ISO 9001- Clause 1 Scope

The first clause of ISO 9001:2015, ‘Scope’, defines the extent to which the requirements of the standard apply to the organization. The standard applies to all processes that contribute to the quality of the product or service. This means that the standard can be applied to all aspects of the business, from design and development to production and delivery.

The clause also states that the requirements of the standard must be followed by all organizations that claim compliance with ISO 9001.

To determine the scope of the quality management system, the organization must first identify the products and services that it provides. The scope must then be documented in the form of a quality management system manual or other equivalent documentation.

This standard specifies the requirements for a quality management system when an organization:

• Needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and
• Aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.

The Scope of an ISO 9001 Quality Management System (QMS) defines the extent to which an organization's QMS applies. It's used to establish the boundary of an organization's QMS. Organizations can use the Scope to state which products, services, locations, and/or processes are included or excluded from the QMS.

The first step in writing the Scope is to understand the organization's QMS. What processes are in place? What products or services does the organization offer? What geographical areas does the organization operate in? Once the organization understands its QMS, it can start writing the Scope.

There are two ways to write the Scope:

Inclusionary: Lists all products, services, locations, and processes that are included in the QMS.

Exclusionary: Lists all products, services, locations, and processes that are not included in the QMS.

The Scope should be clear and concise. It should be easy to understand and should not contain any ambiguities.

How to define the scope of the QMS according to ISO 9001 ?

The Quality Management System (QMS) is a collection of policies, processes and procedures that an organization uses to plan, control and improve its performance. The QMS is also used to ensure that the products and services delivered to customers meet their needs and expectations.

In order to be effective, the QMS must be tailored to the specific needs of the organization. This means that the scope of the QMS must be defined. The scope of the QMS is the part of the organization's activities that is covered by the QMS.

The scope of the QMS can be defined in terms of the:

• Products and services covered by the QMS.
• Processes included in the QMS.
• Sites where the QMS is implemented.
• Organizational units covered by the QMS.

When defining the scope of the QMS, organizations should consider the needs of their customers and other stakeholders. They should also consider the applicable statutory and regulatory requirements.