RoHS
EU regulation restricting hazardous substances in electrical equipment
ISO 19600
International guidelines for compliance management systems.
Quick Verdict
RoHS mandates hazardous substance limits in EEE for EU market access, while ISO 19600 guides CMS frameworks for all organizations. Companies adopt RoHS for legal compliance and sales, ISO 19600 for governance and risk management.
RoHS
Directive 2011/65/EU restricting hazardous substances in EEE
Key Features
- Restricts 10 hazardous substances at 0.1% in homogeneous materials
- Open-scope covers all EEE unless specifically excluded
- Time-limited exemptions reviewed via delegated directives
- Mandates technical documentation and EU Declaration of Conformity
- Tiered verification using IEC 62321 screening and testing
ISO 19600
ISO 19600:2014 Compliance management systems — Guidelines
Key Features
- Risk-based compliance management framework
- Good governance principles for CMS
- Annex SL structure for integration
- Scalable to all organization sizes
- PDCA cycle for continual improvement
Detailed Analysis
A comprehensive look at the specific requirements, scope, and impact of each standard.
RoHS Details
What It Is
RoHS (Directive 2011/65/EU, recast as RoHS 2) is an EU regulation restricting hazardous substances in electrical and electronic equipment (EEE) to protect health and environment during waste management. It applies open-scope to all EEE unless excluded, using homogeneous material thresholds (0.1% w/w for most, 0.01% for cadmium).
Key Components
- Restricts **10 substancesPb, Hg, Cd, Cr(VI), PBB, PBDE, DEHP, BBP, DBP, DIBP.
- Annexes III/IV for time-limited exemptions.
- Compliance via technical documentation, EU Declaration of Conformity (DoC), and CE marking.
- Aligned with IEC 63000 (documentation) and IEC 62321 (testing).
Why Organizations Use It
Ensures EU market access, reduces e-waste risks, improves recyclability with WEEE. Mitigates fines, recalls, reputational damage. Drives supply chain transparency, substitution innovation, ESG advantages.
Implementation Overview
Risk-based: scope products, map BoMs, collect supplier declarations, tiered testing (XRF screening, ICP-MS/GC-MS confirmation), build technical files. Applies globally to EEE makers/importers; decentralized enforcement by Member States requires 10-year retention.
ISO 19600 Details
What It Is
ISO 19600:2014, titled Compliance management systems — Guidelines, is an International Standard from ISO providing non-certifiable guidance for establishing, developing, implementing, evaluating, maintaining, and improving a Compliance Management System (CMS). It uses a risk-based approach with Annex SL structure, applicable to all organizations regardless of size or sector.
Key Components
- Ten clauses: context, leadership, planning, support, operation, performance evaluation, improvement.
- Core principles: good governance, proportionality, transparency, sustainability.
- Focus on obligations identification, risk assessment, controls, PDCA cycle.
- Benchmarking tool, predecessor to certifiable ISO 37301.
Why Organizations Use It
- Mitigates legal/regulatory risks, avoids penalties, operational disruptions.
- Enhances efficiency via integration with ISO 9001/14001.
- Builds integrity culture, improves decision-making, stakeholder trust.
- Provides competitive edge in RFPs, market access.
Implementation Overview
- Phased roadmap: leadership commitment, gap analysis, design/documentation, rollout, continuous improvement.
- Scalable for SMEs/start-ups to MNCs, all industries/geographies.
- No formal certification; internal audits, self-assessment.
Key Differences
| Aspect | RoHS | ISO 19600 |
|---|---|---|
| Scope | Hazardous substances in EEE materials | Compliance management systems organization-wide |
| Industry | EEE manufacturers, global with regional variants | All organizations and sectors worldwide |
| Nature | Mandatory EU product directive | Voluntary CMS guidelines (withdrawn) |
| Testing | Material analysis (XRF, IEC 62321 lab tests) | Internal audits and management reviews |
| Penalties | Fines, recalls, market bans by Member States | No direct penalties (self-improvement focus) |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about RoHS and ISO 19600
RoHS FAQ
ISO 19600 FAQ
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