+Artikolu 47 Dikjarazzjoni tal-konformità tal-UE
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Artikolu 47 Dikjarazzjoni tal-konformità tal-UE
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1. Ħarsa ġenerali
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Regolamentazzjoni |
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Artikolu 47 1.
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Il-fornitur għandu jfassal dikjarazzjoni tal-konformità tal-UE bil-miktub li tinqara mill-magni, ffirmata b’mod fiżiku jew elettroniku, għal kull sistema tal-IA b’riskju għoli u jżommha għad-dispożizzjoni tal-awtoritajiet nazzjonali kompetenti għal 10 snin wara li s-sistema tal-IA b’riskju għoli tkun ġiet introdotta fis-suq jew imqiegħda fis-servizz. Id-dikjarazzjoni ta’ konformità tal-UE għandha tidentifika s-sistema tal-IA b’riskju għoli li għaliha tkun tfasslet. Fuq talba, għandha tiġi ppreżentata kopja tad-dikjarazzjoni tal-konformità tal-UE lill-awtoritajiet nazzjonali kompetenti rilevanti.
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Artikolu 47 2.
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Id-dikjarazzjoni ta’ konformità tal-UE għandha tgħid li s-sistema tal-IA b’riskju għoli ikkonċernata tissodisfa r-rekwiżiti stipulati fit-Taqsima 2. Id-dikjarazzjoni ta’ konformità tal-UE għandu jkun fiha l-informazzjoni stipulata fl-Anness V u għandha tiġi tradotta b’lingwa li tista’ tinftiehem faċilment mill-awtoritajiet nazzjonali kompetenti tal-Istati Membri li fihom tiġi introdotta jew imqiegħda fis-suq is-sistema tal-IA b’riskju għoli.
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Artikolu 47 3.
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Meta s-sistemi tal-IA b’riskju għoli jkunu soġġetti għal leġiżlazzjoni oħra tal-Unjoni dwar l-armonizzazzjoni li ukoll tkun tirrikjedi dikjarazzjoni ta’ konformità tal-UE, għandha titfassal dikjarazzjoni ta’ konformità unika tal-UE fir-rigward tal-liġijiet kollha tal-Unjoni applikabbli għas-sistema tal-IA b’riskju għoli. Id-dikjarazzjoni għandu jkun fiha l-informazzjoni kollha meħtieġa biex tiġi identifikata l-leġiżlazzjoni tal-Unjoni dwar l-armonizzazzjoni li magħha tkun marbuta d-dikjarazzjoni.
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Artikolu 47 4.
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Billi jfassal id-dikjarazzjoni ta’ konformità tal-UE, il-fornitur għandu jassumi r-responsabbiltà għall-konformità mar-rekwiżiti stipulati fit-Taqsima 2. Il-fornitur għandu jżomm id-dikjarazzjoni ta’ konformità tal-UE aġġornata kif xieraq.
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Artikolu 47 5.
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Il-Kummissjoni għandha s-setgħa li tadotta atti delegati f’konformità mal-Artikolu 97 sabiex temenda l-Anness V billi taġġorna l-kontenut tad-dikjarazzjoni ta’ konformità tal-UE stipulata f’dak l-Anness biex tintroduċi elementi li jsiru meħtieġa fid-dawl tal-progress tekniku.
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1.1 Referenzi
1.2 Rekwiżiti identifikati
1.3 Standards relatati
2. Rekwiżiti identifikati
3. Standards relatati
Standards
| Sors |
Rekwiżit |
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SCF
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Declaration of Conformity
Description
Mechanisms exist to generate a declaration of conformity for each conformity assessment, where the document:
(1) Is concise;
(2) Unambiguously reflects the current status;
(3) Is physically or electronically signed; and
(4) Where possible, is machine readable.
Possible Solutions & Considerations
Micro-Small Business (<10 staff) / BLS Firm Size Classes 1-2
∙ Document applicable regulatory requirements in a checklist
Small Business (10-49 staff) / BLS Firm Size Classes 3-4
∙ Compliance checklist
∙ Annual compliance review
Medium Business (50-249 staff) / BLS Firm Size Classes 5-6
∙ Compliance management program
∙ Regulatory mapping
∙ Compliance calendar
Large Business (250-999 staff) / BLS Firm Size Classes 7-8
∙ GRC solution (e.g., SCFConnect, Cyturus, SureCloud, SimpleRisk, Ignyte, ZenGRC, Galvanize, MetricStream, Archer, etc.)
∙ Compliance team
Enterprise (> 1,000 staff) / BLS Firm Size Class 9
∙ GRC solution (e.g., SCFConnect, Cyturus, SureCloud, SimpleRisk, Ignyte, ZenGRC, Galvanize, MetricStream, Archer, etc.)
∙ Dedicated compliance team
∙ Automated compliance monitoring
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
Compliance (CPL) 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 CPL domain capabilities are formally documented and centrally-managed by the entity.
