AS9100 Clause 8.5.1.1 – Control of Production Equipment, Tools, and Software Equipment

AS9100D clause 8.5.1.1 requires that organizations establish, implement, and maintain a production and service provision process that:

1. Controls the Equipment and Tools: The organization must control production equipment, tools, and all associated software to ensure it remains suitable for its intended purpose. The organization needs to have a process in place to periodically inspect and calibrate (where applicable) these items. If any equipment, tool, or software is found to be unfit for its intended purpose, it must be identified and segregated to prevent its use.
2. Validates Software: If software is used in the production or service provision process, the organization must validate and revalidate it as appropriate. The software’s abilities to achieve planned results must be confirmed. This could mean ensuring it’s accurate, reliable, and capable of achieving the intended output.
3. Preserves Product: The organization must also maintain a process to preserve the output during internal processing and delivery to the intended destination. This preservation should include identification, handling, packaging, storage, and protection.
4. Post-Delivery Activities: Depending on the nature of the products and services, the organization might need to provide support for post-delivery activities. These might include warranties, maintenance services, recycling, or final disposal.

It’s important to keep in mind that the process must be suitable for the organization, its context, its environmental conditions, and the risks and opportunities it has identified.