1. FSMS Principles

Food safety is concerned with the presence of food safety hazards at the time of consumption by the consumer. These hazards can emerge at any stage of the food chain, making adequate control across the entire food chain essential. Ensuring food safety requires the combined efforts of all parties involved in the food chain. This document outlines the requirements for a Food Safety Management System (FSMS) that incorporates the following key elements, widely recognized across the industry:

• Interactive communication
• System management
• Prerequisite programs
• Hazard Analysis and Critical Control Point (HACCP) principles
  
  

Additionally, this document is based on the principles shared by ISO management system standards, which are:

• Customer focus
• Leadership
• People engagement
• Process approach
• Continuous improvement
• Evidence-based decision-making
• Relationship management
  
  

2. Process Approach

2.1 General

This document adopts a process-based approach for developing, implementing, and enhancing the effectiveness of a FSMS, aimed at producing safe products and services while complying with relevant requirements. Understanding and managing interconnected processes as part of a system contributes to the organization’s overall efficiency and effectiveness in achieving its intended results. The process approach involves the systematic definition and management of processes and their interactions to achieve intended outcomes aligned with the food safety policy and the organization’s strategic goals. Process and system management can be carried out using the PDCA (Plan-Do-Check-Act) cycle, with a primary focus on risk-based thinking to capitalize on opportunities and prevent undesirable outcomes.

Recognizing the organization’s role and position within the food chain is crucial for ensuring effective communication throughout the food chain.

2.2 Plan-Do-Check-Act Cycle

The PDCA cycle can be described as follows:

• Plan: Establish the objectives for the system and its processes, allocate necessary resources, and identify and address risks and opportunities.
• Do: Implement the plan.
• Check: Monitor and, where applicable, measure processes and resulting products/services, analyze and evaluate data from monitoring, measurement, and verification, and report the results.
• Act: Take corrective actions to improve performance, as needed.
  
  

3. Risk-Based Thinking

3.1 General

Risk-based thinking is crucial for achieving an effective FSMS. In this document, risk-based thinking is addressed on two levels: organizational (see 0.3.3.2) and operational (see 0.3.3.3), consistent with the process approach outlined in 0.3.2.

3.2 Organizational Risk Management

Risk is defined as the effect of uncertainty, which can result in both positive and negative effects. Within organizational risk management, positive deviations may present opportunities, although not all positive outcomes from risk are considered opportunities.

To comply with this document, an organization must plan and implement actions to manage organizational risks (Clause 6). Addressing these risks forms the foundation for enhancing the effectiveness of the FSMS, improving results, and preventing adverse effects.

3.3 Hazard Analysis — Operational Processes

Risk-based thinking, grounded in the HACCP principles, is implicit in this document at the operational level.

Hazards must be reduced to acceptable levels to ensure food safety at the time of consumption (Clause 8). Decisions made in the application of HACCP principles should be based on scientific evidence, free of bias, and thoroughly documented, including key assumptions made during the decision-making process.

4. Relationship with Other Management System Standards

This document has been developed within the ISO High-Level Structure (HLS), which aims to enhance alignment among ISO management system standards. The structure enables organizations to integrate the process approach, PDCA cycle, and risk-based thinking within their FSMS, aligning or integrating it with the requirements of other management systems and related standards.

This document serves as the core principle and framework for FSMSs, specifying the FSMS requirements for organizations in the food chain. Additional guidance related to food safety, as well as specifications or requirements specific to certain food sectors, can be used alongside this framework.

Furthermore, ISO has developed a series of associated documents, which include:

• Prerequisite programs (ISO/TS 22002 series) for specific food sectors
• Requirements for auditing and certification bodies
• Traceability
  
  

ISO also offers guidance documents for organizations on how to implement this document and related standards. More information is available on the ISO website.