AS9100 Clause 4.4 – Quality Management System and Its Processes

AS9100D is a quality management system standard tailored to the aerospace industry, incorporating ISO 9001 requirements along with additional aerospace-specific requirements. Clause 4.4 of AS9100D focuses on the establishment, implementation, maintenance, and continuous improvement of the Quality Management System (QMS) and its processes.

To comply with Clause 4.4, an organization should take the following steps:

1. Establish the QMS: Define the processes needed for the QMS, considering the organization’s context (Clause 4.1), the needs and expectations of interested parties (Clause 4.2), and the determined scope of the QMS (Clause 4.3).
2. Implement the QMS: Apply the defined processes throughout the organization, ensuring that they are documented, controlled, and executed effectively.
3. Determine process interactions: Identify the interactions between the various QMS processes, understanding how they influence and depend on one another. This helps to ensure that the overall system functions effectively and efficiently.
4. Determine process inputs and outputs: For each process, define the inputs and expected outputs, as well as any necessary resources, including personnel, equipment, and infrastructure.
5. Establish process criteria: Define the criteria and methods required for the effective operation and control of each process. This may include performance indicators, documentation requirements, and any relevant legal or regulatory obligations.
6. Assign process responsibilities: Allocate responsibilities and authorities for each process to ensure effective management and control. This includes defining who is responsible for process performance, monitoring, and improvement.
7. Evaluate process risks and opportunities: Assess the risks and opportunities associated with each process, taking appropriate action to address them. This may involve implementing risk mitigation strategies or exploiting opportunities for improvement.
8. Monitor and control processes: Establish a system for monitoring, measuring, and analyzing process performance. This may include process audits, performance metrics, or other evaluation methods to ensure that processes are achieving their intended outputs and meeting their specified criteria.
9. Continual improvement: Use the results of process monitoring and analysis to drive continuous improvement of the QMS. This may involve implementing corrective actions, adjusting process criteria or methods, or identifying opportunities for process innovation.

By following these steps, an organization can develop a robust and effective QMS that aligns with the specific requirements of the aerospace industry, while also meeting the needs and expectations of its interested parties. This helps to ensure ongoing customer satisfaction, regulatory compliance, and continuous improvement of the organization’s products, services, and processes.