FSSC 22000
GFSI-benchmarked scheme for food safety management systems
ISO 13485
International standard for medical device quality management systems
Quick Verdict
FSSC 22000 ensures food safety via ISO 22000, PRPs, and additional requirements for global food chains, while ISO 13485 mandates risk-based QMS for medical devices. Food firms adopt FSSC for GFSI recognition; device makers pursue ISO 13485 for regulatory compliance and market access.
FSSC 22000
Food Safety System Certification 22000 Version 6
Key Features
- GFSI-benchmarked certification combining ISO 22000 and PRPs
- Mandates food defense, fraud, and allergen management plans
- Covers full food chain categories from farming to packaging
- Requires PDCA management system with operational audits
- Additional requirements for culture, quality, and sustainability
ISO 13485
ISO 13485:2016 Medical devices Quality management systems
Key Features
- Risk-based controls for device lifecycle processes
- Design and development planning with validation
- Post-market surveillance and complaint handling
- Supplier evaluation and outsourcing management
- Traceability and medical device file requirements
Detailed Analysis
A comprehensive look at the specific requirements, scope, and impact of each standard.
FSSC 22000 Details
What It Is
FSSC 22000 (Food Safety System Certification 22000 Version 6.0) is a GFSI-benchmarked certification scheme for Food Safety Management Systems (FSMS). It applies across food chain categories like manufacturing, packaging, and logistics. The scheme uses a risk-based PDCA approach integrating ISO 22000:2018 requirements.
Key Components
- **Three pillarsISO 22000:2018 (clauses 4-10), sector-specific PRPs (e.g., ISO/TS 22002 series), FSSC Additional Requirements (e.g., food defense, fraud, allergens).
- Over 100 requirements across management, operations, and verification.
- Built on HACCP principles with PRPs, OPRPs, CCPs.
- Third-party certification via licensed bodies with audits.
Why Organizations Use It
- Meets buyer and retailer demands for global trade.
- Reduces recalls, enhances supply chain trust.
- Manages risks like adulteration and contamination.
- Builds reputation via public certificate register.
- Supports SDG contributions like food loss reduction.
Implementation Overview
- Phased gap analysis, documentation, training, audits.
- 6-24 months typical; suits all sizes in food sector.
- Requires Stage 1/2 audits, surveillance, recertification every 3 years.
ISO 13485 Details
What It Is
ISO 13485:2016, titled "Medical devices — Quality management systems — Requirements for regulatory purposes," is a certifiable international standard establishing a risk-based QMS framework for organizations providing medical devices and services. It ensures consistent conformity to customer and regulatory requirements across design, production, distribution, servicing, and post-market stages.
Key Components
- Clauses 4–8 cover QMS/documentation, management responsibility, resources, product realization, measurement/improvement.
- Emphasizes documented procedures, medical device files, design controls, process validation, supplier controls, traceability, CAPA, and post-market surveillance.
- Integrates ISO 14971 risk management; process approach.
- Third-party certification through accredited bodies with stage audits.
Why Organizations Use It
- Facilitates regulatory compliance (EU MDR, FDA QMSR 2026).
- Mitigates product risks, recalls, non-conformities.
- Enables market access, supply chain assurance, M&A diligence.
- Builds trust with regulators, customers; competitive differentiation.
Implementation Overview
- Phased: gap analysis, documentation build, training, validation, internal audits, certification.
- Suits manufacturers/suppliers of all sizes globally.
- Requires eQMS, cross-functional teams, ongoing surveillance audits.
Key Differences
| Aspect | FSSC 22000 | ISO 13485 |
|---|---|---|
| Scope | Food safety management across food chain | Medical device quality management lifecycle |
| Industry | Food manufacturing, packaging, logistics globally | Medical devices, suppliers, services worldwide |
| Nature | GFSI-benchmarked voluntary certification scheme | Regulatory-purpose voluntary QMS standard |
| Testing | CB audits, PRPs, 50% operational focus | Stage 1/2 audits, process/design validation |
| Penalties | Loss of certification, market access denial | Certification loss, regulatory non-compliance risks |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about FSSC 22000 and ISO 13485
FSSC 22000 FAQ
ISO 13485 FAQ
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