ISO 45001
International standard for occupational health and safety management
ISO 13485
International standard for medical device quality management systems
Quick Verdict
ISO 45001 provides OH&S management for all industries, emphasizing worker participation and risk prevention. ISO 13485 delivers regulatory-focused QMS for medical devices, ensuring lifecycle compliance. Organizations adopt them for certification, risk reduction, and market access.
ISO 45001
ISO 45001:2018 Occupational health and safety management systems
Key Features
- Top management accountability integrates OH&S into business processes
- Worker consultation and participation in hazard identification
- Hierarchy of controls prioritizing hazard elimination first
- Annex SL structure enables IMS integration with ISO 9001/14001
- Risk-based approach addressing risks and opportunities via PDCA
ISO 13485
ISO 13485:2016 Medical devices Quality management systems
Key Features
- Risk-based QMS controls for device safety
- Design and development validation requirements
- Supplier evaluation and outsourcing management
- Post-market surveillance and complaint handling
- Traceability and medical device file mandates
Detailed Analysis
A comprehensive look at the specific requirements, scope, and impact of each standard.
ISO 45001 Details
What It Is
ISO 45001:2018 is an international certification 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 through risk-based thinking and the PDCA cycle.
Key Components
- Clauses 4-10 cover context, leadership, planning, support, operation, evaluation, and improvement.
- Emphasizes hierarchy of controls, worker participation, and Annex SL for integration.
- No fixed controls; scalable requirements with documented information and continual improvement.
Why Organizations Use It
- Reduces incidents, legal risks, and costs; enhances resilience and insurance savings.
- Builds stakeholder trust, talent retention, and market advantage via certification.
- Supports IMS with ISO 9001/14001 for efficiency.
Implementation Overview
- Phased approach: gap analysis, policy/objectives, controls, audits, certification.
- Applicable to all sizes/sectors; 6-12 months typical.
- Involves leadership commitment, worker engagement, and third-party audits.
ISO 13485 Details
What It Is
ISO 13485:2016, titled "Medical devices — Quality management systems — Requirements for regulatory purposes," is a certifiable international standard establishing a risk-based QMS framework for organizations across the medical device lifecycle, from design to post-market surveillance, ensuring devices meet customer and regulatory requirements.
Key Components
- Clauses 4–8: QMS/documentation, management responsibility, resources, product realization, measurement/improvement.
- Emphasizes design controls, process validation, supplier management, traceability, complaint handling, CAPA.
- Integrates ISO 14971 risk management; process approach.
- Certification via accredited bodies (Stage 1/2 audits, surveillance).
Why Organizations Use It
- Facilitates market access (EU MDR, FDA QMSR 2026 alignment).
- Mitigates recalls, compliance risks.
- Enhances stakeholder trust, supply chain assurance.
- Drives operational excellence, competitive differentiation.
Implementation Overview
- Phased: gap analysis, documentation, training, validation, internal audits.
- Applies globally to manufacturers, suppliers; all sizes.
- 9–18 months typical; eQMS recommended.
Key Differences
| Aspect | ISO 45001 | ISO 13485 |
|---|---|---|
| Scope | Occupational health & safety management | Medical device quality management lifecycle |
| Industry | All sectors, high-risk industries worldwide | Medical devices, suppliers, healthcare globally |
| Nature | Voluntary certification standard (HLS) | Regulatory-purpose QMS certification standard |
| Testing | Internal audits, management reviews, surveillance | Internal audits, process validation, Stage 1/2 certification |
| Penalties | Loss of certification, no legal penalties | Loss of certification, regulatory enforcement risks |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about ISO 45001 and ISO 13485
ISO 45001 FAQ
ISO 13485 FAQ
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