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ISO 22000:2018

Food Safety Management System (FSMS)

ISO 22000:2018 is the international standard for Food Safety Management Systems (FSMS). It integrates the principles of HACCP (Hazard Analysis and Critical Control Points) — endorsed by the Codex Alimentarius Commission — with a comprehensive management system framework. ISO 22000 applies to all organizations across the food chain: primary producers, food processors, caterers, retailers, distributors, and food packaging/equipment suppliers. The 2018 revision introduced risk-based thinking and aligned with the Annex SL structure for better integration with ISO 9001 and ISO 14001.

📅4–8 months
💰₹2 Lakh – ₹5 Lakh
🔄3 Years (annual surveillance audits)

What is ISO 22000:2018?

ISO 22000:2018 is the international standard for Food Safety Management Systems (FSMS). It integrates the principles of HACCP (Hazard Analysis and Critical Control Points) — endorsed by the Codex Alimentarius Commission — with a comprehensive management system framework. ISO 22000 applies to all organizations across the food chain: primary producers, food processors, caterers, retailers, distributors, and food packaging/equipment suppliers. The 2018 revision introduced risk-based thinking and aligned with the Annex SL structure for better integration with ISO 9001 and ISO 14001.

Scope of Application

Any organization directly or indirectly involved in the food chain — food production, processing, packaging, storage, distribution, catering, and food ingredient/additive suppliers. Also covers food equipment, cleaning chemicals, and packaging material manufacturers.

Key Principles

  • HACCP-based systematic approach to food hazard analysis
  • Prerequisite Programs (PRPs) for basic food safety hygiene conditions
  • Hazard Analysis identifying biological, chemical, and physical food hazards
  • Critical Control Points (CCPs) with monitoring and corrective actions
  • Operational PRPs (OPRPs) for significant hazard control
  • Traceability — tracking food products from supplier to customer
  • Emergency preparedness for product withdrawal and recall

Applicable Industries

Food ManufacturingFood ProcessingBeveragesDairyReady-to-Eat FoodCatering & HospitalitySpice & Condiment ManufacturingAnimal FeedFood PackagingFood Retail

Recognized Certification Bodies

SGS
Bureau Veritas
TUV SUD
Intertek
DNV
BSI
TUV Rheinland
KPMG
NSF International
IRQS

Complete Certification Process

Step-by-step — from initial assessment to certificate in hand.

PRPs are basic hygiene conditions forming the foundation of food safety. Before HACCP can be implemented, PRPs must be fully established and operational.

Key Activities

1Good Manufacturing Practices (GMP) documentation and implementation
2Pest Control Program (licensed exterminator + records)
3Cleaning and Sanitation Program (SSPs for all equipment, surfaces, areas)
4Personal Hygiene Program (PPE, handwashing, health screening)
5Allergen Management Program
6Glass and Hard Plastic Control Policy
7Temperature Control Program (cold chain)
8Potable water and waste management

Standard Requirements (Clause Structure)

Key requirements of ISO 22000:2018 organized by clause.

Documents Required for Certification

📄Food Safety Policy
📄Food Safety Manual
📄HACCP Team list and qualification records
📄Product Description Documents
📄Process Flow Diagrams (all products, verified on-site)
📄Hazard Analysis Spreadsheet
📄HACCP Plan (CCPs, limits, monitoring, corrective actions)
📄Prerequisite Program (PRP) Procedures (GMP, cleaning, pest control, allergen, etc.)
📄Operational PRP (OPRP) Documents
📄Traceability Procedure and Product Batch Records
📄Product Recall and Withdrawal Procedure
📄Supplier Approval Records
📄Allergen Management Procedure
📄Calibration Records (CCP monitoring equipment)
📄CCP Monitoring Records
📄Internal FSMS Audit Reports
📄Food Safety MRM Minutes

Advantages & Challenges

Advantages

  • FSSAI compliance facilitated — ISO 22000 aligns with FSSAI requirements
  • Enables export to EU, US, Japan markets where food safety certifications are required
  • Required by major food retailers (Walmart, Metro, Reliance Retail) from suppliers
  • Systematically prevents food safety failures, recalls, and product liability
  • HACCP approach is recognized by Codex Alimentarius and all food regulators globally
  • Builds consumer trust in the brand — significant marketing benefit
  • Compatible with FSSC 22000 (if GFSI recognition needed for global retail supply chain)
  • Reduces product liability insurance costs
  • Required for hotel chains (ITC, Marriott, Taj) to qualify as approved food suppliers
  • Integrates easily with ISO 9001 and ISO 14001

Challenges / Limitations

  • !HACCP development requires specialized food science knowledge — expert needed
  • !CCP monitoring requires food-grade calibrated instruments and often lab analysis
  • !Allergen management can be complex in multi-product facilities
  • !Ongoing PRP maintenance (cleaning validation, pest prevention) is labor-intensive
  • !Raw material testing can be expensive
  • !Product recall test exercises require coordination with suppliers and customers
  • !Annual surveillance adds cost — particularly for food science consultant involvement

Frequently Asked Questions

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