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Overview of ISO 22000 FSMS

Food safety is a global concern, so despite their size or product, all food producers are responsible for managing their products' safety and for the better health of their consumers. ISO 22000 gives the requirements for Food Safety Management Systems. ISO 22000 is a standard introduced by the International Organisation for Standardisation dealing with food safety. Food safety is linked with the presence of food-borne germs at the point of consumption. Food safety hazards occur at any stage of the food chain, so it is important to have adequate control in place, and for this, a combined effort on the part of all the parties is required throughout the food chain.

ISO 22000 FSMS specifies the requirements for Food Safety Management System that involves the following elements:

  • Interactive communication
  • System management
  • Pre-requisites programs
  • Hazard Analysis and Critical Control Point principles

ISO 22000 is aligned with ISO 9001 in order to enhance the compatibility of both of them. ISO 22000 is applied independently of other management system standards or integrated with existing management system requirements. It consolidates the principles of the Hazard Analysis and Critical Control Point (HACCP) system, and by means of auditable requirements, it combines the Hazard Analysis and Critical Control Point (HACCP) plan with pre-requisite programmes. Hazard analysis is an essential key to an effective Food Safety Management System because conducting a hazard analysis assists in organising the knowledge required to establish an effective control measure. ISO 22000 requires that hazards reasonably expected to occur in the food chain, especially those associated with the kinds of processes and facilities used, are identified and assessed. And so, it provides a list of hazards that need to be controlled by a particular organisation and also of those which need not be controlled. It also provided a reason for such differentiation. During analysing hazards, the organisation defines the strategy to control such hazards by combining the pre-requisite programmes and the Hazard Analysis and Critical Control Point (HACCP) plan.

Food Safety 22000 is a Global Food Safety Initiative (GFSI) approved scheme. And it is also used in the Food Safety Systems Certification (FSSC) Scheme FS22000.

The Food Safety System Certification provides a certification scheme for auditing and Certification of the Food Safety Management System (FSMS). The Certification is also provided for combined FSMS and QMS, i.e., FSSC 22000-Quality. The scheme uses international and independent standards and technical specifications for sector-specific pre-requisite programs (PRPs).

ISO 22000 FSMS Certification

ISO 22000 FSMS Certification is a procedure to verify that all the specific principles of food safety are applicable throughout the food chain to ensure food safety and the suitability of such food for human consumption. Such Certification is obtained for the following reasons:

  • It helps in building trust among the consumers and producers.
  • It ensures the integrity of the food supply chain.
  • Helps the consumer recognise trustworthy food products.
  • It is considered an important marketing tool.
  • Helps in getting comparatively a better price.

ISO 22000 Series

The ISO 22000 Series consist of the following specifications:

  • ISO 22000- Food Safety Management Systems (FSMS)- Requirements for any organisation in a food chain.
  • ISO 22001- All guidelines on the application of ISO 9001:2000 for the industries/organisations related to food and drink.
  • ISO/TS 22002- Pre-requisite programmes on food safety
  • ISO TS 22003- Food safety management systems for bodies providing audit and certification of Food Safety Management Systems.
  • ISO TS 22004- Food Safety Management Systems (FSMS)- Guidance on the application of ISO 22000:2005.
  • ISO 22005- Traceability in the feed and food chain- General principles and basic system design and implementation requirements.
  • ISO 22006- Quality Management Systems (QMS)- Guidance on the application of ISO 9002:2000 for crop production.

Components of ISO 22000 FSMS

The following are the components of the ISO 22000 FSMS:


Processes and appropriate control measures are available for the fulfilment of legal requirements for food safety.

Normative Reference

Documents on the terms and phrases mentioned under the ISO standard.


Provides many definitions from ISO 9001 for ensuring consistency and continuity.

Management System for Food Safety

Implementation, paper works and maintenance of management system for food safety, including procedures for effective development.

Responsibility of the Management

Commitment to implementation and maintenance of the management system for food safety, indicating responsible persons, food safety group, effective internal and external communication processes, conducts, goals, contingency plans, responsibilities, and regular management evaluations for troubleshooting and information.

Management of Resources

Resource, budget and personnel management, periodic training, employee evaluation, safe work environment and infrastructure.

Planning and Realisation of Safe Products

Good Manufacturing Practices (GMP) and the Hazard Analysis and Critical Control Points (HACCP) system, Preventive Programs (PRPs) for training, legal requirements, hygiene, maintenance, traceability, supplier evaluation, control of defective products and recall procedures for the production of safe and healthy food.

Validation, Verification and Improvement of the Management System

Scientific principles used in the management system, regular planning, implementation and paper works of the tests performed on the system components for the evaluation of the system.

