A Deeper Look into AS9100D
Quality Management Systems for Defense and Aerospace
A deeper look into AS9100D “Quality Management Systems – Requirements for Aviation, Space, and Defense Organizations” reveals the ability of this powerful QMS to continually improve products and processes within an organization.
AS9100D is a Quality Management System (QMS) based on the structure and content of ISO 9001:2015 with the addition of requirements specific to the aerospace, and defense industries. It also includes provisions for customer and regulatory requirements. The standard is applicable to businesses of all sizes who need to consistently provide products and services to specified requirements. Additionally, it provides processes for systematic improvement of the management system and its ability to ensure customer satisfaction.
AS9100D addresses concerns specific to aviation, defense, and space industries. Among these concerns are the following:
It is highly important that specified parts are used in the manufacture of products, especially in cases where those products are safety and or mission critical. In past decades counterfeit parts have posed a huge problem for industry, particularly with regard to electronic components. Counterfeit parts can cause failure of products to operate as required or even cause terminal failures. Preventing the incursion of these parts into manufacturing cycles requires that specific actions be undertaken.
These actions include: training, establishment of a parts monitoring program, use of authorized and approved sources, traceability requirements, verification methodologies, monitoring of counterfeit part reports, and reporting and quarantining of detected or suspected counterfeits.
AS9100D establishes requirements for identification of items that are critical to the product’s use, such as function, safety, and service life. These items have special requirements to address their risks to product integrity.
In addition to critical items, attributes or features of a product can jeopardize function, safety, form, fit, or manufacturability of a product. These characteristics must also be identified so that controls can be implemented to address the risks they pose and ensure that a consistent product is manufactured.
Given the nature of the defense and aerospace industries, it can come to little surprise that product safety is a prime concern. The standard places requirements that products not pose unacceptable risk of harm to property or persons throughout their intended life cycle.
When requirements are set forth by the organization or its customers that are at the limit of the industry’s capability or the organization’s technical or process capabilities. When identified, actions should be taken to ensure that risks have been adequately managed.
Areas of Special Focus
A deeper look into AS9100D reveals that the standard includes specific requirements, over and above those defined in ISO 9001:2015 to address the special concerns of the aerospace and defense industries.
AS9100 rev D places enhanced requirement for personnel’s awareness of the quality management system and the importance of their participation in the program. It also stresses knowledge of relevant product safety concerns and the necessity of engaging in ethical behavior with regards to QMS goals and objectives.
Significant additions to the standard were created to address Operational Planning and Control. This includes enhanced criteria for the determination of requirements for products and services to address issues such as reliability, producibility, embedded software, and recycling.
It addresses the use of statistical methodologies for design and development verification and process control. It also addresses transfer of work from the organization to an outside provider or vice versa. Most importantly it enhances processes for managing operational risks.
Numerous requirements have also been made with regard to product development verification processes to ensure that: Test plans are sufficiently in place to identify items under test, test objectives, parameters to be recorded, and pass/fail criteria. Test plans include clear test methodologies, define data to be recorded, and test configurations. Appropriate monitoring and measurement equipment is used in conjunction with testing.
The standard also places responsibility on the organization for all externally supplied articles or services and establishes methodologies for verification that necessary controls are in place. These processes are to be defined, documented, and reviewed to ensure that products meet requirements.
While risk management is involved with any QMS, AS9100 enhances this process to address additional issues. Operational risks are defined as including special requirements that add complexities to a product or process. The standard requires that processes for managing operational risks be planned, implemented and controlled.
The International Aerospace Quality Group (IAQG) has developed additional related standards to meet needs for associated industries. These include:
- 9110 Quality Management Systems – Requirements for Aviation Maintenance Organizations
- 9120 Quality Management Systems – Requirements for Aviation, Space and Defense Distributors
- 9101 Quality Management Systems – Audit Requirements for Aviation, Space, and Defense Organizations
- 9102 Aerospace First Article Inspection Requirement
- 9103 Variation Management of Key Characteristics
- 9107 Direct Delivery Authorization Guidance for Aerospace Companies
- 9114 Direct Ship Guidance for Aerospace Companies
- 9115 Quality Management Systems – Requirements for Aviation, Space and Defense Organizations – Deliverable Software
- 9116 Aerospace Series – Notice of Change (NOC) Requirements
- 9131 Quality Management Systems – Aerospace – Nonconformance Documentation
- 9132 Data Matrix Quality Requirements for Parts Marking
- 9133 Qualification Procedure for Aerospace Standard Products
- 9134 Supply Chain Risk Management Guideline
- 9162 Aerospace Operator Self-Verification Programs”:
CVG Strategy AS9100D Consultants
Our Exemplar Global Lead Auditor Consultants can help you take a deeper look into AS9100D to develop an effective Quality Management System. Our quality strategy allows clients new to Quality Management Systems to rapidly implement a tailored system, because everything we do as consultants is processed based.
Our Quality Experts have experience with ISO 9001:2015, AS9100D, ISO 13485:2016, ISO IEC 27001:2022 and Association of American Railroads (AAR) M-1003 and can readily deliver compliant procedures and work instructions. CVG Strategy is a consultancy offering coaching, mentoring, training and program development focused on areas including Business Process Improvement, ITAR and Export Compliance, Cyber Security and Product Test and Evaluation.
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