Conformity Assessment Guide

Step-by-step guide for EU AI Act conformity assessment process

Progress: 0%

Project/System Name

Assessment Start Date

Lead Assessor

Target Completion Date

1-2 weeks

Not Started

0/6

2-3 weeks

Not Started

0/6

3-4 weeks

Not Started

0/8

8-16 weeks

Not Started

0/9

4-8 weeks

Not Started

0/9

Identify if the system is an AI system under Article 3(1) definition

Determine if the system is excluded under Article 2

Assess if the system is used for military, defense, or national security

Check if the system is used for research and development only

Document the intended purpose and use cases

Identify all stakeholders and their roles

Check against prohibited AI practices (Article 5)

Evaluate against high-risk criteria (Annex III)

Assess if system is a safety component of regulated product

Determine if limited risk transparency obligations apply

Document classification rationale with evidence

Obtain legal review of classification decision

Review risk management system requirements (Article 9)

Assess data governance practices (Article 10)

Evaluate technical documentation completeness (Annex IV)

Check record-keeping capabilities (Article 12)

Review transparency and information provisions (Article 13)

Assess human oversight mechanisms (Article 14)

Evaluate accuracy, robustness, and cybersecurity (Article 15)

Document all identified gaps with priority levels

Develop and implement risk management system

Establish data governance framework

Create comprehensive technical documentation

Implement logging and record-keeping systems

Develop user information and instructions

Design and implement human oversight controls

Conduct accuracy and robustness testing

Implement cybersecurity measures

Train relevant personnel on new procedures

Determine applicable conformity assessment procedure

Prepare quality management system documentation

Compile technical documentation package

Conduct internal audit of compliance measures

Engage notified body if required (Annex III systems)

Address any non-conformities identified

Obtain conformity assessment certificate if applicable

Prepare EU declaration of conformity

Affix CE marking to system/documentation

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Conformity Assessment Guide

Phase 1: Initial AssessmentDetermine if your AI system falls under EU AI Act scope1-2 weeksNot Started0/6

Phase 2: Risk ClassificationClassify your AI system according to risk categories2-3 weeksNot Started0/6

Phase 3: Requirements Gap AnalysisIdentify gaps between current state and compliance requirements3-4 weeksNot Started0/8

Phase 4: ImplementationImplement required changes and controls8-16 weeksNot Started0/9

Phase 5: Conformity AssessmentComplete the formal conformity assessment procedure4-8 weeksNot Started0/9

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