ISO 13485
International standard for medical device quality management systems
ISO 28000
International standard for supply chain security management systems.
Quick Verdict
ISO 13485 ensures medical device quality and regulatory compliance via lifecycle QMS, while ISO 28000 builds supply chain security through risk-based SMS. Medical firms adopt 13485 for market access; logistics use 28000 for resilience and trust.
ISO 13485
ISO 13485:2016 Medical devices Quality management systems
Key Features
- Risk-based controls for QMS processes
- Regulatory requirements integration for devices
- Full lifecycle coverage design to disposal
- Mandatory process validation and traceability
- Post-market surveillance and complaint handling
ISO 28000
ISO 28000:2022 Security management systems - Requirements
Key Features
- Risk-based supply chain security assessment
- PDCA cycle for continual improvement
- Leadership commitment and policy requirements
- Supplier and external process controls
- Integration with ISO 31000 and 22301
Detailed Analysis
A comprehensive look at the specific requirements, scope, and impact of each standard.
ISO 13485 Details
What It Is
ISO 13485:2016 is an international certification standard titled Medical devices — Quality management systems — Requirements for regulatory purposes. It provides a risk-based framework for organizations to demonstrate consistent provision of safe medical devices meeting customer and regulatory needs across the device lifecycle.
Key Components
- Organized into Clauses 4-8: QMS, management responsibility, resources, product realization, measurement/improvement.
- Emphasizes documented procedures, validation, traceability, risk management (ISO 14971), and post-market surveillance.
- Allows justified exclusions, primarily in product realization.
- Certification via accredited bodies with stage audits and surveillance.
Why Organizations Use It
- Enables market access (EU MDR, FDA QMSR alignment by 2026).
- Reduces risks of recalls, liabilities via robust controls.
- Builds supplier confidence and operational efficiency.
- Enhances regulatory maturity and stakeholder trust.
Implementation Overview
- Phased: gap analysis, documentation, training, validation, audits.
- Applies to manufacturers, suppliers, distributors globally.
- Typical for SMEs to multinationals; 9-18 months with eQMS tools.
ISO 28000 Details
What It Is
ISO 28000:2022 is an international standard specifying requirements for a security management system (SMS) focused on supply chain security. It adopts a risk-based, PDCA (Plan-Do-Check-Act) approach to manage threats like theft, sabotage, and disruptions.
Key Components
- Clauses 4-10 cover context, leadership, planning, support, operation, performance evaluation, and improvement.
- Emphasizes risk assessment aligned with ISO 31000, security plans, and supplier controls.
- Built on harmonized ISO structure for integration; supports third-party certification per ISO 28003.
Why Organizations Use It
- Reduces security incidents and operational disruptions.
- Meets contractual, regulatory, and insurance requirements.
- Enhances resilience, stakeholder trust, and market access.
- Provides competitive edge through certified assurance.
Implementation Overview
- Phased: gap analysis, risk assessment, controls deployment, audits.
- Scalable for all sizes/industries; 6-36 months typical.
- Involves training, documentation, internal audits, and optional certification.
Key Differences
| Aspect | ISO 13485 | ISO 28000 |
|---|---|---|
| Scope | Medical device QMS lifecycle | Supply chain security management |
| Industry | Medical devices, healthcare | Logistics, all supply chains |
| Nature | Voluntary QMS certification | Voluntary SMS certification |
| Testing | Internal audits, validation | Risk assessments, audits |
| Penalties | Loss of certification | Loss of certification |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about ISO 13485 and ISO 28000
ISO 13485 FAQ
ISO 28000 FAQ
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