+Artikel 8 Förenlighet med kraven
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Artikel 8 Förenlighet med kraven
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1. Översikt
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Reglering |
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Artikel 8 1.
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AI-system med hög risk ska uppfylla kraven i detta avsnitt, med beaktande av deras avsedda ändamål samt den allmänt erkända senaste utvecklingen inom AI och AI-relaterad teknik. Det riskhanteringssystem som avses i artikel 9 ska beaktas när förenligheten med dessa krav säkerställs.
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Artikel 8 2.
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Om en produkt innehåller ett AI-system som omfattas av kraven i denna förordning och kraven i unionens harmoniseringslagstiftning som förtecknas i avsnitt A i bilaga I, ska leverantörer ansvara för att säkerställa att deras produkt uppfyller alla tillämpliga krav i tillämplig unionsharmoniseringslagstiftning. Vid säkerställandet av att AI-system med hög risk som avses i punkt 1 överensstämmer med kraven i detta avsnitt, och för att säkerställa samstämmighet, motverka dubbelarbete och minimera ytterligare bördor, ska leverantörer kunna välja att, beroende på vad som är lämpligt, integrera de nödvändiga test- och rapporteringsprocesserna, den information och den dokumentation som de tillhandahåller med avseende på sin produkt i dokumentation och förfaranden som redan finns och som krävs enligt unionens harmoniseringslagstiftning som förtecknas i avsnitt A i bilaga I.
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1.1 Referenser
1.2 Identifierade krav
1.3 Relaterade standarder
2. Identifierade krav
3. Relaterade standarder
Standarder
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Krav |
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SCF
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AI & Autonomous Technologies Context Definition
Description
Mechanisms exist to establish and document the context surrounding Artificial Intelligence (AI) and Autonomous Technologies (AAT), including:
(1) Intended purposes;
(2) Potentially beneficial uses;
(3) Context-specific laws and regulations;
(4) Norms and expectations; and
(5) Prospective settings in which the system(s) will be deployed.
Possible Solutions & Considerations
Micro-Small Business (<10 staff) / BLS Firm Size Classes 1-2
∙ AI use case documentation (purpose, data used, decisions made)
∙ AI governance program
Small Business (10-49 staff) / BLS Firm Size Classes 3-4
∙ AI context documentation for each deployed system
∙ AI governance program
∙ NIST AI RMF Map function
Medium Business (50-249 staff) / BLS Firm Size Classes 5-6
∙ Formal AI context definition process (intended use, users, environment)
∙ NIST AI RMF Map function - context characterization
∙ AI governance program
Large Business (250-999 staff) / BLS Firm Size Classes 7-8
∙ Formal AI context definition integrated with AI governance program
∙ NIST AI RMF Map function - full context characterization
∙ AI use case registry with context documentation
Enterprise (> 1,000 staff) / BLS Firm Size Class 9
∙ Enterprise AI context definition framework
∙ NIST AI RMF Map function at enterprise scale
∙ AI context documentation integrated with AI system registry
∙ Regulatory context considerations (EU AI Act risk classification)
SCR-CMM
Level 0 Not Performed
Practices are non-existent, based on the inability to demonstrate an implemented and operational capability. A reasonable person would conclude the control is not being performed.
Level 1 Performed Informally
Artificial Intelligence and Autonomous Technology (AAT) domain capabilities are ad hoc and inconsistent. Capability criteria associated with this control may include:
▪ Policies, standards & procedures associated with AAT domain capabilities provide limited coverage due to the depth and breadth of the existing documentation.
▪ AAT-related processes are expected to follow the organization's existing processes (e.g., incident response, asset management, change control and risk assessments).
▪ No formal Governance, Risk & Compliance (GRC) team exists to provide AAT oversight, where the Chief Information Officer (CIO), or similar function, governs technology decisions what is acceptable for AAT within the organization.
Level 2 Planned Tracked
Artificial Intelligence and Autonomous Technology (AAT) capabilities are requirements-driven, but are not standardized across the entity (e.g., local/regional level consistency). Capability criteria associated with this control reasonably expect the following criteria to exist:
▪ Policies and standards associated with AAT domain capabilities are formally documented and centrally-managed by the entity.
