Apples to Oranges?
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Clearing up the differences between ISO 22000 and ISO 9001 standards: Consumers around the world demand safe food. Through the years, retailers and food companies continually have pushed their suppliers to have food safety systems in place and improve on them.
This drive started with suppliers being required to have third-party good manufacturing practices (GMP) audits.
From there, audit requirements progressed to requiring suppliers to implement the hazard analysis and critical control points (HACCP) system—whether or not HACCP was required by government regulation. This evolution has further progressed to retailers and food service organizations requiring their suppliers to have a food safety management system (FSMS) certified to a Global Food Safety Initiative (GFSI) recognized audit scheme (see the sidebar, "Global Food Safety").
In 2001, Danish Standards recognized the proliferation of food safety standards. These standards included private standards such as the Safe Quality Foods standard, British Retail Consortium standards and International Featured Standards, as well national standards developed by countries such as Denmark, Germany, Ireland, the Netherlands and the United States. Danish Standards initiated a project to harmonize the food safety management standards. This project led to the publication of ISO 22000:2005—Food safety management systems—Requirements for any organization in the food chain.
Without a doubt, food safety has grown in complexity over the years—and remains at the forefront of activity today because of recently adopted food safety legislation in the United States and other efforts to address seemingly endless food recalls.
So much of the discussion circles back to quality and food safety standards and, more specifically, ISO 22000 and ISO 9001. What exactly is ISO 22000 standard? How is it different from ISO 9001? Clearing up misconceptions and spelling out the differences between the two standards can help organizations plan and implement the right system for them.
Standard writers took specific actions in developing ISO 22000. Its scope would address only food safety. This set ISO 22000 apart from ISO 9001, which covers the quality management system requirements. Thus, if a food organization wants to develop a management system that covers both food safety and quality, the organization should develop a management system that integrates both standards.
As a result of this approach, ISO 22000 was developed to be compatible with ISO 9001. The standard writers never intended for ISO 22000 to replace ISO 9001.
Table 1 provides a clause-by-clause comparison of ISO 9001 and ISO 22000. There are a number of similarities between the two:
- The structure of ISO 90012 and ISO 22000 are similar.
- Many of the clauses in ISO 22000 have identical wording when compared to ISO 9001.
- There are clauses in ISO 22000 that are equivalent to ISO 9001. In these clauses, the slight difference in wording was to clarify the requirements for organizations in the food chain.
In addition, both standards provide guidance on how the clauses link to form a management system. ISO 9001 defines more than 50 formal links, and ISO 22000 defines more than 90 formal links.
To make things clear, however, the major difference between ISO 22000 and ISO 9001 is that ISO 22000 is a risk mitigation standard. The primary objective of ISO 22000 is to reduce food safety hazards to an acceptable level or prevent food safety hazards. ISO 22000 uses HACCP as its risk management approach. HACCP provides the preventive approach to food safety. Thus, ISO 22000 does not have a specific preventive action clause.
The standard does not directly address the application of HACCP to product and process design. One of the basic assumptions of HACCP is the following: HACCP plans are specific to the manufacturing process, the food product and customers. Therefore, the HACCP plan must be designed to meet these conditions. In addition, if there are changes in any of the components, there must be a reassessment and possible revision of the plan.
A HACCP plan can be developed after the formal process and design phase. In reality, most food-processing companies incorporate food safety during the entire food product design process.
ISO 22000 has a requirement for extensive internal communications with regard to issues that involve food safety. It is the responsibility of the food safety team to ensure that the FSMS remains effective. The standard requires communication to the team on changes to the FSMS, including those to products, new products, processes and customers.
In addition, ISO 22000 standard writers define the requirements for the auditors, certification bodies and accreditation bodies. These requirements are presented in ISO/TS 22003:2007. ISO 22003 focuses on two sets of competencies: management system audits and food safety. ISO 22003 uses ISO 19011 to define management system audit competencies.
ISO 22003 specifically defines the competencies in regard to food safety, however. Food safety competencies include knowledge of HACCP, prerequisite programs (PRPs), food safety hazards, implementation and management of critical control points (CCP), food safety laws and regulations, general microbiology, general chemistry and specific technical knowledge needed to audit various parts of the food chain.
If the audit is being conducted in the food manufacturing sector, for example, additional competencies include demonstrated knowledge in food microbiology, food processing fundamentals and food chemistry, including food analysis.
Even though ISO 22000 does not define specific food safety competencies for organizations implementing ISO 22000, the food safety competencies defined in ISO 22003 can provide useful guidance regarding the competencies needed for the food safety team, internal auditors and external consultants.
A critical part of developing an FSMS that meets the requirements of ISO 22000 is developing PRPs appropriate for the size and type of organization in the food chain. Currently, the International Organization for Standardization (ISO) has published ISO 22002-1:2009—Prerequisite programs on food safety—Part 1: Food manufacturing. ISO is developing additional PRP standards for the following sectors in the food chain: farming, transport and storage, catering, packaging and feed production.