What is AS9100?
The AS9100 standard is a quality management system intended for use by organizations that design, develop and/or produce aviation, space and defense products; and by organizations providing post-delivery support, including the provision of maintenance, spare parts or materials for their own products. It is published by the Society of Automotive Engineers (SAE) for the aerospace industry.
What are the requirements?
The AS9100 standard builds on the ISO 9001 with nearly 100 additional requirements specific to the aerospace industry, and is implemented when a quality management system with additional requirements over an ISO 9001 system is needed. AS9100 requires the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer requirements.
What is a process approach?
For any organization, in order to function effectively, it has to determine and manage several linked activities. A process is an activity or set of activities using resources, and managed in order to enable the transformation of inputs into outputs. Often the output from one process directly forms the input to the next. The implementation of a system of processes within an organization, together with the identification and interactions of these processes, and their management to produce the desired outcome, can be referred to as the “process approach”.
When used within a quality management system, such an approach emphasizes the importance of
a) Understanding and meeting requirements,
b) The need to consider processes in terms of added value,
c) Obtaining results of process performance and effectiveness, and
d) Continual improvement of processes based on objective measurement.
Components of the AS9100 standard:
1. Quality Management System
2. Management Responsibility
3. Resource Management
4. Product Realization
5. Measurement, Analysis and Improvement
1. Quality Management System:
The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard. The organization’s quality management system shall also address customer and applicable statutory and regulatory quality management system requirements.
2. Management Responsibility:
Top management shall provide evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness.
Top management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction.
Top management shall ensure that product conformity and on-time delivery performance are measured and that appropriate action is taken if planned results are not, or will not be, achieved.
Top management shall ensure that quality objectives, including those needed to meet requirements for product, are established at relevant functions and levels within the organization. The quality objectives shall be measurable and consistent with the quality policy.
Top management shall ensure that responsibilities and authorities are defined and communicated within the organization.
Top management shall appoint a member of the organization’s management who, irrespective of other responsibilities, shall have responsibility and authority that includes the organizational freedom and unrestricted access to top management to resolve quality management issues.
Top management shall ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the quality management system.
Top management shall review the organization's quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. This review shall include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives.
3. Resource Management:
The organization shall determine and provide the resources needed to implement and maintain the quality management system and continually improve its effectiveness, and to enhance customer satisfaction by meeting customer requirements.
Personnel performing work affecting conformity to product requirements shall be competent on the basis of appropriate education, training, skills and experience.
The organization shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirements.
The organization shall determine and manage the work environment needed to achieve conformity to product requirements.
4. Product Realization:
The organization shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirements of the other processes of the quality management system. The output of this planning shall be in a form suitable for the organization's method of operations.
As appropriate to the organization and the product, the organization shall plan and manage product realization in a structured and controlled manner to meet requirements at acceptable risk, within resource and schedule constraints.
The organization shall establish, implement and maintain a process for managing risk to the achievement of applicable requirements.
The organization shall establish, implement and maintain a configuration management process.
The organization shall establish, implement and maintain a process to plan and control the temporary or permanent transfer of work (e.g., from one organization facility to another, from the organization to a supplier, from one supplier to another supplier) and to verify the conformity of the work to requirements.
The organization shall review the requirements related to the product. This review shall be conducted prior to the organization's commitment to supply a product to the customer.
Where the customer provides no documented statement of requirement, the customer requirements shall be confirmed by the organization before acceptance.
Where product requirements are changed, the organization shall ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements.
Where appropriate, the organization shall divide the design and development effort into distinct activities and, for each activity, define the tasks, necessary resources, responsibilities, design content, input and output data and planning constraints.
The different design and development tasks to be carried out shall be based on the safety and functional objectives of the product in accordance with customer, statutory and regulatory requirements.
Design and development planning shall consider the ability to produce, inspect, test and maintain the product.
The outputs of design and development shall be in a form suitable for verification against the design and development input and shall be approved prior to release.
The organization shall define the data required to allow the product to be identified, manufactured, inspected, used and maintained.
Verification shall be performed in accordance with planned arrangements to ensure that the design and development outputs have met the design and development input requirements.
Design and development validation shall be performed in accordance with planned arrangements to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use, where known.
At the completion of design and/or development, the organization shall ensure that reports, calculations, test results, etc., demonstrate that the product definition meets the specification requirements for all identified operational conditions.
Design and development changes shall be identified and records maintained. The changes shall be reviewed, verified and validated, as appropriate, and approved before implementation. The review of design and development changes shall include evaluation of the effect of the changes on constituent parts and product already delivered.
The organization shall ensure that purchased product conforms to specified purchase requirements. The type and extent of control applied to the supplier and the purchased product shall be dependent upon the effect of the purchased product on subsequent product realization or the final product.
