4.1 Understanding the organization and its context
The organization shall determine external and internal issues that are relevant to its purpose and that affect its ability to achieve the intended result(s) of its FSMS.
The organization shall identify, review and update information related to these external and internal issues.
NOTE 1 Issues can include positive and negative factors or conditions for consideration.
NOTE 2 Understanding the context can be facilitated by considering external and internal issues, including, but not limited to, legal, technological, competitive, market, cultural, social and economic environments, cybersecurity and food fraud, food defence and intentional contamination, knowledge and performance of the organization, whether international, national, regional or local.
4.2 Understanding the needs and expectations of interested parties
To ensure that the organization has the ability to consistently provide products and services that meet applicable statutory, regulatory and customer requirements with regard to food safety, the organization shall determine:
a）the interested parties that are relevant to the FSMS;
b）the relevant requirements of the interested parties of the FSMS.
The organization shall identify, review and update information related to the interested parties and their requirements.
4.3 Determining the scope of the food safety management system
The organization shall determine the boundaries and applicability of the FSMS to establish its scope. The scope shall specify the products and services, processes and production site(s) that are included in the FSMS. The scope shall include the activities, processes, products or services that can have an influence on the food safety of its end products.
When determining this scope, the organization shall consider:
a）the external and internal issues referred to in 4.1;
b）the requirements referred to in 4.2.
The scope shall be available and maintained as documented information.
4.4 Food safety management system
The organization shall establish, implement, maintain, update and continually improve a FSMS, including the processes needed and their interactions, in accordance with the requirements of this document.