+Člen 30 Pravila in pogoji za namestitev oznake CE
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Člen 30 Pravila in pogoji za namestitev oznake CE

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1. Pregled

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Člen 30 1.
Oznaka CE se vidno, čitljivo in neizbrisno namesti na izdelek z digitalnimi elementi. Kadar to zaradi narave izdelka z digitalnimi elementi ni mogoče ali upravičeno, se namesti na embalažo in na EU izjavo o skladnosti iz člena 28, priloženo izdelku z digitalnimi elementi. Pri izdelkih z digitalnimi elementi v obliki programske opreme se oznaka CE namesti na EU izjavo o skladnosti iz člena 28 ali na spletno mesto, povezano z izdelkom programske opreme. V slednjem primeru mora biti ustrezen razdelek spletnega mesta potrošnikom enostavno in neposredno dostopen.
Člen 30 2.
Glede na naravo izdelka z digitalnimi elementi je lahko višina oznake CE, nameščene na izdelek z digitalnimi elementi, manj kot 5 mm, če ob tem ostane vidna in čitljiva.
Člen 30 3.
Oznaka CE se namesti, preden se izdelek z digitalnimi elementi da na trg. Lahko ji sledi piktogram ali katera koli druga oznaka, ki označuje posebno tveganje za kibernetsko varnost ali uporabo, določeno v izvedbenih aktih iz odstavka 6.
Člen 30 4.
Oznaki CE sledi identifikacijska številka priglašenega organa, kadar je ta vključen v postopek ugotavljanja skladnosti na podlagi popolnega zagotavljanja kakovosti (na podlagi modula H) iz člena 32.

Identifikacijsko številko priglašenega organa namesti organ sam ali jo na podlagi njegovih navodil namesti proizvajalec ali njegov pooblaščeni zastopnik.
Člen 30 5.
Države članice nadgrajujejo obstoječe mehanizme, da zagotovijo pravilno uporabo sistema za označevanje z oznako CE, in sprejmejo ustrezne ukrepe v primeru nepravilne rabe te oznake. Kadar izdelek z digitalnimi elementi poleg te uredbe ureja harmonizacijska zakonodaja Unije, ki prav tako določa namestitev oznake CE, taka oznaka kaže, da izdelek izpolnjuje tudi zahteve, določene v drugi taki harmonizacijski zakonodaji Unije.
Člen 30 6.
Komisija lahko z izvedbenimi akti določi tehnične specifikacije glede označb, piktogramov ali katerih koli drugih oznak, ki se nanašajo na varnost izdelkov z digitalnimi elementi, obdobja podpore in mehanizme za spodbujanje njihove uporabe ter povečanje ozaveščenosti javnosti o varnosti izdelkov z digitalnimi elementi. Komisija se pri pripravi osnutkov izvedbenih aktov posvetuje z ustreznimi deležniki in, če je že bila ustanovljena na podlagi člena 52(15), s skupino ADCO. Ti izvedbeni akti se sprejmejo v skladu s postopkom pregleda iz člena 62(2).

1.1 Sklici

1.2 Ugotovljene zahteve

1.3 Povezani standardi

2. Ugotovljene zahteve

Zahteve

3. Povezani standardi

Standardi
SCF Product Management

Description

Mechanisms exist to design and implement product management processes to proactively govern the design, development and production of Technology Assets, Applications and/or Services (TAAS) across the System Development Life Cycle (SDLC) to:
(1) Improve functionality;
(2) Enhance security and resiliency capabilities;
(3) Correct security deficiencies; and
(4) Conform with applicable statutory, regulatory and/or contractual obligations.

Possible Solutions & Considerations

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

∙ Defined business processes
∙ Product / project management
∙ Defined technical requirements
∙ Defined business requirements

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

∙ Defined business processes
∙ Product / project management
∙ Defined technical requirements
∙ Defined business requirements

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

∙ Defined business processes
∙ Product / project management
∙ Defined technical requirements
∙ Defined business requirements
∙ System Development Lifecycle (SDLC) governance / oversight

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

∙ Defined business processes
∙ Product / project management
∙ Defined technical requirements
∙ Defined business requirements
∙ System Development Lifecycle (SDLC) governance / oversight

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

∙ Defined business processes
∙ Product / project management
∙ Defined technical requirements
∙ Defined business requirements
∙ System Development Lifecycle (SDLC) governance / oversight

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

Technology Development & Acquisition (TDA) domain capabilities are ad hoc and inconsistent. Capability criteria associated with this control may include:
▪ Policies, standards & procedures associated with TDA domain capabilities provide limited coverage due to the depth and breadth of the existing documentation.
▪ Technology development & acquisition-related activities are decentralized (e.g., a localized/regionalized function) and uses non-standardized methods to implement secure, resilient and compliant practices.
▪ Secure development practices loosely conform to industry-recognized standards for secure engineering (e.g., OWASP, NIST SP 800-218 and NIST SP 800-160).
▪ IT and/or cybersecurity personnel use an informal process to govern changes to the software library to prevent unauthorized changes and create an audit trail of changes made.

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.
▪ Development and acquisition management is decentralized (e.g., a localized/regionalized function) and uses non-standardized methods to implement secure, resilient and compliant practices.

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 design and implement product management processes to proactively govern the design, development and production of Technology Assets, Applications and/or Services (TAAS) across the System Development Life Cycle (SDLC) to:
(1) Improve functionality;
(2) Enhance security and resiliency capabilities;
(3) Correct security deficiencies; and
(4) Conform with applicable statutory, regulatory and/or contractual obligations.

Level 4 Quantitatively Controlled

Technology Development & Acquisition (TDA) 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.