+Quality Management System (QMS)

Quality Management System (QMS)

Description

Mechanisms exist to govern a Quality Management System (QMS) to ensure security, compliance and resilience processes conform with applicable statutory, regulatory and/or contractual obligations.

Possible Solutions & Considerations

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

∙ Document basic quality checkpoints for security processes

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

∙ Written quality standards for key security processes

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

∙ Formal QMS procedures for security processes
∙ Internal quality reviews

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

∙ ISO 9001-aligned QMS for security operations
∙ Formal QA function
∙ Periodic internal audits

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

∙ ISO 9001 certified QMS
∙ Dedicated quality assurance team
∙ Continuous process improvement program
∙ Integrated QMS platform

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

Cybersecurity & Data Protection Governance (GOV) domain capabilities are ad hoc and inconsistent. Capability criteria associated with this control may include:
▪ Policies, standards & procedures associated with GOV domain capabilities provide limited coverage due to the depth and breadth of the existing documentation.
▪ Governance-related activities are decentralized (e.g., a localized/regionalized function) and uses non-standardized methods to implement secure, resilient and compliant practices.
▪ No formal Governance, Risk & Compliance (GRC) team exists. GRC roles are assigned to existing IT/cybersecurity personnel.
▪ Cybersecurity and data protection governance is informally assigned as an additional duty to existing IT/cybersecurity personnel.
▪ Unstructured review of the cybersecurity and/or data privacy program is performed on an annual basis.
▪ Administrative processes require all employees and contractors to apply cybersecurity and data protection principles in their daily work (e.g., policies & standards).

Level 2 Planned Tracked

SCR-CMM Level 2 criteria definitions are not available for this control:
▪ A reasonable person would conclude a well-defined and standardized process is required.
▪ At this level of maturity, the “requirements-driven” nature of performing the control is focused on a localized and/or regionalized implementation, not uniform and consistent across the organization.
▪ Requirements are narrowly scoped for applicability and are primarily derived from compliance obligations (e.g., laws, regulations and contracts).

Level 3 Well Defined

Cybersecurity & Data Protection Governance (GOV) 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 GOV 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 GOV domain capabilities are well-documented and kept current by process owners.
▪ The entity's Governance, Risk & Compliance (GRC) team, or similar function, is appropriately staffed and supported to implement and maintain GOV 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).
▪ Technology is leveraged to enhance the efficiency and accuracy of governance, risk management and compliance operations (e.g., GRC platform).
▪ An implemented and operational capability exists to govern a Quality Management System (QMS) to ensure security, compliance and resilience processes conform with applicable statutory, regulatory and/or contractual obligations.

Level 4 Quantitatively Controlled

Cybersecurity & Data Protection Governance (GOV) 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.

1. Áttekintés

Megnevezés Szabvány

1.1 Hivatkozások

1.2 Azonosított követelmények

1.3 Kapcsolódó szabályozások

2. Azonosított követelmények

Követelmények
Forrás Követelmény

3. Kapcsolódó szabályozások

Szabályozások
Forrás Szabályozás
EULAW 16. cikk A nagy kockázatú MI-rendszerek szolgáltatóinak kötelezettségei

16. cikk

A nagy kockázatú MI-rendszerek szolgáltatóinak kötelezettségei

A nagy kockázatú MI-rendszerek szolgáltatóinak:

a) 

biztosítaniuk kell, hogy nagy kockázatú MI-rendszereik megfeleljenek a 2. szakaszban meghatározott követelményeknek;

b) 

fel kell tüntetniük a nagy kockázatú MI-rendszeren – vagy amennyiben ez nem lehetséges, annak csomagolásán vagy adott esetben a kísérő dokumentációján – a nevüket, bejegyzett kereskedelmi nevüket vagy bejegyzett védjegyüket és azt a címüket, amelyen velük kapcsolatba lehet lépni;

c) 

a 17. cikknek megfelelő minőségirányítási rendszerrel kell rendelkezniük;

d) 

vezetniük kell a 18. cikkben említett dokumentációt;

e) 

a 19. cikkben említettek szerint meg kell őrizniük a nagy kockázatú MI-rendszereik által automatikusan generált naplókat, ha azok az ellenőrzésük alatt állnak;

f) 

biztosítaniuk kell, hogy a nagy kockázatú MI-rendszert forgalomba hozatala vagy üzembe helyezése előtt alávessék a 43. cikkben említett vonatkozó megfelelőségértékelési eljárásnak;

g) 

a 47. cikkel összhangban EU-megfelelőségi nyilatkozatot kell készíteniük;

h) 

a 48. cikkel összhangban fel kell tüntetniük a CE-jelölést a nagy kockázatú MI-rendszeren – vagy amennyiben ez nem lehetséges, annak csomagolásán vagy kísérő dokumentációján –, hogy jelezzék az e rendeletnek való megfelelést;

i) 

eleget kell tenniük a 49. cikk (1) bekezdésében említett regisztrációs kötelezettségeknek;

j) 

a 20. cikkben előírtak szerint meg kell hozniuk a szükséges korrekciós intézkedéseket és tájékoztatást kell nyújtaniuk;

k) 

az illetékes nemzeti hatóság indokolással ellátott kérésére igazolniuk kell, hogy a nagy kockázatú MI-rendszer megfelel a 2. szakaszban meghatározott követelményeknek;

l) 

az (EU) 2016/2102 és az (EU) 2019/882 irányelvvel összhangban biztosítaniuk kell, hogy a nagy kockázatú MI-rendszer megfeleljen az akadálymentesítési követelményeknek.

EULAW 17. cikk Minőségirányítási rendszer

Kapcsolt feladatok

Kapcsolatok
Kapcsolattípus Feladat
is related to Semi-Annual
is related to relative Control Weighting = 08
is related to Process
is related to Govern
is related to SCRM Focus Tier 1 STRATEGIC
is related to SCRM Focus Tier 2 OPERATIONAL
blocks Regulatory / Legal / Contractual Financial Liability
is related to Annual
is related to relative Control Weighting = 04
blocks Contractual Default / Termination
blocks Loss of Authorization / Certification / License
blocks Failure to Support Business / Mission Objectives
blocks Unaddressed Security / Compliance Exposure
blocks Unperformed / Unowned Control Responsibilities
blocks Uncontrolled Internal Security / Privacy Exposure
blocks Lack of oversight of internal controls
blocks Lack of oversight of third-party controls
blocks Inability to Demonstrate Due Diligence / Due Care
blocks Unreliable Assurance / Decision Information
blocks Drought & Water Shortage
blocks Earthquakes
blocks Fire & Wildfires
blocks Floods
blocks Hurricanes & Tropical Storms
blocks Landslides & Debris Flow
blocks Pandemic (Disease) Outbreaks
blocks Severe Weather
blocks Space Weather
blocks Thunderstorms & Lightning
blocks Tornadoes
blocks Tsunamis
blocks Volcanoes
blocks Winter Storms & Extreme Cold
blocks Dysfunctional Management Practices
blocks Human Error
blocks Technical / Mechanical Failure
blocks Statutory / Regulatory / Contractual Change
blocks Data Quality Degradation / Data Poisoning
blocks Fraud, Corruption and/or Intentional Criminal Conduct
blocks Conflict of Interest (COI) / Undue Influence / Insider Misconduct
blocks Workforce Shortage / Loss of Critical Skills / Labor Disruption
is blocked by GOV-17 Quality Management System (QMS) – Assessment Procedure