▪ Standardized Operating Procedures (SOP) associated with CPL 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 CPL domain capabilities to address applicable statutory, regulatory and/or contractual requirements for Technology Assets, Applications, Services and/or Data (TAASD).
▪ Compliance management controls-related controls are primarily administrative and preventative in nature (e.g., policies, standards and procedures & guidelines).
▪ Compliance management may be a defined function (e.g., team or department) or assigned as an additional duty to existing IT and/or cybersecurity personnel.
▪ External compliance requirements for cybersecurity and data privacy are identified and documented, based on applicable laws, regulations and contractual obligations.
▪ A formal report is generated for each security assessment/audit with sufficient details to understand the organization's ability to demonstrate conformity with its requirements.
Level 3 Well Defined
Compliance (CPL) 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 CPL 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 CPL domain capabilities are well-documented and kept current by process owners.
▪ A Governance, Risk & Compliance (GRC) team, or similar function, is appropriately staffed and supported to implement and maintain CPL domain capabilities.
▪ Technology is leveraged to enhance the efficiency and accuracy of governance, risk management and compliance operations (e.g., GRC 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 CPL 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 generate a declaration of conformity for each conformity assessment, where the document:
(1) Is concise;
(2) Unambiguously reflects the current status;
(3) Is physically or electronically signed; and
(4) Where possible, is machine readable.
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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Declaration of Conformity
Description
Mechanisms exist to generate a declaration of conformity for each conformity assessment, where the document:
(1) Is concise;
(2) Unambiguously reflects the current status;
(3) Is physically or electronically signed; and
(4) Where possible, is machine readable.
Possible Solutions & Considerations
Micro-Small Business (<10 staff) / BLS Firm Size Classes 1-2
∙ Document applicable regulatory requirements in a checklist
Small Business (10-49 staff) / BLS Firm Size Classes 3-4
∙ Compliance checklist
∙ Annual compliance review
Medium Business (50-249 staff) / BLS Firm Size Classes 5-6
∙ Compliance management program
∙ Regulatory mapping
∙ Compliance calendar
Large Business (250-999 staff) / BLS Firm Size Classes 7-8
∙ GRC solution (e.g., SCFConnect, Cyturus, SureCloud, SimpleRisk, Ignyte, ZenGRC, Galvanize, MetricStream, Archer, etc.)
∙ Compliance team
Enterprise (> 1,000 staff) / BLS Firm Size Class 9
∙ GRC solution (e.g., SCFConnect, Cyturus, SureCloud, SimpleRisk, Ignyte, ZenGRC, Galvanize, MetricStream, Archer, etc.)
∙ Dedicated compliance team
∙ Automated compliance monitoring
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
Compliance (CPL) 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 CPL domain capabilities are formally documented and centrally-managed by the entity.
▪ Standardized Operating Procedures (SOP) associated with CPL 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 CPL domain capabilities to address applicable statutory, regulatory and/or contractual requirements for Technology Assets, Applications, Services and/or Data (TAASD).
▪ Compliance management controls-related controls are primarily administrative and preventative in nature (e.g., policies, standards and procedures & guidelines).
▪ Compliance management may be a defined function (e.g., team or department) or assigned as an additional duty to existing IT and/or cybersecurity personnel.
▪ External compliance requirements for cybersecurity and data privacy are identified and documented, based on applicable laws, regulations and contractual obligations.
▪ A formal report is generated for each security assessment/audit with sufficient details to understand the organization's ability to demonstrate conformity with its requirements.
Level 3 Well Defined
Compliance (CPL) 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 CPL 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 CPL domain capabilities are well-documented and kept current by process owners.
▪ A Governance, Risk & Compliance (GRC) team, or similar function, is appropriately staffed and supported to implement and maintain CPL domain capabilities.
▪ Technology is leveraged to enhance the efficiency and accuracy of governance, risk management and compliance operations (e.g., GRC 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 CPL 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 generate a declaration of conformity for each conformity assessment, where the document:
(1) Is concise;
(2) Unambiguously reflects the current status;
(3) Is physically or electronically signed; and
(4) Where possible, is machine readable.
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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Declaration of Conformity
Description
Mechanisms exist to generate a declaration of conformity for each conformity assessment, where the document:
(1) Is concise;
(2) Unambiguously reflects the current status;
(3) Is physically or electronically signed; and
(4) Where possible, is machine readable.
Possible Solutions & Considerations
Micro-Small Business (<10 staff) / BLS Firm Size Classes 1-2
∙ Document applicable regulatory requirements in a checklist
Small Business (10-49 staff) / BLS Firm Size Classes 3-4
∙ Compliance checklist
∙ Annual compliance review
Medium Business (50-249 staff) / BLS Firm Size Classes 5-6
∙ Compliance management program
∙ Regulatory mapping
∙ Compliance calendar
Large Business (250-999 staff) / BLS Firm Size Classes 7-8
∙ GRC solution (e.g., SCFConnect, Cyturus, SureCloud, SimpleRisk, Ignyte, ZenGRC, Galvanize, MetricStream, Archer, etc.)
