ISO 9001
International standard for quality management systems
RoHS
EU regulation restricting hazardous substances in EEE
Quick Verdict
ISO 9001 provides voluntary QMS certification for operational excellence across industries, while RoHS mandates hazardous substance restrictions in EEE for EU market access. Companies adopt ISO 9001 for efficiency and trust; RoHS to avoid fines and enable sales.
ISO 9001
ISO 9001:2015 Quality management systems
Key Features
- Process-based framework using PDCA cycle
- Risk-based thinking integrated throughout
- Seven quality management principles foundation
- Leadership commitment and top accountability
- High-Level Structure for multi-standard integration
RoHS
Directive 2011/65/EU (RoHS 2)
Key Features
- Restricts 10 substances in homogeneous materials at 0.1% limit
- Open scope for all EEE unless explicitly excluded
- Requires technical file and EU Declaration of Conformity
- Time-limited exemptions via delegated directives
- Tiered verification with IEC 62321 testing methods
Detailed Analysis
A comprehensive look at the specific requirements, scope, and impact of each standard.
ISO 9001 Details
What It Is
ISO 9001:2015 is the international certification standard for quality management systems (QMS). It provides a flexible, process-oriented framework applicable to any organization, emphasizing consistent delivery of products/services meeting customer and regulatory needs via PDCA cycle and risk-based thinking.
Key Components
- 10 clauses (4-10 auditable): context, leadership, planning, support, operation, evaluation, improvement
- Built on **7 quality principlescustomer focus, leadership, engagement, process approach, improvement, evidence-based decisions, relationships
- Over 1M global certifications; voluntary third-party audits every 3 years with surveillance
Why Organizations Use It
- Enhances customer satisfaction, efficiency, risk management
- Boosts market access, compliance, reputation
- Drives cost savings, continual improvement, stakeholder trust
Implementation Overview
- Gap analysis, process mapping, training, internal audits
- 6-12 months typical; suits all sizes/industries
- Certification via accredited bodies; integrates with ISO 14001 via HLS
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 employs an open-scope approach (all EEE unless excluded) with homogeneous material concentration limits.
Key Components
- Restricts 10 substances (e.g., lead, mercury, phthalates) at 0.1% (Cd: 0.01%) in homogeneous materials.
- Annexes III/IV for time-limited exemptions.
- Compliance via technical documentation, EU Declaration of Conformity (DoC), and CE marking.
- Built on IEC 63000 (documentation) and IEC 62321 (testing).
Why Organizations Use It
- Mandatory for EU market access; prevents fines, recalls.
- Enhances recyclability, supply chain governance.
- Builds stakeholder trust, supports ESG goals.
- Drives material substitution, competitive edge.
Implementation Overview
- **Phasedscoping, gap analysis, supplier controls, testing, documentation.
- Applies to manufacturers/importers of EEE; all sizes, global reach.
- Risk-based; no central certification, but 10-year retention for audits. (178 words)
Key Differences
| Aspect | ISO 9001 | RoHS |
|---|---|---|
| Scope | Quality management systems for all processes | Hazardous substances in electrical equipment |
| Industry | All industries worldwide, any size | EEE manufacturers, primarily EU market |
| Nature | Voluntary certifiable management standard | Mandatory EU product regulation |
| Testing | Internal audits, management reviews | Material analysis, XRF/ICP-MS testing |
| Penalties | Loss of certification, no legal fines | Fines, recalls, market bans |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about ISO 9001 and RoHS
ISO 9001 FAQ
RoHS FAQ
You Might also be Interested in These Articles...
The Panoramic View: How Integrated Compliance Monitoring Creates Unprecedented Organizational Visibility and Adaptability
Gain unprecedented organizational visibility with integrated compliance monitoring. Automate real-time alerts, ensure GDPR & SOC 2 adherence, reduce risks, and
The CIS Controls v8.1 Evidence Pack: What Auditors Ask For (and How to Produce Proof Fast)
Fail CIS Controls v8.1 audits due to missing evidence? Get the blueprint: exact artifacts auditors want, repository structure, and automation from security tool
CIS Controls v8.1, Operationalized: Top 10 Reasons Compliance Monitoring Software Accelerates Real-World Implementation
Operationalize CIS Controls v8.1 with compliance monitoring software. Turn checklists into dashboards, tickets, and audit-proof workflows. Top 10 reasons it acc
Run Maturity Assessments with GRADUM
Transform your compliance journey with our AI-powered assessment platform
Assess your organization's maturity across multiple standards and regulations including ISO 27001, DORA, NIS2, NIST, GDPR, and hundreds more. Get actionable insights and track your progress with collaborative, AI-powered evaluations.
Check out these other Gradum.io Standards Comparison Pages
CSL (Cyber Security Law of China) vs APPI
Unlock CSL vs APPI: Compare China's data localization & security mandates with Japan's consent-driven privacy rules. Master Asia compliance strategies today.
SAFe vs SOX
Compare SAFe vs SOX: Scale agile enterprises with SAFe's frameworks while ensuring SOX compliance. Discover integration strategies for regulated IT/software delivery, boosting agility & ROI. Explore now!
FISMA vs ISO/IEC 42001:2023
Compare FISMA vs ISO/IEC 42001:2023—US federal cybersecurity meets global AI governance. Uncover key differences, compliance strategies & integration for ethical AI. Boost resilience now!