▪ Standardized Operating Procedures (SOP) associated with AAT domain capabilities are documented and maintained by process owners.
▪ IT and/or cybersecurity personnel work with business stakeholders and process owners to appropriately scope and reasonably implement cybersecurity and data protection controls associated with AAT domain capabilities to address applicable statutory, regulatory and/or contractual requirements for Technology Assets, Applications, Services and/or Data (TAASD).
▪ Artificial Intelligence (AI)-related controls are primarily administrative and preventative in nature (e.g., policies, standards and procedures & guidelines).
▪ Asset management may be a defined function (e.g., team or department) or assigned as an additional duty to existing IT and/or cybersecurity personnel.
▪ AAT is regarded as a technology and governed by the entity's existing IT governance practices.
▪ No formal Governance, Risk & Compliance (GRC) team exists to provide oversight of AAT-related activities. GRC functions are assigned to existing IT and/or cybersecurity personnel.
Level 3 Well Defined
Artificial Intelligence and Autonomous Technology (AAT) capabilities are standardized across the entity for applicability to People, Processes, Technologies, Data and/or Facilities (PPTDF) to ensure consistency for Technology Assets, Applications, Services and/or Data (TAASD). Capability criteria associated with this control reasonably expect the following criteria to exist:
▪ Policies and standards associated with AAT domain capabilities are formally documented and centrally-managed by the entity's Governance, Risk & Compliance (GRC) team, or similar function.
▪ Standardized Operating Procedures (SOP) associated with AAT domain capabilities are well-documented and kept current by process owners.
▪ An Artificial Intelligence Governance (AIG) team, or similar function, is appropriately staffed and supported to implement and maintain AAT domain capabilities.
▪ Technology is leveraged to enhance the efficiency and accuracy of AI governance, risk management and compliance operations (e.g., dedicated AI governance platform).
▪ The entity's Governance, Risk & Compliance (GRC) team, or similar function, works with business stakeholders and process owners to appropriately scope and reasonably implement cybersecurity and data protection controls associated with AAT domain capabilities to address Minimum Compliance Requirements (MCR) (e.g., applicable statutory, regulatory and/or contractual requirements) and Discretionary Security Requirements (DSR) (e.g., entity-required controls).
▪ An implemented and operational capability exists to establish and document the context surrounding AAT, including:
(1) Intended purposes;
(2) Potentially beneficial uses;
(3) Context-specific laws and regulations;
(4) Norms and expectations; and
(5) Prospective settings in which the system(s) will be deployed.
Level 4 Quantitatively Controlled
Utilize SCR-CMM Level 3 criteria definitions:
▪ There are no defined Level 4 criteria, since it is reasonable to assume a quantitatively-controlled process is not necessary to operationalize this control.
▪ While it may be possible to develop “metrics-driven” capabilities for this control, the criteria would be organization-specific to define.
Level 5 Continuously Improving
Utilize SCR-CMM Level 3 or Level 4 (if available) criteria definitions:
▪ There are no defined Level 5 criteria, since it is reasonable to assume a continuously-improving process is not necessary to operationalize this control.
▪ Level 5 capabilities should be considered “world-class” where the control builds on Level 4 capabilities, but are continuously improving through Artificial Intelligence (AI) and/or Machine Learning (ML) technologies.
▪ While it may be possible to develop responsive capabilities for this control through the use of AI and/or ML technologies, the criteria would be organization-specific to define.
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SCF
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Risk Management Program
Description
Mechanisms exist to facilitate the implementation of strategic, operational and tactical risk management controls that are aligned with:
(1) The organization's Enterprise Risk Management (ERM); and
(2) Industry-recognized cybersecurity risk management practices.
Possible Solutions & Considerations
Micro-Small Business (<10 staff) / BLS Firm Size Classes 1-2
∙ Risk Management Program (RMP)
Small Business (10-49 staff) / BLS Firm Size Classes 3-4
∙ Risk Management Program (RMP)
Medium Business (50-249 staff) / BLS Firm Size Classes 5-6
∙ Risk Management Program (RMP)
Large Business (250-999 staff) / BLS Firm Size Classes 7-8
∙ Risk Management Program (RMP)
Enterprise (> 1,000 staff) / BLS Firm Size Class 9
∙ Risk Management Program (RMP)
SCR-CMM
Level 0 Not Performed
Practices are non-existent, based on the inability to demonstrate an implemented and operational capability. A reasonable person would conclude the control is not being performed.
