What It Is

CE Marking (Conformité Européenne) is the EU's mandatory conformity marking framework for products under harmonised legislation. It signifies the manufacturer's declaration that a product meets essential health, safety, environmental, and consumer protection requirements. Scope covers categories like electrical equipment, machinery, toys, and medical devices via directives/regulations (e.g., LVD 2014/35/EU). Key approach is risk-based, using New Legislative Framework (NLF) modules for assessment.

Key Components

• Essential requirements and harmonised standards (OJEU-published for presumption of conformity).
• Conformity assessment modules (A-H: self-assessment to full quality assurance).
• Technical documentation, EU Declaration of Conformity (DoC), and CE mark affixing.
• Post-market surveillance under Regulation (EU) 2019/1020. Self-declaration or notified body verification; no central EU certification.

Why Organizations Use It

Mandated for EEA market access; prevents customs holds, fines, recalls. Drives single-market scale, risk management, fair competition. Builds stakeholder trust, supports tenders; aligns with sustainability (RoHS, Ecodesign).

Implementation Overview

Map applicable legislation, conduct risk assessments, compile technical file (10-year retention), issue DoC, affix mark. Applies to manufacturers/importers across industries/geographies targeting EEA. Self-assessment (low-risk: 6-12 weeks) or notified body (high-risk: 6-24 months); ongoing PMS required.

What It Is

ISO 31000:2018, Risk management — Guidelines is a non-certifiable international standard providing principles, framework, and process for managing uncertainty's effect on objectives. It applies universally to any organization, emphasizing leadership integration and value creation/protection through systematic risk practices.

Key Components

• **Eight principlesIntegrated, structured, customized, inclusive, dynamic, best information, human/cultural factors, continual improvement.
• Framework (Clause 5): Leadership, integration, design, implementation, evaluation, improvement (PDCA-aligned).
• Process (Clause 6): Communication, scope/context/criteria, assessment (identify/analyze/evaluate), treatment, monitoring/review, recording/reporting.
• Guidelines only; no certification.

Why Organizations Use It

• Enhances decision-making, resilience, opportunity capture.
• Builds governance, stakeholder trust; aligns with regulations/best practices.
• Drives efficiency, reduces losses; competitive edge in volatile environments.

Implementation Overview

• Phased: sponsorship, gap analysis, pilot, rollout, monitoring.
• Tailored to size/sector; focuses on culture, training, tools like GRC platforms.
• No audits required; internal assurance via reviews/metrics. (178 words)