+Член 30 Правила и условия за нанасяне на маркировката „СЕ“
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Член 30 Правила и условия за нанасяне на маркировката „СЕ“
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1. Преглед
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Регулация |
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Член 30 1.
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Маркировката „СЕ“ се нанася върху самия продукт с цифрови елементи така, че да бъде видима, четлива и незаличима. Когато това не е възможно или не е подходящо поради естеството на продукта с цифрови елементи, тя се нанася върху опаковката и върху ЕС декларацията за съответствие, посочена в член 28, придружаваща продукта с цифрови елементи. За продукти с цифрови елементи, които са под формата на софтуер, маркировката „СЕ“ се нанася или в ЕС декларацията за съответствие, посочена в член 28, или в уебсайта, придружаващ софтуерния продукт. В последния случай съответният раздел на уебсайта трябва да бъде лесно и пряко достъпен за потребителите.
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Член 30 2.
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Поради естеството на продукта с цифрови елементи височината на маркировката „СЕ“, нанесена върху продукта с цифрови елементи, може да бъде по-малка от 5 mm, при условие че тя остава видима и четлива.
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Член 30 3.
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Маркировката „СЕ“ се нанася, преди продуктът с цифрови елементи да бъде пуснат на пазара. Тя може да бъде следвана от пиктограма или друг знак, указващи специален киберриск или употреба, определени в актовете за изпълнение, посочени в параграф 6.
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Член 30 4.
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Маркировката „СЕ“ е следвана от идентификационния номер на нотифицирания орган, когато този орган участва в процедурата за оценяване на съответствието въз основа на пълно осигуряване на качеството (въз основа на модул Н), посочена в член 32. Идентификационният номер на нотифицирания орган се нанася от самия орган или, по негови указания, от производителя или от упълномощения представител на производителя.
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Член 30 5.
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Държавите членки доразвиват съществуващите механизми, за да гарантират правилното прилагане на режима, уреждащ маркировката „СЕ“, и предприемат подходящи действия в случай на неправомерно използване на тази маркировка. Когато спрямо продукта с цифрови елементи се прилага друго законодателство на Съюза за хармонизиране, различно от настоящия регламент, което също предвижда нанасянето на маркировката „СЕ“, маркировката „СЕ“ показва, че продуктът отговаря и на изискванията, установени в това друго законодателство на Съюза за хармонизация.
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Член 30 6.
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Комисията може чрез актове за изпълнение да определя технически спецификации за етикети, пиктограми или други знаци, свързани със сигурността на продуктите с цифрови елементи, техните периоди на поддръжка, както и механизми за насърчаване на тяхното използване и за повишаване на обществената осведоменост за сигурността на продуктите с цифрови елементи. При изготвянето на проектите на актове за изпълнение Комисията се консултира със съответните заинтересовани страни и, ако вече е създадена съгласно член 52, параграф 15, с ADCO групата. Тези актове за изпълнение се приемат в съответствие с процедурата по разглеждане, посочена в член 62, параграф 2.
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1.1 Препратки
1.2 Идентифицирани изисквания
1.3 Свързани стандарти
2. Идентифицирани изисквания
Изисквания
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Изискване |
3. Свързани стандарти
Стандарти
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Изискване |
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SCF
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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.
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