ISO 9001 -Clause 4.3 Determining the scope of the quality management system

Organizations that wish to implement a quality management system (QMS) or improve an existing one can use ISO 9001. This standard provides guidance on how to set up a quality management system, as well as how to maturity, implement, and improve it.

An important part of setting up a quality management system is defining its scope. Clause 4.3 of ISO 9001 explains how to do this and provides guidance on what to consider.

The following points should be considered when determining the scope of the quality management system:

• The products, services, and processes that the quality management system covers.
• The geographical locations where the quality management system is applied.
• The organizational units that are covered by the quality management system.
• Any external factors that may affect the operation of the quality management system.

The scope of the quality management system (QMS) is the extent to which the QMS applies to an organization. It should be determined before the QMS is implemented and should be reviewed and updated as necessary.

The purpose of this clause is to ensure that the QMS is appropriate for the organization and that its scope is known and well-defined.

There are four main elements to be considered when determining the scope of the QMS:

• The size, type, and complexity of the organization
• The products and services offered by the organization.
• The processes used by the organization.
• The geographical locations where the organization operates.

Each of these elements should be considered when determining the scope of the QMS. The decision on whether to include a particular element in the scope of the QMS should be made based on its relevance to the organization and its ability to meet customer requirements.

When establishing the quality management system (QMS), the organization should determine the scope of the QMS. The scope of the QMS should include all relevant elements of the organization's activities, products, services, and contracts that can affect conformity to customer, statutory, and regulatory requirements.

The organization's QMS should also be designed to enhance customer satisfaction by continually improving its effectiveness of the QMS.

In determining the QMS scope, the organization should consider, as a minimum:

• The quality management system requirements specified in ISO 9001
• The organization's products, services, contracts, and any relevant external factors
• The sequence and interaction of processes within the QMS
• The interaction between the QMS and other management systems of the organization
• The need for quality management system interfaces with external organizations.