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AI risk and lifecycle management
AI system design and development lifecycle process
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AI risk and lifecycle management

AI system design and development lifecycle process

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Task description

AI system design and development lifecycle process

The organisation should establish and document a formal process for the design and development of its AI systems. This lifecycle process should ensure that security and ethical principles are integrated at every stage, from data collection and model training to system testing. This ensures all AI engineering is conducted in a responsible and accountable manner.

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Task name
Priority
Policy
Other requirements
Staff guidance and training procedure in AI literacy
Critical
High
Normal
Low
AI risk and lifecycle management
2
requirements

Examples of other requirements this task affects

Article 4: Ensuring personnel have a sufficient level of AI literacy
AI Act (Base)
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Staff guidance and training procedure in AI literacy
Conducting and documenting AI risk assessments
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

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Conducting and documenting AI risk assessments
Conducting and documenting AI system impact assessments
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

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Conducting and documenting AI system impact assessments
Top management's commitment to the AI management system
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

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Top management's commitment to the AI management system
Documentation of high-risk AI system characteristics and intended purpose
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

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Documentation of high-risk AI system characteristics and intended purpose
Implementing, verifying, and updating the AI risk treatment plan
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

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Implementing, verifying, and updating the AI risk treatment plan
Process for AI system impact assessment
Critical
High
Normal
Low
AI risk and lifecycle management
2
requirements

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Process for AI system impact assessment
Context analysis for AI management
Critical
High
Normal
Low
AI risk and lifecycle management
2
requirements

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Context analysis for AI management
AI objective setting and management
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

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AI objective setting and management
Implementation and verification of responsible AI development controls
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

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Implementation and verification of responsible AI development controls
Identifying interested parties for the AI management system
Critical
High
Normal
Low
AI risk and lifecycle management
3
requirements

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Identifying interested parties for the AI management system
Policy portfolio harmonization for AI alignment
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

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Policy portfolio harmonization for AI alignment
Defining and communicating AI management system roles and responsibilities
Critical
High
Normal
Low
AI risk and lifecycle management
2
requirements

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Defining and communicating AI management system roles and responsibilities
AI system verification and validation procedures
Critical
High
Normal
Low
AI risk and lifecycle management
2
requirements

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AI system verification and validation procedures
AI policy development and communication
Critical
High
Normal
Low
AI risk and lifecycle management
2
requirements

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AI policy development and communication
Implementing operational controls for the AI management system
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

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Implementing operational controls for the AI management system
Establishing and maintaining an AI management system
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

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Establishing and maintaining an AI management system
Change management for the AI management system
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

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Change management for the AI management system
AI system design and development lifecycle process
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

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AI system design and development lifecycle process
AI system impact assessment -report publishing, informing and maintenance
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

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AI system impact assessment -report publishing, informing and maintenance
Leadership commitment to the effective management of AI systems
Critical
High
Normal
Low
AI risk and lifecycle management
2
requirements

Examples of other requirements this task affects

Article 4: Ensuring personnel have a sufficient level of AI literacy
AI Act (Base)
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Leadership commitment to the effective management of AI systems
Maintaining a log of AI literacy training
Critical
High
Normal
Low
AI risk and lifecycle management
2
requirements

Examples of other requirements this task affects

Article 4: Ensuring personnel have a sufficient level of AI literacy
AI Act (Base)
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Maintaining a log of AI literacy training
Appointment of personnel to monitor changes to AI system classifications
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

Examples of other requirements this task affects

Article 25.1-2: Conditions to be considered a provider of high-risk AI systems
AI Act (Base)
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Appointment of personnel to monitor changes to AI system classifications
Conformity assessment and registration of high-risk AI systems
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

Examples of other requirements this task affects

Article 16: Obligations for providers of high-risk AI systems
AI Act (Base)
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Conformity assessment and registration of high-risk AI systems
Technical documentation for high-risk AI systems
Critical
High
Normal
Low
AI risk and lifecycle management
2
requirements

Examples of other requirements this task affects

Article 16: Obligations for providers of high-risk AI systems
AI Act (Base)
Article 11: Technical documentation
AI Act (Base)
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Technical documentation for high-risk AI systems
Post-market monitoring and corrective actions for high-risk AI systems
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

