ISO 22000:2005

Food Safety

Food Safety Management System

ABOUT ISO 22000

ISO 22000:2005 sets out the requirements for a food safety management system and can be certified to. It maps out what an organization needs to do to demonstrate its ability to control food safety hazards in order to ensure that food is safe. It can be used by any organization regardless of its size or position in the food chain.

WHAT IS ISO 22000:2005

ISO 22000 is a Food Safety Management System that can be applied to any organization in the food chain, farm to fork. Becoming certified to ISO 22000 allows a company to show their customers that they have a food safety management system in place. This provides customer confidence in the product. This is becoming more and more important as customers demand safe food and food processors require that ingredients obtained from their suppliers to be safe.

The International Organization for Standardization (ISO) developed the Food Safety Management System Certification: ISO 22000. ISO and its member countries used the Quality Management System approach, and tailored it to apply to Food Safety, incorporating the widely used and proven HACCP principles and Good Manufacturing Principles (addressed by Prerequisite Programs in ISO 22000).
The standard has requirements for Food Safety Management Systems processes and procedures, and requires that the organization implement prerequisite programs and HACCP.
Unlike some of the other Food Safety Management Systems Certification programs (for example FSSC 22000 and SQF) the ISO 22000 does not have specific requirements for prerequisite programs (PRPs), but requires that the organization identifies and implements the appropriate programs. This makes it more flexible, and food organizations of any type can implement and be certified to ISO 22000.
The goal was to be able to encourage harmonization of the many national and private standards in existence and add the management systems approach of ISO 9001. Starting with many of the same concepts as the Quality Management Standard, changing the focus to food safety management, and incorporating PRP and HACCP principles led to what is now ISO 22000. This standard can be applied to any company in the food chain, from field to store.

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BENEFITS

The potential benefits of ISO 22000 are numerous, but the most significant are tangible and demonstrable improvements in food safety performance and a greater level of assurance in the area of legal compliance.

  • Introduce internationally recognized processes to your business
  • Give suppliers and stakeholders confidence in your hazard controls
  • Put these hazard controls in place across your supply chain
  • Introduce transparency around accountability and responsibilities
  • Continually improve and update your systems so it stays effective
  • ISO 22000 contains the food safety management system requirements of FSSC 22000 (which is a Global Food Safety Initiative, GFSI recognised scheme) and is used along with requirements for prerequisite programs for the appropriate industry sector.

ISO 22000 provides businesses with a comprehensive framework for a Food Safety Management System related to food safety. Organisation can purchase different ISO 22000 packages depending on their individual requirements.

Organisations certified in ISO 22000 can indicate to their customers that they have a Food Safety Management System in place. Having an ISO 22000 certification can help make customers feel more secure in the safety of a business’s product; an increasingly important issue for both businesses and consumers.

WHAT IS FOOD SAFETY?

“Food safety” is about the prevention, elimination, or control of food-borne hazards at the point of consumption.  Everywhere around the world, people agree on this one point –consumers need and deserve assurance that the food sold to them is safe to consume.  As food safety hazards may be introduced at any stage of the food supply chain, every company in the supply chain must exercise adequate hazard controls.  In fact, food safety can only be ensured through the combined efforts of all parties in the food chain.

Organizations within the food supply chain range from primary producers (e.g., farmers) through food processors, storage and transportation operators, subcontractors, and all the way to retail outlets (e.g., groceries, restaurants), as well as every point and company in between.  And though their products are not part of the food we consume, makers of processing equipment, packaging material, cleaning agents, additives / ingredients, and even service providers (e.g., equipment testers) are also integral parts of the supply chain.

The US Food and Drug Administration (FDA) interprets “safe food” as food in which illness-causing substances (bacteria, chemicals, etc.), when they are present, are within acceptable levels. Through food research, the definition of “acceptable levels” is continually changing – for the better, it is hoped.

