Scope Statement

ISO 9001:2015, clause 4, Context of the Organization, includes requirements for the organization to determine its:

  • external and internal issues (4.1)
  • relevant interested parties (4.2)
  • quality management system scope (4.3)
  • processes and their interaction (4.4)

This article is on clause 4.3 and determining the Scope of a quality management system. See the Interested Parties article in this March 2018 newsletter. See the External Issues and Internal Issues articles in our February 2018 newsletter.

4.3 Determining the scope of the quality management system
 
Requirements

The organization must determine the boundaries and applicability of the quality management system (QMS) to establish its scope.

When determining this scope, the organization must consider:

a) the external and internal issues referred to in 4.1;
b) the requirements of relevant interested parties referred to in 4.2;
c) the products and services of the organization.

The organization must apply all the requirements of ISO 9001 if they are applicable within the determined scope of its QMS.

The scope of the organization’s QMS must be available and maintained as documented information. The scope must state the types of products and services covered and provide justification for any ISO 9001 requirement that the organization determines is not applicable to its QMS scope.

Conformity to ISO 9001 may only be claimed if the requirements determined as not being applicable do not affect the organization’s ability or responsibility to ensure the conformity of its products and services and the enhancement of customer satisfaction.

Definition

ISO 9000:2015, Fundamentals and Vocabulary, does not specifically define QMS Scope. However, it does say that the scope of a management system can include the whole of the organization, specific and identified functions of the organization, specific and identified sections of the organization, or one or more functions across a group of organizations.

ISO 9000 defines a “quality management system” as the part of a management system with regard to quality. A “management system” is defined as a set of interrelated or interacting elements of an organization to establish policies and objectives, and processes to achieve those objectives.

The management system elements establish the organization’s structure, roles and responsibilities, planning, operation, policies, practices, rules, beliefs, objectives, and processes to achieve those objectives.

References

ISO 9001:2015, Annex A5, Applicability, states that an organization can review the applicability of requirements due to the size or complexity of the organization, the management model it adopts, the range of the organization’s activities, and the nature of the risks and opportunities it encounters.

The requirements for applicability are addressed in clause 4.3 (see Requirements above), which defines conditions under which an organization can decide that a requirement cannot be applied to any of the processes within its QMS scope. The organization can only decide that a requirement is not applicable if its decision will not result in failure to achieve conformity of products and services.

Guidance

The intent of determining the system scope is to define its boundaries in a way that helps the organization meet requirements and achieve the intended results of the system.
The scope should be established based on external and internal issues, relevant requirements of relevant interested parties, and the provided products and services.

When determining the scope, consider such issues as infrastructure, remote sites and activities, policies and strategies, and centralized or externally provided functions, activities, processes, products, and services.

All requirements of ISO 9001 are considered applicable within the scope unless they do not affect the organization’s ability to provide a product, or deliver a service, that meets requirements or enhances customer satisfaction.

To determine the application of requirements in ISO 9001, the organization should consider each individual requirement, and not just decide that a whole clause is not applicable. Some of the requirements may be applicable in a clause, or all the requirements within a clause may, or may not, be applicable.

The scope statement should include details of the products and services covered. It should also include justification for any requirements that are determined as not applicable. This documented information can be maintained in whatever method the organization determines to meet its needs, such as a quality manual, standalone document, or a website.

For further guidance, see our December 2013 article on Certification Scope.