SQF
GFSI-benchmarked food safety certification standard
ISO 13485
International standard for medical device quality management systems.
Quick Verdict
SQF ensures food safety via HACCP and GMPs for global supply chains, while ISO 13485 mandates risk-based QMS for medical devices. Food companies adopt SQF for retailer access; medtech firms use ISO 13485 for regulatory compliance and market entry.
SQF
SQF Food Safety Code Edition 9
Key Features
- GFSI-benchmarked certification across food supply chain
- Modular structure: Module 2 plus sector GMP modules
- Mandatory HACCP-based Food Safety Plan implementation
- Requires full-time onsite SQF Practitioner oversight
- Leadership commitment via signed policy and reviews
ISO 13485
ISO 13485:2016 Medical devices quality management systems
Key Features
- Risk-based QMS controls for device lifecycle
- Design development and process validation requirements
- Supplier evaluation and outsourcing controls
- Post-market surveillance and complaint handling
- Traceability and medical device file mandates
Detailed Analysis
A comprehensive look at the specific requirements, scope, and impact of each standard.
SQF Details
What It Is
SQF (Safe Quality Food) is a GFSI-benchmarked certification program administered by SQFI. It provides a HACCP-based management system for food safety and quality across the supply chain, from farm to fork, via modular codes like Edition 9.
Key Components
- **Module 2Universal system elements (management commitment, HACCP plan, verification, traceability).
- Sector-specific modules (e.g., Module 11 GMPs for manufacturing).
- Built on Codex HACCP principles; mandatory elements include SQF Practitioner, internal audits, CAPA.
- Third-party audits with scoring (E/G/C/F grades).
Why Organizations Use It
- Meets retailer/brand requirements for market access.
- Reduces recalls, audit duplication; aligns with FSMA/EU regs.
- Builds food safety culture, supplier trust, operational resilience.
Implementation Overview
- Phased: gap analysis, document/implement HACCP/PRPs, train, audit.
- Applies to manufacturers, storage, distributors; all sizes.
- Annual audits by licensed CBs; unannounced options.
ISO 13485 Details
What It Is
ISO 13485:2016 is the international standard titled Medical devices — Quality management systems — Requirements for regulatory purposes. It provides a risk-based framework for organizations to demonstrate ability to consistently meet customer and regulatory requirements across the medical device lifecycle, from design to post-market surveillance.
Key Components
- Organized into Clauses 4–8: QMS, management responsibility, resources, product realization, measurement/improvement.
- Emphasizes documented procedures, validation, traceability, risk management (linked to ISO 14971), supplier controls, CAPA.
- Requires quality manual, medical device files, record retention.
- Certification via accredited bodies with stage 1/2 audits and surveillance.
Why Organizations Use It
- Enables market access (EU MDR, FDA QMSR alignment by 2026).
- Reduces risks of recalls, noncompliance; builds stakeholder trust.
- Drives operational efficiency, supply chain resilience, competitive differentiation.
Implementation Overview
- Phased: gap analysis, process design, documentation, validation, audits.
- Applies to manufacturers, suppliers, distributors globally.
- 9–18 months typical; needs cross-functional teams, eQMS tools.
Key Differences
| Aspect | SQF | ISO 13485 |
|---|---|---|
| Scope | Food safety management across supply chain | Medical device QMS lifecycle from design to post-market |
| Industry | Food manufacturing, storage, distribution globally | Medical devices, suppliers, services worldwide |
| Nature | GFSI-benchmarked voluntary certification | Regulatory-purpose voluntary QMS standard |
| Testing | Annual third-party audits, unannounced, scoring | Certification audits, internal audits, process validation |
| Penalties | Certification loss, market access denial | Audit nonconformities, regulatory non-compliance risks |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about SQF and ISO 13485
SQF FAQ
ISO 13485 FAQ
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