RoHS
EU directive restricting hazardous substances in EEE
ISO 37301
Certifiable international standard for compliance management systems
Quick Verdict
RoHS restricts hazardous substances in EEE for EU market access, while ISO 37301 builds certifiable CMS for all compliance risks. Companies adopt RoHS for legal sales compliance; ISO 37301 for governance, culture, and stakeholder trust.
RoHS
Directive 2011/65/EU (RoHS 2) on hazardous substances
Key Features
- Homogeneous material thresholds limit 10 substances at 0.1% (Cd 0.01%)
- Open scope covers all EEE unless explicitly excluded
- Time-limited exemptions in Annexes III/IV require tracking
- Mandates technical file and EU Declaration of Conformity
- Tiered verification using IEC 62321 screening and testing
ISO 37301
ISO 37301:2021 Compliance management systems requirements
Key Features
- Certifiable requirements replacing guidance-only ISO 19600
- HLS alignment for integrated management systems
- Risk-based planning of compliance obligations
- Leadership commitment and compliance culture emphasis
- Protected whistleblowing channels and investigations
Detailed Analysis
A comprehensive look at the specific requirements, scope, and impact of each standard.
RoHS Details
What It Is
Directive 2011/65/EU (RoHS 2) is an EU regulation restricting hazardous substances in electrical and electronic equipment (EEE) to protect health and environment during waste management. It adopts an open-scope approach, applying to all EEE unless excluded, with restrictions at homogeneous material level using maximum concentration values (MCVs).
Key Components
- Restricts 10 substances (Pb, Hg, Cd, Cr(VI), PBB, PBDE, DEHP, BBP, DBP, DIBP) at 0.1% (Cd 0.01%).
- Annexes III/IV provide time-limited exemptions.
- Requires technical documentation, EU Declaration of Conformity (DoC), and CE marking.
- Compliance via IEC 63000 documentary and IEC 62321 testing methods; decentralized enforcement by Member States.
Why Organizations Use It
Ensures EU/EEA market access, reduces e-waste risks, improves recyclability with WEEE. Mitigates fines, recalls, liabilities; enhances supply chain, ESG reputation, global competitiveness.
Implementation Overview
Risk-based: scope analysis, BoM review, supplier declarations, tiered testing (XRF screening, ICP-MS/GC-MS confirmation), technical files (10-year retention). Applies to manufacturers/importers of EEE; no certification but audit-ready evidence for surveillance. Suits all sizes, complex for multi-tier supply chains.
ISO 37301 Details
What It Is
ISO 37301:2021, officially "Compliance management systems – Requirements with guidance for use," is a certifiable international standard for Compliance Management Systems (CMS). It provides auditable requirements to identify obligations, manage risks, and foster integrity culture using a risk-based Plan-Do-Check-Act (PDCA) cycle and High-Level Structure (HLS).
Key Components
- Core elements: leadership commitment, risk planning, whistleblowing channels, performance evaluation, continual improvement.
- Aligned with HLS for integration with ISO 9001, 14001, 27001.
- Supported by companions like ISO 37302 (measurement), 37303 (competence).
- Certifiable through accredited bodies (e.g., ANAB).
Why Organizations Use It
- Delivers third-party assurance, reduces fines/reputational risks.
- Meets ESG/investor demands, supports UN SDGs 8, 16.
- Builds compliance culture, enables early detection via protected reporting.
- Enhances stakeholder trust, market access.
Implementation Overview
- Phased: context analysis, obligation register, training, audits, certification.
- Scalable for all sizes/sectors; 12-18 months typical.
- Requires resources, cultural shift; 2024 amendment adds climate focus.
Key Differences
| Aspect | RoHS | ISO 37301 |
|---|---|---|
| Scope | Hazardous substances in EEE materials | All compliance obligations and risks |
| Industry | EEE manufacturers, global with regional variations | All sectors and sizes worldwide |
| Nature | Mandatory EU product directive | Voluntary certifiable management standard |
| Testing | Material chemical analysis (XRF, IEC 62321) | Internal audits and management reviews |
| Penalties | Fines, recalls, market bans by Member States | Loss of certification, no legal penalties |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about RoHS and ISO 37301
RoHS FAQ
ISO 37301 FAQ
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