To verify compliance with ISO 9001 clause 8.4.1, an organization should begin by reviewing whether clear and objective criteria have been established for the evaluation, selection, monitoring, and re-evaluation of external providers. This involves assessing if criteria exist that gauge an external provider’s ability to meet defined quality requirements. For instance, documented information should show that suppliers have been evaluated against specific standards relevant to the products or services they provide, and that these criteria align with the organization’s quality expectations. The aim is to confirm that any products, services, or processes provided externally meet the necessary specifications before they are incorporated into the organization’s offerings or delivered directly to customers.

In addition to evaluation criteria, it is essential to verify if there is an ongoing process for monitoring supplier performance and a structured approach for re-evaluation. Compliance in this area would be evidenced by documented procedures or records that detail the frequency and method of monitoring supplier performance—such as regular audits, performance scorecards, or key performance indicators (KPIs). These records should show that evaluations are conducted consistently and that any issues discovered in performance are addressed with corrective actions as needed.

Finally, the organization should maintain records of all evaluations, monitoring activities, and re-evaluations of external providers. Compliance here would involve a thorough review of these records to confirm that they are complete, accurate, and up to date. These records also provide a clear trail of actions taken as a result of each evaluation, demonstrating the organization’s proactive approach to managing external provider relationships. By having detailed and accessible documentation, the organization ensures transparency and accountability in maintaining control over externally provided products and services.