Information for External Providers

The organization shall ensure the adequacy of requirements prior to their communication to the external provider.

The organization shall communicate to external providers its requirements for:

  1. the processes, products, and services to be provided including the identification of relevant technical data (e.g., specifications, drawings, process requirements, work instructions);

  2. the approval of:

    1. products and services;

    2. methods, processes, and equipment;

    3. the release of products and services;

  3. competence, including any required qualification of persons;

  4. the external providers’ interactions with the organization;

  5. control and monitoring of the external providers’ performance to be applied by the organization;

  6. verification or validation activities that the organization, or its customer, intends to perform at the external providers’ premises;

  7. design and development control;

  8. special requirements, critical items, or key characteristics;

  9. test, inspection, and verification (including production process verification);

  10. the use of statistical techniques for product acceptance and related instructions for acceptance by the organization;

  11. the need to:

    1. implement a quality management system;

    2. use customer-designated or approved external providers, including process sources (e.g., special processes);

    3. notify the organization of nonconforming processes, products, or services and obtain approval for their disposition;

    4. prevent the use of counterfeit parts (see 8.1.4);

    5. notify the organization of changes to processes, products, or services, including changes of their external providers or location of manufacture, and obtain the organization’s approval;

    6. flow down to external providers applicable requirements including customer requirements;

    7. provide test specimens for design approval, inspection/verification, investigation, or auditing;

    8. retain documented information, including retention periods and disposition requirements;

  12. the right of access by the organization, their customer, and regulatory authorities to the applicable areas of facilities and to applicable documented information, at any level of the supply chain;

  13. ensuring that persons are aware of:

    1. their contribution to product or service conformity;

    2. their contribution to product safety;

    3. the importance of ethical behavior.