AS9100 Clause 8.3.5 – Design and Development Outputs

AS9100 8.3.5 Design and Development Outputs requires organizations to produce outputs that meet the input requirements and are suitable for subsequent processes. The outputs should be documented and include or refer to appropriate monitoring and measuring requirements and their acceptance criteria. The outputs should also define the characteristics of the product or service that are essential for its intended purpose and its safe and proper provision.

The following are some examples of design and development outputs:

• Product specifications
• Manufacturing drawings
• Assembly instructions
• Software code
• Test plans
• Test reports
• Risk assessments
• Change control records

The outputs should be reviewed and approved by relevant personnel to ensure that they meet the input requirements. The outputs should also be maintained throughout the product life cycle to ensure that they are up-to-date and accurate.

By following these requirements, organizations can help to ensure that their products and services meet customer requirements and are fit for purpose.

Here are some additional tips for ensuring that design and development outputs meet the requirements:

• Use a structured approach: The design and development process should be structured and systematic, with clear objectives and milestones. This will help to ensure that the outputs are comprehensive and meet the requirements.
• Involve all relevant stakeholders: The design and development process should involve all relevant stakeholders, including customers, engineers, and manufacturing personnel. This will help to ensure that the final product or service meets the needs of all stakeholders.
• Use appropriate tools and techniques: The organization should use appropriate tools and techniques to support the design and development process. This could include tools such as computer-aided design (CAD), finite element analysis (FEA), and risk management software.
• Establish a process for managing changes: The organization should establish a process for managing changes to the design and development outputs. This process should ensure that changes are properly authorized and implemented, and that the impact of changes is assessed.
• Maintain documentation: The organization should maintain documentation of the design and development process and the results of the reviews, verification, and validation activities. This documentation should be accessible to all relevant personnel.

By following these tips, organizations can help to ensure that their design and development outputs meet the requirements and that their products and services are fit for purpose.