8.4.3 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:
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:
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 instruction for acceptance by the organization;
k. the need to:
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: