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AI risk and lifecycle management
Impact assessment procedure for AI systems
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AI risk and lifecycle management

Impact assessment procedure for AI systems

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Task description

Impact assessment procedure for AI systems

The organisation should formally assess the impact of its AI systems on individuals, groups and society prior to deployment. This is particularly relevant for public bodies, providers of public services, and deployers of AI systems in employment and credit evaluation.

The assessment should include:

  • A description of the processes where the AI system will be used.
  • The intended period and frequency of use.
  • The groups of people likely to be affected.
  • The impact on minors and other vulnerable groups
  • The specific risks of harm to those groups and measures to mitigate them.
  • A description of the planned human oversight measures.

The assessment should be updated if any core system elements change during use. It should complement existing Data Protection Impact Assessments (DPIAs) where applicable.

Requirements connected to the task

Article 27.1-4: Fundamental rights impact assessment prior to deployment of high-risk AI systems
AI Act (Base)
Article 9.2: Risk management system planning, processes and maintenance
AI Act (Base)
Article 9.9: Considering the impact on vulnerable groups in risk management
AI Act (Base)

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Submission of the quality management system and technical documentation to a notified body
Pre-market Declaration of Conformity preparation for high-risk AI systems
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

Examples of other requirements this task affects

Article 43.2: Conformity assessment procedure for providers of high-risk AI systems listed in Annex III
AI Act (Base)
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Pre-market Declaration of Conformity preparation for high-risk AI systems
Verification and documentation of the internal conformity assessment
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

Examples of other requirements this task affects

Article 43.2: Conformity assessment procedure for providers of high-risk AI systems listed in Annex III
AI Act (Base)
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Verification and documentation of the internal conformity assessment
CE marking for high-risk AI systems
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

Examples of other requirements this task affects

Article 43.2: Conformity assessment procedure for providers of high-risk AI systems listed in Annex III
AI Act (Base)
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CE marking for high-risk AI systems
Process for conformity assessment of AI systems under existing legislation
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

Examples of other requirements this task affects

Article 43.3: Conformity assessment procedure for providers of high-risk AI systems covered by EU harmonisation legislation
AI Act (Base)
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Process for conformity assessment of AI systems under existing legislation
Specific documentation for combined conformity assessments
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

Examples of other requirements this task affects

Article 43.3: Conformity assessment procedure for providers of high-risk AI systems covered by EU harmonisation legislation
AI Act (Base)
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Specific documentation for combined conformity assessments
Selection of a Notified Body for combined assessments
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

Examples of other requirements this task affects

Article 43.3: Conformity assessment procedure for providers of high-risk AI systems covered by EU harmonisation legislation
AI Act (Base)
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Selection of a Notified Body for combined assessments
Creation, management and maintenance of declarations of conformity for high-risk AI systems
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

Examples of other requirements this task affects

Article 47: EU declaration of conformity
AI Act (Base)
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Creation, management and maintenance of declarations of conformity for high-risk AI systems
Process for CE marking of high-risk AI systems
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

Examples of other requirements this task affects

Article 48: CE markings for high-risk AI systems
AI Act (Base)
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Process for CE marking of high-risk AI systems
Register of CE marking for high-risk AI systems
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

Examples of other requirements this task affects

Article 48: CE markings for high-risk AI systems
AI Act (Base)
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Register of CE marking for high-risk AI systems
Process for cooperation with competent authorities
Critical
High
Normal
Low
AI risk and lifecycle management
2
requirements

Examples of other requirements this task affects

Article 17.1 (QMS instructions): Quality management instructions
AI Act (Base)
Article 21: Cooperation with competent authorities
AI Act (Base)
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Process for cooperation with competent authorities
Creating post-market monitoring plans for high-risk AI systems
Critical
High
Normal
Low
AI risk and lifecycle management
2
requirements

Examples of other requirements this task affects

Article 17.1 (QMS instructions): Quality management instructions
AI Act (Base)
Article 72: Post-market monitoring and monitoring plan for high-risk AI systems
AI Act (Base)
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Creating post-market monitoring plans for high-risk AI systems
Process for post-market data collection and analysis
Critical
High
Normal
Low
AI risk and lifecycle management
2
requirements

Examples of other requirements this task affects

Article 9.2: Risk management system planning, processes and maintenance
AI Act (Base)
Article 72: Post-market monitoring and monitoring plan for high-risk AI systems
AI Act (Base)
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Process for post-market data collection and analysis
Procedure for serious AI incident reporting
Critical
High
Normal
Low
AI risk and lifecycle management
2
requirements

Examples of other requirements this task affects

Article 17.1 (QMS instructions): Quality management instructions
AI Act (Base)
Article 73: Incident reporting procedure for providers of high-risk AI systems
AI Act (Base)
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Procedure for serious AI incident reporting
Record of serious AI incidents and corrective actions
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

Examples of other requirements this task affects

Article 73: Incident reporting procedure for providers of high-risk AI systems
AI Act (Base)
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Record of serious AI incidents and corrective actions
Process for authority notifications on AI testing
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

Examples of other requirements this task affects

Article 60.8: Notification of national market authorities where real-world testing is conducted
AI Act (Base)
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Process for authority notifications on AI testing
Registration of AI systems in critical infrastructure
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

Examples of other requirements this task affects

Article 49: Registration of AI systems
AI Act (Base)
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Registration of AI systems in critical infrastructure
Process for managing modifications to high-risk AI systems
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

Examples of other requirements this task affects

Article 17.1 (QMS policy): Quality management policy
AI Act (Base)
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Process for managing modifications to high-risk AI systems
Process for notifying stakeholders about AI system non-compliance
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

Examples of other requirements this task affects

Article 20: Corrective actions and duty of information
AI Act (Base)
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Process for notifying stakeholders about AI system non-compliance
AI system event logging planning and implementation
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

Examples of other requirements this task affects

Article 12: Record-keeping (logs)
AI Act (Base)
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AI system event logging planning and implementation
Defining AI roles and responsibilities
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

Examples of other requirements this task affects

Article 26.1-4: Technical and organisational obligations for deployers of high-risk AI-systems
AI Act (Base)
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Defining AI roles and responsibilities
Mitigation and control measures for residual AI risks
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

Examples of other requirements this task affects

Article 9.2: Risk management system planning, processes and maintenance
AI Act (Base)
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Mitigation and control measures for residual AI risks
Confidentiality of GPAI model information and documentation
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

Examples of other requirements this task affects

Article 55: Obligations for providers of general-purpose AI models with systemic risk
AI Act (GPAI)
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Confidentiality of GPAI model information and documentation
Copyright compliance policy for GPAI model training
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

Examples of other requirements this task affects

Article 53.1-2: Maintaining accurate and up-to-date technical information of general purpose AI models
AI Act (GPAI)
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Copyright compliance policy for GPAI model training
Alternative compliance demonstration for GPAI models
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

Examples of other requirements this task affects

Article 53.4: Codes of practice for providers of general-purpose AI models
AI Act (GPAI)
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Alternative compliance demonstration for GPAI models
Compliance with harmonised standards for GPAI models
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

Examples of other requirements this task affects

Article 53.4: Codes of practice for providers of general-purpose AI models
AI Act (GPAI)
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Compliance with harmonised standards for GPAI models

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