What It Is

CE Marking (Conformité Européenne) is the EU's mandatory product marking under harmonised legislation like the New Legislative Framework (NLF). It represents the manufacturer's declaration that products meet essential requirements for health, safety, and environmental protection. The risk-based approach uses conformity modules (A-H) and harmonised standards for presumption of conformity.

Key Components

• Applicable directives (e.g., LVD 2014/35/EU, Machinery 2006/42/EC)
• Conformity assessment (self-assessment or Notified Body)
• Technical documentation (risk analysis, tests, designs)
• EU Declaration of Conformity (DoC)
• CE mark affixing and post-market surveillance Self-declaration model for most; no central EU certification.

Why Organizations Use It

• Ensures legal EEA market access without barriers
• Mitigates enforcement risks (fines, recalls)
• Provides liability defense via evidence
• Leverages standards for efficiency and trust
• Boosts competitiveness in regulated sectors.

Implementation Overview

Map legislation, conduct risk assessment, compile evidence, issue DoC, affix mark. Applies to manufacturers/importers of covered products; scales by risk/size. Typical 6-12 months; Notified Body audits for high-risk. (178 words)

What It Is

Six Sigma is a disciplined, data-driven methodology and de facto industry framework for improving process performance. Anchored partially by ISO 13053:2011, it focuses on reducing variation, preventing defects, and achieving high-quality outputs through statistical methods. Its core approach uses DMAIC (Define, Measure, Analyze, Improve, Control) for existing processes and DMADV for new designs.

Key Components

• Structured DMAIC/DMADV lifecycle with tollgates and deliverables like Project Charters, SIPOC maps, and control plans.
• **Belt hierarchyChampions, Master Black Belts, Black Belts, Green Belts.
• Metrics: 3.4 DPMO, sigma levels, capability indices (Cp/Cpk).
• Tools: Gage R&R, DOE, FMEA, SPC. Certification via bodies like ASQ (experience + projects required).

Why Organizations Use It

Drives financial savings (e.g., GE $1B+), customer satisfaction, risk reduction. Voluntary but boosts competitiveness, compliance readiness (e.g., ISO integration), and stakeholder trust in regulated sectors like healthcare, finance.

Implementation Overview

Phased rollout: executive sponsorship, training, project portfolio, DMAIC execution, sustainment. Applies to all sizes/industries; requires training, change management. No mandatory audits, but internal governance and ASQ certification optional. (178 words)