✔ RoHS Guide

• RoHS 3
• Lead Exemptions
• RoHS Testing
• RoHS Worldwide

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• WEEE Compliance
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RoHS Certification

Steps to Pass an Audit and Obtain RoHS Compliance

1. Understand RoHS Requirements
   • Action: Review the EU RoHS Directive (2011/65/EU), including restricted substances (e.g., lead <0.1%, cadmium <0.01%), 11 EEE categories, and exemptions (Annexes III, IV).
   • Details: Identify applicable scope (e.g., consumer electronics, medical devices) and deadlines (e.g., phthalate restrictions since 2019, exemption expirations like lead in bearings by 2026).
   • Responsible Party: Compliance team or product managers.
2. Conduct a Material Assessment
   • Action: Break down EEE into homogeneous materials (e.g., solder, plastic casing) per IEC 62321-1:2013.
   • Details: Map components to a bill of materials (BoM) and flag potential RoHS substances (e.g., lead in solder, phthalates in cables).
   • Responsible Party: Engineering and supply chain teams.
3. Collect Supplier Data
   • Action: Request RoHS compliance declarations from suppliers for all components and materials.
   • Details: Ensure declarations specify substance concentrations (e.g., Lead <0.1% w/w) and align with EN 50581:2012 (updated 2023) standards.
   • Responsible Party: Procurement team.
4. Perform RoHS Testing
   • Action: Test materials using appropriate methods (e.g., XRF screening, ICP-MS for metals, GC-MS for phthalates) per IEC 62321 series.
   • Details: Screen with XRF for rapid checks; verify suspect materials with lab-based methods (e.g., hexavalent chromium via IEC 62321-7-2:2017). Use ISO 17025-accredited labs for credibility.
   • Responsible Party: Quality assurance and third-party labs.
5. Evaluate Exemptions
   • Action: Check if exemptions apply (e.g., lead in steel <0.35% per Annex III) and document their validity.
   • Details: Track expiration dates (e.g., July 21, 2026, for certain exemptions) and plan substitutions.
   • Responsible Party: Compliance and engineering teams.
6. Compile Technical Documentation
   • Action: Assemble a Technical Documentation File per RoHS Article 7 and EN 50581:2012.
   • Details: Include BoM, supplier declarations, test reports, exemption justifications, and risk assessments.
   • Responsible Party: Compliance team.
7. Issue Declaration of Conformity (DoC)
   • Action: Draft and sign a DoC certifying RoHS compliance.
   • Details: List product details, restricted substances, compliance status, and reference supporting documents, per EEA standards.
   • Responsible Party: Authorized representative (e.g., manufacturer).
8. Apply CE Marking
   • Action: Affix the CE mark to compliant EEE, signaling RoHS adherence for EEA market entry.
   • Details: Ensure marking is visible, legible, and indelible per EU Directive 768/2008/EC.
   • Responsible Party: Manufacturing and labeling teams.
9. Prepare for Audit
   • Action: Conduct an internal audit to verify documentation and processes.
   • Details: Simulate market surveillance (e.g., by German UBA or Norwegian authorities), ensuring files are accessible within 10 days of request.
   • Responsible Party: Compliance and quality teams.
10. Maintain Compliance
    • Action: Monitor supply chain changes, RoHS updates (e.g., new substances), and exemption expirations.
    • Details: Retain records for 10 years post-market placement, per RoHS Article 7.
    • Responsible Party: Compliance team.

Outputs for RoHS Compliance and Audit Success

1. Bill of Materials (BoM)
   • Description: Detailed list of all EEE components and materials.
   • Content: Part numbers, descriptions, and supplier details.
   • Purpose: Basis for identifying RoHS-relevant materials.
2. Supplier Declarations
   • Description: Statements from suppliers confirming component compliance.
   • Content: Substance concentrations (e.g., Mercury <0.1%), signed by supplier.
   • Purpose: Evidence of supply chain due diligence.
3. Test Reports
   • Description: Results from RoHS testing (e.g., XRF, ICP-MS).
   • Content: Method used, sample details, measured levels (e.g., Cadmium: 0.005% w/w), lab accreditation.
   • Purpose: Proof of substance compliance.
4. Exemption Documentation
   • Description: Records justifying use of RoHS exemptions.
   • Content: Exemption reference (e.g., Annex III, 7(a)), validity period, substitution plan.
   • Purpose: Demonstrates legal use of exceptions.
5. Technical Documentation File
   • Description: Comprehensive compliance record.
   • Content: BoM, supplier declarations, test reports, exemption docs, risk assessments.
   • Purpose: Auditable evidence for regulators, retained 10 years.
6. Declaration of Conformity (DoC)
   • Description: Signed statement of RoHS compliance.
   • Content: Product ID, substance limits, responsible party, date.
   • Purpose: Legal market entry document.
7. CE Marking
   • Description: Visible mark on EEE.
   • Content: CE logo, applied per EU standards.
   • Purpose: Signals compliance for EEA market access.

Audit Readiness and Certification Outcome

• Audit Process: Market surveillance authorities (e.g., UK HSE, German UBA) may request the Technical Documentation File within 10 days. They verify DoC, test data, and CE marking against RoHS limits.
• Passing the Audit: Successful audits confirm compliance via complete, accurate outputs - no formal certificate is issued, but the DoC and CE mark serve as market authorization.
• Non-Compliance Risks: Fines, product recalls, or market bans if documentation is incomplete or substances exceed limits.