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AI risk and lifecycle management
AI risk assessment process establishment and management
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AI risk and lifecycle management

AI risk assessment process establishment and management

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Task description

AI risk assessment process establishment and management

The organization should establish and maintain a process for assessing AI risks. This process must be guided by the organization's AI policy and AI objectives, ensuring that subsequent assessments yield consistent, valid, and comparable results.

The process should identify risks that could either help or hinder the achievement of the organization's AI objectives. Risk analysis should involve evaluating the potential consequences for the organization, people, and society, assessing the probability of these risks where possible, and establishing the levels of these risks.

Thhe process should also inlcude evaluating AI risks by comparing the analysis results against the defined risk criteria and prioritizing the identified risks for subsequent treatment. Documented information concerning the AI risk assessment process and its results should be maintained.

Requirements connected to the task

Article 9.2: Risk management system planning, processes and maintenance
AI Act (Base)

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Task name
Priority
Policy
Other requirements
Staff guidance and training procedure in AI literacy
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Article 4: Ensuring personnel have a sufficient level of AI literacy
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Critical
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Article 4: Ensuring personnel have a sufficient level of AI literacy
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Critical
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Article 16: Obligations for providers of high-risk AI systems
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Low
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Examples of other requirements this task affects

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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
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requirements

Examples of other requirements this task affects

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Post-market monitoring and corrective actions for high-risk AI systems
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Critical
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Article 17.4: Quality management systems for financial institutions
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Critical
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Low
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Operational process for deployed high-risk AI systems
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Article 26.5: Monitoring the operation of deployed high-risk AI systems
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Impact assessment procedure for AI systems
Critical
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Impact assessment procedure for AI systems
Fundamental rights assessment -report publishing, informing and maintenance
Critical
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Critical
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Examples of other requirements this task affects

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Examples of other requirements this task affects

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Critical
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AI risk and lifecycle management
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Article 60.7: Reporting of serious incidents connected to real-world testing of high-risk AI systems
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Critical
High
Normal
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AI risk and lifecycle management
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Examples of other requirements this task affects

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Critical
High
Normal
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AI risk and lifecycle management
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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
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AI risk and lifecycle management
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Examples of other requirements this task affects

Article 9.2: Risk management system planning, processes and maintenance
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Adopting a code of practice for general-purpose AI models
Critical
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AI risk and lifecycle management
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Examples of other requirements this task affects

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Adopting a code of practice for general-purpose AI models
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Critical
High
Normal
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AI risk and lifecycle management
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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
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Critical
High
Normal
Low
AI risk and lifecycle management
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requirements

Examples of other requirements this task affects

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Process for cooperating with competent authorities
Critical
High
Normal
Low
AI risk and lifecycle management
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requirements

Examples of other requirements this task affects

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
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requirements

Examples of other requirements this task affects

Article 54: Authorised representatives of providers of general-purpose AI models
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Critical
High
Normal
Low
AI risk and lifecycle management
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Examples of other requirements this task affects

Article 4: Ensuring personnel have a sufficient level of AI literacy
AI Act (Base)
See all related requirements and other information from tasks own page.
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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)
See all related requirements and other information from tasks own page.
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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
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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
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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
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requirements

Examples of other requirements this task affects

Article 16: Obligations for providers of high-risk AI systems
AI Act (Base)
See all related requirements and other information from tasks own page.
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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
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requirements

Examples of other requirements this task affects

Article 16: Obligations for providers of high-risk AI systems
AI Act (Base)
See all related requirements and other information from tasks own page.
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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
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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
Critical
High
Normal
Low
AI risk and lifecycle management
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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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Secure storage and transport of distributed high-risk AI systems
Critical
High
Normal
Low
AI risk and lifecycle management
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Critical
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Critical
High
Normal
Low
AI risk and lifecycle management
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Examples of other requirements this task affects

Article 26.5: Monitoring the operation of deployed high-risk AI systems
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Incident reporting for deployed high-risk AI systems
Monitoring equivalencies for high-risk AI systems deployed by financial institutions
Critical
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Low
AI risk and lifecycle management
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Examples of other requirements this task affects

