Subpart H—Acceptance Activities
§ 820.80 Receiving, in-process, and finished device acceptance.
(a)
General. Each manufacturer shall establish and maintain procedures for
acceptance activities. Acceptance activities include inspections, tests, or
other verification activities.
(b) Receiving acceptance activities. Each manufacturer shall establish and
maintain procedures for acceptance of incoming product. Incoming product shall be inspected, tested, or otherwise verified as conforming to specified requirements. Acceptance or rejection shall be documented.....
(e) Acceptance records. Each manufacturer shall documentacceptance activities required by this part. These records shall include: (1) The acceptance activities performed; (2) the dates acceptance activities are performed; (3) the results; (4) the signature of the individual(s) conducting the acceptance activities; and (5) where appropriate the equipment used. These records shall be part of the DHR.