ISO 22000
International standard for food safety management systems
ISO 13485
International standard for medical device quality management systems
Quick Verdict
ISO 22000 ensures food safety via HACCP-integrated FSMS for food chain organizations, while ISO 13485 mandates rigorous QMS for medical devices meeting regulatory demands. Companies adopt them for certification, compliance, market access, and risk reduction.
ISO 22000
ISO 22000:2018 Food safety management systems
Key Features
- High-Level Structure for integrated management systems
- Dual PDCA cycles: organizational and operational levels
- HACCP principles embedded in management system framework
- PRP, OPRP, CCP systematic hazard control categorization
- Interactive communication across entire food chain
ISO 13485
ISO 13485:2016 Medical devices Quality management systems
Key Features
- Risk-based QMS controls for device lifecycle
- Regulatory compliance and post-market surveillance
- Design validation and process controls
- Supplier evaluation and traceability requirements
- Certification with management review and CAPA
Detailed Analysis
A comprehensive look at the specific requirements, scope, and impact of each standard.
ISO 22000 Details
What It Is
ISO 22000:2018 is the international certification standard for Food Safety Management Systems (FSMS). It applies to all food chain organizations, providing a systematic framework to ensure safe food through hazard prevention, regulatory compliance, and chain communication. Built on risk-based thinking and HLS, it uses dual PDCA cycles for strategic and operational control.
Key Components
- Clauses 4-10 cover context, leadership, planning, support, operation, evaluation, improvement.
- Integrates PRPs, hazard analysis, CCPs/OPRPs, traceability, verification.
- Based on HACCP principles with management system discipline.
- Certification via accredited bodies with staged audits.
Why Organizations Use It
- Meets customer/regulatory demands, enables market access.
- Reduces recalls, enhances resilience, builds trust.
- Supports GFSI schemes like FSSC 22000.
- Drives efficiency, integration with ISO 9001/14001.
Implementation Overview
- Phased: gap analysis, PRPs/hazard plans, training, audits.
- Scalable for SMEs to multinationals in food sectors globally.
- Requires 6-18 months, cross-functional teams, certification audits.
ISO 13485 Details
What It Is
ISO 13485:2016 is the international standard titled Medical devices — Quality management systems — Requirements for regulatory purposes. It is a certifiable framework for organizations in the medical device lifecycle, emphasizing risk-based controls to ensure devices meet customer and regulatory requirements consistently.
Key Components
- Organized into Clauses 4–8: QMS/documentation (4), management responsibility (5), resources (6), product realization (7), measurement/improvement (8).
- Requires documented procedures, medical device files, validation, traceability, and post-market surveillance.
- Built on process approach with ISO 9001 compatibility but enhanced for regulatory needs.
- Certification via accredited bodies with stage audits and surveillance.
Why Organizations Use It
- Enables market access (EU MDR, FDA QMSR alignment by 2026).
- Mitigates risks like recalls through supplier controls and CAPA.
- Builds stakeholder trust and competitive edge in supply chains.
Implementation Overview
- Phased: gap analysis, documentation, training, validation, audits.
- Applies to manufacturers, suppliers, distributors globally.
- Involves eQMS, cross-functional teams; timelines 9–18 months typically.
Key Differences
| Aspect | ISO 22000 | ISO 13485 |
|---|---|---|
| Scope | Food safety management across food chain | Medical device quality management lifecycle |
| Industry | Food production, processing, distribution globally | Medical devices, suppliers, services worldwide |
| Nature | Voluntary certifiable management system standard | Regulatory-purpose certifiable QMS standard |
| Testing | Internal audits, hazard verification, certification audits | Process validation, design verification, internal audits |
| Penalties | Loss of certification, market access denial | Regulatory enforcement, market withdrawal, fines |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about ISO 22000 and ISO 13485
ISO 22000 FAQ
ISO 13485 FAQ
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