Article 26.5: Monitoring the operation of deployed high-risk AI systems
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Monitoring equivalencies for high-risk AI systems deployed by financial institutions
Technical implementation of AI system log retention
Critical
High
Normal
Low
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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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Technical implementation of AI system log retention
Registration of high-risk AI system registration before deployment
Critical
High
Normal
Low
AI risk and lifecycle management
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Article 26.8: Registration of deployed high-risk AI systems for public authorities and union institutions
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Critical
High
Normal
Low
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Notification of fundamental rights impact assessment
Critical
High
Normal
Low
AI risk and lifecycle management
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Internal governance and complaint mechanisms for AI systems
Critical
High
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Critical
High
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Article 27.1-4: Fundamental rights impact assessment prior to deployment of high-risk AI systems
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Use of previous impact assessments for AI systems
Review of explanation obligations for AI systems
Critical
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AI risk and lifecycle management
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Article 86: Right to explanation of individual decision-making
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Review of explanation obligations for AI systems
Identification and documentation of risks in AI systems
Critical
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Identification and documentation of risks in AI systems
Documentation of linked risks for identified incidents in AI systems
Critical
High
Normal
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AI risk and lifecycle management
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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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Documentation of linked risks for identified incidents in AI systems
Evaluation process and documentation of significant changes to high-risk AI systems
Critical
High
Normal
Low
AI risk and lifecycle management
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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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AI Act (Base)
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Evaluation process and documentation of significant changes to high-risk AI systems
Evaluation of risks from foreseeable misuse of high-risk AI systems
Critical
High
Normal
Low
AI risk and lifecycle management
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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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Evaluation of risks from foreseeable misuse of high-risk AI systems
Defining and documenting risk management metrics for AI systems
Critical
High
Normal
Low
AI risk and lifecycle management
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requirements

Examples of other requirements this task affects

Article 9.5: Risk management measures
AI Act (Base)
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Defining and documenting risk management metrics for AI systems
Testing of high-risk AI systems
Critical
High
Normal
Low
AI risk and lifecycle management
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requirements

Examples of other requirements this task affects

Article 9.6: Testing for risk management measures and compliance
AI Act (Base)
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Testing of high-risk AI systems
Definition of testing metrics and thresholds 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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Definition of testing metrics and thresholds for high-risk AI systems
Unified technical documentation for AI systems in regulated products
Critical
High
Normal
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AI risk and lifecycle management
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requirements

Examples of other requirements this task affects

Article 11: Technical documentation
AI Act (Base)
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Unified technical documentation for AI systems in regulated products
Simplified technical documentation for SMEs and start-ups
Critical
High
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AI risk and lifecycle management
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requirements

Examples of other requirements this task affects

Article 11: Technical documentation
AI Act (Base)
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Simplified technical documentation for SMEs and start-ups
Specification of AI system log content
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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Specification of AI system log content
Built-in human oversight mechanisms for high-risk AI systems
Critical
High
Normal
Low
AI risk and lifecycle management
1
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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Built-in human oversight mechanisms for high-risk AI systems
Analysis of human oversight measures for high-risk AI systems
Critical
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Normal
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AI risk and lifecycle management
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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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Analysis of human oversight measures for high-risk AI systems
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Critical
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Article 15.1: Accuracy, robustness and cybersecurity of high-risk AI systems
AI Act (Base)
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Technical requirements for AI system performance and security
Measures against feedback loops in learning AI systems
Critical
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AI risk and lifecycle management
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Examples of other requirements this task affects

Article 15.4: Robustness against errors and mitigation of feedback loops
AI Act (Base)
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Measures against feedback loops in learning AI systems
Conformity assessment process for high-risk AI systems
Critical
High
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AI risk and lifecycle management
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Examples of other requirements this task affects

Article 17.1 (QMS policy): Quality management policy
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Conformity assessment process for high-risk AI systems
Submission of the quality management system and technical documentation to a notified body
Critical
High
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AI risk and lifecycle management
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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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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
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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)
See all related requirements and other information from tasks own page.
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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)
See all related requirements and other information from tasks own page.
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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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