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. test, inspection, and verification (including production process verification);
h. the use of statistical techniques for product acceptance and related instructions for acceptance by the organization;
i. 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 suspect unapproved, unapproved and 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 period of 10 years and disposition requirements;
j. 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;
k. ensuring that persons are aware of:
− their contribution to product or service conformity;
− their contribution to product safety;
− the importance of ethical behavior.