What must organizations establish regarding external providers?

Organizations must establish criteria for evaluating and selecting external providers to ensure that their needs and requirements are met consistently. This practice is crucial in maintaining the quality of products and services, as external providers can significantly influence an organization's ability to meet customer expectations.

By having well-defined criteria, organizations can assess potential providers based on factors such as their capability, reliability, and adherence to quality standards. This process helps organizations to mitigate risks associated with outsourcing and establishes a systematic approach to ensure that all external sources align with the organization's quality management system.

The criteria set by the organization should consider various aspects, such as the provider's past performance, qualifications, and their ability to meet specific standards relevant to the organization's products or services. This not only enhances the quality of the end product but also ensures compliance with ISO 9001 requirements, which emphasizes the importance of managing external relationships effectively.

In contrast, the other options do not align with the best practices outlined in ISO 9001. Without established criteria, organizations could face inconsistencies in quality and potentially increase the risk of non-compliance. A verbal agreement lacks accountability and formal record-keeping, while relying solely on a written contract may overlook the critical evaluation phase necessary to ensure that the provider can meet quality expectations.