Understanding ISO 22000: A U.S. Perspective on Certification Requirements

The ISO 22000:2018 food safety management system is a set of requirements for any organization in the food chain that describes what a processor must do to show that it can control food safety issues and assure that the food produced is safe. It can be applied to organizations of any size and at any place in the food production or processing chain. The basic approach contained in this document to developing and implementing a food safety management system is based on risk analysis, which includes the probability of the occurrence of a hazard and the severity of the outcome of the hazard if it occurs. The ISO document includes a cross reference section to the Codex Alimentarius Hazard Analysis and Critical Control Points (HACCP) document, which further emphasizes the need for hazard (risk) analysis.

To understand ISO 22000, it is helpful to recognize how the International Organization for Standardization (ISO) is structured and how the United States interacts with it. ISO is a global organization established in 1947 that provides standards for many different operations and manufacturing processes. It is a non-governmental organization that is linked to national standards institutes of member countries. There are approximately 165 member countries, and the U.S. representative is the American National Standards Institute (ANSI).

ISO is managed by a central secretariat, located in Geneva, Switzerland. The secretariat handles the operations and management of the organization. The general assembly is the final authority of the organization for statutory decisions, and all member nations and ISO officers participate in it. ISO is governed by a council that consists of six permanent members and 14 rotating members who address strategic, financial, commercial, and external relations issues. ANSI is one of the six permanent members, and the council reports directly to the general assembly. As the U.S. representative, ANSI also has a vote in the general assembly. The management of the preparation and revision of standards is addressed by the technical management board, which reports to the governing council. This board oversees the technical committees that develop and revise the standards.

ISO has a standardized procedure for the development of a new standard. To initiate a new standard, a preliminary work item may be developed for the initial study of a subject before starting actual standards development, but this is not required. A formal proposal (a new work item) is developed for ISO members to vote on, and, if approved, actual standards development begins on a working draft. If the proposed project does not appear to relate to an existing committee, the technical management board will assign the project to an existing committee, or a new committee will be created. The committee will then develop a working draft to be issued eventually as a draft international standard for formal voting, after which it may be issued as a final draft international standard. The final draft will undergo further review and approval by ISO members. Once approved, the new or revised international standard is published.

The United States has many technical advisory groups (TAGs) to represent the U.S. position on various ISO standards. These TAGs address all aspects of the ISO process, from the development of new work to determining the U.S. position on draft international standards. The TAGs are managed by a U.S. administrator who serves a similar function to a standards development committee secretary by managing the day-to-day administrative activities of the groups.

The management of the food safety activities of ISO is addressed by the ISO Technical Committee 34, Sub-committee 17. The scope of this committee is defined as “standardization in the field of food safety management systems, covering the food supply chain from primary production to consumption, human and animal foodstuffs, as well as animal and vegetable propagation materials.”