RoHS
EU directive restricting hazardous substances in EEE
ISO 45001
International standard for occupational health and safety management systems.
Quick Verdict
RoHS mandates hazardous substance limits in EEE for EU market access, while ISO 45001 provides a voluntary framework for occupational health & safety management. Companies adopt RoHS for legal compliance and sales, ISO 45001 for risk reduction, culture, and certification benefits.
RoHS
Directive 2011/65/EU (RoHS 2)
Key Features
- Homogeneous material limits at 0.1% for most substances
- Restricts ten hazardous substances in electrical equipment
- Open scope applies to all EEE unless excluded
- Time-limited exemptions via delegated directives
- Requires technical documentation and Declaration of Conformity
ISO 45001
ISO 45001:2018 Occupational health and safety management systems
Key Features
- Top management accountability and leadership commitment
- Worker consultation and participation in hazard identification
- Hierarchy of controls for risk prioritization
- Annex SL alignment for IMS integration
- Management of change and contractor controls
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). It aims to protect health and environment by limiting substances during waste management, using a homogeneous material approach with maximum concentration values (MCVs): 0.1% for most, 0.01% for cadmium.
Key Components
- Ten restricted substances: lead, mercury, cadmium, hexavalent chromium, PBB, PBDE, four phthalates.
- Open scope covering 11 EEE categories unless excluded.
- Annex III/IV exemptions, time-limited and reviewed via delegated acts.
- Compliance via Declaration of Conformity (DoC), technical files (EN IEC 63000), CE marking.
Why Organizations Use It
Mandated for EU market access, prevents fines, recalls. Enhances recyclability, supply chain governance, ESG reporting. Reduces risks from exemptions expiry, decentralized enforcement.
Implementation Overview
Risk-based: scope analysis, BoM review, supplier declarations, tiered testing (XRF/ICP-MS per IEC 62321). Applies to manufacturers/importers globally selling EEE. Retain files 10 years; no certification but audit-ready evidence essential. (178 words)
ISO 45001 Details
What It Is
ISO 45001:2018 is the international standard for Occupational Health and Safety Management Systems (OHSMS). It provides a framework to prevent work-related injuries and ill health, proactively improving OH&S performance. Built on the High-Level Structure (HLS, Annex SL) and PDCA cycle, it adopts a risk-based approach emphasizing leadership and worker participation.
Key Components
- Clauses 4–10 cover context, leadership, planning, support, operation, performance evaluation, and improvement.
- Core elements: hazard identification, hierarchy of controls, contractor management, emergency preparedness.
- Relies on documented information, monitoring, audits, and continual improvement; no fixed number of controls.
- Voluntary certification via accredited bodies.
Why Organizations Use It
- Reduces incidents, legal risks, and costs; enhances resilience and insurance savings.
- Meets stakeholder expectations, integrates with ISO 9001/14001 for efficiency.
- Builds safety culture, competitive edge, and reputation through demonstrated commitment.
Implementation Overview
- Phased: gap analysis, policy/objectives, training, controls, audits (6-12 months typical).
- Scalable for all sizes/sectors; requires leadership buy-in, worker involvement.
- Certification optional but involves Stage 1/2 audits, surveillance.
Key Differences
| Aspect | RoHS | ISO 45001 |
|---|---|---|
| Scope | Hazardous substances in EEE materials | Occupational health & safety management |
| Industry | EEE manufacturers, electronics, global | All industries/sectors worldwide |
| Nature | Mandatory EU directive for market access | Voluntary certification standard |
| Testing | XRF screening, IEC 62321 lab analysis | Internal audits, management reviews |
| Penalties | Fines, recalls, market bans by states | No legal penalties, certification loss |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about RoHS and ISO 45001
RoHS FAQ
ISO 45001 FAQ
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