Mark Ames  |  03/31/2009

The Importance of ISO 22000

More than just a quality management system for the food industry, ISO 22000 incorporates HACCP and other preventive plans that ensure food safety.

The last few years have provided ample evidence that control of food safety is critical. Recent media reports have clearly documented supply chain shortcomings that have threatened consumers’ health and safety. These ongoing problems and the need for consumer safety cry out for additional tools to dramatically reduce or eliminate risks.

Milestones in U.S. Food and Drug Law History


Dr. Harvey W. Wiley becomes chief chemist for the U.S. Department of Agriculture. Campaigning for a federal law, Dr. Wiley is called the “Crusading Chemist” and “Father of the Pure Food and Drug Act.”


The original Pure Food and Drug Act is passed by Congress on June 30 and signed by President Theodore Roosevelt. The Meat Inspection Act is passed the same day.


The name of the Food, Drug, and Insecticide Administration is shortened to the Food and Drug Administration (FDA).


The first food standards are issued (for canned tomatoes, tomato puree, and tomato paste).


The Food Additives Amendment is enacted, requiring manufacturers of new food additives to establish safety. The Delaney proviso prohibits the approval of any food additive shown to induce cancer in humans or animals. The FDA publishes in the Federal Register the first list of substances generally recognized as safe (GRAS).


The Fair Packaging and Labeling Act requires all consumer products in interstate commerce to be honestly and informatively labeled.


The FDA begins administering sanitation programs for milk, shellfish, food service, and interstate travel facilities, and for preventing poisoning and accidents.


The National Academy of Sciences releases “Scientific Criteria to Ensure Safe Food,” a report commissioned by the FDA and the Department of Agriculture that buttresses the value of the HACCP approach to food safety already in place at FDA, and invokes the need for continued efforts to make food safety a vital part of the United States’ overall public health mission.


Source: The U.S. Food and Drug Administration


Early food safety

Food safety rules have a long history. Evidence clearly shows that governments and governing authorities were concerned with protecting consumers from unsafe foods from the earliest times. In ancient Athens, beer and wines were inspected for purity.

In the United States, the concern over food safety began in earnest in the late 1800s but didn’t become law until 1906 with the formation of the Pure Food and Drug Act. (See sidebar, “Milestones in U.S. Food and Drug Law History” on page 38.) Over time, preventive approaches were increasingly adapted for food safety, culminating in 1995 with the U.S. publication of Hazard Analysis Critical Control Point (HACCP) requirements and their subsequent evolution into ISO 22000.

ISO 22000

ISO 22000 is an international standard intended to be used by organizations within the food chain. It contains traditional quality assurance preventive measures plus preventive food-safety measures. The purpose of ISO 22000 is to provide a practical approach to ensure the reduction and elimination of food safety risks as a means to protect consumers. ISO 22000 is intended to help organizations:

Embed and improve the internal processes needed to provide consistently safe food

Provide confidence to the organization and the management team that the organization’s practices and procedures are in place and that they are effective and robust

Provide confidence to customers and other stakeholders (through the ISO 22000 certification process) that the organization has the ability to control food safety hazards and provide safe products

Provide a means of continual improvement that ensures that the food safety management system is reviewed and updated so that all activities related to food safety are continually optimized and effective

Ensure adequate control at all stages of the food supply chain to prevent the introduction of food safety hazards


Food-safety management systems function only when the interdependent methods between food producers, suppliers, and customers are understood and managed. This includes a clear understanding of responsibility and provisions for accountability at all levels. This can only be done in light of a structured management system such as one conforming with ISO 22000.

Largely preventive

ISO 22000 follows a long tradition of preventive actions, identified and regulated by quality and food safety professionals. Three brief ISO 22000 concepts imported from ISO 9001 are planning (i.e., things work better when there is a plan and the plan is followed and enforced), procedures (i.e., consistency for extended time periods, especially when multiple people are involved), and employee competence (i.e., the use of competent personnel is necessary to achieve required results).

Other concepts include document control, control of records, corrective action, measurement, and many others too numerous to mention in this article. Approximately half of the pages of ISO 22000 closely follow or are identical to the text in ISO 9001.

ISO 22000 dedicates substantial effort to defining requirements specific to food safety management. These requirements can be divided into two broad themes:

Methods and practices related to planning and realization of safe foods

Methods and practices for validation, verification, and improvement of the food safety management system


Food safety requirements

Because much of HACCP was included in ISO 22000, it’s important to understand a little bit of what HACCP is. HACCP could be defined as the system used to formally identify, evaluate, and control hazards that are significant to food safety. HACCP activities require 12 very logical and straightforward steps:

1. Assemble the HACCP team that will ensure that the HACCP plan is properly completed and implemented.

2. Describe the product associated with the specific HACCP plan; organizations that produce multiple products may have several HACCP plans.

