AS9100 Clause 4.3 – Determining the Scope Of the Quality Management System

AS9100D is an aerospace-specific quality management system standard that incorporates the ISO 9001 requirements along with additional requirements tailored to the aerospace industry. Clause 4.3 of AS9100D addresses determining the scope of the quality management system (QMS).

The scope of the QMS is a critical element because it outlines the boundaries and applicability of the system within the organization. It helps ensure that the QMS is tailored to the organization’s specific context, products, and services, as well as the needs and expectations of relevant interested parties.

To determine the scope of the QMS, an organization should take the following steps:

1. Consider the context: Review the organization’s context, as established in Clause 4.1, taking into account internal and external factors, such as organizational culture, strategic direction, market conditions, and applicable legal and regulatory requirements.
2. Identify interested parties’ requirements: Evaluate the needs and expectations of relevant interested parties, as identified in Clause 4.2, to ensure that the QMS addresses their requirements effectively.
3. Evaluate products and services: Analyze the organization’s product and service offerings, including the range of aerospace products or services, their complexity, and the applicable regulatory requirements.
4. Determine boundaries: Establish the boundaries of the QMS, considering the organization’s structure, physical locations, and the extent of control or influence it has over external providers or outsourced processes.
5. Document the scope: Create a written document that clearly defines the scope of the QMS, including its applicability to the organization’s processes, products, and services. The document should also mention any exclusions, which are specific requirements that do not apply to the organization’s QMS due to the nature of its operations. Note that any exclusions must not affect the organization’s ability to provide conforming products and services.
6. Communicate the scope: Ensure that the scope of the QMS is communicated and understood throughout the organization, and make it available to relevant interested parties when required.

By establishing a well-defined scope for the QMS, an organization can ensure that its quality management system is relevant, effective, and aligned with its context and the needs of its stakeholders. This allows the organization to maintain a robust QMS that enhances customer satisfaction, improves operational efficiency, and meets the specific requirements of the aerospace industry.