ISO 22000:2018, the base standard of FSSC 22000: every operator in the food chain must demonstrate hazard control.

Documentation kit · ISO 22000:2018 and Amendment 1:2024

Your ISO 22000 documentation, without starting from scratch.

Word and Excel templates to structure your FSMS, adapt your procedures and prepare your audit evidence.

Clauses 4 to 10, with Amendment 1:2024 on climate change
PRPs, hazard analysis, HACCP/OPRP plan, traceability and recall
108 editable files and a Codex HACCP and FDA FSMA mapping
FSSC 22000: ISO 22000 is the base standard of this GFSI-recognized scheme

Buy the kit · $389

Single-site licenseInstant download30-day money-back guarantee

108

Documents included

Requirement clauses (4 to 10)

100%

Requirements mapped

HACCP

Codex integrated

Who this kit is for

Designed for every player in the food chain, from farm to fork.

Four profiles, one need: an ISO 22000 documentation base ready to adapt.

Food manufacturers and processors

Canneries, dairies, industrial bakeries, meat processors, beverages, ready meals.

ProcessingRetailer audits

Foodservice and institutional catering

Central kitchens, restaurant chains, event caterers: HACCP control and traceability of every batch served.

Central kitchensRestaurant chainsCaterers

Logistics, storage and distribution

Cold storage, refrigerated transport, wholesalers and distributors facing certification requirements.

StorageTransportDistribution

Indirect suppliers and consultants

Packaging, cleaning products, process equipment. Advisory firms for their client engagements.

PackagingEquipmentConsultant license on request

What is in the kit

108 documents organized by ISO 22000:2018 clause.

The kit covers clauses 4 to 10 of ISO 22000:2018 and includes Amendment 1:2024 (climate change, clauses 4.1 and 4.2). It addresses the PRPs of §8.2, the initial steps of hazard analysis and the HACCP/OPRP hazard control plan.

Master document list · ISO 22000:2018

Version 2.0, May 2026

108 documents · 73 Word · 35 Excel

Clause 4 · Context of the organization

4 documents · Internal and external issues including climate, interested parties, scope, process map.

W
Process Map and Their Interactions
W
Internal and External Context Analysis with Climate Assessment
W
FSMS Scope
X
Interested-Parties Map with Climate Requirements

Clause 5 · Leadership

4 documents · Food safety policy, team leader appointment, roles, responsibilities and authorities.

W
Food Safety Team Leader Appointment Letter
W
Roles, Responsibilities, and Authorities Records
W
Food Safety Team Assignment Records
W
Food Safety Policy

Clause 6 · Planning

4 documents · Risks and opportunities, FSMS objectives, planning of changes.

W
Risk and Opportunity Identification Procedure
W
Change Planning Procedure
W
FSMS Objectives and Action Plan
X
Risks and Opportunities Register

Clause 7 · Support

7 documents · Resources, external providers, competence, awareness, communication, documented information.

W
Resource Management Procedure
W
Awareness Procedure
W
Internal and External Communication Procedure
W
Control of External Providers Procedure
W
Control of Documented Information Procedure
X
Food Safety Team Competence Matrix
X
FSMS Training Plan

Clause 8 · Prerequisite programs (8.2)

37 documents · PRP procedures a) to l) and records: buildings, utilities, pests, cleaning, hygiene, food defense.

