ISO 22000:

Requirements for food safety management systems

John G. Surak
Department of Applied Economics and Statistics
Clemson University
Clemson, SC 29634-0371
Tel 864-506-2190
Email jgsurak@yahoo.com

Summary
HACCP is the current definition of a food safety system. It is a system that builds food safety into products, and then
controls the process to ensure the production of safe food.

Dr. Harold Bauman, one of the original developers of HACCP, correctly predicted that HACCP would evolve over the years.
This evolution resulted in the development of a more effective definition of a food safety system without jeopardizing the key
structural elements of HACCP.

In 2001, Danish Standards proposed to the International Organization for Standardization, the development of a standard that
would define the requirements for a food safety management standard. This standard would incorporate the concepts of
HACCP into an auditable standard. It is expected that ISO 22000:200x Food safety management systems – Requirements
for any organization in the food chain, will be published in the last quarter of 2005.

Background
The development of both HACCP and a total food safety system has not been static. Over the years, HACCP as been
improved as practioneers, have used the system to ensure the production of safe foods. However, improvement to HACCP
has never jeopardized the key structure of HACCP.

The HACCP concept is over 40 years old. It was developed as a joint project between the Pillsbury Company, U.S. Army
Natick Laboratories and NASA to ensure the safe production of food for the manned spaced program. The original concept
of HACCP had three principles (Table 1). These concepts were presented to the public at the 1971 National Conference on
Food Protection.

Table 1
The original three principles of HACCP
1. Identification and assessment of hazards
2. Determination of critical control points
3. Establishment of a system to monitor critical control points
Source: Steven and Bernard. 1999

Initially the use of HACCP was adopted by a few large food processors. During the 1970s and 1980s, there were a few major
incidents that increased the interest of HACCP by the food processing industry. In 1974, the FDA published the Low Acid
Canned Food Regulations. The regulations incorporated HACCP principles into controlling Clostridium botulinum in low
acid canned foods. In 1985, the National Academies of Sciences published the landmark book entitled, An evaluation of the
role of microbiological criteria for foods and food ingredients. In this book, the NAS recognized that if HACCP was to be
broadly implemented in the food processing industry, HACCP would have to be incorporated into the food processing
regulations.
As a result of this report, the United States government formed the National Advisory Committee on the Microbiological
Criteria for Foods (NACMCF). This committee is an expert panel that provides advice on food safety issues to the
Secretaries of Health and Human Services, Agriculture, Commerce, and Defense. In 1989, this committee published the first
HACCP guideline that described the seven principles of HACCP (NACMCF,1989). In addition, the guideline stated that the
company must describe the food and the intended use and develop a flow diagram of the food manufacturing process. These
latter elements were incorporated into the “five preliminary steps of HACCP” when the guideline was revised in 1992
(NACMF, 1992). A third revision was published in 1997 (NACMCF 1997). This revision formally addressed the concept of
prerequisite programs (PRP). In addition, there was a reordering of the seven principles to make them equivalent to the
Codex Alimentarius Commission’s (Codex) definition of HACCP. Table 2 contains the five preliminary steps and the seven
principles of HACCP which are also known as the 12 steps of HACCP. The National Advisory Committee on the
Microbiological Criteria for Foods HACCP publications have become the de-facto US standard for HACCP. These
document is written in guideline format and is primarily intended to assist food processors in the implementation of HACCP.

Table 2
NACMCF’s five preliminary steps and seven principles of HACCP
Step 1 Assemble the HACCP team
Step 2 Describe the food and its distribution
Step 3 Describe the intended use and consumers of the food
Step 4 Develop a flow diagram which describes the processes
Step 5 Verify the flow diagram
Principle 1 Conduct a hazard analysis
Principle 2 Determine the critical control points
Principle 3 Establish critical limits
Principle 4 Establish monitoring procedures
Principle 5 Establish corrective actions
Principle 6 Establish verification procedures
Principle 7 Establish record-keeping and documentation procedures
Source: NACMCF, 1997

PRPs were incorporated into the definition of HACCP because food safety experts realized that HACCP was a food safety
system, and it needed a number of supporting systems to ensure the effectiveness of the HACCP plsan. Many of these PRPs
were identified in the Good Manufacturing Procedures (GMP) regulations or in the Good Hygienic Practices (GHP). Other
PRPs were developed because of the need to maintain an effective food safety system. Thus, a number of critical activities
have been classified as PRPs. There is not a consensus of what activities constitute a complete list of PRPs (Table 3).
However, PRPs typically have three things in common (Stevenson and Bernard, 1999):
• They address indirect food safety issues.
• They cover general programs related to food safety that can be applied to multiple production lines.
• Momentary failure to meet a PRP seldom results in a food safety hazard
The critical aspect of PRPs is that even though a specific momentary failure of a PRP seldom results in a food safety hazard,
the break down and frequent failure of a PRP may result in a food safety hazard. Therefore, it is critical that the food
processor properly develop, implement and maintain all PRPs. As a result, the food processor must continually assess the
PRPs for continued effectiveness.
 Table 3
Typical PRPs
Facilities
Production equipment
Education and training
Employee hygiene and cleanliness
Employee health status
Employee behavior
Visitors
Control of raw products
Production and quality control
Specifications
Water
Packaging
Lot identification
Labeling
Glass control
Metal control
Receiving, storage and distribution
Cleaning and Sanitation
Chemical control
Pest control
Waste management
Traceability
Recall
Complaint investigation

In 1983, Codex completed the development of the first international HACCP standard, which was entitled: Hazard Analysis
and Critical Control Point (HACCP) System and Guidelines for its Application. This standard was incorporated into the
General Principles of Food Hygiene (Codex 1999). The Codex definition of HACCP is written as a guideline for
implementation.

