ISO 13485
International standard for medical device quality management systems
ISO 27017
Code of practice for cloud security controls.
Quick Verdict
ISO 13485 ensures medical device quality and regulatory compliance across lifecycles, while ISO 27017 provides cloud-specific security guidance extending ISO 27001. Medical firms adopt 13485 for market access; cloud users leverage 27017 for shared responsibility clarity.
ISO 13485
ISO 13485:2016 Medical devices Quality management systems
Key Features
- Risk-based controls for medical device lifecycle
- Regulatory-focused QMS with post-market surveillance
- Mandatory medical device files and traceability
- Process and software validation requirements
- Tailored exclusions justified in quality manual
ISO 27017
ISO/IEC 27017: Code of practice for cloud controls
Key Features
- Adds 7 cloud-specific CLD security controls
- Clarifies shared CSP-CSC responsibilities
- Provides guidance for 37 ISO 27002 cloud adaptations
- Addresses multi-tenancy and VM hardening
- Integrates into ISO 27001 certification audits
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 specifies requirements for a risk-based QMS to ensure medical devices meet customer and regulatory needs across the lifecycle, from design to post-market activities.
Key Components
- Organized into Clauses 4–8: QMS/documentation, management responsibility, resources, product realization, measurement/improvement.
- Emphasizes documented procedures, medical device files, validation, traceability, supplier controls.
- Built on process approach with regulatory integration; allows justified exclusions.
- Third-party certification via audits.
Why Organizations Use It
- Enables market access (EU MDR, FDA QMSR alignment by 2026).
- Reduces risks via validation, CAPA, post-market surveillance.
- Builds trust with regulators, partners; lowers costs of poor quality.
- Strategic for scaling, supply chain assurance.
Implementation Overview
- Phased: gap analysis, documentation, training, validation, audits.
- Applies to manufacturers, suppliers globally; 9–18 months typical.
- Requires certification audits, ongoing surveillance.
ISO 27017 Details
What It Is
ISO/IEC 27017:2015 is a code of practice extending ISO/IEC 27002 with cloud-specific information security controls. It provides guidance for implementing security in cloud services, focusing on shared responsibilities in public, private, and hybrid environments. Its risk-based approach integrates into ISO 27001 ISMS.
Key Components
- Guidance on 37 ISO 27002 controls adapted for cloud.
- 7 additional CLD controls for shared roles, multi-tenancy, VM hardening, admin security, monitoring, asset removal, network alignment.
- Built on ISO 27001/27002; no standalone certification—assessed within ISO 27001 audits.
Why Organizations Use It
- Addresses cloud risks like isolation and data lifecycle.
- Meets procurement, regulatory demands (e.g., GDPR alignment).
- Enhances risk management, trust with stakeholders.
- Competitive edge for CSPs/CSCs via proven controls.
Implementation Overview
- Integrate into existing ISO 27001 ISMS via risk assessment.
- Map controls, update SoA, implement configs/monitoring.
- Suits CSPs, CSCs across sizes/industries globally.
- Joint audits (9-12 months); annual surveillance.
Key Differences
| Aspect | ISO 13485 | ISO 27017 |
|---|---|---|
| Scope | Medical device QMS lifecycle | Cloud security controls guidance |
| Industry | Medical devices global | Cloud services worldwide |
| Nature | QMS certification standard | 27001 extension code of practice |
| Testing | Stage 1/2 audits, surveillance | Integrated into 27001 audits |
| Penalties | Certification loss, market access denial | No direct penalties, audit findings |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about ISO 13485 and ISO 27017
ISO 13485 FAQ
ISO 27017 FAQ
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