Level 1 Performed Informally
Risk Management (RSK) domain capabilities are ad hoc and inconsistent. Capability criteria associated with this control may include:
▪ Policies, standards & procedures associated with RSK domain capabilities provide limited coverage due to the depth and breadth of the existing documentation.
▪ Risk management-related activities are decentralized (e.g., a localized/regionalized function) and uses non-standardized methods to implement secure, resilient and compliant practices.
▪ IT and/or cybersecurity personnel use an informal process to identify, assess, remediate and report on risk.
▪ Risk management processes (e.g., risk assessments) focus on protecting High Value Assets (HVAs), including environments where sensitive/regulated data is stored, transmitted and processed.
▪ Data/process owners are expected to self-manage risks associated with their Technology Assets, Applications, Services and/or Data (TAASD), based on the organization's published policies and standards, including the identification, remediation and reporting of risks.
Level 2 Planned Tracked
Risk Management (RSK) capabilities are requirements-driven, but are not standardized across the entity (e.g., local/regional level consistency). Capability criteria associated with this control reasonably expect the following criteria to exist:
▪ Policies and standards associated with RSK domain capabilities are formally documented and centrally-managed by the entity.
▪ Standardized Operating Procedures (SOP) associated with RSK domain capabilities are documented and maintained by process owners.
▪ IT and/or cybersecurity personnel work with business stakeholders and process owners to appropriately scope and reasonably implement cybersecurity and data protection controls associated with RSK domain capabilities to address applicable statutory, regulatory and/or contractual requirements for Technology Assets, Applications, Services and/or Data (TAASD).
▪ Risk management-related controls are primarily administrative and preventative in nature (e.g., policies, standards and procedures & guidelines).
▪ Risk management may be a defined function (e.g., team or department) or assigned as an additional duty to existing IT and/or cybersecurity personnel.
▪ Risk management processes (e.g., risk assessments) and technologies focus on protecting High Value Assets (HVAs), including environments where sensitive/regulated data is stored, transmitted and processed.
▪ IT and/or cybersecurity personnel implement and maintain a form of Risk Management Program (RMP) that provides operational guidance on how risk is identified, assessed, remediated and reported.
▪ Data/process owners are expected to self-manage risks associated with their systems, applications, services and data, based on the organization's published policies and standards, including the identification, remediation and reporting of risks.
▪ Business process owners (BPOs) are made aware of cybersecurity and data protection risk(s).
Level 3 Well Defined
Risk Management (RSK) capabilities are standardized across the entity for applicability to People, Processes, Technologies, Data and/or Facilities (PPTDF) to ensure consistency for Technology Assets, Applications, Services and/or Data (TAASD). Capability criteria associated with this control reasonably expect the following criteria to exist:
▪ Policies and standards associated with RSK domain capabilities are formally documented and centrally-managed by the entity's Governance, Risk & Compliance (GRC) team, or similar function.
▪ Standardized Operating Procedures (SOP) associated with RSK domain capabilities are well-documented and kept current by process owners.
▪ A risk management team, or similar function, is appropriately staffed and supported to implement and maintain RSK domain capabilities.
▪ Technology is leveraged to enhance the efficiency and accuracy of risk management operations (e.g., risk management solution, GRC platform and TPRM tool).
▪ The entity's Governance, Risk & Compliance (GRC) team, or similar function, works with business stakeholders and process owners to appropriately scope and reasonably implement cybersecurity and data protection controls associated with RSK domain capabilities to address Minimum Compliance Requirements (MCR) (e.g., applicable statutory, regulatory and/or contractual requirements) and Discretionary Security Requirements (DSR) (e.g., entity-required controls).
▪ An implemented and operational capability exists to facilitate the implementation of strategic, operational and tactical risk management controls.
