New ISO 22004 – Guidance for ISO 22000 on Food Safety

Food supply chain safety is in the news as products from around the world enter into the U.S. food supply at an increasingly faster pace.  Standardization is ideal for these types of issues, as it creates a baseline that both exporters and importers can agree on.  For food safety, the ISO 22000 provides basic requirements for organizations throughout the food chain.  And the new ISO 22004 standard provides you with clause-by-clause guidance on how to implement those requirements.  Titled “Food safety management systems – Guidance on the application of ISO 22000,” it’s available from Document Center now.

Originally released as a Technical Specification, the new 1st Edition (dated September 1st 2014) is a technical revision of the document.  Additionally, it assures the user that the information in the document will have permanent status as a standard (unlike the TS edition which by definition is only temporary).

Why would you want to use the ISO 22000 and it’s companion guidance document the ISO 22004?  If your company is involved anywhere in the food chain, you need a methodology of ensuring compliance with regulatory and other legal requirements.  You may also have customer requirements that the ISO 22000 system can address.  And you’ll have a way to reduce the risk to public health that food products can be associated with.

The ISO 22004 is organized into four primary informative sections:  Planning (Section 5), Implementation (Section 6), Verification (Section 7) and Improvement (Section 8).  This follows the general mantra of all quality systems: Plan, Do, Check, Act.  As noted above, within these sections, guidance is provided for each of the sub-clauses in the ISO 22000.

Another great feature of the new guidance document are the charts and text that show you the relationship of the various standards in the ISO 22000 series.  And there’s also general information on the structure of the ISO 22000 itself, providing you with both visual and textual support for the workflow and responsibilities you’ll need to implement this quality system.

ISO 22004 also provides you with tips on using outside resources, how the ISO 22004 relates to each of the 4 other ISO 22000 standards, and on using training and learning to provide improvement and motivation.  The document closes with a 16 item bibliography for further review.

Of course, if the ISO 22004 applies to your situation, you’re going to need a copy of the document.  Turn to Document Center Inc.  You can order online at our webstore,  Or you can contact our staff by phone (650-591-7600), fax (650-591-7617) or email (  The ISO standards are available in paper format, for single-user pdf download, or as part of our multi-user access Standards Online service.

You’ll find Document Center has plenty of support services that will make it far easier to meet your documentation requirements for any quality program.  We’ve been working with customers like you since 1982 from our Silicon Valley location.  Make us your Standards Experts!

Food safety management standards from ISO

With all the recent interest in food safety for cross-border food supply chains, a review of the Food Safety Management Standards developed by ISO, the International Organization for Standards, seems appropriate.

The ISO 22000 series has been developed expressly for the purpose of helping organizations set up a good safety management system viable for international trade.

The ISO 22000 international standard is derived from  ISO-9001. It specifies the requirements for a food safety management system that involves interactive communication, system management, prerequisite programs, and HACCP (Hazard Analysis Critical Control Point) principles.

The documents in the series are:

ISO-22000:2005, Food safety management systems — Requirements for any organization in the food chain

ISO/TS-22004:2005, Food safety management systems — Guidance on the application of ISO 22000:2005

ISO/TS-22003:2007, Food safety management systems — Requirements for bodies providing audit and certification of food safety management systems

ISO-22006:2009, Quality management systems — Guidelines for the application of ISO 9001:2008 to crop production

ISO/TS-22002-1:2009, Prerequisite programmes on food safety — Part 1: Food manufacturing

Here is the abstract for the ISO-22000:

ISO 22000:2005 specifies requirements for a food safety management system where an organization in the food chain needs to demonstrate its ability to control food safety hazards in order to ensure that food is safe at the time of human consumption.

It is applicable to all organizations, regardless of size, which are involved in any aspect of the food chain and want to implement systems that consistently provide safe products. The means of meeting any requirements of ISO 22000:2005 can be accomplished through the use of internal and/or external resources.

ISO 22000:2005 specifies requirements to enable an organization

— to plan, implement, operate, maintain and update a food safety management system aimed at providing products that, according to their intended use, are safe for the consumer,

— to demonstrate compliance with applicable statutory and regulatory food safety requirements,

— to evaluate and assess customer requirements and demonstrate conformity with those mutually agreed customer requirements that relate to food safety, in order to enhance customer satisfaction,

— to effectively communicate food safety issues to their suppliers, customers and relevant interested parties in the food chain,

— to ensure that the organization conforms to its stated food safety policy,

— to demonstrate such conformity to relevant interested parties, and

— to seek certification or registration of its food safety management system by an external organization, or make a self-assessment or self-declaration of conformity to ISO 22000:2005.

