ISO 9001
International standard for quality management systems
REACH
EU regulation for chemical registration, evaluation, authorisation, restriction.
Quick Verdict
ISO 9001 provides voluntary QMS certification for global quality excellence, while REACH mandates chemical registration and risk management for EU market access. Companies adopt ISO 9001 for efficiency and trust; REACH to comply legally and avoid penalties.
ISO 9001
ISO 9001:2015 Quality management systems — Requirements
Key Features
- Process-based framework with PDCA cycle
- Risk-based thinking integrated throughout
- Seven quality management principles
- Leadership commitment and accountability
- High-Level Structure for integration
REACH
Regulation (EC) No 1907/2006 (REACH)
Key Features
- Industry-led registration for substances over 1 tonne/year
- SVHC Candidate List triggers communication and notification
- Annex XIV authorisation with sunset dates for SVHCs
- Annex XVII EU-wide restrictions and bans
- Supply chain SDS and exposure scenario obligations
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 specifies requirements for organizations to consistently meet customer and regulatory needs through a process-based approach using the PDCA cycle and risk-based thinking.
Key Components
- 10 clauses (4-10 auditable): context, leadership, planning, support, operation, evaluation, improvement.
- Built on **seven quality principlescustomer focus, leadership, engagement, process approach, improvement, evidence-based decisions, relationships.
- High-Level Structure (Annex SL) enables integration with other ISO standards.
- Voluntary third-party certification with audits.
Why Organizations Use It
- Enhances customer satisfaction, efficiency, risk management.
- Boosts market access, reputation, compliance.
- Drives cost savings, continual improvement.
- Over 1 million certifications worldwide build stakeholder trust.
Implementation Overview
- Gap analysis, process mapping, training, internal audits.
- Applicable to all sizes/sectors; 6-12 months typical.
- Certification via accredited bodies, ongoing surveillance.
REACH Details
What It Is
REACH (Regulation (EC) No 1907/2006) is a directly applicable EU regulation governing the Registration, Evaluation, Authorisation and Restriction of Chemicals. Its primary purpose is to ensure a high level of protection for human health and the environment from chemical risks by shifting responsibility to industry for generating and managing safety data. It adopts a risk-based approach across the chemical lifecycle, from manufacture to use in articles.
Key Components
- Four pillars: Registration (>1 tonne/year), Evaluation (dossier/substance checks), Authorisation (SVHCs on Annex XIV), Restriction (Annex XVII bans/limits).
- 17 technical Annexes detailing data requirements, SDS rules, exemptions.
- Built on precautionary principles, with ECHA managing databases and Member States enforcing.
- Continuous compliance model, no certification but mandatory dossiers and updates.
Why Organizations Use It
- Legal obligation for EU market access; non-compliance risks fines, market bans.
- Manages supply chain risks, drives substitution, enhances ESG reporting.
- Builds stakeholder trust via transparency (e.g., Article 33 SVHC disclosure).
- Competitive edge through innovation in safer chemicals.
Implementation Overview
- Phased: governance, inventory, gap analysis, dossiers, monitoring.
- Applies to manufacturers/importers/downstream users in chemicals/products; all sizes, EU/EEA focus.
- No certification; requires ECHA submissions, national audits, 10-year records.
Key Differences
| Aspect | ISO 9001 | REACH |
|---|---|---|
| Scope | Quality management systems and processes | Chemical registration, evaluation, authorisation, restriction |
| Industry | All industries, any organization size globally | Chemicals, manufacturing, EU/EEA market actors |
| Nature | Voluntary certifiable standard | Mandatory EU regulation with penalties |
| Testing | Internal audits, third-party certification audits | Hazard, exposure, toxicological testing per tonnage |
| Penalties | Loss of certification, no legal fines | Fines, product seizures, market bans |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about ISO 9001 and REACH
ISO 9001 FAQ
REACH FAQ
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