a. The quality policy shall be defined documented understood implemented and maintained.
b. Responsibilities and authorities for all personnel specifying achieving and monitoring quality shall be defined. In house verification resources shall be defined, trained and funded. A designated management person sees that the Q91 program is implemented and maintained.
a. Procedure shall be prepared.
b. Procedure shall be implemented.
a. Incoming contracts ( and purchase orders) shall be reviewed to see whether the requirements are adequately defined agree with the bid, and can be implemented.
a. The design project shall be planned,
b. Design input parameters shall be defined,
c. Design output including crucial product characteristics shall be documented.
d. Design output shall be verified to meet input requirements,
e. Design changes shall b e controlled.