"In the United States, food-borne diseases have been estimated to cause 6 million to 81 million illnesses and up to 9,000 deaths each year"  CDC Website

Through food research, the definition of “acceptable levels” is continually changing.

Latest Development: ISO22000:2018

Revision is ongoing for ISO 22000 on food safety management systems, which has just reached the Draft International Standard (DIS) stage. The revised standard will incorporate a new core structure as well as recognized key elements to ensure food safety at every step of the food chain. The new version of ISO 22000 will contain a number of minor alterations that have been introduced to increase the readability and clarity of the standard, as well as some substantial changes that are more structural in nature. The main highlights are as follows:

  • The new version will adopt ISO’s new High-Level Structure (HLS), which is the common framework for all management systems standards. This common structure makes it easier for businesses to integrate more than one management system into their processes at a given time.
  • The revised standard will provide a new understanding of the notion of “risk”. Risk is a vital concept for food businesses and the standard will distinguish between risk at the operational level (through the Hazard Analysis Critical Control Point approach, or HACCP) and risk at the strategic level of the management system (business risk) with its ability to embrace opportunities in order to reach a business’s specific goals.
  • The standard will clarify the distinction between two Plan-Do-Check-Act (PDCA) cycles. The first applies to the management system as a whole while the second, embedded within it, addresses the operations described in Clause 8, which simultaneously covers the principles of HACCP defined by the Codex Alimentarius.

WHAT DOES ISO 22000 SYSTEM REQUIRES

  • ISO 22000 requires that you build a Food Safety Management System. This means that you will have a documented system in place and fully implemented throughout your facility that includes:
    • Effective Prerequisite Programs in place to ensure a clean sanitary environment
    • A Hazard Analysis and Critical Control Plan developed to identify, prevent and eliminate food safety hazards,
    • Established documented food safety management system processes to manage food safety throughout your organization - from management and business planning aspects to day to day communication and operations affecting food safety.

    The ISO 22000 standard contains the specific requirements to be addressed by the Food Safety Management System. The standard requires food safety management system processes including:

    • Having an overall Food Safety Policy for your organization, developed by top management.
    • Setting objectives that will drive your companies efforts to comply with this policy.
    • Planning and designing a management system and documenting the system.
    • Maintaining records of the performance of the system.
    • Establishing a group of qualified individuals to make up a Food Safety Team.
    • Defining communication procedures to ensure effective communication with important contacts outside the company (regulatory, customers, suppliers and others) and for effective internal communication.
    • Having an emergency plan.
    • Holding management review meetings to evaluate the performance of the FSMS.
    • Providing adequate resources for the effective operation of the FSMS including appropriately trained and qualified personnel, sufficient infrastructure and appropriate work environment to ensure food safety.
    • Implementing Prerequisite Programs.
    • Following HACCP principles.
    • Establishing a traceability system for identification of product.
    • Establishing a corrective action system and control of nonconforming product.
    • Maintaining a documented procedure for handling withdrawal of product.
    • Controlling monitoring and measuring devices.
    • Establishing and maintaining and internal audit programme
    • Continually updating and improving the FSMS.

Frequently Asked Questions

Everyday all around the world food is produced, transported, sold and consumed. This means there’s always a risk of contamination and other food safety hazards. The ISO 22000 standards aim to lower the risk of bacterial contamination and therefore the risk of disease throughout the entire food supply-chain process.

ISO 22000 provides businesses with a comprehensive framework for a Food Safety Management System related to food safety. Organisation can purchase different ISO 22000 packages depending on their individual requirements.

Organisations certified in ISO 22000 can indicate to their customers that they have a Food Safety Management System in place. Having an ISO 22000 certification can help make customers feel more secure in the safety of a business’s product; an increasingly important issue for both businesses and consumers.

International food safety standards are continually reviewed so as to remain relevant to the current food safety industry. The next update of the ISO food safety standards is expected to be published in 2017.

The countries that require CE marking are the 31 countries in the European Economic Area. This includes:

All of the 28 EU member states: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and the UK.

