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Key Changes

Here is a summary of the key changes in ISO 22000:2018 requirements for a Food Safety Management System:

ISO 22000:2018 has been developed within the ISO high level structure to improve alignment between ISO management system standards. Sections have changed to:

• 4 Context of the organization.
• 5 Leadership.
• 6 Planning.
• 7 Support.
• 8 Operation
• 9 Performance evaluation.
• 10 Improvement.

4.1 Understanding the organization and its context

A new requirement to determine external and internal issues (positive and negative) that affect the organization’s ability to achieve the intended result(s) of its Food Safety Management System.

4.2 Understanding the needs and expectations of interested parties

A new requirement to determine relevant interested parties and the relevant requirements of the interested parties.

5.1 Leadership and commitment

A greater emphasis on Top Management to demonstrate leadership and commitment.

6.1 Actions to address risks and opportunities

A new requirement plan to address the issues referred to in 4.1 and the requirements referred to in 4.2 and 4.3 and determine the risks and opportunities that need to be addressed.

6.2 Objectives of the food safety management system and planning to achieve them

A greater emphasis on specifying objectives for the FSMS.

7.1.6 Control of externally provided processes, products or services

A new requirement to establish and apply criteria for the evaluation, selection, monitoring of performance and re- evaluation of external providers of processes, products and/or services and ensure adequate communication of requirements.

7.4 Communication

A greater emphasis on specifying internal and external communications relevant to the FSMS.

8.2.3 A new requirement to consider the applicable part of the ISO/TS 22002 series when selecting and/or establishing PRP(s).

8.4.2 New requirements for the Handling of emergencies and incidents

8.5.4 Hazard control plan (HACCP/OPRP Plan)

A change where there is now a requirement to document CCPs and OPRPS in a Hazard Control Plan. A new definition of action criteria for OPRPs.

9.1 Monitoring, measurement, analysis and evaluation

A greater emphasis on specifying monitoring, measurement, analysis and evaluation.

The Assured 22000 Certification Package includes:

• Food Safety Management System Procedures
• Food Safety Management System Records
• Prerequisite Programmes Manual
• Operational Prerequisite Programme Templates
• HACCP Manual including the ISO 22000 HACCP Calculator
• A set of PowerPoint Training Presentations covering ISO 22000, GMPs, Prerequisites, HACCP and Internal Audits
• ISO 22000/22002/CODEX Gap Analysis Checklists
• New Version 5.1 Implementation Workbook to guide you through the implementation of your ISO 22000:2018 compliant Food Safety Management System
• Start Up Guide
• Allergen Management Module & Risk Assessment Tool
• Supplier Risk Assessment Tool
• Product Development Module
• Complaint Management Guidelines & Analyser
• Hygiene Inspection Training
• Verification Schedule Risk Assessment Tool and Template
• Food Fraud Prevention Procedures and Raw Material Food Fraud Assessment Tool
• Free online support via e-mail

Food Safety Management System

The Food Safety Manual contains comprehensive top level procedures templates that match the clauses of the ISO 22000:2018 standard and form the foundations of your Food Safety Management System so you don't have to spend 1,000's of hours writing compliant procedures.

Below is a table that shows how the documents match the requirements of the ISO 22000 standard with the Food Safety Management System provided to assist you in implementing the system and understanding the requirements of the standard.