Level 4 Quantitatively Controlled
Risk Management (RSK) capabilities, in addition to being standardized across the entity and centrally managed to ensure consistency across Technology Assets, Applications, Services and/or Data (TAASD), efforts are metrics driven to provide sufficient insight for decision makers to predict optimal performance, ensure continued operations and/or identify areas for improvement. Capability criteria associated with this control reasonably expect the following criteria to exist:
▪ Applicable SCR-CMM Level 3 (Well Defined) capabilities are implemented and operational.
▪ Metrics reporting includes quantitative analysis of Key Performance Indicators (KPIs).
▪ Metrics reporting includes quantitative analysis of Key Risk Indicators (KRIs).
▪ Scope of metrics, KPIs and KRIs covers organization-wide cybersecurity and data protection controls, including functions performed by third-parties.
▪ Organizational leadership maintains a formal process to objectively review and respond to metrics, KPIs and KRIs (e.g., monthly or quarterly review).
▪ Based on metrics analysis, process improvement recommendations are submitted for review and are handled in accordance with change control processes.
▪ Business and technical stakeholders are involved in reviewing and approving proposed changes to evolve capabilities.
Level 5 Continuously Improving
Utilize SCR-CMM Level 3 or Level 4 (if available) criteria definitions:
▪ There are no defined Level 5 criteria, since it is reasonable to assume a continuously-improving process is not necessary to operationalize this control.
▪ Level 5 capabilities should be considered “world-class” where the control builds on Level 4 capabilities, but are continuously improving through Artificial Intelligence (AI) and/or Machine Learning (ML) technologies.
▪ While it may be possible to develop responsive capabilities for this control through the use of AI and/or ML technologies, the criteria would be organization-specific to define.
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SCF
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Product Conformity Governance
Description
Mechanisms exist to ensure developed Technology Assets, Applications and/or Services (TAAS) conform to applicable statutory and regulatory requirements, based on the product's and/or service's:
(1) Use case(s); and
(2) Geographic markets.
Possible Solutions & Considerations
Micro-Small Business (<10 staff) / BLS Firm Size Classes 1-2
∙ Identify laws/regulations applicable to any developed products (e.g., privacy, accessibility)
Small Business (10-49 staff) / BLS Firm Size Classes 3-4
∙ Regulatory requirements checklist for product development
∙ Legal review before release
Medium Business (50-249 staff) / BLS Firm Size Classes 5-6
∙ Product compliance requirements defined at project start
∙ Compliance validation before release
∙ Regulatory conformity records
Large Business (250-999 staff) / BLS Firm Size Classes 7-8
∙ Product conformity governance program (statutory, regulatory, certification requirements)
∙ Compliance gates in release management
∙ Conformity documentation (e.g., declarations of conformity)
Enterprise (> 1,000 staff) / BLS Firm Size Class 9
∙ Enterprise product compliance program covering statutory/regulatory conformity (e.g., EU CRA, FDA, UL 2900)
∙ Regulatory affairs and product security integration
∙ Conformity assessment and certification management
SCR-CMM
Level 0 Not Performed
Practices are non-existent, based on the inability to demonstrate an implemented and operational capability. A reasonable person would conclude the control is not being performed.
Level 1 Performed Informally
SCR-CMM Level 1 criteria definitions are not available for this control:
▪ A reasonable person would conclude this control requires a structured process.
▪ At this level of maturity, the "ad hoc" nature of performing a capability informally would indicate the intent of the control is not met due to a lack of consistency and formality.
Level 2 Planned Tracked
Technology Development & Acquisition (TDA) capabilities are requirements-driven, but are not standardized across the entity (e.g., local/regional level consistency). Capability criteria associated with this control reasonably expect the following criteria to exist:
▪ Policies and standards associated with TDA domain capabilities are formally documented and centrally-managed by the entity.
▪ Standardized Operating Procedures (SOP) associated with TDA domain capabilities are documented and maintained by process owners.
▪ IT and/or cybersecurity personnel work with business stakeholders and process owners to appropriately scope and reasonably implement cybersecurity and data protection controls associated with TDA domain capabilities to address applicable statutory, regulatory and/or contractual requirements for Technology Assets, Applications, Services and/or Data (TAASD).
▪ Technology development and acquisition-related controls are primarily administrative and preventative in nature (e.g., policies, standards and procedures & guidelines).
