ISO 31000
International guidelines for enterprise risk management
ISO 13485
International standard for medical device quality management systems.
Quick Verdict
ISO 31000 provides voluntary risk management guidelines for all organizations worldwide, while ISO 13485 mandates certifiable QMS for medical device safety. Companies adopt 31000 for enterprise resilience; 13485 for regulatory compliance and market access.
ISO 31000
ISO 31000:2018 Risk management — Guidelines
Key Features
- Defines risk as effect of uncertainty on objectives
- Eight principles guide integrated risk management
- Framework embeds risk in governance operations
- Iterative process identifies treats monitors risks
- Non-certifiable guidelines for any organization size
ISO 13485
ISO 13485:2016 Medical devices Quality management systems
Key Features
- Risk-based QMS controls for device lifecycle
- Medical device files and traceability requirements
- Post-market surveillance and complaint handling
- Design validation and process controls
- Supplier evaluation and outsourcing management
Detailed Analysis
A comprehensive look at the specific requirements, scope, and impact of each standard.
ISO 31000 Details
What It Is
ISO 31000:2018, Risk management — Guidelines is an international standard offering non-certifiable guidance for systematic enterprise risk management. It defines risk as the effect of uncertainty on objectives, providing a principles-based approach applicable to any organization, promoting value creation and protection through better decisions.
Key Components
- **Eight principlesintegrated, structured, customized, inclusive, dynamic, best information, human factors, continual improvement.
- **Frameworkleadership commitment, integration, design, implementation, evaluation, improvement (PDCA-aligned).
- **Processcommunication, scope/context/criteria, assessment (identify/analyze/evaluate), treatment, monitoring/review, recording/reporting.
- No fixed controls; flexible, iterative model.
Why Organizations Use It
- Drives strategic decisions, resilience, efficiency.
- Builds stakeholder trust, aligns with regulations like ISO 27001.
- Reduces losses, captures opportunities; competitive edge via risk intelligence.
Implementation Overview
- Phased: secure leadership, design framework, pilot process, integrate/scale, monitor.
- Suits all sizes/sectors; no certification—internal audits/governance assure alignment. (178 words)
ISO 13485 Details
What It Is
ISO 13485:2016 is the international standard titled Medical devices — Quality management systems — Requirements for regulatory purposes. It provides a risk-based framework for QMS tailored to medical devices across their lifecycle, from design to post-market surveillance, emphasizing regulatory compliance and patient safety.
Key Components
- Organized into Clauses 4–8: QMS/documentation, management responsibility, resources, product realization, measurement/improvement.
- Core principles: documented processes, traceability, validation, risk management (linked to ISO 14971).
- Requires quality manual, medical device files, CAPA, internal audits; certification via accredited bodies.
Why Organizations Use It
- Enables market access (EU MDR, FDA QMSR alignment by 2026), reduces risks/recalls.
- Builds stakeholder trust, supplier controls, operational efficiency.
- Strategic for scaling, M&A, international expansion.
Implementation Overview
- Phased: gap analysis, documentation, training, validation, audits (9–36 months typical).
- Applies to manufacturers, suppliers, distributors globally; voluntary certification but regulatory expectation.
Key Differences
| Aspect | ISO 31000 | ISO 13485 |
|---|---|---|
| Scope | Enterprise-wide risk management guidelines | Medical device QMS lifecycle requirements |
| Industry | All sectors, any organization globally | Medical devices and related services |
| Nature | Non-certifiable guidelines, voluntary | Certifiable standard for regulatory compliance |
| Testing | Internal audits, management reviews | Internal audits, certification body audits |
| Penalties | No legal penalties, loss of alignment | Regulatory non-compliance, market access denial |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about ISO 31000 and ISO 13485
ISO 31000 FAQ
ISO 13485 FAQ
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