Examples of other requirements this task affects

Article 16: Obligations for providers of high-risk AI systems
AI Act (Base)
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Post-market monitoring and corrective actions for high-risk AI systems
Quality management equivalencies for financial institutions
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

Examples of other requirements this task affects

Article 17.4: Quality management systems for financial institutions
AI Act (Base)
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Quality management equivalencies for financial institutions
Conformity process for distributors of high-risk AI systems
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

Examples of other requirements this task affects

Article 24: Declaration of conformity for distributors of high-risk AI systems
AI Act (Base)
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Conformity process for distributors of high-risk AI systems
Operational process for deployed high-risk AI systems
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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Operational process for deployed high-risk AI systems
Process for monitoring high-risk AI systems
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

Examples of other requirements this task affects

Article 26.5: Monitoring the operation of deployed high-risk AI systems
AI Act (Base)
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Process for monitoring high-risk AI systems
Maintaining a log of monitoring activities of deployed high-risk AI systems
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

Examples of other requirements this task affects

Article 26.5: Monitoring the operation of deployed high-risk AI systems
AI Act (Base)
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Maintaining a log of monitoring activities of deployed high-risk AI systems
Log retention policy for deployed high-risk AI systems
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

Examples of other requirements this task affects

Article 26.6: Minimum log retention periods in deployed high-risk AI systems
AI Act (Base)
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Log retention policy for deployed high-risk AI systems
Impact assessment procedure for AI systems
Critical
High
Normal
Low
AI risk and lifecycle management
4
requirements

Examples of other requirements this task affects

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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Impact assessment procedure for AI systems
Fundamental rights assessment -report publishing, informing and maintenance
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

Examples of other requirements this task affects

Article 27.1-4: Fundamental rights impact assessment prior to deployment of high-risk AI systems
AI Act (Base)
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Fundamental rights assessment -report publishing, informing and maintenance
Evaluation of AI risk management measures in the risk management phase
Critical
High
Normal
Low
AI risk and lifecycle management
2
requirements

Examples of other requirements this task affects

Article 9.4: Considerations for risk management measures
AI Act (Base)
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Evaluation of AI risk management measures in the risk management phase
Acceptance of overall residual AI risk
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

Examples of other requirements this task affects

Article 9.5: Risk management measures
AI Act (Base)
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Acceptance of overall residual AI risk
Mitigation and control measures for AI risks
Critical
High
Normal
Low
AI risk and lifecycle management
2
requirements

Examples of other requirements this task affects

Article 9.5: Risk management measures
AI Act (Base)
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Mitigation and control measures for AI risks
Testing plan for high-risk AI systems
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

Examples of other requirements this task affects

Article 9.8: Testing frequency and metrics
AI Act (Base)
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Testing plan for high-risk AI systems
Documentation of AI system design and development
Critical
High
Normal
Low
AI risk and lifecycle management
2
requirements

Examples of other requirements this task affects

Article 10.2: Management of training, validation and testing data sets
AI Act (Base)
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Documentation of AI system design and development
Logging capabilities for high-risk AI systems
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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Logging capabilities for high-risk AI systems
Amount, competence and adequacy of human oversight personnel
Critical
High
Normal
Low
AI risk and lifecycle management
3
requirements

Examples of other requirements this task affects

Article 14: Effective human oversight of high-risk AI-systems
AI Act (Base)
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Amount, competence and adequacy of human oversight personnel
Management of AI-specific cybersecurity risks
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

Examples of other requirements this task affects

Article 15.5: Cybersecurity and resilience against manipulation attempts
AI Act (Base)
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Management of AI-specific cybersecurity risks
AI cybersecurity incident response plan
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

Examples of other requirements this task affects

Article 15.5: Cybersecurity and resilience against manipulation attempts
AI Act (Base)
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AI cybersecurity incident response plan
Verification process for imported high-risk AI systems
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

Examples of other requirements this task affects

Article 23: Declaration of conformity for importers of high-risk AI systems
AI Act (Base)
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Verification process for imported high-risk AI systems
Handling non-conformities in imported high-risk AI systems
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

Examples of other requirements this task affects

Article 23: Declaration of conformity for importers of high-risk AI systems
AI Act (Base)
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Handling non-conformities in imported high-risk AI systems
Internal control procedure for conformity assessment
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

