CE Marking
EU marking for product conformity to harmonised legislation
ISO 37301
International standard for compliance management systems
Quick Verdict
CE Marking mandates product conformity for EU market access via technical files and DoCs, while ISO 37301 provides voluntary CMS certification for systematic compliance management. Companies adopt CE for legal sales; ISO for governance, risk reduction, and stakeholder trust.
CE Marking
CE Marking
Key Features
- Manufacturer's declaration of EU conformity compliance
- Enables free product circulation across EEA markets
- OJEU harmonised standards presume conformity proof
- Risk-proportionate modules A-H assessment routes
- Mandatory technical documentation 10-year retention
ISO 37301
ISO 37301:2021 Compliance management systems requirements
Key Features
- Certifiable CMS requirements replacing ISO 19600 guidance
- HLS alignment for integration with other ISO standards
- Risk-based planning for compliance obligations and controls
- Leadership commitment and organizational culture emphasis
- Robust whistleblowing channels with anti-retaliation protections
Detailed Analysis
A comprehensive look at the specific requirements, scope, and impact of each standard.
CE Marking Details
What It Is
CE Marking is the EU's conformity marking indicating products meet harmonised legislation requirements. It is a manufacturer's self-declaration framework, not third-party certification, for health, safety, and environmental protection. Scope covers specific product categories like electrical equipment and machinery under New Legislative Framework (NLF). Key approach is risk-based, using essential requirements and voluntary harmonised standards for presumption of conformity.
Key Components
- Legislation mapping to directives like LVD 2014/35/EU, RED 2014/53/EU.
- Conformity modules A-H, self-assessment or Notified Body involvement.
- Technical file, EU Declaration of Conformity (DoC), CE affixation rules.
- Post-market surveillance under Regulation (EU) 2019/1020. Self-declaration model with OJEU standards as core evidence pathway.
Why Organizations Use It
Mandated for EEA market access, enabling free movement. Reduces trade barriers, builds stakeholder trust, manages liability risks. Strategic for competitive edge in tenders, avoids fines/recalls. Enhances governance via risk assessment and documentation.
Implementation Overview
Phased: scope determination, conformity assessment, documentation compilation, DoC issuance, marking. Applies to manufacturers/importers across industries, EEA-focused. No central certification; authority audits technical files on request. Typical for mid-large firms, 6-12 months with Notified Bodies for high-risk products.
ISO 37301 Details
What It Is
ISO 37301:2021, titled Compliance management systems – Requirements with guidance for use, is a certifiable international standard. It provides requirements for establishing, implementing, maintaining, and improving a Compliance Management System (CMS). Applicable to all organization sizes and sectors, it uses a risk-based, PDCA cycle approach aligned with ISO High-Level Structure (HLS).
Key Components
- **LeadershipCommitment, policy, roles, culture
- **PlanningObligation identification, risk assessment, objectives
- **SupportResources, competence (ISO 37303), awareness, whistleblowing
- **OperationControls, third-party management, investigations
- **Performance evaluationMonitoring, audits, reviews (ISO 37302 guidance)
- **ImprovementCorrective actions, continual enhancement Follows 10 HLS clauses; certifiable via accredited bodies.
Why Organizations Use It
- Third-party certification builds stakeholder trust
- Mitigates regulatory, reputational risks; supports ESG/SDGs
- Integrates with ISO 9001/27001 for efficiency
- Enhances culture, early issue detection via whistleblowing
Implementation Overview
Phased: context analysis, register building, training, audits. All sizes; 12-18 months typical. Certification involves initial/surveillance audits by ANAB-accredited bodies. (178 words)
Key Differences
| Aspect | CE Marking | ISO 37301 |
|---|---|---|
| Scope | Product conformity to EU harmonised legislation | Compliance management systems for all obligations |
| Industry | Manufacturers of regulated products (electronics, machinery) | All sectors and organization types worldwide |
| Nature | Mandatory EU market access marking | Voluntary certifiable management standard |
| Testing | Conformity assessment modules, notified bodies | Internal audits, management reviews |
| Penalties | Market withdrawal, fines, customs holds | Loss of certification, no legal penalties |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about CE Marking and ISO 37301
CE Marking FAQ
ISO 37301 FAQ
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