3. Identify the intended use of the product.

4. Construct flow diagrams showing the flow and steps associated with the product and process steps.

5. Confirm the flow diagram by direct investigation or observation, list all potential hazards associated with the flow, and conduct a hazard analysis to determine which hazards need to be controlled.

6. Identify and consider control measures that can be undertaken to prevent the hazard.

7. Determine the critical control points where controls will be put in place to ensure food safety.

8. Establish critical limits for each critical control point where acceptable levels are clearly defined.

9. Establish a monitoring system for each critical control point.

10. Establish corrective actions to be taken when critical limits have been exceeded.

11. Establish verification procedures to monitor results.

12. Establish documentation and record keeping to provide evidence of control.


One of the differences between HACCP and ISO 22000 is the ISO standard’s emphasis of the use of prerequisite programs (PRPs). PRPs are generic controls used by any food business operation to maintain hygienic conditions in the processing environment. PRPs stipulate the preconditions necessary for producing safe food. Depending on the type of activity involved, the following defined requirements should be considered:

Good Agricultural Practice (GAP)

Good Hygienic Practice (GHP)

Good Production Practice (GPP)

Good Distribution Practice (GDP)


Additional components of prerequisite programs include, for example, cleaning and sanitizing; pest control; personnel hygiene; construction and layout of buildings and associated utilities; supplies of air, water, energy, and other utilities; supporting services such as waste and sewage disposal; supplier control; employee training; and more.

Rationale for adoption of ISO 22000

Organizations should consider adoption of ISO 22000 for three principle reasons:

Benefits in the marketplace. Customers receive confidence through the demonstrated implementation and ongoing maintenance of the system. As organizations along the supply chain adopt ISO 22000 or become subject to customer controls along the food supply chain, the market achieves assurance that there are no weak links in the food chain.

Benefits to the organization producing the food . The organization has confidence that it has done the right things to provide control over activities that affect food safety. The system is well-planned, monitored, audited (internally and externally), and measured, and feedback is provided in a timely manner to decision makers.

ISO 22000 goes well beyond regulatory requirements . ISO 22000 includes--but goes beyond--existing HACCP programs. HACCP programs are excellent and work very well to prevent food safety problems, but they are not supported by an overarching systematic approach that includes many of the components extracted from ISO 9001.

What potential users should know about ISO 22000

ISO 22000 works for all organizations regardless of their size. The standard outlines best practices that deliver results and convey confidence to the organization as well as its stakeholders. This confidence is demonstrated by the internal audit process and, in particular, the external audit process through ISO 22000 registration.

Failures in food safety practices are dangerous and expensive. It is obviously easier, less dangerous, and less expensive to prevent these problems before they occur.

ISO 22000 harmonizes various industry and national standards for food safety. Increasing requirements from customers and other stakeholders within the food chain demand increased rigor and demonstrated results. There is an increasing need to provide evidence of conformance to an internationally accepted and approved set of requirements.

If your organization participates in any part of the food industry, you will likely want to consider learning more about ISO 22000. A brief list of organizations that may need to consider ISO 22000 may include:

Food manufacturers

Producers of food ingredients

Agricultural producers

Transporters of raw or finished food products

Storage facilities for raw or finished food products


Subcontractors within the food chain



Producers of animal feed

Food equipment manufacturers

Food packaging manufacturers



For a successful implementation of ISO 22000 you will need to create a clear project plan including the identification of responsibilities, tasks, and an associated timeline. Wherever possible, make use of what you are currently doing related to quality or food safety. It doesn’t make sense to change something that’s working.

You will need to communicate the purpose and benefits of ISO 22000 to employees. Be prepared to overcome the arguments, which are the same arguments encountered by any standards implementation: There’s too much paper, there’s too much complexity, it’s not appropriate for a small business, and/or the bar is set too high for the organization.

Educate people on the technical aspects of ISO 22000 (i.e., auditing, creation of effective documents, food safety specific tasks, biological contamination, etc.).

The future

ISO 22000 is currently undergoing review and approval by the Global Food Safety Initiative (GFSI). Acceptance by GFSI will energize acceptance and usage of ISO 22000 worldwide.

All ISO standards are reviewed and amended as needed on a five-year cycle. The revision process for ISO 22000 will begin in the next few months.

ISO 22000 overlaps and works well in conjunction with existing HACCP and ISO 9001 initiatives. Expect future revisions to increase the links between these documents as well as future revisions of other standards: environmental management, risk management, security management, and others.


About The Author

Mark Ames’s picture

Mark Ames

Mark Ames is president of AQS Management Systems Inc., a Minneapolis-based company that provides consulting, auditor training, coaching, and project assistance in support of organizational improvement in the areas of food safety, environmental, quality, and occupational health and safety, and aerospace; and for implementation of international management system standards. Ames has a bachelor’s degree in industrial technology and a master’s degree in manufacturing systems engineering.