on people and legal rights.
For high-risk use cases, especially in the public sector, a Fundamental Rights Impact Assessment (FRIA) may be required (see Article 27 of EU AI Act). We guide your team through identifying, documenting, and addressing the real-world impact of your system on privacy, equality, and freedom.
Our support services include:
- Risk mapping to rights and freedoms (privacy, non-discrimination, etc.)
- FRIA templates and structure
- Cross-referencing with technical mitigations
- Documentation support for legal and audit use
This protects both individuals and your organisation from liability.
Technical Documentation & Evidence Pack
Build clear, structured documentation that supports audits, procurement, and governance.
This deliverable is structured to support ISO/IEC 42001, ISO/IEC 27001, and EU AI Act compliance and can be adapted to procurement requirements in both public and private sector tenders.
This includes:
- Intended purpose, lifecycle, and risk profile
- System architecture and interfaces
- Control catalogue and mitigation plan
- Transparency, explainability, logging, and human intervention summary
- Evidence of post-deployment monitoring
You can integrate this documentation into internal systems or submit it as part of a certification package.
Sector-Specific Compliance Mapping
Customised outputs for defence, healthcare, finance, SaaS, and space-sector use cases.
We align your AI risk posture with industry-specific obligations so you meet both regulatory requirements and procurement expectations in your sector.
Key applicable frameworks include:
- DORA – for financial institutions and ICT providers
- NIS2 – for essential and important entities
- GDPR – for all data-processing systems
- ePrivacy Directive – for electronic communications, tracking, and profiling
- ISO/IEC 27001 and SOC 2 – for information security and cloud infrastructure
- EU MDR – for AI systems used in diagnostic or medical contexts
- EHDS – for secondary use of health data and AI in healthcare
- EU Space Law / ESA Guidelines – for satellite data processing and critical infrastructure
- EU Digital Services Act (DSA) – for platform-integrated AI and user-facing systems
This mapping ensures you are fully prepared to respond to EU tenders, public procurement, and regulatory reviews across different industries.
Secure AI ENCLAVE Hosting on Quantiti ∞
Ensure compliance with EU data residency, access control, and evidence logging.
Quantiti ∞ is Niskaa’s secure, EU-based cloud environment designed for sensitive or regulated workloads. For AI systems it provides a secure AI enclave:
- Physical and logical separation of AI systems from general infrastructure
- Centralised logging, monitoring, and alerting
- Built-in encryption, retention policies, and role-based access
- Hosting infrastructure that supports ISO 27001, ISO 27017, ISO 27018 & SOC 2 Type 2 audit needs
- Compliance with EU AI Act and ISO 42001
This supports both internal governance and external assurance.
Executive Training & Certification Support
Prepare leadership to oversee AI compliance and certification.
We provide targeted executive training to equip senior leaders, legal teams, and board members with the knowledge required to supervise AI deployment responsibly. Sessions are adapted to your sector, use case, and regulatory exposure.
Training includes:
- Legal and governance duties under the EU AI Act and GDPR
- What ISO/IEC 42001 requires from senior management
- Oversight expectations under NIS2, DORA, and sector rules
- Certification planning and internal responsibilities
- Role of executives in audits, management reviews, and policy enforcement
This enables your organisation’s leadership to fulfill their role in governance, support certification, and respond confidently to regulators or buyers.
AI Assessment Delivery Model
We deliver the AI Impact Assessment through a structured sequence:
Phase 1 – Assessment & Gap Analysis
- Use case scoping and risk classification
- Governance and control maturity benchmark
- Risk register initiation and mapping
Phase 2 – Implementation Support/Roadmap
- Documentation and evidence preparation
- Policy, control, and governance model refinement
Phase 3 – Certification & Audit Readiness
- ISO/IEC 42001 internal audit checklist
- Readiness tracker for gap closure
- Support for integration/alignment with ISO/IEC 27001
Phase 4 – Monitoring & Continuous Update
- KPI and review cycle design
- Bias, drift, and incident watch setup
- Regulatory update alerts (NIS2, GDPR, DORA)
Frequently Asked Questions (FAQ)
Who is AI Impact Assessment Service for?
This assessment is designed for any organisation developing, deploying, or procuring AI systems in regulated environments, including finance, defence, space, healthcare, energy, utilities, and SaaS. It helps meet obligations under the EU AI Act, GDPR, ISO 42001, DORA, NIS2, etc.
Does it help with EU tenders and public procurement?
Yes. We provide outputs that map directly to common EU tender requirements, including risk logs, accountability structures, compliance declarations, and audit-ready documentation aligned with ISO/IEC 42001 and ISO/IEC 27001.
What is required under the EU AI Act for high-risk systems?
High-risk AI systems must undergo risk assessment, data governance checks, monitoring setup, documentation, and post-market follow-up. This service helps you meet those requirements through structured implementation phases.
How does AI Assessment Service related to ISO/IEC 42001 certification?
The output of the AI assessment includes everything needed to support an AI Management System (AIMS), including policy structure, risk controls, continuous monitoring, and audit trail documentation, fully aligned with ISO/IEC 42001:2023 and ISO/IEC 23894:2023.
Can your AI Assessment Service be tailored to our sector or internal frameworks?
Yes. All assessments are tailored to your sector (e.g. DORA in finance, NIS2 in essential services) and internal controls. We adapt the deliverables and methodology to match your compliance obligations, architecture, and maturity level.
Contact US
Start a conversation about trustworthy and compliant AI
Whether you are preparing for the EU AI Act, implementing an AI Management System (AIMS) under ISO/IEC 42001, or responding to public or private sector tender requirements, we help you design, assess, and document AI systems that comply with European standards for security, privacy, transparency, accountability, and human oversight.
Request an AI Impact Assessment consultation or share your upcoming use case. Our team will advise on the fastest path to compliance.
