AS9100 Clause 8.3.1 – General

AS9100 8.3.1 General requires organizations to establish and maintain a design and development process that is appropriate to the nature, complexity and risks associated with the product or service being developed. The process must ensure that the product or service meets all applicable requirements, including those of the customer, regulatory authorities and other interested parties.

The design and development process must be documented and controlled, and it must include the following elements:

• Planning
• Input
• Output
• Review and verification
• Validation
• Changes

The planning phase of the design and development process must identify the risks associated with the product or service, and it must develop a plan to mitigate those risks. The input phase must gather all of the information that is needed to design the product or service, including customer requirements, regulatory requirements and other relevant information. The output phase must produce the design documentation, which must be clear, concise and complete. The review and verification phase must ensure that the design meets all applicable requirements. The validation phase must ensure that the product or service meets the needs of the intended user. The changes phase must manage any changes to the design and development process or to the product or service.

Organizations must also ensure that the design and development process is effective by monitoring and reviewing its performance. This includes identifying and addressing any problems or issues that may arise.

AS9100 8.3.1 General is an important requirement that helps to ensure that products and services are designed and developed in a controlled and systematic manner. This helps to reduce the risk of defects and to ensure that products and services meet the needs of the customer.

Here are some additional tips for complying with AS9100 8.3.1 General:

• Make sure that the design and development process is documented and controlled.
• Identify the risks associated with the product or service and develop a plan to mitigate those risks.
• Gather all of the information that is needed to design the product or service, including customer requirements, regulatory requirements and other relevant information.
• Produce clear, concise and complete design documentation.
• Ensure that the design meets all applicable requirements.
• Manage any changes to the design and development process or to the product or service.
• Monitor and review the performance of the design and development process to identify and address any problems or issues.