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:

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

b. the approval of:

1. products and services;
2. methods, processes, and equipment;
3. the release of products and services;

c. competence, including any required qualification of persons;

d. the external providers’ interactions with the organization;

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

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

g. design and development control;

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

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

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

k. the need to:

− implement a quality management system;

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

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

− prevent the use of counterfeit parts (see 8.1.4);

− 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;

− flow down to external providers applicable requirements including customer requirements;

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

− retain documented information, including retention periods and disposition requirements;

l. 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;

m. ensuring that persons are aware of:

− their contribution to product or service conformity;

− their contribution to product safety;

− the importance of ethical behavior.