ISO 22000 Food Safety Management System
4 Context of the organization
FSMS 4.1 Understanding the organization and its context
FSMS 4.2 Understanding the needs and expectations of interested parties
FSMS 4.3 Determining the scope of the food safety management system
FSMS 4.4 Food safety management system
5 Leadership
FSMS 5.1 Leadership and commitment
FSMS 5.2 Policy
FSMS 5.3 Organizational roles, responsibilities and authorities
6 Planning
FSMS 6.1 Actions to address risks and opportunities
FSMS 6.2 Objectives of the food safety management system and planning to achieve them
FSMS 6.3 Planning of changes
7 Support
FSMS 7 Support	7.1 Resources
	7.1.1 General
	7.1.2 People
	7.1.3 Infrastructure
	7.1.4 Work environment
	7.1.5 Externally developed elements of the food safety management system
	7.1.6 Control of externally provided processes, products or services
	7.2 Competence
	7.3 Awareness
FSMS 7.4 Communication	7.4.1 General
	7.4.2 External communication
	7.4.3 Internal communication
FSMS 7.5 Documented information	7.5.1 General
	7.5.2 Creating and updating
	7.5.3 Control of documented information
8 Operation
FSMS 8.1 Operational planning and control
FSMS 8.2 Prerequisite programmes (PRPs)
FSMS 8.3 Traceability system
FSMS 8.4 Emergency preparedness and response
8.5 Hazard control
FSMS 8.5.1 Preliminary steps to enable hazard analysis	8.5.1.1 General
	8.5.1.2 Characteristics of raw materials, ingredients and product contact materials
	8.5.1.3 Characteristics of end products
	8.5.1.4 Intended use
	8.5.1.5 Flow diagrams and description of processes
	8.5.1.5.1 Preparation of the flow diagrams
	8.5.1.5.2 On-site confirmation of flow diagrams
	8.5.1.5.3 Description of processes and process environment
FSMS 8.5.2 Hazard analysis	8.5.2.1 General
	8.5.2.2 Hazard identification and determination of acceptable levels
	8.5.2.3 Hazard assessment
	8.5.2.4 Selection and categorization of control measure(s)
FSMS 8.5.3 Validation of control measure(s) and combinations of control measures
FSMS 8.5.4 Hazard control plan (HACCP/OPRP plan)	8.5.4.1 General
	8.5.4.2 Determination of critical limits and action criteria
	8.5.4.3 Monitoring systems at CCPs and for OPRPs
	8.5.4.4 Actions when critical limits or action criteria are not met
	8.5.4.5 Implementation of the hazard control plan
FSMS 8.6 Updating the information specifying the PRPs and the hazard control plan
FSMS 8.7 Control of monitoring and measuring
FSMS 8.8 Verification related to PRPs and the hazard control plan	8.8.1 Verification
	8.8.2 Analysis of results of verification activities
FSMS 8.9 Control of product and process nonconformities	8.9.1 General
	8.9.2 Corrections
	8.9.3 Corrective actions
	8.9.4 Handling of potentially unsafe products
	8.9.4.1 General
	8.9.4.2 Evaluation for release
	8.9.4.3 Disposition of nonconforming products
FSMS 8.9.5 Withdrawal/recall
9 Performance evaluation
FSMS 9.1 Monitoring, measurement, analysis and evaluation	9.1.1 General
	9.1.2 Analysis and evaluation
FSMS 9.2 Internal audit
FSMS 9.3 Management review	9.3.1 General
	9.3.2 Management review input
	9.3.3 Management review output
10 Improvement
FSMS 10 Improvement	10.1 Nonconformity and corrective action
	10.2 Continual improvement
	10.3 Update of the FSMS

FSQMS Record Templates

The Food Safety Manual includes over 60 record templates.

Prerequisite Programmes Manual

A comprehensive set of prerequisite programme templates compliant with TECHNICAL ISO/TS SPECIFICATION 22002-1 Prerequisite programmes on food safety — Part 1: Food manufacturing and FSSC 22000 Certification Scheme Additional Requirements Version 5.1 are included.

ISO 22000 HACCP Manual containing the HACCP Calculator

There are supplementary ISO HACCP Manual documents including the HACCP Calculator ISO 22000 2018 & Instructions.

How does the ISO 22000 HACCP Calculator help?

The ISO 22000 HACCP Calculator provides the Food Safety Team with a system to assess each of the control measures selected and formulating a Hazard Control Plan of Critical Control Points and Operational Prerequisite Programmes as per the new requirements in ISO 22000:2018.

Operational Prerequisite Programmes Manual

A set of operational prerequisite programme samples with corresponding verification and validation records are provided.

Laboratory Quality Manual

A comprehensive Laboratory Quality Manual based on the requirements of ISO 17025 is provided in Microsoft Word format. The laboratory quality manual includes template records, procedures and product sampling plans.

Training – PowerPoint Presentations are included

Introduction to ISO 22000

This PowerPoint presentation will introduce the ISO 22000 standard to the management team and explain exactly how to start the process of implementing an ISO 22000 compliant Food Safety Management System.

Food Safety Team: ISO 22000 Implementation Guide

The Food Safety Team: ISO 22000 Implementation Guide PowerPoint presentation supplied with the system explains to the Food Safety Team their role in implementing an ISO 22000:2018 compliant Food Safety Management System.

ISO 22000 Document Requirement Guide

The ISO 22000 Document Requirement Guide PowerPoint presentation supplied explains to the Management Team the documentation required in an ISO 22000 compliant Food Safety Management System.

FSSC 22000 Additional Requirements Presentation

The FSSC 22000 Additional Requirements Version 5.1 PowerPoint presentation supplied explains to the Management Team the Additional Requirements of the FSSC 22000 Certification Scheme.

Codex GMP & Prerequisite Training

CODEX GMP and ISO 22002 Prerequisites PowerPoint presentations are included.

HACCP Training

An illustrated PowerPoint HACCP training presentation is included.

Internal Auditor Training Guide ISO 22000 2018

A PowerPoint Internal Auditor training presentation is included and can be used to train your Internal Auditors.

Internal Audit Training - Warehouse Audit

An example of a Warehouse Audit is included.

Internal Audit Training - GMP Audit

A PowerPoint training presentation of a GMP Audit protocol is included.

Internal Audit Checklists

There is a checklist for each section of the ISO 22000 standard.

ISO 22000/22002 Audit Plan with Risk Rating

ISO 22000 & 22002 Audit Plans and risk rating system are included.