Development of a food safety management system standard

During the 1990s, a number of countries including Denmark, the Netherlands, Germany, Ireland, Australia, and the United
States developed national standards that incorporated various concepts of a food safety management system. In addition,
various non-governmental agencies such as the CIES-Business Forum, British Retail Consortium, the Food Safety Initiative,
and the National Food Processors Association developed programs to certify various parts of a food safety system. Because
of these marketplace pressures, Danish Standards proposed the development of an auditable ISO standard that would define
the requirements of a food safety management system. This standard would have the following characteristics:
• Focuses only on a food safety management system. (The quality management system would be addressed by ISO
9001.)
• Utilizable by all organizations in the food chain.
• Combines recognized food safety elements including: HACCP principles as defined by Codex, prerequisite
programs, systems approach, communications along the food chain, and prerequisite programs.
• Harmonizes national food safety standards.
• Provides an auditable standard that could be used as part of third party certification.
• Addresses customer and regulator food safety concerns and requirements.
• Allows food safety control to be achieved through either the HACCP plan or operational PRPs.
• Ensures that the process to control food safety is validated, verified, implemented, monitored, and managed.
ISO 22000 complies with ISO Guide 72 – Guidelines for the justification and development of management system standards.
This guideline states that all management system standards should contain the following elements:
• Policy.
• Planning.
• Implementation and operations.
• Performance assessment.
• Improvement.
• Management review.
ISO 22000 has been developed with a structure similar to ISO 9001. Thus, ISO 22000 can be utilized with other
management system standards. In addition, the working group ensured that the standard was in alignment with the Codex
definition of HACCP (Codex, 1999). Table 4 presents the current structure for ISO FDIS 22000.

Table 4
Structure of ISO FDIS 22000:200x Food safety management system – Requirements for any
organization in the food chain
4 Food safety management system
4.1 General requirements
4.1 Documentation requirements
5 Management responsibility
5.1 Management commitment
5.2 Food safety policy
5.3 Food safety management system planning
5.4 Responsibility and authority
5.5 Food safety team leader
5.6 Communication
5.7 Emergency preparedness and response
5.8 Management review
6 Resource management
6.1 Provision of resources
6.2 Human resources
6.3 Infrastructure
6.4 Work environment
7 Planning and realization of safe products
7.1 General
7.2 Prerequisite programmes (PRPs)
7.3 Preliminary steps to enable hazard analysis
7.4 Hazard analysis
7.5 Establishing the operational prerequisite programmes (PRPs)
7.6 Establishing the HACCP plan
7.7 Updating of preliminary information and documents specifying the
prerequisite programmes and the HACCP plan
7.8 Verification planning
7.9 Traceability system
7.10 Control of nonconformity
8 Validation, verification and improvement of the food safety management system
8.1 General
8.2 Validation of control measure combinations
8.3 Control of monitoring and measuring
8.4 Food safety management system verification
8.5 Improvement
Source: ISO, 2005
One of the most frequent questions that is raised with the development of a new management system standard is “What
documentation will be required?” ISO 22000 will require a number of documents and procedures that go beyond the
documentation requirements required by Codex. Documents and records that will be required include the following:
• Food safety policy and objectives.
• Documents to ensure effective development, implementation and updating of the food safety management system.
• Document control procedure.
• Record control procedure.
• Documents to manage the prerequisite programs.
• Documents defining raw materials, ingredient and product contact material, end product characteristics for hazard
analysis.
• HACCP plan.
• Document showing the rationale for establishing control limits.
• Procedure to handle potentially unsafe products and review of implemented corrections.
• Corrective action procedure.
• Recall procedure.
• Internal audit procedure.
• Emergency response procedure including recall procedure.
• Monitoring procedures to ensure operational PRPs are in-place.
• Monitoring procedures for CCPs.
• Procedure to update the food safety management system.
• Procedure to update communications.

Future work of Working Group 8 to ISO Technical Committee 34

The ISO 22000 working group is developing a set of technical specifications that will include a guidance standard on the
interpretation of ISO 22000 and a standard that provides guidance for certification to ISO 22000. It is expected that this set
of standards will be will be published in the last quarter of 2005.

References
Codex, 1999, Food hygiene, Basic Text, Codex Alimentarius Commission, Geneva, Switzerland

ISO, 2005, ISO FDIS 22000 Food safety management systems – Requirements for any organization in the food chain,
International Organization for Standardization, Geneva, Switzerland

NACMCF, 1989, Hazard analysis and critical control point system, National Advisory Committee on Microbiological
Criteria for Food, Washington, DC

NACMCF, 1992, Hazard analysis and critical control point system, International J. Food Microbiology 16: 1-23

NACMCF, 1997, Hazard analysis and critical control point principles and application guidelines, J Food Protection 16:
1246-1259.

NAS, 1987, An evaluation of the role of microbiological criteria for foods and food ingredients, National Academy Press,
Washington, DC

Stevenson, K.E., and D. T. Bernard, 1999, HACCP: A systematic approach to food safety, Second Edition, Food Processors
Institute, Washington, DC.