CE Marking
EU marking for product health, safety compliance
AS9120B
Aerospace QMS standard for parts distributors.
Quick Verdict
CE Marking mandates EU product conformity declaration for free market access, while AS9120B certifies aerospace distributors' QMS for traceability and counterfeit prevention. Companies adopt CE for legal EU sales; AS9120B for OEM contracts and supply chain trust.
CE Marking
CE Marking (Conformité Européenne)
Key Features
- Manufacturer's declaration of EU essential requirements conformity
- Enables free product circulation across EEA market
- Presumption of conformity via OJEU harmonised standards
- Risk-proportionate conformity assessment modules A-H
- Requires technical file retention for 10 years
AS9120B
AS9120B Quality Management Systems - Requirements
Key Features
- Counterfeit and unapproved parts prevention processes
- Traceability and chain-of-custody controls for split lots
- Risk-based external provider evaluation and monitoring
- Configuration management for distribution operations
- Product preservation and storage requirements
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 conformity marking framework for products under harmonised legislation. It signifies the manufacturer's declaration that products meet essential health, safety, and environmental requirements. Scope covers categories like electrical equipment, machinery, and medical devices. Approach is risk-based, using New Legislative Framework (NLF) modules for assessment.
Key Components
- Legislation mapping to directives/regulations (e.g., LVD 2014/35/EU, Machinery 2006/42/EC)
- Conformity modules A-H (self-assessment to full quality assurance)
- Technical documentation, EU Declaration of Conformity (DoC), CE affixing
- Harmonised standards for presumption of conformity via OJEU Self-declaration or notified body certification model.
Why Organizations Use It
Mandated for EEA market access; avoids fines, withdrawals. Manages liability risks, enables free movement. Builds stakeholder trust, competitive edge in tenders. Supports supply chain governance and post-market surveillance.
Implementation Overview
Phased: scope analysis, risk assessment, testing/documentation, DoC issuance, marking. Applies to manufacturers/importers in EU/EEA. Involves audits for notified body routes; retain files 10 years. Cross-industry, scales by product risk.
AS9120B Details
What It Is
AS9120B is the IAQG quality management system standard for aviation, space, and defense distributors. It augments ISO 9001:2015's high-level structure with distributor-specific requirements. Primary purpose: ensure traceability, prevent counterfeits, and maintain product conformity without altering characteristics. Employs risk-based thinking and Plan-Do-Check-Act (PDCA) methodology.
Key Components
- Over 100 aerospace additions to ISO 9001 clauses 4-10.
- Pillars: context analysis, leadership, planning, support, operations (traceability, preservation, external providers), performance evaluation, improvement.
- Built on 10-clause HLS; requires documented information.
- Certification via accredited bodies, OASIS listing.
Why Organizations Use It
- Commercial necessity for OEM supply chains.
- Mitigates risks like counterfeit infiltration, traceability loss.
- Builds customer trust, enables market access (2,442 global certifications).
- Enhances efficiency, reduces nonconformities.
Implementation Overview
- Phased: gap analysis, process design, training, audits (6-12 months).
- For distributors globally; scales by size.
- Stage 1/2 certification audits required.
Key Differences
| Aspect | CE Marking | AS9120B |
|---|---|---|
| Scope | Product conformity to EU essential requirements | Aerospace distributor QMS and traceability |
| Industry | EU-wide consumer/industrial products | Aviation/space/defense distributors globally |
| Nature | Mandatory manufacturer self-declaration | Voluntary QMS certification standard |
| Testing | Self-assessment or notified body modules | Internal audits and certification body reviews |
| Penalties | Market withdrawal, fines, recalls | Loss of certification, contract exclusion |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about CE Marking and AS9120B
CE Marking FAQ
AS9120B FAQ
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