ISO 22000:2005 was designed to cover all the processes along the food chain that deal directly or indirectly with the end product being consumed. In addition, it specifies the requirements for a FSMS by incorporating all the elements of Good Manufacturing Practices (GMPs), PRPs, and HACCP systems together with a comprehensive management system. The ISO 22000:2005 standard is made up of eight core elements.
Scope. The scope focuses on control measures to be implemented to ensure that processes are in place to meet customer and regulatory food safety requirements.
Normative reference. This refers to materials that can be used to determine definitions associated with terms and vocabulary used in the ISO standard document.
Terms and definitions. The ISO 22000:2005 terms and definitions section refers to the use of the 82 definitions found in ISO 9001:2008 and lists definitions that are specific to this application.
Food safety management system. In this section, the emphasis is on establishing, documenting, implementing, and maintaining an effective system. This includes the procedures and records that are needed to ensure effective development, implementing, and updating of the food safety management system. This clause also covers the requirement for the organization to take ultimate responsibility for the competent performance of any outsourced activities that impact food safety control.
FSSC 22000 certification enables manufacturers to focus their food safety efforts on scientific and technical advances, and their audit resources on improvement rather than compliance.
Management responsibility. This section outlines the commitment of top management to the implementation and maintenance of the food safety management system. The key elements include assigning a food safety system manager and team; setting clear policies, goals, emergency contingency plans, and responsibilities; and establishing effective communication mechanisms within the organization and with suppliers or customers.
Resource management. An effectively implemented food safety management system requires that top management provide adequate resources, budgets, and personnel to effectively run the system. Scheduled, documented training and evaluations of key personnel and provision of a safe work environment and infrastructure are crucial to the continuity of the system.
Planning and realization of safe products. This section incorporates the elements of GMPs and HACCP, including any regulatory requirements applicable to the organization and processes. Adequate PRPs (e.g. training, sanitation, maintenance, traceability, supplier review, control of nonconforming product, and recall procedures) are required to provide a foundation for the production of safe food.
Validation, verification, and improvement of the food safety management system. To maintain and demonstrate the effectiveness of the FSMS, the organization must validate that all assumptions used within the system are scientifically sound. In addition, the organization must plan, conduct and document regular verification of all components of the system to evaluate whether or not the system is operating as designed, or if modifications are needed. The verification must also form part of a continual improvement process whereby the organization reviews verification.
Prerequisite Programs
Among the specific food safety requirements that ISO 22000:2005 was established for is the need to create, implement, and maintain PRPs to assist in eliminating food safety hazards in the manufacturing process:
- ISO/TS 22002-1:2009 supplements the prerequisite programs for food and ingredient manufacturing;
- PAS223:2011 supplements the prerequisite programs for food packaging manufacturing; and
- PAS222:2011 supplements the prerequisite programs for animal food and feed manufacturing.
The PRP requirements apply to all organizations, regardless of size or complexity.
Transitioning to FSSC 22000
An organization with any of the existing food safety programs discussed here can build on their existing platform and seamlessly transition to FSSC 22000 certification. The FSSC 22000 scheme, through its inclusion of ISO 22000:2005 and prerequisite programs (ISO/TS 22002-1:2009 standards or PAS223 or PAS222 based on its sector), covers key requirements contained in major existing food safety standards or programs, including GMP/PRPs, HACCP, SQF, BRC, IFS, and GlobalGAP.
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