W
Construction and Layout of Buildings and Associated Utilities
W
Layout of Premises, Zoning, Workspaces, and Employee Facilities
W
Supply of Air, Water, Energy, and Other Utilities
W
Pest Control and Disposal of Waste and Sewage
W
Equipment Cleanability and Maintenance
W
Supplier Approval and Monitoring (Raw Materials, Ingredients, Chemicals, Packaging)
W
Receiving, Storage, Shipping, Transport, and Handling
W
Cross-Contamination Prevention Measures
W
Cleaning and Sanitation
W
Personnel Hygiene
W
Product Information and Consumer Awareness
W
Food Defense, Biovigilance, and Bioterrorism Protection
W
Compressed Air Control Form
W
Breakdown and Intervention Report Form
W
Initial Supplier Qualification Sheet
W
Annual Supplier Evaluation Sheet
W
Standard Supplier Specification Sheet
W
Incoming Raw-Material Inspection Sheet
W
Shipping and Loading Control Sheet
W
Cleaning Effectiveness Verification Sheet (Visual + ATP)
W
Job Authorization and Certification Sheet
W
Medical Register and Temporary Unfitness
W
Food Defense Intrusion Test Record
X
Infrastructure and Building Inspection Log
X
Site Hygienic Zoning Plan
X
Water Analysis Log (Potability, Microbiology)
X
Pest Control Log (Rodents, Insects, Birds)
X
Waste and By-Products Register
X
Preventive and Corrective Equipment Maintenance Register
X
Storage and FIFO-FEFO Rotation Register
X
Cross-Contamination Management Matrix
X
Detailed Cleaning and Sanitation Plan by Zone
X
Daily Cleaning and Sanitation Record
X
Personnel Hygiene Training Register
X
Visitors and External Contractors Register
X
Allergen Labeling Matrix (FALCPA Big 9 Allergens)
X
Site Food Defense Threat Matrix

Clause 8 · Traceability and emergencies (8.3 and 8.4)

4 documents · Traceability procedure, test with quantitative reconciliation, emergency plan and drills.

W
Traceability Procedure
W
Emergency Preparedness and Response Procedure
W
Traceability Test with Quantitative Finished-Product-Ingredient Reconciliation
W
Emergency and Incident Management Plan with Periodic Drills

Clause 8 · Hazard control (8.5)

23 documents · Initial steps, hazard analysis, OPRP and CCP classification, validation, HACCP/OPRP plan, monitoring.

W
Hazard Analysis Procedure
W
Validation of Control Measures and Combinations Procedure
W
Procedure for Actions upon Failure to Meet Critical Limits or Action Criteria
W
Sanitary Incident Form, Contamination Detected
W
Microbiological Challenge Test Template
W
Initial Documented Information Record
W
Raw Material, Ingredient, and Food-Contact Material Characteristics Record
W
Finished Product Characteristics Record
W
Intended Use and Vulnerable Group Identification Record
W
Flow Diagram Template, On-Site Confirmation Record, and Process Description
W
Hazard Identification and Acceptable Levels Record
W
Determination of Critical Limits (CCP) and Action Criteria (OPRP) Record
W
Standard Validation Report, Evidence of Control Capability
X
Site CCP and OPRP Identification Table
X
Annual Summary of CCP-OPRP Deviations
X
HACCP-Specific Corrective Action Log
X
Thermal Validation Record Template (Cooking, Pasteurization)
X
Product Shelf-Life Study Template (Use-By, Best-By)
X
Control Measure Selection and Classification Record, OPRP vs CCP
X
CCP Monitoring Record
X
OPRP Monitoring Record
X
Hazard Evaluation Matrix, Probability x Severity
X
Hazard Control Plan, Template

Clause 8 · Verification and nonconformities (8.6 to 8.9)

11 documents · Updating, calibration, verification, environmental monitoring, corrections, withdrawal and recall.

W
Updating of PRP Information and Hazard Control Plan Procedure
W
Control of Monitoring and Measuring Equipment Procedure
W
Verification of PRPs and the HACCP Plan Procedure
W
Analysis of the Results of Verification Activities Procedure
W
Control of Nonconforming Outputs Procedure
W
Corrections Procedure
W
Corrective Actions Procedure
W
Disposition and Release of Potentially Unsafe Products Procedure
W
Withdrawal-Recall and Simulations Procedure
X
Environmental Monitoring Plan (Listeria, Salmonella, ATP)
X
Calibration and Verification Plan, Traceable to International Standards

Clause 9 · Performance evaluation

6 documents · Monitoring and analysis of data, internal audit, management review.

W
Monitoring, Measurement, Analysis, and Evaluation Procedure
W
Data Analysis and Evaluation Procedure, Trends and Performance
W
Internal Audit Procedure
W
Management Review Procedure
W
Agenda and Minutes Template, 7 Inputs and Outputs
X
Annual Audit Program

Clause 10 · Improvement

3 documents · Nonconformity and corrective action, continual improvement, FSMS update.

