ISO 13485
International standard for medical device quality management systems
ISO 27701
International standard for Privacy Information Management Systems (PIMS)
Quick Verdict
ISO 13485 ensures QMS for medical devices meeting regulatory needs, while ISO 27701 establishes PIMS for privacy accountability. Companies adopt 13485 for market access and compliance; 27701 for GDPR alignment and trust.
ISO 13485
ISO 13485:2016 Medical devices Quality management systems
Key Features
- Risk-based QMS controls for device safety
- Regulatory compliance integrated with customer requirements
- Mandatory design controls and process validation
- Post-market surveillance and complaint handling
- Traceability via medical device files
ISO 27701
ISO/IEC 27701:2025 Privacy Information Management
Key Features
- Establishes Privacy Information Management System (PIMS)
- Controller-specific controls in Annex A
- Processor-specific controls in Annex B
- Aligns and extends ISO 27001 ISMS
- GDPR and regulatory mappings provided
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 a risk-based QMS framework for organizations in the medical device lifecycle, from design to post-market surveillance, emphasizing consistent conformity to customer and regulatory requirements.
Key Components
- Clauses 4–8 cover QMS/documentation, management responsibility, resources, product realization, and measurement/improvement.
- Includes risk management (ISO 14971 integration), design controls, validation, traceability, supplier controls, CAPA, and post-market activities.
- Built on process approach with documented procedures, records, and objective evidence.
- Third-party certification via accredited bodies with stage audits and surveillance.
Why Organizations Use It
- Enables market access (EU MDR, FDA QMSR alignment by 2026), reduces regulatory friction.
- Mitigates device safety risks, lowers recalls/costs.
- Builds stakeholder trust, supplier partnerships, competitive edge.
Implementation Overview
- Phased: gap analysis, process design, documentation, validation, audits.
- Applies to manufacturers, suppliers, distributors globally.
- 9–18 months typical; requires eQMS, training, management reviews.
ISO 27701 Details
What It Is
ISO/IEC 27701:2025 is the international standard defining requirements and guidance for establishing, implementing, maintaining, and improving a Privacy Information Management System (PIMS). It targets organizations handling personally identifiable information (PII) as controllers or processors, emphasizing accountability, risk management, and alignment with privacy laws like GDPR. It uses a risk-based PDCA (Plan-Do-Check-Act) methodology, extending ISO/IEC 27001 structures.
Key Components
Core elements include Clauses 4–10 for management system extensions (context, leadership, planning, operation, evaluation, improvement). Annex A provides PII controller controls; Annex B for processors. Features mappings to GDPR (Annex D), ISO 27002, and others. Supports certification through accredited bodies with a 3-year cycle including surveillance audits.
Why Organizations Use It
Drives regulatory compliance, reduces breach risks, and builds trust. Offers competitive differentiation in procurement, harmonizes multi-jurisdiction efforts, and generates auditable evidence for fines avoidance and insurance benefits.
Implementation Overview
Follows phased approach: discover/scope, design/plan, implement/operate, validate/improve. Involves PII inventory, gap analysis, controls, training, audits. Applicable to all sizes/sectors processing PII globally; certification optional but recommended.
Key Differences
| Aspect | ISO 13485 | ISO 27701 |
|---|---|---|
| Scope | Medical device QMS lifecycle | Privacy Information Management System (PIMS) |
| Industry | Medical devices, healthcare globally | Any PII-processing organizations worldwide |
| Nature | Voluntary QMS certification standard | Voluntary PIMS certification standard |
| Testing | Stage 1/2 audits, surveillance, recertification | Stage 1/2 audits, surveillance, recertification |
| Penalties | Loss of certification, market access issues | Loss of certification, regulatory compliance risks |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about ISO 13485 and ISO 27701
ISO 13485 FAQ
ISO 27701 FAQ
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