▪ Technology development and acquisition management may be a defined function (e.g., team or department) or assigned as an additional duty to existing IT and/or cybersecurity personnel.
▪ Secure development practices mostly conform to industry-recognized standards for secure engineering of Technology Assets, Applications and/or Services (TAAS) (e.g., OWASP, NIST SP 800-218 and NIST SP 800-160).
▪ An application development team, or similar function, uses a structured process to design, build and maintain secure configurations for test, development, staging and production environments.
Level 3 Well Defined
Technology Development & Acquisition (TDA) capabilities are standardized across the entity for applicability to People, Processes, Technologies, Data and/or Facilities (PPTDF) to ensure consistency for Technology Assets, Applications, Services and/or Data (TAASD). Capability criteria associated with this control reasonably expect the following criteria to exist:
▪ Policies and standards associated with TDA domain capabilities are formally documented and centrally-managed by the entity's Governance, Risk & Compliance (GRC) team, or similar function.
▪ Standardized Operating Procedures (SOP) associated with TDA domain capabilities are well-documented and kept current by process owners.
▪ A software development team, or similar function, is appropriately staffed and supported to implement and maintain TDA domain capabilities.
▪ Technology is leveraged to enhance the efficiency and accuracy of technology development and acquisition management (e.g., project management software, software escrow solution and software testing tools).
▪ The entity's Governance, Risk & Compliance (GRC) team, or similar function, works with business stakeholders and process owners to appropriately scope and reasonably implement cybersecurity and data protection controls associated with TDA domain capabilities to address Minimum Compliance Requirements (MCR) (e.g., applicable statutory, regulatory and/or contractual requirements) and Discretionary Security Requirements (DSR) (e.g., entity-required controls).
▪ An implemented and operational capability exists to ensure developed Technology Assets, Applications and/or Services (TAAS) conform to applicable statutory and regulatory requirements, based on the product's and/or service's:
(1) Use case(s); and
(2) Geographic markets.
Level 4 Quantitatively Controlled
Utilize SCR-CMM Level 3 criteria definitions:
▪ There are no defined Level 4 criteria, since it is reasonable to assume a quantitatively-controlled process is not necessary to operationalize this control.
▪ While it may be possible to develop “metrics-driven” capabilities for this control, the criteria would be organization-specific to define.
Level 5 Continuously Improving
Utilize SCR-CMM Level 3 or Level 4 (if available) criteria definitions:
▪ There are no defined Level 5 criteria, since it is reasonable to assume a continuously-improving process is not necessary to operationalize this control.
▪ Level 5 capabilities should be considered “world-class” where the control builds on Level 4 capabilities, but are continuously improving through Artificial Intelligence (AI) and/or Machine Learning (ML) technologies.
▪ While it may be possible to develop responsive capabilities for this control through the use of AI and/or ML technologies, the criteria would be organization-specific to define.
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SCF
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Product Conformity Governance
Description
Mechanisms exist to ensure developed Technology Assets, Applications and/or Services (TAAS) conform to applicable statutory and regulatory requirements, based on the product's and/or service's:
(1) Use case(s); and
(2) Geographic markets.
Possible Solutions & Considerations
Micro-Small Business (<10 staff) / BLS Firm Size Classes 1-2
∙ Identify laws/regulations applicable to any developed products (e.g., privacy, accessibility)
Small Business (10-49 staff) / BLS Firm Size Classes 3-4
∙ Regulatory requirements checklist for product development
∙ Legal review before release
Medium Business (50-249 staff) / BLS Firm Size Classes 5-6
∙ Product compliance requirements defined at project start
∙ Compliance validation before release
∙ Regulatory conformity records
Large Business (250-999 staff) / BLS Firm Size Classes 7-8
∙ Product conformity governance program (statutory, regulatory, certification requirements)
∙ Compliance gates in release management
∙ Conformity documentation (e.g., declarations of conformity)
Enterprise (> 1,000 staff) / BLS Firm Size Class 9
∙ Enterprise product compliance program covering statutory/regulatory conformity (e.g., EU CRA, FDA, UL 2900)
∙ Regulatory affairs and product security integration
∙ Conformity assessment and certification management
SCR-CMM
Level 0 Not Performed
Practices are non-existent, based on the inability to demonstrate an implemented and operational capability. A reasonable person would conclude the control is not being performed.