W
Nonconformity and Corrective Action Procedure
W
Continual Improvement Procedure
W
FSMS Update Procedure

Audit and control

5 documents · FSMS manual, master list, Codex HACCP and FDA mapping matrices, audit checklist.

X
Master List of Documented Information
X
ISO 22000 to Codex HACCP Mapping Matrix (Annex A)
X
ISO 22000 to US FDA Food-Safety Regulation Mapping
W
FSMS Manual, Documentary Overview and System Summary
X
ISO 22000 2018 Audit Checklist (Clauses 4 to 10) and Sample Audit Report

Full master document list, implementation checklist and one complete procedure in the free sample.

Why this kit exists

An FSMS can't be drafted from a blank page.

7 requirement clauses, 7 HACCP principles, a combined PRP, OPRP and CCP approach. Each one calls for procedures, records and evidence.

Clause 8.5

Generic templates fall short

Often ISO 9001 derivatives: they ignore hazard analysis, OPRPs and CCPs, validation, traceability and recall.

FDA, USDA-FSIS, states

Official inspections give no warning

Without a current documentation system: FDA Form 483 observations, warning letters, product withdrawals.

Supplier prerequisite

Certification conditions listing

Retailers, buying groups and food manufacturers list ISO 22000 or FSSC 22000 in their supplier specifications.

$10,000 to $25,000

A consulting engagement is costly

15 to 40 consultant days. The kit provides the written base, your budget goes to hazard analysis and CCP validation.

Clause-by-clause mapping

Every ISO 22000:2018 requirement → one document in the kit.

Clause by clause, the normative requirements and the documents provided. This is what a certification auditor asks to see first.

4.1 to 4.4 + Amd 1:2024

Context of the organization: internal/external issues (including climate change relevance, Amd 1:2024), interested parties and their requirements (including climate-related requirements, Amd 1:2024), FSMS scope (documented information required), processes and their interactions

Context analysis + climate evaluation (§4.1 + Amd 1:2024)Interested parties + climate (§4.2 + Amd 1:2024)FSMS scope (§4.3)Process mapping (§4.4)

5.1 to 5.3

Leadership and management commitment, food safety policy (documented information required), roles/responsibilities/authorities, food safety team leader appointment

Food safety policy (§5.2)Team leader appointment (§5.3)Responsibility sheets (§5.3)Food safety team mission

6.1 to 6.3

Actions to address risks and opportunities, FSMS objectives and action planning (documented information required), planning of changes

Risk & opportunity procedure (§6.1)FSMS objectives and action plan (§6.2)Change planning procedure (§6.3)Risk & opportunity register

7.1 to 7.5

Resources (human, infrastructure, work environment, external providers, externally developed elements), competence, awareness, internal/external communication, documented information

Resource management (§7.1)Training planCompetency matrix (§7.2)Awareness procedure (§7.3)Internal & external communication (§7.4)External provider control (§7.1.6)Documented information control (§7.5)Master list

8.1 to 8.2 + ISO 22002-100:2025

Operational planning and control. Prerequisite Programs (PRPs), the 12 domains a) to l) of §8.2 must be considered when establishing PRPs. Alignment with the new ISO 22002:2025 family (ISO 22002-100 common foundation + sector-specific parts).

PRP a) Buildings & facilitiesPRP b) Premises & zoningPRP c) Air, water, energyPRP d) Pests & wastePRP e) EquipmentPRP f) SuppliersPRP g) Receiving, storage, transportPRP h) Cross-contaminationPRP i) Cleaning & sanitizationPRP j) Personnel hygienePRP k) Product informationPRP l) Food defense

8.3

Traceability system, unique identification of incoming material suppliers and first stage of distribution, effectiveness verification through quantitative reconciliation (FSMA 204 Food Traceability Rule)

Traceability procedure (§8.3)Traceability test + quantitative reconciliation

8.4

Emergency preparedness and response, with periodic drills

Emergency preparedness procedure (§8.4.1)Emergency & incident management + drills (§8.4.2)

8.5.1

Initial steps enabling hazard analysis: initial information, raw material/ingredient/contact material characteristics, finished product characteristics, intended use (vulnerable groups), flow diagrams and process description

