Last updated on: 2025-10-29

ISO 22000:2018 — Food Safety Management System (FSMS) Certification in India

ISO 22000:2018 is the international standard for Food Safety Management Systems (FSMS). It integrates HACCP principles with prerequisite programmes (PRPs) and a risk-based, Plan-Do-Check-Act (PDCA) approach to prevent food safety hazards across the supply chain.

Hazard analysis with CCP/OPRP decision making
PRPs (e.g., ISO/TS 22002 series) suited to your segment
Traceability, withdrawal & recall procedures
Monitoring, verification, validation & continual improvement

PrecisionTech delivers ISO 22000:2018 consulting and certification readiness across India. We run HACCP studies, define PRPs, identify CCPs/OPRPs, build traceability and recall plans, train teams, and coordinate audits with accredited certification bodies.

FSMS gap analysis & scope definition
HACCP study, PRPs, CCP/OPRP controls
Supplier controls & end-to-end traceability
Internal audits, management review, audit readiness

ISO 22000:2018 FSMS consulting across India with end-to-end certification readiness.

We implement an FSMS tailored to your operations—from PRPs and HACCP hazard analysis to CCP/OPRP controls, traceability & recall, monitoring/verification, and internal audits. With deep food-sector experience, we coordinate with accredited bodies for a smooth Stage-1 and Stage-2 audit journey.

How to Get ISO 22000:2018 Certified?

Start with discovery and FSMS gap analysis. We’ll define scope and product categories, establish PRPs, conduct a HACCP study, determine CCPs/OPRPs, document SOPs, set monitoring & verification plans, train your teams, and run internal audits & management review—then facilitate Stage-1 (documentation & readiness) and Stage-2 (implementation & effectiveness) with an accredited certification body.

Compare FSMS scope, regulatory drivers, and risk profile to choose a pragmatic, audit-ready approach for your business.

ISO 22000:2018 Food Safety Management System

About ISO 22000

ISO 22000:2018 specifies requirements for an FSMS to ensure food safety along the food chain. It applies to all organisations involved in food—production, processing, packaging, storage, transport, retail and food service— as well as manufacturers of food-contact materials.

Implemented well, ISO 22000 reduces food safety incidents and recalls, improves compliance, builds customer confidence, and strengthens supplier controls and traceability.

Introduction to ISO 22000 Certification

Adoption should be a planned decision. Design, implementation and timing depend on:

Scope, product categories and processes (including outsourced)
Regulatory obligations and customer requirements
Hazards, allergens and vulnerable points in the chain
PRPs needed (per ISO/TS 22002-x) and infrastructure
Competence, awareness and resources
Number of sites and organisational structure

Benefits of ISO 22000:2018 Certification

Improves legal compliance and due diligence
Reduces incidents, withdrawals and recalls
Strengthens supplier controls and incoming checks
Enhances traceability and crisis management
Delivers PDCA-driven improvement and measurable KPIs
Builds brand trust and supports market access

Myths about ISO 22000:2018

“HACCP alone is enough.” — ISO 22000 adds management-system controls, PRPs and governance.
“It’s only for manufacturers.” — Logistics, storage and food service are squarely in scope.
“It certifies products.” — ISO 22000 certifies the management system, not the product.

ISO 22000:2018 Focus Areas

Leadership, policy and communication (internal/external)
PRPs selection and implementation (ISO/TS 22002-x)
Hazard analysis and CCP/OPRP determination
Monitoring, verification and validation
Traceability, withdrawal and recall
Control of nonconforming product
Internal audit, management review and improvement

Roadmap for ISO 22000:2018 FSMS

Key steps for a pragmatic, audit-ready implementation:

Gap analysis vs. ISO 22000 clauses and regulatory needs
Define scope, products, process flow and PRPs
Conduct HACCP study; determine CCPs/OPRPs
Document SOPs and monitoring/verification plans
Establish traceability and recall/withdrawal procedures
Train teams; implement supplier and incoming controls
Run internal audits and management review
Close findings; prepare for Stage-1 & Stage-2 audits