Project Tools

This contains project tools to assist in achieving ISO or FSSC 22000 certification.

Senior Management Implementation Guidance & Checklists

An 11 step Senior Management Implementation Checklist and Guidance are provided.

Project Plan

Excel and Word Project Planner templates are supplied with the system to help establish a Project Plan.

Allergen Management Module & Risk Assessment Tool

Comprehensive allergen management documentation and the Allergen Management Tool which assist PRP 10.3 Allergen Control.

Food Fraud Prevention Procedures and Raw Material Food Fraud Assessment Tool

Product Development Module

Supplier Risk Assessment Tool

Complaint Management Guidelines & Analyser

Free online support via e-mail

We provide online support and expertise to assist you in developing your 22000 Food Safety Management System. Support is guaranteed until you achieve certification.

About the FSSC 22000 Certification Scheme

ISO 22000 Food safety management systems — Requirements for any organization in the food chain which was initially published in 2005 and has never been recognized by GFSI and GFSI recognition is playing an important role in Food Safety Management Systems Certification.

To address this in 2009, four leading global food manufacturers joined forces and created the FSSC 22000 scheme. By using the ISO 22000 standard, adding Prerequisite Program requirements based on ISO Technical Specifications/Publicly Available Standards (PAS) and FSSC 22000 additional requirements the Foundation created an ISO 22000 based scheme that was benchmarked and recognized by GFSI.

For example, under the FSSC 22000 Certification Scheme, ISO 22000:2018 Food safety management systems — Requirements for any organization in the food chain, ISO/TS 22002-1:2009 Prerequisite programmes on food safety — Part 1: Food manufacturing and FSSC 22000 Additional Requirements Version 5.1 are now applicable for the following Food Sector Categories:

• CI Processing of perishable animal products
• CII Processing of perishable plant products
• CIII Processing of perishable animal and plant products (mixed products)
• CIV Processing of ambient stable products
• DIIa Production of pet food (only for dogs and cats).
• K Production of Bio-chemicals

The FSSC 22000 Scheme is now managed by Foundation FSSC 22000 and governed by an independent Board of Stakeholders, consisting of representatives from several sectors in the food industry. On 3 November 2020, the Foundation FSSC 22000 has published Version 5.1 of its FSSC 22000 certification Scheme. The updated version is compliant with the latest Global Food Safety Initiative (GFSI) Benchmarking Requirements - Version 2020.

Version 5.1 2.5 FSSC 22000 Additional Requirements Change Summary (Changes in Red):

2.5.1 Management of Services and Purchased Materials

a) Requirements for laboratory analysis services apply to both internal and external laboratories as applicable

b) documented procedure for procurement in emergency situations 

c) policy for the procurement of animals, fish and seafood that are subject to control of prohibited substances

d) For food chain categories C, D, I, G and K, a review process for product specifications

2.5.2 Product Labelling

... ensure that finished products are labelled according to all applicable statutory and regulatory requirements in the country of intended sale, including allergen and customer specific requirements.

Where product is unlabeled, all relevant product information shall be made available to ensure the safe use of the food by the customer or consumer.

2.5.3 Food Defense - Same

2.5.4 Food Fraud Mitigation - Same

2.5.5 Logo Use

2.5.6 Management of Allergens (Food Chain Categories C, E, FI, G, I & K) - Same

2.5.7 Environmental Monitoring (Food Chain Categories C, I & K) - Same

2.5.8 Formulation of Products (Food Chain Category D) - Same

2.5.9 Transport and Delivery (Food Chain Category FI) - Same

* NEW * 2.5.10 Storage and Warehousing (All Food Chain Categories)

a) stock rotation system that includes FEFO principles 

b) define post-slaughter time and temperature in relation with chilling or freezing of the products.

* NEW *2.5.11 Hazard Control and Measures for Preventing Cross-Contamination (Food Chain Categories C & I) 

a) For food chain category I, (Packaging) specified requirements in place in case packaging is used to impart or provide a functional effect on food (e.g. shelf life extension).

b) For food chain category CI, requirements for an inspection process at lairage and/or at evisceration

* NEW *2.5.12 PRP Verification (Food Chain Categories C, D, G, I & K) 

For food chain categories C, D, G, I and K, site inspections/PRP checks 

* NEW *2.5.13 Product Development (Food Chain Categories C, D, E, F, I & K)

A product design and development procedure for new products and changes 

a) Evaluation of the impact of the change on the FSMS 

b) Consideration of the impact on the process flow 

c) Resource and training needs

d) Equipment and maintenance requirements

e) The need to conduct production and shelf-life trials

* NEW *2.5.14 HEALTH STATUS (FOOD CHAIN CATEGORY D)

* NEW * 2.5.15 Requirements for Organizations with Multi-Site Certification (Food Chain Category A, E, FI & G)

See www.fssc22000.com for more details about FSSC 22000 Certification Scheme Version 5.1|November 2020