IFS Food
GFSI-benchmarked standard for food safety and quality manufacturing
ISO 13485
International standard for medical device quality management systems.
Quick Verdict
IFS Food ensures safe food manufacturing via GFSI audits for retailers, while ISO 13485 mandates rigorous QMS for medical devices to meet regulatory demands. Food firms adopt IFS for market access; device makers use 13485 for compliance and patient safety.
IFS Food
IFS Food Standard Version 8
Key Features
- Product and Process Approach with traceability tests
- Minimum 50% audit time in production areas
- Risk-based HACCP and operational controls
- Knock-Out requirements for critical failures
- Unannounced audits for Star status
ISO 13485
ISO 13485:2016 Medical devices Quality management systems
Key Features
- Risk-based QMS processes and controls
- Full device lifecycle coverage design to post-market
- Mandatory medical device files and traceability
- Process validation and supplier controls
- Certification for regulatory market access
Detailed Analysis
A comprehensive look at the specific requirements, scope, and impact of each standard.
IFS Food Details
What It Is
IFS Food Version 8 is a GFSI-benchmarked certification standard for auditing food product and process compliance. It focuses on food safety, quality, legality, authenticity, and customer requirements in manufacturing sites. The risk-based Product and Process Approach (PPA) emphasizes on-site verification and traceability.
Key Components
- Governance, HACCP/PRPs, operational controls (e.g., allergens, fraud, defense), performance monitoring.
- Over 200 checklist requirements organized in 5 sections.
- Built on HACCP principles with 10 Knock-Out (KO) critical items.
- Annual certification with scoring (Higher/Foundation levels) and unannounced options.
Why Organizations Use It
- Meets European retailer demands for market access.
- Reduces duplicate audits, enhances supply chain trust.
- Manages risks like recalls, fraud; builds resilience.
- Provides competitive edge via Star status.
Implementation Overview
- Phased gap analysis, FSMS development, training, internal audits.
- Site-specific for food processors; 6-12 months typical.
- Requires accredited body for initial/recertification audits.
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. Its primary purpose is to ensure consistent provision of safe devices meeting customer and regulatory requirements across the lifecycle. It employs a risk-based process approach with documented controls, validation, and traceability.
Key Components
- Clauses 4–8 cover QMS, management responsibility, resources, product realization, and measurement/improvement.
- Emphasizes medical device files, risk management (ISO 14971), supplier controls, process validation, post-market surveillance.
- Built on process interactions, objective evidence, and continual improvement.
- Third-party certification via accredited bodies with stage audits.
Why Organizations Use It
- Enables market access (EU MDR, FDA QMSR alignment by 2026).
- Reduces risks of recalls, liabilities via robust controls.
- Builds stakeholder trust, supplier partnerships.
- Drives efficiency, scalability in regulated markets.
Implementation Overview
- Phased: gap analysis, process design, validation, audits (9–36 months).
- Applies to manufacturers, suppliers globally; scalable by size.
- Involves documentation, training, eQMS; requires certification audits.
Key Differences
| Aspect | IFS Food | ISO 13485 |
|---|---|---|
| Scope | Food manufacturing processes, safety, quality, fraud/defense | Medical device lifecycle, QMS, regulatory compliance, risk management |
| Industry | Food processing, manufacturing, global retailers | Medical devices, healthcare, global manufacturers/suppliers |
| Nature | GFSI-benchmarked voluntary certification, annual audits | Voluntary QMS standard for regulatory purposes, certification |
| Testing | Annual product/process audits, 50% on-site, traceability tests | Stage 1/2 audits, internal audits, process validation IQ/OQ/PQ |
| Penalties | Certification loss, no legal penalties, customer rejection | Certification withdrawal, regulatory enforcement, market bans |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about IFS Food and ISO 13485
IFS Food FAQ
ISO 13485 FAQ
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