∙ Compliance team
Enterprise (> 1,000 staff) / BLS Firm Size Class 9
∙ GRC solution (e.g., SCFConnect, Cyturus, SureCloud, SimpleRisk, Ignyte, ZenGRC, Galvanize, MetricStream, Archer, etc.)
∙ Dedicated compliance team
∙ Automated compliance monitoring
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
Compliance (CPL) 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 CPL domain capabilities are formally documented and centrally-managed by the entity.
▪ Standardized Operating Procedures (SOP) associated with CPL 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 CPL domain capabilities to address applicable statutory, regulatory and/or contractual requirements for Technology Assets, Applications, Services and/or Data (TAASD).
▪ Compliance management controls-related controls are primarily administrative and preventative in nature (e.g., policies, standards and procedures & guidelines).
▪ Compliance management may be a defined function (e.g., team or department) or assigned as an additional duty to existing IT and/or cybersecurity personnel.
▪ External compliance requirements for cybersecurity and data privacy are identified and documented, based on applicable laws, regulations and contractual obligations.
▪ A formal report is generated for each security assessment/audit with sufficient details to understand the organization's ability to demonstrate conformity with its requirements.
Level 3 Well Defined
Compliance (CPL) 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 CPL 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 CPL domain capabilities are well-documented and kept current by process owners.
▪ A Governance, Risk & Compliance (GRC) team, or similar function, is appropriately staffed and supported to implement and maintain CPL domain capabilities.
▪ Technology is leveraged to enhance the efficiency and accuracy of governance, risk management and compliance operations (e.g., GRC 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 CPL 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 generate a declaration of conformity for each conformity assessment, where the document:
(1) Is concise;
(2) Unambiguously reflects the current status;
(3) Is physically or electronically signed; and
(4) Where possible, is machine readable.
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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Declaration of Conformity
Description
Mechanisms exist to generate a declaration of conformity for each conformity assessment, where the document:
(1) Is concise;
(2) Unambiguously reflects the current status;
(3) Is physically or electronically signed; and
(4) Where possible, is machine readable.
Possible Solutions & Considerations
Micro-Small Business (<10 staff) / BLS Firm Size Classes 1-2
∙ Document applicable regulatory requirements in a checklist
Small Business (10-49 staff) / BLS Firm Size Classes 3-4
∙ Compliance checklist
∙ Annual compliance review
Medium Business (50-249 staff) / BLS Firm Size Classes 5-6
∙ Compliance management program
∙ Regulatory mapping
∙ Compliance calendar
Large Business (250-999 staff) / BLS Firm Size Classes 7-8
∙ GRC solution (e.g., SCFConnect, Cyturus, SureCloud, SimpleRisk, Ignyte, ZenGRC, Galvanize, MetricStream, Archer, etc.)
∙ Compliance team
Enterprise (> 1,000 staff) / BLS Firm Size Class 9
∙ GRC solution (e.g., SCFConnect, Cyturus, SureCloud, SimpleRisk, Ignyte, ZenGRC, Galvanize, MetricStream, Archer, etc.)
∙ Dedicated compliance team
∙ Automated compliance monitoring
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
Compliance (CPL) 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 CPL domain capabilities are formally documented and centrally-managed by the entity.
▪ Standardized Operating Procedures (SOP) associated with CPL 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 CPL domain capabilities to address applicable statutory, regulatory and/or contractual requirements for Technology Assets, Applications, Services and/or Data (TAASD).
▪ Compliance management controls-related controls are primarily administrative and preventative in nature (e.g., policies, standards and procedures & guidelines).
▪ Compliance management may be a defined function (e.g., team or department) or assigned as an additional duty to existing IT and/or cybersecurity personnel.
▪ External compliance requirements for cybersecurity and data privacy are identified and documented, based on applicable laws, regulations and contractual obligations.
▪ A formal report is generated for each security assessment/audit with sufficient details to understand the organization's ability to demonstrate conformity with its requirements.
Level 3 Well Defined
Compliance (CPL) 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 CPL 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 CPL domain capabilities are well-documented and kept current by process owners.
▪ A Governance, Risk & Compliance (GRC) team, or similar function, is appropriately staffed and supported to implement and maintain CPL domain capabilities.
▪ Technology is leveraged to enhance the efficiency and accuracy of governance, risk management and compliance operations (e.g., GRC 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 CPL 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 generate a declaration of conformity for each conformity assessment, where the document:
(1) Is concise;
(2) Unambiguously reflects the current status;
(3) Is physically or electronically signed; and
(4) Where possible, is machine readable.
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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