CE Marking
EU marking declaring conformity to harmonised product rules
ISO 45001
International standard for occupational health and safety management systems.
Quick Verdict
CE Marking mandates product safety compliance for EU market access, while ISO 45001 provides voluntary OH&S management systems for workplace safety. Manufacturers require CE for legal sales; all firms adopt ISO 45001 to reduce risks, improve culture, and demonstrate leadership commitment.
CE Marking
CE Marking (Conformité Européenne)
Key Features
- Enables free movement across EU/EEA single market
- Manufacturer's declaration of conformity to essential requirements
- Presumption of conformity via OJEU harmonised standards
- Risk-proportionate conformity assessment modules A-H
- Mandates technical file and DoC retention
ISO 45001
ISO 45001:2018 Occupational Health and Safety Management Systems
Key Features
- Leadership accountability and worker participation
- Risk-based planning with hierarchy of controls
- Operational controls for contractors and change management
- PDCA cycle and Annex SL integration
- Performance evaluation and continual improvement
Detailed Analysis
A comprehensive look at the specific requirements, scope, and impact of each standard.
CE Marking Details
What It Is
CE Marking (Conformité Européenne) is the EU's mandatory compliance marking for products under harmonised legislation like LVD and Machinery Directive. It represents the manufacturer's declaration of conformity with essential health, safety, and environmental requirements. The risk-based approach uses conformity assessment modules (A-H) and OJEU-published harmonised standards for presumption of conformity.
Key Components
- Identification of applicable directives/regulations
- Essential requirements and integrated risk assessments
- Technical documentation, EU Declaration of Conformity (DoC)
- CE mark affixation rules
- Post-market surveillance under Regulation (EU) 2019/1020 Built on New Legislative Framework (NLF); self-declaration or notified body model.
Why Organizations Use It
Unlocks EEA free movement, avoids fines/recalls, leverages standards efficiency, builds stakeholder trust. Mandatory for covered products; strategic for global exporters managing liability and competition.
Implementation Overview
Phased: regulatory mapping, conformity assessment/testing, documentation assembly, DoC issuance, marking, surveillance setup. Applies to manufacturers/importers selling to EU; NB for high-risk; audit-ready files essential.
ISO 45001 Details
What It Is
ISO 45001:2018 is the international standard specifying requirements for an Occupational Health and Safety Management System (OHSMS). It provides a framework to prevent work-related injuries and ill health, improve OH&S performance, using a risk-based, PDCA cycle approach aligned with Annex SL for integration with other ISO standards.
Key Components
- Clauses 4–10 cover context, leadership, planning, support, operation, performance evaluation, and improvement.
- Emphasizes hierarchy of controls, worker participation, and contractor management.
- Built on PDCA and high-level structure; voluntary certification via audits.
Why Organizations Use It
- Reduces incidents, legal risks, and costs; enhances resilience and reputation.
- Meets stakeholder expectations; integrates with ISO 9001/14001 for efficiency.
- Drives safety culture, talent retention, and competitive supply-chain advantage.
Implementation Overview
- Phased: gap analysis, policy/objectives, training, controls, audits.
- Scalable for all sizes/sectors; 6–12 months typical; optional third-party certification.
Key Differences
| Aspect | CE Marking | ISO 45001 |
|---|---|---|
| Scope | Product conformity to EU safety rules | Occupational health & safety management systems |
| Industry | Manufacturers of regulated products EEA-wide | All industries/sectors worldwide scalable |
| Nature | Mandatory EU market access marking | Voluntary international certification standard |
| Testing | Conformity assessment modules/notified bodies | Internal audits/management reviews |
| Penalties | Market withdrawal/fines/recalls | Loss of certification/no legal penalties |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about CE Marking and ISO 45001
CE Marking FAQ
ISO 45001 FAQ
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