Initial information (§8.5.1.1)Raw material characteristics (§8.5.1.2)Finished product characteristics (§8.5.1.3)Intended use (§8.5.1.4)Flow diagrams + description (§8.5.1.5)

8.5.2

Hazard analysis: hazard identification and acceptable level determination, hazard evaluation (likelihood × severity), control measure selection and classification (oPRP vs CCP)

Hazard analysis procedure (§8.5.2.1)Hazard ID + acceptable levels (§8.5.2.2)Likelihood × severity matrix (§8.5.2.3)oPRP/CCP selection (§8.5.2.4)

8.5.3

Validation of control measure(s) and combinations of control measures, before implementation and after modification

Validation procedure (§8.5.3)Standard validation report

8.5.4

Hazard control plan (HACCP/oPRP plan), for each CCP and each oPRP: hazards to control, critical limits or action criteria, monitoring, corrections, responsibilities, records

Hazard control plan (§8.5.4.1)Critical limits & action criteria (§8.5.4.2)CCP monitoring sheet (§8.5.4.3)oPRP monitoring sheet (§8.5.4.3)Actions on non-compliance (§8.5.4.4)

8.6 to 8.8

Updating PRP information and HACCP plan, metrology control (calibrated equipment with NIST-traceable / international references), verification, with monitoring/verification segregation

Update procedure (§8.6)Monitoring equipment control (§8.7)Calibration & verification planVerification procedure (§8.8.1)Verification result analysis (§8.8.2)

8.9

Control of nonconforming products and processes: general, corrections, corrective actions, disposition of potentially unsafe products (release evaluation, NC product disposition), withdrawal/recall with simulations (FDA Reportable Food Registry)

Nonconformity control (§8.9.1)Corrections (§8.9.2)Corrective actions (§8.9.3)Potentially unsafe products (§8.9.4)Withdrawal/recall + drills (§8.9.5)

9.1

Monitoring, measurement, analysis, and evaluation, confirmation of overall performance, trend identification, audit program planning

Monitoring & measurement procedure (§9.1.1)Data analysis & evaluation (§9.1.2)

9.2

Internal audit, audit program, competent and impartial auditors, reports to food safety team and management

Internal audit procedure (§9.2)Annual audit programISO 22000 audit checklist + standard report

9.3

Management review, with the 7 input elements a) to g) of §9.3.2 (including 9 sub-items on performance in c)), output elements with decisions, updates, and actions

Management review procedure (§9.3.1)Standard agenda + minutes (§9.3.2 and §9.3.3)

10.1 to 10.3

Improvement: nonconformity and corrective action handling, continual improvement, FSMS update by the food safety team at planned intervals

Nonconformities and corrective actions (§10.1)Continual improvement (§10.2)FSMS update (§10.3)

Annex A + FSMA / FDA

Cross-references and master documentation: mapping with the 7 HACCP principles of Codex (Annex A of the standard); correspondence with FDA FSMA / 21 CFR 117 / USDA-FSIS / FDA labeling regulations (FDA Big 9 allergens including sesame since 2023); FSMS manual

ISO 22000 ↔ Codex HACCP matrix (Annex A)ISO 22000 ↔ FSMA / FDA matrixFSMS Manual

Not included

Site- and product-line-specific elements, which must be built case by case by the food safety team (§5.3), because ISO 22000:2018 requires hazard analysis based on the actual characteristics of products, processes, and environment (§8.5.1 and §8.5.2)

Filled-in hazard analysis (per product and process)Scientifically validated CCPs (per process)Specific validated oPRPsFilled-in flow diagrams (per product line)Shelf-life and aging studiesMicrobiological challenge testsThermal validation (specific time/temperature pairs)

XThe kit also contains two Excel mapping matrices (ISO 22000 to Codex HACCP, Annex A; ISO 22000 to US FDA food safety regulation), to complete with your own documents.

Technical compliance

The points an experienced ISO 22000 auditor checks.

Twelve ISO 22000:2018 requirements auditors check first. The kit addresses them one by one.

Climate change

Climate relevance assessed in FSMS issues and in interested party requirements.

4.1 and 4.2, Amd 1:2024

Fraud and cybersecurity in context

Food fraud, food defense, intentional contamination and cybersecurity among the issues.

