PCI DSS
Global standard for securing payment cardholder data
ISO 13485
International standard for medical device quality management systems
Quick Verdict
PCI DSS secures payment card data for merchants via contractual controls and scans, while ISO 13485 establishes QMS for medical device makers ensuring lifecycle safety and regulatory compliance. Organizations adopt PCI DSS to avoid fines and retain processing rights; ISO 13485 for market access and certification.
PCI DSS
Payment Card Industry Data Security Standard
Key Features
- 12 requirements across 6 control objectives protecting cardholder data
- Contractual enforcement by payment brands with fines and bans
- Over 300 granular sub-requirements for technical security
- Merchant levels dictate SAQ or QSA-led ROC validation
- Network segmentation minimizes Cardholder Data Environment scope
ISO 13485
ISO 13485:2016 Medical devices Quality management systems
Key Features
- Risk-based QMS controls for device lifecycle
- Design and development controls with validation
- Medical device files and traceability requirements
- Post-market surveillance and complaint handling
- Supplier evaluation and outsourcing management
Detailed Analysis
A comprehensive look at the specific requirements, scope, and impact of each standard.
PCI DSS Details
What It Is
PCI DSS (Payment Card Industry Data Security Standard) is a contractual security framework managed by the PCI Security Standards Council. It mandates protection of cardholder data (CHD) and sensitive authentication data (SAD) for merchants and service providers. Organized into 12 requirements under 6 control objectives, it uses a control-based approach with v4.0 emphasizing customized implementations.
Key Components
- 12 requirements covering network security, data protection, vulnerability management, access controls, monitoring, and policies.
- Over 300 sub-requirements with testing procedures.
- Compliance via SAQ (self-assessment) or QSA ROC based on transaction volume levels.
- Built on Assess-Repair-Report cycle.
Why Organizations Use It
- Contractual obligation from payment brands to avoid fines, bans.
- Reduces breach risks/costs ($37/record avg.).
- Builds customer trust, enables card processing.
- Supports GDPR alignment for personal data.
Implementation Overview
- Scope CDE, gap analysis, remediate controls like segmentation/tokenization.
- Applies globally to card-handling entities.
- Quarterly ASV scans, annual audits for high-volume.
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 ensures devices meet customer and regulatory requirements across the lifecycle, using a risk-based process approach emphasizing documentation, validation, and traceability.
Key Components
- Clauses 4–8: QMS/documentation, management responsibility, resources, product realization, measurement/improvement.
- Core areas: design controls, supplier management, process validation, post-market surveillance.
- Aligned with ISO 9001 but regulatory-focused; requires medical device files.
- Certification via accredited bodies with stage 1/2 audits and surveillance.
Why Organizations Use It
- Facilitates market access (EU MDR, FDA QMSR by 2026).
- Mitigates risks, reduces recalls, ensures compliance.
- Builds trust, enables partnerships, supports scalability.
Implementation Overview
- Phased: gap analysis, documentation, training, validation, internal audits.
- Suits manufacturers/suppliers of all sizes globally.
- Involves certification audits; 9–18 months typical.
Key Differences
| Aspect | PCI DSS | ISO 13485 |
|---|---|---|
| Scope | Protects cardholder data during storage, processing, transmission | QMS for medical device lifecycle from design to post-market |
| Industry | Payment card industry, merchants, service providers globally | Medical devices, manufacturers, suppliers worldwide |
| Nature | Contractual standard, enforced by card brands, voluntary certification | Voluntary QMS certification standard for regulatory purposes |
| Testing | Quarterly ASV scans, annual pentests, QSA ROC/SAQ | Internal audits, management reviews, certification body audits |
| Penalties | Fines, loss of processing privileges, contractual enforcement | Loss of certification, regulatory non-conformity risks |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about PCI DSS and ISO 13485
PCI DSS FAQ
ISO 13485 FAQ
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