AS9100 Clause 8.4.1 – General

AS9100 8.4.1 General requires organizations to control externally provided processes, products, and services. This means that organizations must ensure that these items meet their requirements, and that they are used in a way that does not compromise the organization’s overall quality management system.

There are a number of things that organizations can do to control externally provided items. These include:

• Evaluating suppliers: Organizations should evaluate their suppliers to ensure that they have the capability to provide the required items. This evaluation should include an assessment of the supplier’s quality management system, as well as their technical capabilities.
• Establishing requirements: Organizations should establish clear requirements for the externally provided items. These requirements should be communicated to the supplier in a clear and unambiguous way.
• Monitoring performance: Organizations should monitor the performance of their suppliers to ensure that they are meeting the agreed-upon requirements. This monitoring should be ongoing, and should include regular audits of the supplier’s facilities and processes.
• Taking corrective action: If a supplier is not meeting the agreed-upon requirements, organizations should take corrective action to address the issue. This may include issuing a warning to the supplier, or terminating the relationship with the supplier.

By taking these steps, organizations can help to ensure that externally provided items meet their requirements, and that they do not compromise the organization’s overall quality management system.

Here are some additional points to consider when controlling externally provided processes, products, and services:

• The organization should ensure that the selection of external providers is based on objective criteria.
• The organization should ensure that the requirements for externally provided processes, products, and services are clearly defined and communicated to the external providers.
• The organization should monitor the performance of external providers and take appropriate action when necessary.
• The organization should retain documented information about the evaluation of external providers and the results of monitoring their performance.

By following these guidelines, organizations can help to ensure that externally provided processes, products, and services meet their requirements and do not compromise the organization’s overall quality management system.