ISO 13485
International standard for medical device quality management systems
ISO 56002
International guidance standard for innovation management systems
Quick Verdict
ISO 13485 mandates rigorous QMS for medical device safety and regulatory compliance, while ISO 56002 provides voluntary guidance for systematic innovation management. Medical firms adopt 13485 for market access; all organizations use 56002 to govern innovation strategically.
ISO 13485
ISO 13485:2016 Medical devices Quality management systems
Key Features
- Risk-based controls for device safety and performance
- Regulatory requirements integrated into QMS processes
- Medical device files ensuring full traceability
- Mandatory process validation where output unverifiable
- Post-market surveillance and complaint handling required
ISO 56002
ISO 56002:2019 Innovation management system — Guidance
Key Features
- PDCA cycle and HLS alignment for IMS
- Leadership commitment and policy requirements
- Portfolio management and uncertainty governance
- Performance evaluation with KPIs and audits
- Integration with other ISO management systems
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, management responsibility, resources, product realization, and measurement/improvement.
- Over 100 requirements including documented procedures, medical device files, process validation, and traceability.
- Built on process approach, aligned with ISO 9001 but enhanced for regulatory needs like risk per ISO 14971.
- Third-party certification via staged audits.
Why Organizations Use It
- Enables market access (EU MDR, FDA QMSR alignment by 2026).
- Mitigates risks of recalls, liabilities via validation and CAPA.
- Builds stakeholder trust, reduces supplier audits.
- Drives operational efficiency and scalability.
Implementation Overview
- Phased: gap analysis, process design, validation, audits (9–18 months typical).
- Applies to manufacturers, suppliers globally; eQMS recommended.
- Involves training, documentation, internal audits for certification.
ISO 56002 Details
What It Is
ISO 56002:2019 is an international guidance standard titled Innovation management — Innovation management system — Guidance. It provides a generic framework for organizations to establish, implement, maintain, and continually improve an innovation management system (IMS). Applicable across all sectors, sizes, and innovation types, it uses a PDCA (Plan-Do-Check-Act) cycle and High-Level Structure (HLS) for systemic governance.
Key Components
- **Clauses 4–10Context, leadership, planning, support, operation, performance evaluation, improvement.
- **Eight principlesValue realization, future-focused leadership, strategic direction, culture, portfolio thinking, uncertainty management, learning, stakeholder engagement.
- Non-prescriptive guidance; supports conformity assessment, not formal certification (ISO 56001 for requirements).
Why Organizations Use It
- Drives strategic innovation, portfolio discipline, and value creation.
- Manages uncertainty and reduces 'innovation theater'.
- Builds stakeholder trust, competitiveness, and integration with ISO 9001/27001.
- Enhances governance, risk management, and cultural enablement.
Implementation Overview
- Phased roadmap: awareness, gap analysis, design, pilot, scale, sustain.
- Involves policy definition, training, KPIs, audits; suits all organizations globally; voluntary with optional external audits. (178 words)
Key Differences
| Aspect | ISO 13485 | ISO 56002 |
|---|---|---|
| Scope | Medical device QMS lifecycle requirements | Innovation management system guidance |
| Industry | Medical devices and suppliers globally | All sectors and organization types |
| Nature | Requirements standard for certification | Voluntary guidance, non-certifiable |
| Testing | Stage 1/2 audits, surveillance, validation | Internal audits, management reviews |
| Penalties | Certification loss, regulatory actions | No formal penalties |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about ISO 13485 and ISO 56002
ISO 13485 FAQ
ISO 56002 FAQ
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