What It Is

CE Marking (Conformité Européenne) is the EU's mandatory conformity marking for products under harmonised legislation. It serves as the manufacturer's declaration that products meet essential health, safety, and environmental requirements. Scope covers categories like electrical equipment, machinery, and medical devices. Key approach: risk-proportionate conformity assessment via modules A-H, using OJEU-published harmonised standards for presumption of conformity.

Key Components

• Essential requirements from directives/regulations (e.g., LVD 2014/35/EU).
• Conformity modules (self-assessment or notified body).
• Technical documentation, EU Declaration of Conformity (DoC).
• CE mark affixing, post-market surveillance under Reg (EU) 2019/1020. Self-declaration model for low-risk; third-party for high-risk; no central certification.

Why Organizations Use It

Mandated for EEA market access; enables free movement. Reduces trade barriers, builds trust, mitigates liability. Strategic for scale, procurement preference; aligns with risk management and standards innovation pathway.

Implementation Overview

Map applicable legislation, conduct risk assessment, compile technical file, issue DoC, affix mark. Applies to manufacturers/importers across industries/geographies targeting EEA. Varies by risk: 6-12 weeks self-assessment; longer for notified bodies. Involves audits, testing; ongoing surveillance required.

What It Is

BRCGS Global Standard for Food Safety is a third-party certification framework for food manufacturers, processors, and packers. It ensures product safety, legality, authenticity, and quality through a structured, auditable management system. The primary approach is Codex HACCP-based with robust prerequisite programs (GMP/GHP) and risk assessments.

Key Components

• Nine core clauses (Issue 8) or seven sections (Issue 9): senior management, HACCP plan, FSQMS, site standards, product/process controls, personnel, risk zones.
• Fundamental requirements like traceability, allergen management, internal audits.
• Built on GFSI-benchmarked protocols with grading (AA/A/B/C/D).
• Annual audits, announced/unannounced options.

Why Organizations Use It

• Mandated by retailers for supply chain access.
• Reduces recalls, ensures compliance (e.g., FSMA).
• Builds trust, operational resilience, continuous improvement via CAPA.
• Competitive edge in global markets.

Implementation Overview

Phased approach: gap analysis, documentation, training, mock audits. Suited for manufacturers of all sizes; 6-12 months typical. Requires certification body audits for grading.