ensuring employee competence, including required qualifications;
communicating and interaction with customer’s organizations;
control and monitoring performance of the supplier;
verification or validation activities performed at the supplier’s premises;
design and development control;
control of special requirements, critical items or key characteristics;
test, inspection, and verification (including production process verification);
the use of statistical techniques for product acceptance and related instructions for acceptance by the customer.
The supplier must:
Implement a quality management system;
use customer-designated or approved external providers where applicable, 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;
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;
maintain 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;
ensure that persons are aware of their contribution to product conformity, safety, and the importance of ethical behavior.