What It Is

CE Marking (Conformité Européenne) is the EU's mandatory conformity marking for products under harmonised legislation. It signifies the manufacturer's declaration that products meet essential health, safety, and environmental requirements. Scope covers categories like electrical equipment, machinery, and medical devices via the New Legislative Framework (NLF). Approach is risk-based, using conformity assessment modules (A-H).

Key Components

• Identify applicable directives/regulations and essential requirements.
• Harmonised standards published in OJEU for presumption of conformity.
• Technical documentation, EU Declaration of Conformity (DoC), and CE mark affixing.
• Self-assessment or Notified Body involvement based on risk. Self-declaration model for low-risk; third-party certification for high-risk.

Why Organizations Use It

Mandated for EEA market access; enables free circulation. Reduces trade barriers, ensures liability protection, and builds stakeholder trust. Mitigates enforcement risks like recalls/fines; provides competitive edge in tenders.

Implementation Overview

Map legislation, conduct risk assessments, compile technical files, issue DoC, affix mark. Applies to manufacturers/importers in EEA-impacting industries. Involves testing, audits; post-market surveillance required. Timelines: 6-12 months typical; scalable by organization size.

What It Is

HITRUST Common Security Framework (CSF) is a certifiable, threat-adaptive control framework consolidating requirements from 60+ standards like HIPAA, NIST, ISO 27001, PCI DSS, and GDPR. It employs a risk-based, maturity-driven approach for scalable security and privacy assurance.

Key Components

• 19 assessment domains covering governance, technical controls, and resilience.
• 14 categories, 49 objectives, ~156 specifications with tiered implementation levels.
• Built on ISO 27001 taxonomy and NIST-derived maturity model (policy, procedure, implemented, measured, managed).
• Certification via e1/i1/r2 assessments using MyCSF platform.

Why Organizations Use It

• Rationalizes multi-regulatory compliance (assess once, report many).
• Delivers credible third-party assurance for healthcare, finance.
• Reduces breach risk (99.4% certified breach-free); lowers insurance premiums.
• Enhances market access, TPRM efficiency, competitive differentiation.

Implementation Overview

• Phased: scoping, readiness, remediation, validated assessment, continuous monitoring.
• Involves MyCSF tooling, inheritance, evidence automation.
• Targets regulated industries; suits mid-to-large organizations globally.
• Requires Authorized External Assessors for certification.