What is the 1st section of the ISO 9001 standard?

Point 1 of the ISO 9001:2015 standard requires organizations to determine the scope of their QMS

ISO 9001 : Point 1

Point 1 of the ISO 9001:2015 standard requires organizations to determine the scope of their QMS. This means defining the boundaries of the system, including which processes, products, and services are included, and which are not. The scope of the QMS should be based on the organization’s goals, objectives, and the needs and expectations of its customers.

To achieve point 1 of the ISO 9001:2015 standard, organizations must take the following steps:

1. Identify the Processes:

The first step in defining the scope of the QMS is to identify the processes that are relevant to achieving the organization’s goals and objectives. This includes all processes that directly or indirectly impact the quality of the organization’s products or services.

2. Define the Boundaries:

Once the relevant processes have been identified, the next step is to define the boundaries of the QMS. This includes identifying the products or services that are within the scope of the system, as well as any exclusions. Exclusions should be documented and justified.

3. Document the Scope:

Organizations must document the scope of their QMS. This includes describing the processes, products, and services that are within the scope of the system, as well as any exclusions. The documented scope should be communicated to all relevant parties, including employees, customers, and suppliers.

4. Review and Revise:

The scope of the QMS should be reviewed and revised as needed. This may be necessary when there are changes to the organization’s goals and objectives, or when there are changes to the products or services that are provided.

5. Monitor and Control:

Organizations must monitor and control the processes that are within the scope of their QMS. This includes ensuring that the processes are carried out consistently and effectively, and that the products or services that are provided meet customer requirements.

In conclusion, achieving point 1 of the ISO 9001:2015 standard requires organizations to define the scope of their QMS. This means identifying the relevant processes, defining the boundaries of the system, documenting the scope, reviewing and revising as required, and monitoring and controlling the processes. By doing so, organizations can ensure that their QMS is focused on achieving their goals and objectives, and also providing consistent quality products and services to their customers.

ISO 9001

A global quality management standard, one of the most widely adopted management standards in the world.

ISO Certification Body