Examples of other requirements this task affects

Article 43.1: Conformity assessment procedure for providers of high-risk AI systems
AI Act (Base)
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Internal control procedure for conformity assessment
Internal conformity assessment procedure 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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Internal conformity assessment procedure for high-risk AI systems
Process for managing substantial modifications to AI systems
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

Examples of other requirements this task affects

Article 43.4: Conditions for high-risk AI systems to undergo a new conformity assessment procedure
AI Act (Base)
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Process for managing substantial modifications to AI systems
Policy on CE marking responsibility and usage 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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Policy on CE marking responsibility and usage for high-risk AI systems
Management of serious incidents during real-world AI testing
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

Examples of other requirements this task affects

Article 60.7: Reporting of serious incidents connected to real-world testing of high-risk AI systems
AI Act (Base)
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Management of serious incidents during real-world AI testing
Registration of AI systems before market placement
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 before market placement
Considering AI risks in the ISMS
Critical
High
Normal
Low
AI risk and lifecycle management
3
requirements

Examples of other requirements this task affects

Article 9.1: Establishing a risk management system for high-risk AI systems
AI Act (Base)
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Considering AI risks in the ISMS
AI risk assessment process establishment and management
Critical
High
Normal
Low
AI risk and lifecycle management
3
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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AI risk assessment process establishment and management
Adopting a code of practice for general-purpose AI 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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Adopting a code of practice for general-purpose AI models
Appointment of an authorised representative for GPAI model providers from outside the EU
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

Examples of other requirements this task affects

Article 54: Authorised representatives of providers of general-purpose AI models
AI Act (GPAI)
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Appointment of an authorised representative for GPAI model providers from outside the EU
Evaluating and managing systemic risk in GPAI models
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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Evaluating and managing systemic risk in GPAI models
Process for cooperating with competent authorities
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

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Article 52.3: Cooperation with competent authorities for providers of general purpose AI models
AI Act (GPAI)
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Process for cooperating with competent authorities
Support for authorised representatives of GPAI model providers
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

Examples of other requirements this task affects

Article 54: Authorised representatives of providers of general-purpose AI models
AI Act (GPAI)
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Support for authorised representatives of GPAI model providers
AI system operational procedures and monitoring
Critical
High
Normal
Low
AI risk and lifecycle management
1
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AI system operational procedures and monitoring
Integrating customer expectations into AI development and usage
Critical
High
Normal
Low
AI risk and lifecycle management
1
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Integrating customer expectations into AI development and usage
Consideration of technical, societal, and legal environment in AI impact assessments
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

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Consideration of technical, societal, and legal environment in AI impact assessments
Defining objectives for responsible AI
Critical
High
Normal
Low
AI risk and lifecycle management
2
requirements

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Defining objectives for responsible AI
Secure storage of AI system impact assessment documentation
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

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Secure storage of AI system impact assessment documentation
AI policy
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

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AI policy
AI personnel competence management
Critical
High
Normal
Low
AI risk and lifecycle management
1
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AI personnel competence management
AI supplier management procedure
Critical
High
Normal
Low
AI risk and lifecycle management
1
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AI supplier management procedure
Documentation of AI system resources and activities
Critical
High
Normal
Low
AI risk and lifecycle management
1
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Documentation of AI system resources and activities
AI risk and opportunity management
Critical
High
Normal
Low
AI risk and lifecycle management
1
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AI risk and opportunity management
Documenting personnel skills and roles in AI system life cycle
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

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Documenting personnel skills and roles in AI system life cycle
AI system deployment plan
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

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AI system deployment plan
AI policy review and validation
Critical
High
Normal
Low
AI risk and lifecycle management
2
requirements

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AI policy review and validation
Defining and documenting AI system requirements
Critical
High
Normal
Low
AI risk and lifecycle management
2
requirements

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Defining and documenting AI system requirements
Identifying specific risks of harm in AI fundamental rights impact assessment
Critical
High
Normal
Low
AI risk and lifecycle management
1
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Identifying specific risks of harm in AI fundamental rights impact assessment
Review of AI management system resource sufficiency
Critical
High
Normal
Low
AI risk and lifecycle management
1
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Review of AI management system resource sufficiency
Process for AI risk treatment and control implementation
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

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Process for AI risk treatment and control implementation
AI management system resource management
Critical
High
Normal
Low
AI risk and lifecycle management
1
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AI management system resource management
Maintaining an inventory of AI system tools
Critical
High
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Low
AI risk and lifecycle management
1
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Maintaining an inventory of AI system tools
Societal impact assessment for AI systems
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

