Determining the Scope of the Quality Management System

The most recent revisions of the ISO 9001/AS9100/AS9120 standards bring more emphasis on the importance of determining the scope of the QMS. This is because the clauses that lead up to 4.3 yield the information an organization needs to identify the scope. Based on the knowledge obtained from understanding the context of the organization and its interested parties, the organization is expected to make an informed decision about the scope of the QMS.

The scope can be defined as the boundaries that surround the QMS processes. These boundaries are reflective of which standard requirements apply to the organization and what parts of the  processes will be included in the QMS. Additionally, the scope specifies any exclusions from the standard requirements with justification. Moreover, this scope also appears on the certificate that is issued by the Certification Body if the organization is certified to any of the quality management system standards.

Here is an example of a scope statement as it may appear in the documentation:

The scope of the quality management system for ‘XYZ’ is ‘ manufacture and assembly of machined parts for commercial, semiconductor, laser, medical, defense, and aerospace industries’. The design and development requirements of the ISO 9001:2015 standard have been excluded because ‘XYZ’ does not perform any design activities as all orders are processed in accordance with customer drawings or technical data.

The standard requires the organization to consider three elements when determining the QMS scope. These three elements are the context of the organization (4.1), the interested parties (4.2), and the organization’s products and services (4.3). Examining these three elements are imperative when considering the scope and should provide the organization with the insight to confidently construct the scope statement.