Assessment & Certification Process (ISO 22000:2018)

Step	Description
1	Application to PRECISION & quotation
2	Review of application & scope
3	Agreement between PRECISION & client
4	Stage-1 audit (documentation & readiness)
5	Stage-2 audit (implementation & effectiveness)
6	Certificate issuance by accredited body
7	Surveillance audits (year 1 & 2)
8	Recertification (year 3)

Cost of ISO 22000:2018 Certification in India

Cost Component	Basis	Nature
Audit fees	Man-days, FSMS scope, risk & sites	Variable
Registration fees	Product categories & complexity	Variable
Other expenses	Travel, accommodation, misc.	Actuals

The charges for ISO 22000:2018 depend on organisation size, locations, product categories, process complexity and regulatory profile. We provide a tailored estimate after scoping and gap analysis.

Integrated Management System (IMS)

ISO 22000 (FSMS) integrates well with:

QMS — ISO 9001
EMS — ISO 14001
OH&S — ISO 45001
Information Security — ISO 27001
Service Management — ISO/IEC 20000-1
FSSC 22000 (GFSI)

Apply for ISO 22000:2018 Certification in India?

Contact Sales for ISO 22000:2018 Food Safety Management (FSMS) Certification in India

Frequently Asked Questions

What Is ISO 22000:2018?

ISO 22000:2018 is the international standard for Food Safety Management Systems (FSMS). It integrates HACCP principles, prerequisite programmes (PRPs), and a risk-based PDCA approach to prevent food safety hazards across the supply chain.

What Are The Benefits Of ISO 22000 Certification?

Benefits include improved legal compliance and due diligence, fewer incidents and recalls, stronger supplier controls, robust traceability and crisis management, measurable KPIs, and increased market access and brand trust.

Who Should Get ISO 22000 Certification?

Any organisation in the food chain—primary production, processing, packaging, storage, transport, retail, food service, and manufacturers of food-contact materials—that must control food safety hazards.

How Does ISO 22000 Certification Work?

After implementing the FSMS, an accredited certification body conducts a two-stage audit (Stage-1: documentation & readiness; Stage-2: implementation & effectiveness). Post-certification, surveillance audits are annual, with recertification at year three.

How Much Does ISO 22000 Certification Cost in India?

Costs in India depend on man-days, number of sites, product categories, process complexity, risk profile, and current readiness. Additional costs may include training, PRP infrastructure, monitoring equipment, and calibration.

What Changed In ISO 22000:2018?

The 2018 revision adopts Annex SL (common high-level structure), clarifies risk-based thinking at operational and strategic levels, strengthens communication, emphasises traceability/recall, and refines CCP/OPRP determination.

How Is ISO 22000 Different From HACCP?

HACCP focuses on hazard analysis and control points. ISO 22000 embeds HACCP within a full management system: leadership, policy, objectives, PRPs, documented information, internal audits, management review, and continual improvement.

What Are PRPs In ISO 22000?

Prerequisite programmes (PRPs) are foundational hygiene and infrastructure controls (e.g., premises, cleaning, pest control, personal hygiene). Sector-specific guidance is provided in ISO/TS 22002-x documents.

What Is The Difference Between CCP And OPRP?

A CCP (Critical Control Point) requires a critical limit and strict monitoring to prevent or eliminate a significant hazard. An OPRP (Operational PRP) controls significant hazards but may not have a critical limit—still essential for hazard reduction.

What Documented Information Is Required?

Scope, policy, objectives, PRPs, HACCP study (hazard analysis, CCP/OPRP rationale), monitoring/verification plans, validation records, traceability and recall procedures, supplier controls, internal audits, and management reviews.

What Is Validation vs Verification?

Validation confirms that control measures (e.g., cooking time/temperature) are capable of achieving intended results. Verification checks that they are implemented and effective (e.g., monitoring records, audits, tests).

How Does Traceability Work In ISO 22000?