4.1 Note 2

Two-level PDCA

Organizational PDCA (clauses 4 to 7, 9, 10) and operational PDCA (clause 8), risk-based thinking.

0.3

PRP, OPRP and CCP distinguished

Three levels of control measures, each measure systematically classified.

8.5.2.4

Validation, monitoring, verification

Three separate concepts: capability upstream, intervention during, conformity downstream.

3.44, 3.27, 3.45

Step-by-step hazard analysis

Identification and acceptable levels, likelihood × severity evaluation, selection of measures.

8.5.2

Allergens and radiological hazards

Biological, chemical and physical agents, including allergens and radiological substances.

3.22

Tested traceability

Quantitative reconciliation of finished products and ingredients as evidence of effectiveness.

8.3

Food defense and bioterrorism

Food protection and bioterrorism covered in the PRPs and in emergency situations.

8.2 l) and 8.4

Independent verification

Verification not performed by the person responsible for monitoring the same activity.

8.8.1

Complete management review

Inputs a) to g), including FSMS performance and effectiveness.

9.3.2

PRPs based on the ISO 22002 series

ISO 22002-100:2025 common base, plus the sector-specific part that applies to you.

ISO 22002:2025

ISO

ISO 22000:2018: international reference

Applies to any organization in the food chain, regardless of size. Foundation of GFSI schemes, notably FSSC 22000.

United States (FDA FSMA / 21 CFR 117)FSSC 22000 (GFSI)Canada (SFCR / CFIA)European UnionUnited Kingdom (FSA)Australia / New Zealand (FSANZ)China (GB 14881)Japan (JFS-C)

FSMS flash audit

Where do you stand today?

Answer the 12 clause-by-clause questions to get your ISO 22000:2018 maturity score. Questions are drawn from the requirements of the normative text. Instant result, free, no personal information required.

Question 1 / 12

Clause 4: Context

/ 100

Buy the ISO 22000 Package · $389

Deployment process

From order to certification audit, here is the path.

Day 1

Download

Full ZIP: 108 Word and Excel documents.

Weeks 1 to 4

Customization

Logo, org chart, products, flow diagrams. Hazard analysis with the food safety team, OPRPs and CCPs.

Weeks 5 to 10

Implementation

Training, PRP rollout, CCP and OPRP monitoring, first verification data.

Weeks 10 to 12

Mock audit

Internal audit with the kit's checklist, traceability test, action plan, certification readiness.

Typical timeline: 10 to 12 weeks. From 8 to 16 depending on your starting point.

Need a hand? Our consultants can tailor the kit to your site and support the rollout, on quote.

Request a quote

Risk-free

30-day guarantee, no questions asked.

You test the package. If you change your mind, we refund you.

You have 30 days to download the package, review its content, open the documents, and verify that the writing quality matches your expectations. If something is off, you write us an email, no justification needed, and the refund is processed within 5 business days. That simple.

Frequently asked questions

Answers to your most common questions.

Is the kit enough to get ISO 22000 certified?

No. It provides the documentation base required by the standard. Certification depends on implementation: hazard analysis of your processes, CCP validation, training, records, demonstrated traceability.

Are the documents editable?

Yes. 73 Word files and 35 Excel files, no locked PDFs. Neutral layout, ready for your logo and references.

Does the kit cover the HACCP plan and hazard analysis?

It provides the method and the supports: hazard analysis procedure, likelihood × severity matrix, OPRP and CCP classification, hazard control plan template, monitoring records. The analysis of your processes remains for your food safety team.

Does the license cover several sites?

It covers a single production site, with unlimited internal use. Multi-site rollouts or consulting firms: contact us for a suitable license.

When will I receive the files?

As soon as payment is confirmed, the full ZIP is available for download. Folders by document type: procedures, forms and records, Excel files, manual and policies, audit checklists.

What if the kit does not suit me?

You have 30 days to review it. Write to support@qse-academy.com explaining what does not meet your needs: the refund is issued to your original payment method, 4 to 5 business days after processing.

Take the next step

Your ISO 22000 FSMS. Ready today.

108 Word and Excel documents, instant download after payment.