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;
- 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, investigations, 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.