ISO 13485
International standard for medical device quality management systems
ISO 27018
International code of practice for PII protection in public clouds.
Quick Verdict
ISO 13485 ensures medical device quality compliance for manufacturers, while ISO 27018 protects PII in public clouds for processors. Companies adopt 13485 for regulatory market access and 27018 for privacy trust and procurement acceleration.
ISO 13485
ISO 13485:2016 Medical devices Quality management systems
ISO 27018
ISO/IEC 27018:2025 PII protection in public clouds
Key Features
- Privacy-specific controls for cloud PII processors
- Subprocessor transparency and disclosure requirements
- Breach notification obligations to customers
- Prohibits PII use for marketing without consent
- Supports data subject rights in cloud environments
Detailed Analysis
A comprehensive look at the specific requirements, scope, and impact of each standard.
ISO 13485 Details
What It Is
ISO 13485:2016, titled Medical devices — Quality management systems — Requirements for regulatory purposes, is an international certification standard for QMS in medical device organizations. It applies across the device lifecycle—design, production, distribution, servicing, and disposal—using a risk-based process approach tailored for regulatory compliance.
Key Components
- Clauses 4–8 cover QMS foundation, management responsibility, resources, product realization, and measurement/improvement.
- Emphasizes documented procedures, validation, traceability, and ISO 14971 risk integration.
- Requires quality manual, medical device files, and records retention.
- Certification via accredited bodies with stage 1/2 audits and surveillance.
Why Organizations Use It
- Enables market access (EU MDR, FDA QMSR alignment by 2026).
- Mitigates risks of recalls and liabilities.
- Builds stakeholder trust and supply chain assurance.
- Drives operational efficiency and continual improvement.
Implementation Overview
- Phased: gap analysis, documentation, training, validation, audits.
- Suits manufacturers, suppliers, SMEs to multinationals.
- 9–18 months typical; focuses on evidence generation and eQMS tools.
ISO 27018 Details
What It Is
ISO/IEC 27018 is a code of practice extending ISO 27001 and ISO 27002 for protecting personally identifiable information (PII) in public clouds where providers act as PII processors. Its primary purpose is to provide privacy-specific controls for cloud environments, focusing on multi-tenancy, subprocessors, and data flows. It uses a risk-based approach integrated into an Information Security Management System (ISMS).
Key Components
- Privacy controls (~25-30 additional) on consent, purpose limitation, transparency, and breach notification.
- Built on ISO 27001 Annex A (93 controls) with cloud PII guidance.
- Principles: consent/choice, data minimization, accuracy, security, accountability.
- Assessed via ISO 27001 audits; no standalone certification.
Why Organizations Use It
- Builds customer trust and accelerates procurement.
- Aligns with GDPR, HIPAA for processor obligations.
- Reduces risk in cloud PII handling; aids cyber insurance.
- Differentiates CSPs in competitive markets.
Implementation Overview
- Layer onto existing ISO 27001 ISMS; gap analysis, SoA updates.
- Involves policies, training, subprocessor disclosure, audits.
- Suits CSPs of all sizes; global applicability.
- Requires annual surveillance audits.
Key Differences
| Aspect | ISO 13485 | ISO 27018 |
|---|---|---|
| Scope | Medical device QMS lifecycle | PII protection in public clouds |
| Industry | Medical devices globally | Cloud service providers globally |
| Nature | Certifiable QMS standard | Privacy code of practice |
| Testing | Stage 1/2 audits, surveillance | Integrated with ISO 27001 audits |
| Penalties | Loss of certification | No direct penalties |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about ISO 13485 and ISO 27018
ISO 13485 FAQ
ISO 27018 FAQ
You Might also be Interested in These Articles...
Image this: What if GDPR would have NOT been implemented by the EU
What if the EU never implemented GDPR? Explore this hypothetical: consumer data protection in Dec 2025, key differences, pros/cons for users & companies. Read t
Top 10 Reasons CMMC Level 3 Certification Unlocks Competitive Edge for Primes Handling Critical DoD Programs
Discover top 10 reasons CMMC Level 3 certification unlocks competitive edge for DoD primes. Reduced APT risks, procurement prefs, NIST 800-172 compliance via v2
5 Ways Modern Compliance Software Makes Evolving Regulations Your Strategic Advantage
Discover 5 ways modern compliance software turns evolving regulations into strategic advantage. Automate monitoring, cut 3x non-compliance costs, stay audit-rea
Run Maturity Assessments with GRADUM
Transform your compliance journey with our AI-powered assessment platform
Assess your organization's maturity across multiple standards and regulations including ISO 27001, DORA, NIS2, NIST, GDPR, and hundreds more. Get actionable insights and track your progress with collaborative, AI-powered evaluations.
Check out these other Gradum.io Standards Comparison Pages
PDPA vs CSA
PDPA vs CSA: Compare Asia's data privacy laws (Singapore, Thailand PDPA) with CSA safety standards. Key diffs in consent, breaches, risks—unlock compliant strategies for global ops now!
PIPL vs CIS Controls
Discover PIPL vs CIS Controls: China's privacy powerhouse meets cybersecurity gold standard. Unlock compliance strategies, risk mitigation & implementation roadmaps. Compare now!
ISO 19600 vs SAMA CSF
Discover ISO 19600 vs SAMA CSF: Compare compliance guidelines with Saudi financial cybersecurity framework. Build resilient CMS, mitigate risks, achieve maturity. Read now!