Management system guidance
4.0 Context of the Organization
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4.3 Determining the scope of the quality management system
Defining the scope of your quality management system (QMS) is a key step when developing any management system. The scope should concisely describe the types of activities, products and services covered by the QMS and the sites where those activities are carried out. The ISO 9001:2026 requirements for scope are essentially unchanged from 2015.
The scope of registration and certification will need to reflect precisely and clearly the activities covered by your organization's management system. The scope must state the types of products and services covered and must include a justification for any requirement of ISO 9001 that your organization determines is not applicable. ISO 9001 does not use the term 'exclusions'; instead a requirement can be determined as not applicable, with justification. No single business-related activity should exist outside of the scope. You should discuss the scope of registration very early in your contact with the registrar, prior to or during the selection process.
From a review of the nature of your business's operations, products and services, the scope of the management system should be apparent by the extent of the processes and controls that your organization has already established. If you need a procedure to help determine and document your organization's scope, click here.
Look for confirmation that your organization has determined the boundaries and applicability of the management system to establish its scope with reference to any external and internal issues (Clause 4.1), the requirements of relevant interested parties (Clause 4.2), and the nature of your organization's products and services. Consideration of the boundaries and applicability of the management system can include:
- The range of products and services;
- Different sites and activities;
- External provision of processes, products and services;
- Common support provided by centralised functions;
- Processes, procedures, instructions, or site-specific requirements.
The scope of your management system may include the whole of the organization, specific and identified functions within the organization, specific sections of the organization, or one or more functions shared across a group of organizations. Auditors will challenge your organization if any activities, products or services that affect product and service conformity or customer satisfaction are omitted from the scope. Your organization’s scope determinations should be reasonable and consistently applied.
Remember that the boundaries of the QMS can be influenced by specific customer requirements. If your organization is part of a larger entity, define the organizational boundaries of the system clearly, as these can affect how the QMS operates. Individual sites can have their own specific scopes where this is appropriate.
Your organization must apply every requirement of ISO 9001 that is applicable within its scope. A requirement can only be determined as not applicable if this does not affect your organization’s ability or responsibility to ensure that its products and services conform and to enhance customer satisfaction; otherwise conformity to ISO 9001 cannot be claimed.
The management system scope must be available as documented information (see Clause 7.5), often within the management system manual. The scope statement is normally shown on the certificate, for most registrars, 15 words or less, is generally sufficient. Here are two examples shown below:
'provision of marketing, sales, support, development and implementation of software solutions, located at...'
'manufacture of precision machined components for aerospace and industrial customers, including the delivery of these activities to requirements, located at...'
You may not design your products because your customers supply product specifications and drawings. In that case you may determine that the design and development requirements (Clause 8.3) are not applicable, provided that you state the justification in your scope.
More information on PDCA
Planning
Context
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