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Societal impact assessment for AI systems
Assessment of foreseeable AI system abuses
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

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Assessment of foreseeable AI system abuses
AI system impact assessment documentation
Critical
High
Normal
Low
AI risk and lifecycle management
3
requirements

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AI system impact assessment documentation
AI system use verification
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

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AI system use verification
Establishing documented processes for the responsible use of AI systems
Critical
High
Normal
Low
AI risk and lifecycle management
3
requirements

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Establishing documented processes for the responsible use of AI systems
AI-related concern reporting mechanism
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

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AI-related concern reporting mechanism
Defining responsibilities for AI system lifecycle management
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

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Defining responsibilities for AI system lifecycle management
AI objectives and organizational policies
Critical
High
Normal
Low
AI risk and lifecycle management
2
requirements

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AI objectives and organizational policies
AI system impact assessment on individuals and groups
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

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AI system impact assessment on individuals and groups
Transparency in the AI development lifecycle
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

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Transparency in the AI development lifecycle
Awareness and mitigation of automation bias in AI system use
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

Examples of other requirements this task affects

Article 4: Ensuring personnel have a sufficient level of AI literacy
AI Act (Base)
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Awareness and mitigation of automation bias in AI system use
Unit or role-specific AI literacy program
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

Examples of other requirements this task affects

Article 4: Ensuring personnel have a sufficient level of AI literacy
AI Act (Base)
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Unit or role-specific AI literacy program
Implementing changes to AI system classifications
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

Examples of other requirements this task affects

Article 25.3: Manufacturer conditions for AI systems as safety components of products
AI Act (Base)
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Implementing changes to AI system classifications
Code of conduct for organisations deploying or providing AI systems
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

Examples of other requirements this task affects

Article 95.3: Code of conduct for providers or deployers of AI systems and their organisations
AI Act (Base)
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Code of conduct for organisations deploying or providing AI systems
Process for managing classification changes for AI systems
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

Examples of other requirements this task affects

Article 25.1-2: Conditions to be considered a provider of high-risk AI systems
AI Act (Base)
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Process for managing classification changes for AI systems
Automatic log-generation for high-risk AI systems
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

Examples of other requirements this task affects

Article 16: Obligations for providers of high-risk AI systems
AI Act (Base)
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Automatic log-generation for high-risk AI systems
Cooperation with national competent authorities for providers of high-risk AI systems
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

Examples of other requirements this task affects

Article 16: Obligations for providers of high-risk AI systems
AI Act (Base)
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Cooperation with national competent authorities for providers of high-risk AI systems
Termination clause in the authorised representative's mandate
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

Examples of other requirements this task affects

Article 22: Authorised representatives of high-risk AI system providers
AI Act (Base)
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Termination clause in the authorised representative's mandate
Appointment and responsibilities of the authorised representative of providers of high-risk AI systems
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

Examples of other requirements this task affects

Article 22: Authorised representatives of high-risk AI system providers
AI Act (Base)
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Appointment and responsibilities of the authorised representative of providers of high-risk AI systems
Secure storage and transport of distributed high-risk AI systems
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

Examples of other requirements this task affects

Article 24: Declaration of conformity for distributors of high-risk AI systems
AI Act (Base)
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Secure storage and transport of distributed high-risk AI systems
Notification procedure for risks in distributed high-risk AI systems
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

Examples of other requirements this task affects

Article 24: Declaration of conformity for distributors of high-risk AI systems
AI Act (Base)
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Notification procedure for risks in distributed high-risk AI systems
Incident reporting for deployed high-risk AI systems
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

Examples of other requirements this task affects

Article 26.5: Monitoring the operation of deployed high-risk AI systems
AI Act (Base)
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Incident reporting for deployed high-risk AI systems
Monitoring equivalencies for high-risk AI systems deployed by financial institutions
Critical
High
Normal
Low
AI risk and lifecycle management
2
requirements

Examples of other requirements this task affects

Article 26.5: Monitoring the operation of deployed high-risk AI systems
AI Act (Base)
Article 26.6: Minimum log retention periods in deployed high-risk AI systems
AI Act (Base)
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Monitoring equivalencies for high-risk AI systems deployed by financial institutions

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