Level 1 Performed Informally
SCR-CMM Level 1 criteria definitions are not available for this control:
▪ A reasonable person would conclude this control requires a structured process.
▪ At this level of maturity, the "ad hoc" nature of performing a capability informally would indicate the intent of the control is not met due to a lack of consistency and formality.
Level 2 Planned Tracked
Technology Development & Acquisition (TDA) capabilities are requirements-driven, but are not standardized across the entity (e.g., local/regional level consistency). Capability criteria associated with this control reasonably expect the following criteria to exist:
▪ Policies and standards associated with TDA domain capabilities are formally documented and centrally-managed by the entity.
▪ Standardized Operating Procedures (SOP) associated with TDA domain capabilities are documented and maintained by process owners.
▪ IT and/or cybersecurity personnel work with business stakeholders and process owners to appropriately scope and reasonably implement cybersecurity and data protection controls associated with TDA domain capabilities to address applicable statutory, regulatory and/or contractual requirements for Technology Assets, Applications, Services and/or Data (TAASD).
▪ Technology development and acquisition-related controls are primarily administrative and preventative in nature (e.g., policies, standards and procedures & guidelines).
▪ Technology development and acquisition management may be a defined function (e.g., team or department) or assigned as an additional duty to existing IT and/or cybersecurity personnel.
▪ Secure development practices mostly conform to industry-recognized standards for secure engineering of Technology Assets, Applications and/or Services (TAAS) (e.g., OWASP, NIST SP 800-218 and NIST SP 800-160).
▪ An application development team, or similar function, uses a structured process to design, build and maintain secure configurations for test, development, staging and production environments.
Level 3 Well Defined
Technology Development & Acquisition (TDA) capabilities are standardized across the entity for applicability to People, Processes, Technologies, Data and/or Facilities (PPTDF) to ensure consistency for Technology Assets, Applications, Services and/or Data (TAASD). Capability criteria associated with this control reasonably expect the following criteria to exist:
▪ Policies and standards associated with TDA domain capabilities are formally documented and centrally-managed by the entity's Governance, Risk & Compliance (GRC) team, or similar function.
▪ Standardized Operating Procedures (SOP) associated with TDA domain capabilities are well-documented and kept current by process owners.
▪ A software development team, or similar function, is appropriately staffed and supported to implement and maintain TDA domain capabilities.
▪ Technology is leveraged to enhance the efficiency and accuracy of technology development and acquisition management (e.g., project management software, software escrow solution and software testing tools).
▪ The entity's Governance, Risk & Compliance (GRC) team, or similar function, works with business stakeholders and process owners to appropriately scope and reasonably implement cybersecurity and data protection controls associated with TDA domain capabilities to address Minimum Compliance Requirements (MCR) (e.g., applicable statutory, regulatory and/or contractual requirements) and Discretionary Security Requirements (DSR) (e.g., entity-required controls).
▪ An implemented and operational capability exists to ensure developed Technology Assets, Applications and/or Services (TAAS) conform to applicable statutory and regulatory requirements, based on the product's and/or service's:
(1) Use case(s); and
(2) Geographic markets.
Level 4 Quantitatively Controlled
Utilize SCR-CMM Level 3 criteria definitions:
▪ There are no defined Level 4 criteria, since it is reasonable to assume a quantitatively-controlled process is not necessary to operationalize this control.
▪ While it may be possible to develop “metrics-driven” capabilities for this control, the criteria would be organization-specific to define.
Level 5 Continuously Improving
Utilize SCR-CMM Level 3 or Level 4 (if available) criteria definitions:
▪ There are no defined Level 5 criteria, since it is reasonable to assume a continuously-improving process is not necessary to operationalize this control.
▪ Level 5 capabilities should be considered “world-class” where the control builds on Level 4 capabilities, but are continuously improving through Artificial Intelligence (AI) and/or Machine Learning (ML) technologies.
▪ While it may be possible to develop responsive capabilities for this control through the use of AI and/or ML technologies, the criteria would be organization-specific to define.
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