Three members of the European Free Trade Association: Iceland, Liechtenstein and Norway.

In addition, Turkey has fully implemented many of the CE marking directives, even though it’s not a member of the EU or the EEA.

Switzerland is also not an EU or EEA member. However, it is part of the European Free Trade Association, so accepts CE marking as a presumption of conformity with its own national technical regulations for some products.

CE marking is a declaration by the manufacturer that the product meets all the appropriate provisions of the relevant legislation implementing certain European Directives. CE marking gives companies easier access into the European market to sell their products without adaptation or rechecking. The initials “CE” do not stand for any specific words but are a declaration by the manufacturer that his product meets the requirements of the applicable European Directive(s).

You need to establish first which, if any, of the New Approach Directives or older Global Approach Directives applies to your product. CE marking only applies to products within the scope of these Directives. It should not be applied to products if they are outside the scope of the Directives.

The same principles above apply to imported products. It is the responsibility of the importer / person placing the product on the market to ensure that the product is correctly CE-marked.

It is necessary first to establish which Directives apply to the product. It is impossible to draw up hard-and-fast rules, and it is important to seek independent and impartial advice if you are in any doubt. Guidance booklets on many of the EC Directives (or UK regulations implementing those Directives) that contain CE marking requirements are available.

It is important also to understand that not all EC Directives relating to products, e.g. the General Product Safety Directive, require CE marking, nor that a particular Directive applies to all products that could be described by its title e.g. the Machinery Directive does not apply to every conceivable product that might be termed a machine. Most of the Directives set out ‘scopes’ i.e. the range of products to which they apply.

You should therefore study the UK regulations implementing the Directives. Copies of the regulations can be obtained from The Office of Public Sector Information (OPSI).

In general CE marking must appear on the product but see the individual guidance for exceptions. It may also appear on the packaging, in manuals or other supporting literature, but again it is best to study the guidance.

The CE mark must not be less than 5mm in its vertical height, and the proportions maintained. It is generally shown on a grid in the guidance booklets, as at the top of this page (the grid does not form part of the marking and is for information only):

This mark looks the same as some previous marks, but there are subtle changes, and it should be studied closely. It should be noted, for example, that the C and E are not formed by perfect semi-circles, i.e. the top and bottom arms extend one square beyond the semi-circles, and the middle arm of the E stops one square short.

CE-marking applies to the circulation of a product within the EEA. It is not required for exporting a product to non-EEA countries. You need to check on the particular regulatory requirements or standards that apply to your product in the country in question. The same standards may apply but they may also be different.

Advice on exporting is available from the UK Trade & Investment network, which delivers services co-ordinated by the former British Trade International, the organisation set up in May 1999 to take lead responsibility within Government for trade development and promotion.

The Technical Help for Exporters service run by the BSI may also be able to offer some advice.

Enforcement varies according to the Directives. Some are enforced by local Trading Standards Departments , others by HSE and yet others by the Medical and Healthcare Products Regulatory Agency and the Vehicle Certification Agency.

Enforcement procedures/penalties: Except where safety is at risk, the relevant enforcement authority will usually provide you with an opportunity to ensure that your product is correctly CE-marked. If you fail to comply then you will be obliged to take your product off the market, and you may also be liable to a fine and/or imprisonment.

Any supply of the (individual) construction product for the first time within the European Internal Market for distribution or use in the course of a commercial activity, whether in return for payment or free of charge. NB: Every product or batch of products (that is, every window or every package / truckload of bricks) is placed on the market individually. The fact that similar products have been marketed before, does not change this. Therefore, manufacturers have to draw up a Declaration of Performance (DoP) and affix the CE marking pursuant to the Construction Products Regulation (CPR) for all the products entering the market from 01/07/2013 onwards, even if similar products had been commercialised before this date.

No. Essential characteristics included in hENs cannot be attested again in any kind of other (public or private) marks for construction products than the CE marking. (see Articles 4(2) and 8(3) of the CPR).

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