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:
- the processes, products, and services to be provided including the identification of relevant technical data (e.g., specifications, drawings, process requirements, work instructions);
- the approval of:
- products and services;
- methods, processes, and equipment;
- the release of products and services;
- competence, including any required qualification of persons;
- the external providers’ interactions with the organization;
- control and monitoring of the external providers’ performance to be applied by the organization;
- verification or validation activities that the organization, or its customer, intends to perform at the external providers’ premises;
- design and development control;
- 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 organization;
- 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;
- 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;
- ensuring that persons are aware of:
− their contribution to product or service conformity;
− their contribution to product safety;
− the importance of ethical behavior.