The ISO-22004 is a generic guidance document for the ISO-22000.

For the ISO-22003, the abstract is as follows:

ISO/TS 22003:2007 defines the rules applicable for the audit and certification of a food safety management system (FSMS) complying with the requirements given in ISO 22000:2005 (or other sets of specified FSMS requirements), and provides the necessary information and confidence to customers about the way certification of their suppliers has been granted.

FSMS certification does not attest to the safety or fitness of the products of an organization within the food chain. However, ISO 22000:2005 requires an organization to meet all applicable food-safety-related statutory and regulatory requirements through its management system.

And for the ISO-22006, the abstract states:

ISO 22006:2009 gives guidelines to assist crop producers in the adoption of ISO 9001:2008 for crop production processes. The term “crop” includes seasonal crops (such as grains, pulses, oilseeds, spices, fruit and vegetables), row-planted crops that are cultivated, perennial crops that are managed over a period of time, and wild crops that are not formally planted or managed. Horticultural crops provide an even broader range of types from annual and perennial fruits, vegetables, and ornamental flowering plants to perennial shrubs and trees, and root crops. These diverse crops require a broad range of planting, cultivating, pest control, and harvesting methods and practices. Decisions regarding planting, growing, and harvesting activities can be similar, although specific steps can be quite different when considering the range of crops.

ISO 22006:2009 gives guidelines on the use and application of ISO 9001:2008 to the establishment and management of a quality management system (QMS) by an organization involved in crop production.

ISO 22006:2009 is not intended to change, add or reduce the requirements of ISO 9001:2008, nor is it intended for certification.

Further down the supply chain, in manufacturing processes, the language of ISO 9001:2008, ISO 15161 or ISO 22000 is considered more appropriate. The need for an ISO 9001:2008-based system containing agricultural terminology became apparent due to difficulties in the interpretation of the language of ISO 9001:2008 for crop production applications.

Lastly, for the ISO-22002-1, more information follows:

ISO/TS 22002-1:2009 specifies requirements for establishing, implementing and maintaining prerequisite programmes (PRP) to assist in controlling food safety hazards.

ISO/TS 22002-1:2009 is applicable to all organizations, regardless of size or complexity, which are involved in the manufacturing step of the food chain and wish to implement PRP in such a way as to address the requirements specified in ISO 22000:2005, Clause 7.

ISO/TS 22002-1:2009 is neither designed nor intended for use in other parts of the food supply chain.

Food manufacturing operations are diverse in nature and not all of the requirements specified in ISO/TS 22002-1:2009 apply to an individual establishment or process.

Where exclusions are made or alternative measures implemented, these need to be justified and documented by a hazard analysis, as described in ISO 22000:2005, 7.4. Any exclusions or alternative measures adopted should not affect the ability of the organization to comply with these requirements. Examples of such exclusions include the additional aspects relevant to manufacturing operations listed under 1), 2), 3), 4), and 5) below.

ISO/TS 22002-1:2009 specifies detailed requirements to be specifically considered in relation to ISO 22000:2005, 7.2.3: a) construction and layout of buildings and associated utilities; b) layout of premises, including workspace and employee facilities; c) supplies of air, water, energy, and other utilities; d) supporting services, including waste and sewage disposal; e) suitability of equipment and its accessibility for cleaning, maintenance and preventive maintenance; f) management of purchased materials; g) measures for the prevention of cross-contamination; h) cleaning and sanitizing; i) pest control; j) personnel hygiene.

In addition, ISO/TS 22002-1:2009 adds other aspects which are considered relevant to manufacturing operations: 1) rework; 2) product recall procedures; 3) warehousing; 4) product information and consumer awareness; 5) food defence, biovigilance, and bioterrorism.

For additional information on these standards, to purchase them, or to talk with a standards expert on any other standards question, please contact us at, by phone (650-591-7600) or fax (650-591-7617).  You can also use our website at to search for any standards you’re interested in.