Pre-Requisites for ISO 22000 FSMS

A comprehensive set of pre-requisites for ISO 22000 Food Safety Management System are:

  • Hygiene and Housekeeping Management
  • Management of Pest Control
  • Control of contractors and visitors
  • Maintenance
  • Management of cleaning
  • Despatch and distribution
  • Hygiene Policy
  • Glass Policy
  • Metal detection
  • Ingredients Foreign Body Control Policy
  • Nut handling procedure
  • Glass and Brittle Material Breakage Procedure
  • Control of Brittle Materials
  • Control of knives
  • Types of Allergens
  • Storage
  • Allergen Control Procedures
  • HACCP Pre-requisites
  • Control of First Aid Dressings
  • Food Defence System

Benefits of ISO 22000 FSMS

Benefits of Implementation of ISO 22000 and obtaining ISO 22000 FSMS Certification are as follows:

  • Comprehend to main principles of ISO 22000 FSMS
  • An assurance of quality, safety and reliability
  • Ensuring that organisation is conforming to ISO 22000 FSMS requirements
  • Enabling organisations to achieve food safety objectives
  • Improved management
  • Decrease costs from withdrawals or recalls
  • Support and guide organisations in their performance in food safety
  • Assist in understanding best practices for the food safety
  • Helps in understanding adequate necessary control in the food chain
  • Less food-borne diseases
  • Confidence in disclosure
  • Better quality and safe jobs in the food industry
  • Increase in utilisation of resources
  • Efficient food safety hazard control
  • Help organisations in preventing and reducing the risk of contaminants in their food products and work environment
  • More systematic management of pre-requisite programmes
  • Relevant basis for taking decisions
  • Saves resources by reducing duplication
  • Control focuses on priorities
  • Help organisation establish a traceability system
  • Support organisation in creating and protecting the value
  • Better planning, thus less post-process verification
  • Development of Food Safety Management System (FSMS)
  • Gives organisations a competitive advantage

Documents Required for ISO 22000 FSMS Certification

Documents required for obtaining ISO 22000 FSMS Certificates are as follows:

  • Business Registration Proof
  • Letter head including address
  • Sale and Purchase invoice or GST Registration Certificate
  • Description of business
  • Desired Scope
  • Name and address of the organisation
  • Process and operations, including legal obligations of the organisation
  • Information related to the organisation's activities
  • Human and technical resources
  • Functions of the organisation
  • Relationship in a larger corporation, if any
  • Information of all outsourced processes used by the organisation that affects the conformity to requirements
  • Information regarding the use of consultancy related to the management system
  • Standards or other requirements

Procedure Required for ISO 22000 FSMS Certification

Procedure for Certification according to the FSSC 22000 standard for food safety is as follows:

Stage 1 Audit

At the organisation, an audit is carried on to assess whether the Food Safety Management System conforms to all the requirements of ISO 22000 standards. The audit is also done to verify that Food Safety Management System is designed to achieve the food safety policy and objectives and to access the capabilities of the Food Safety Management System in managing the compliances with statutory, regulatory and contractual requirements. The purpose of it is to check the readiness of the Organisation's Management System. It covers the validation of the scope of the management system and Certification, design of the management system, Document review, applicable legal and other requirements, internal audit and management review processes.

Before the stage 2 audit, the organisation has to do all required clarifications. The interval between stage 1 and stage 2 audits cannot be more than six months.

Stage 2 Audit

It is also called Certification Audit. It is carried out to confirm the implementation of the organisation's Food Safety Management System and its effectiveness in all the requirements of ISO 22000 FSMS. It is also done to verify that information and evidence of conformity are achieved per all the requirements of Food Safety Management System standards. During this audit, the capabilities of the Food Safety Management System to perform key responsibilities and compliance of the same with the statutory, regulatory and legal requirements are assessed. This audit is conducted to confirm that the Food Safety Management System of the organisation is effective and achieving the food safety goals, policies and objectives.


After completion of both audits, the audit report is forwarded to the reviewer for further review, and if he grants permission for Certification based on the audit conclusion and recommendation of the audit team, then the report is forwarded to Chief Executive Officer or Director, who is signing authority to finally grant Certification.

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Frequently Asked Questions

ISO Stands for International Organisation for Standards.

Yes, ISO is an independent non-governmental organisation.

ISO 22000 FSMS is an international standard that provides specific requirements for Food Safety Management systems. It gives a structure for approach and mechanism to manage the safety of food products and services to their producers.

ISO 22000 FSMS is advantageous in many ways, such as ensuring food safety, reducing food-borne diseases, better utilisation of resources, increased profits, efficient validation and paper works of techniques, etc.

The extract from components of ISO 22000 FSMS standard is as follows:

  • To plan, operate, implement, maintain and update a Food Safety Management System providing products and services that are safe
  • To demonstrate compliance with statutory and regulatory food safety requirements
  • To evaluate and assess food safety requirements
  • To effectively communicate to interested parties on food safety issues
  • To ensure that the organisation conforms to food safety policy
  • To demonstrate conformity to relevant interested parties
  • To obtain certification or registration of its FSMS

Primary Documents required for ISO 22000 FSMS Certification are as follows:

  • Business Registration Proof
  • Letter head or vising card (including address)
  • Sale and Purchase Invoice/ receipt or GST Registration Certificate
  • Scope of Business

Hazard Analysis Critical Control Points (HACCP) is a globally accepted method for identifying and managing food safety risks or hazards. It is a management system where an organisation's food safety is addressed through analysing and controlling any biological, chemical, and physical risks or hazards from raw material production, procurement and handling to manufacturing, distribution and consumption of final food products.

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