Traceability requires identifying product lots and associating them with raw materials and processing history to enable targeted withdrawal/recall. Organisations should periodically test traceability to ensure it works.

What Is Withdrawal And Recall?

Withdrawal removes product not yet available to consumers; recall removes product already supplied. ISO 22000 requires documented procedures, roles, communication plans, and periodic mock exercises.

How Do We Manage Allergens?

Identify allergen hazards, segregate and label correctly, validate cleaning to prevent cross-contact, and verify via testing where appropriate. Ensure suppliers declare allergens and update specifications when changes occur.

What Supplier Controls Are Required?

Define specifications, approve suppliers, communicate requirements (including allergens and hazards), verify incoming materials, and evaluate supplier performance—especially for high-risk ingredients or services.

What Training And Competence Are Needed?

Personnel must be competent for their roles. Provide training on GMP/PRPs, HACCP principles, CCP/OPRP monitoring, allergen control, traceability/recall, hygiene, and crisis communication; retain competence records.

How Often Should Internal Audits Be Conducted?

Plan risk-based internal audits to cover all FSMS processes across sites within a defined cycle (often annually), ensuring auditor competence and impartiality. Address nonconformities with timely corrective actions.

What Is Management Review In ISO 22000?

Top management periodically reviews FSMS performance: objectives, KPIs, audit results, incidents/recalls, customer complaints, regulatory changes, resource needs, and opportunities for improvement.

What KPIs Are Typical In FSMS?

Examples: complaint rate by cause, nonconforming batches, CCP/OPRP deviations, micro results vs limits, allergen cross-contact incidents, recall/withdrawal drill time, on-time supplier COAs, environmental monitoring results.

How Are Transport And Storage Controlled?

Define conditions for storage and transport (e.g., temperature, humidity, segregation), monitor/record them, manage cold-chain breaks, and verify vehicle and container hygiene and integrity.

How Does Multi-Site Certification Work?

Groups with central control and uniform processes may use sampling by the certification body. Eligibility and sampling depend on risk, size, and consistency; central oversight must be demonstrable.

Is ISO 22000 The Same As FSSC 22000?

FSSC 22000 is a GFSI-recognised scheme built on ISO 22000 plus additional PRP and scheme requirements. Many retailers mandate GFSI; choose based on customer and market expectations.

How Long Does ISO 22000 Certification Take?

Typical programmes take 8–16 weeks for small to mid-sized organisations, depending on scope, sites, hazards, regulatory complexity, and baseline maturity.

What Are Common Nonconformities?

Weak hazard analysis or CCP/OPRP justification, incomplete PRPs, gaps in allergen control, inadequate supplier approval, ineffective traceability/recall tests, and missing verification/validation evidence.

How Often Should The HACCP Study Be Reviewed?

At planned intervals (often annually) and whenever changes occur—new products, process changes, supplier changes, incidents, or new hazards/regulations.

Is Product Certification Part Of ISO 22000?

No. ISO 22000 certifies your management system, not individual products. Product safety is achieved through the FSMS (PRPs, HACCP, CCP/OPRP controls, verification and improvement).

How Often Should Traceability And Recall Be Tested?

Conduct mock traceability and recall/withdrawal exercises at planned intervals (commonly annually) to verify speed, completeness, and communication effectiveness.

Can Small Businesses Implement ISO 22000?

Yes. The standard is scalable. Controls should be proportionate to risk. Many small processors, caterers, and logistics providers implement ISO 22000 to meet customer and regulatory requirements.

How Does ISO 22000 Integrate With Other Standards?

ISO 22000 follows Annex SL, easing integration with ISO 9001 (quality), ISO 14001 (environment), and ISO 45001 (OH&S). Shared processes like document control, audits, CAPA, and management review can be unified.

How Are Outsourced Processes And Co-Packers Controlled?

Define and communicate requirements, qualify and monitor providers, ensure equivalent controls for hazards and traceability, and retain evidence of oversight and performance.