+82. pants Atbilstīgas MI sistēmas, kas rada risku
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82. pants Atbilstīgas MI sistēmas, kas rada risku

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1. Pārskats

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82. pants 1.
Ja dalībvalsts tirgus uzraudzības iestāde pēc 79. pantā paredzētās izvērtēšanas, apspriedusies ar attiecīgo valsts publisko iestādi, kas minēta 77. panta 1. punktā, secina, ka augsta riska MI sistēma gan atbilst šai regulai, bet rada risku personu veselībai vai drošībai, pamattiesībām vai citiem sabiedrības interešu aizsardzības aspektiem, tā pieprasa attiecīgajam operatoram bez liekas kavēšanās termiņā, kuru tā var noteikt, veikt visus pienācīgos pasākumus, lai nodrošinātu, ka attiecīgā MI sistēma, kad tā tiek laista tirgū vai nodota ekspluatācijā, vairs nerada minēto risku.
82. pants 2.
Nodrošinātājs vai cits attiecīgs operators 1. punktā minētās dalībvalsts tirgus uzraudzības iestādes noteiktajā termiņā nodrošina, ka tiek veikta korektīva darbība attiecībā uz visām attiecīgajām MI sistēmām, kuras tas ir darījis pieejamas Savienības tirgū.
82. pants 3.
Dalībvalstis nekavējoties informē Komisiju un pārējās dalībvalstis par 1. punktā paredzēto secinājumu. Informācijā ietver visas pieejamās ziņas, jo īpaši datus, kas nepieciešami attiecīgās MI sistēmas identificēšanai, datus par MI sistēmas izcelsmi un piegādes ķēdi, saistītā riska raksturu un veikto valsts pasākumu raksturu un ilgumu.
82. pants 4.
Komisija bez liekas kavēšanās sāk apspriešanos ar attiecīgajām dalībvalstīm un attiecīgajiem operatoriem un izvērtē veiktos valsts pasākumus. Pamatojoties uz minētā izvērtējuma rezultātiem, Komisija pieņem lēmumu par to, vai pasākums ir pamatots, un vajadzības gadījumā ierosina citus pienācīgus pasākumus.
82. pants 5.
Komisija nekavējoties savu lēmumu dara zināmu attiecīgajām dalībvalstīm un attiecīgiem operatoriem. Tā informē arī pārējās dalībvalstis.

1.1 Atsauces

1.2 Identificētās prasības

1.3 Saistītie standarti

2. Identificētās prasības

Prasības

3. Saistītie standarti

Standarti
SCF Non-Conformity Corrective Action

Description

Mechanisms exist to implement corrective action to remediate instances of non-conformity with applicable statutory, regulatory, and/or contractual compliance obligations.

Possible Solutions & Considerations

Micro-Small Business (<10 staff) / BLS Firm Size Classes 1-2

∙ Corrective action log (spreadsheet)
∙ Documented remediation plans for audit findings

Small Business (10-49 staff) / BLS Firm Size Classes 3-4

∙ Corrective action register with remediation tracking
∙ Management review of open findings

Medium Business (50-249 staff) / BLS Firm Size Classes 5-6

∙ Formal corrective action plan process
∙ GRC platform for finding tracking and remediation
∙ Management review of open findings

Large Business (250-999 staff) / BLS Firm Size Classes 7-8

∙ Enterprise corrective action management program
∙ GRC platform with workflow-driven remediation tracking
∙ Executive reporting on open findings

Enterprise (> 1,000 staff) / BLS Firm Size Class 9

∙ Enterprise GRC platform for corrective action management
∙ Automated finding tracking and escalation workflows
∙ Board-level reporting on material findings

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

Compliance (CPL) domain capabilities are ad hoc and inconsistent. Capability criteria associated with this control may include:
▪ Policies, standards & procedures associated with CPL domain capabilities provide limited coverage due to the depth and breadth of the existing documentation.
▪ Compliance management-related activities are decentralized (e.g., a localized/regionalized function) and uses non-standardized methods to implement secure, resilient and compliant practices.
▪ Compliance efforts are narrowly-limited to certain compliance requirements.
▪ IT and/or cybersecurity personnel use an informal process to govern statutory, regulatory and contractual compliance obligations.

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.

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 take corrective action to remediate instances of non-conformity with applicable statutory, regulatory, and/or contractual compliance obligations.

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.