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Clause 4.0 Context of the organisation

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Focuses on defining the scope of the 1quality Management System (QMS). This clause helps businesses identify the areas that the QMS will cover, which can include specific products, services, or processes.

4.1 Understanding the organisation and its context

This involves analysing the internal factors such as; structure, culture, and resources, as well as the external factors that can affect their operations and QMS

 

By understanding the context of the organisation, businesses can determine the scope of the QMS and identify the interested parties that need to be considered when defining the QMS.

4.2 Understanding the needs and expectations of interested parties

Interested parties are individuals or groups that have an interest in the organisation’s activities or products and can affect or be affected by the organisation’s QMS. These parties can include customers, suppliers, employees, shareholders, regulators, and other stakeholders.

 

This clause requires businesses to identify the interested parties that are relevant to their QMS and understand their needs and expectations.

 

This involves gathering information about the interested parties’ requirements, such as their expectations for product quality, delivery times, and customer service.

 

By understanding the needs and expectations of interested parties, businesses can develop a QMS that meets the needs of all stakeholders and improve customer satisfaction.

4.3 Determining the scope of the quality management system

The scope of the QMS defines the boundaries of the QMS, including the products, services, and processes that it covers.

 

The scope of the QMS should be based on the organisation’s internal and external context, the needs and expectations of interested parties, and the organisation’s strategic objectives. By defining the scope of the QMS, businesses can ensure that their QMS covers all relevant areas and meets the needs of all stakeholders.

 

To determine the scope of their QMS, organisations would need to identify the products, services, and processes that the QMS will cover and ensure that they are consistent with the organisation’s internal and external context and the needs and expectations of interested parties.

 

By defining the scope of the QMS, businesses can ensure that their QMS covers all relevant areas and meets the needs of all stakeholders.

4.4 Quality management system and its processes

The organisation must create, use, and improve a quality management system that meets the requirements of this standard. To do this, the organisation must:

 

  • Identify the necessary processes and how they apply across the organisation
  • Determine what’s needed to make each process work well and how to measure success
  • Make sure there are enough resources to carry out the processes
  • Assign responsibilities and authority for each process
  • Address risks and opportunities
  • Evaluate and improve the processes and the quality management system.

 

The organisation must keep records as needed to support its processes and to ensure they are carried out as planned. This includes:

 

  • Maintaining documents that support the operation of processes
  • Keeping records that provide confidence that processes are being carried out according to plan.