The organization shall be responsible for the conformity of all products purchased from suppliers, including product from sources defined by the customer.
The organization shall evaluate and select suppliers based on their ability to supply product in accordance with the organization's requirements. Criteria for selection, evaluation and re-evaluation shall be established.
The organization shall ensure the adequacy of specified purchase requirements prior to their communication to the supplier.
The organization shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements.
Where purchased product is released for production use pending completion of all required verification activities, it shall be identified and recorded to allow recall and replacement if it is subsequently found that the product does not meet requirements.
Where the organization delegates verification activities to the supplier, the requirements for delegation shall be defined and a register of delegations maintained.
Where the organization or its customer intends to perform verification at the supplier's premises, the organization shall state the intended verification arrangements and method of product release in the purchasing information.
The organization shall use a representative item from the first production run of a new part or assembly to verify that the production processes, production documentation and tooling are capable of producing parts and assemblies that meet requirements. This process shall be repeated when changes occur that invalidate the original results (e.g., engineering changes, manufacturing process changes, tooling changes).
Personnel authorized to approve changes to production processes shall be identified. The organization shall control and document changes affecting processes, production equipment, tools or software programs. The results of changes to production processes shall be assessed to confirm that the desired effect has been achieved without adverse effects to product conformity.
Production equipment, tools and software programs used to automate and control/monitor product realization processes, shall be validated prior to release for production and shall be maintained.
Storage requirements, including periodic preservation/condition checks, shall be defined for production equipment or tooling in storage.
The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement and, as a consequence, deficiencies become apparent only after the product is in use or the service has been delivered.
Where appropriate, the organization shall identify the product by suitable means throughout product realization. The organization shall maintain the identification of the configuration of the product in order to identify any differences between the actual configuration and the agreed configuration.
The organization shall identify the product status with respect to monitoring and measurement requirements throughout product realization. When acceptance authority media are used (e.g., stamps, electronic signatures, passwords), the organization shall establish appropriate controls for the media. Where traceability is a requirement, the organization shall control the unique identification of the product and maintain records.
The organization shall exercise care with customer property while it is under the organization‘s control or being used by the organization. The organization shall identify, verify, protect and safeguard customer property provided for use or incorporation into the product. If any customer property is lost, damaged or otherwise found to be unsuitable for use, the organization shall report this to the customer and maintain records.
The organization shall preserve the product during internal processing and delivery to the intended destination in order to maintain conformity to requirements. As applicable, preservation shall include identification, handling, packaging, storage and protection. Preservation shall also apply to the constituent parts of a product.
The organization shall maintain a register of the monitoring and measuring equipment and define the process employed for their calibration/verification including details of equipment type, unique identification, location, frequency of checks, check method and acceptance criteria.
The organization shall ensure that environmental conditions are suitable for the calibration, inspection, measurement and testing being carried out.
The organization shall establish, implement and maintain a process for the recall of monitoring and measuring equipment requiring calibration or verification.
5. Measurement, Analysis and Improvement
The organization shall plan and implement the monitoring, measurement, analysis and improvement processes needed to demonstrate conformity to product requirements, to ensure conformity of the quality management system, and to continually improve the effectiveness of the quality management system.
Information to be monitored and used for the evaluation of customer satisfaction shall include, but is not limited to, product conformity, on-time delivery performance, customer complaints and corrective action requests. Organizations shall develop and implement plans for customer satisfaction improvement that address deficiencies identified by these evaluations, and assess the effectiveness of the results.
In the event of process nonconformity, the organization shall take appropriate action to correct the nonconforming process, evaluate whether the process nonconformity has resulted in product nonconformity, determine if the process nonconformity is limited to a specific case or whether it could have affected other processes or products, and identify and control any nonconforming product.
When critical items, including key characteristics, have been identified the organization shall ensure they are controlled and monitored in accordance with the established processes.
When the organization uses sampling inspection as a means of product acceptance, the sampling plan shall be justified on the basis of recognized statistical principles and appropriate for use (i.e., matching the sampling plan to the criticality of the product and to the process capability).
Where product is released for production use pending completion of all required measurement and monitoring activities, it shall be identified and recorded to allow recall and replacement if it is subsequently found that the product does not meet requirements.
Where required to demonstrate product qualification, the organization shall ensure that records provide evidence that the product meets the defined requirements.
The organization shall determine, collect and analyze appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the effectiveness of the quality management system can be made. This shall include data generated as a result of monitoring and measurement and from other relevant sources.
The organization shall continually improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review.
The organization shall monitor the implementation of improvement activities and evaluate the effectiveness of the results.
The organization shall continually improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review.
The organization shall take action to eliminate the causes of nonconformities in order to prevent recurrence. Corrective actions shall be appropriate to the effects of the nonconformities encountered.
The organization shall determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventive actions shall be appropriate to the effects of the potential problems.