Under this subpart J, what records must you make and keep?

(a) You must make and keep records required under this subpart J in accordance with subpart P of this part. (b) You must make and keep the following records: (1) Written procedures for laboratory operations, including written procedures for the tests and examinations that you conduct to determine whether specifications are met; (2) Documentation that laboratory methodology established in accordance with this subpart J is followed. (i) The person who conducts the testing and examination must document, at the time of performance, that laboratory methodology established in accordance with this subpart J is followed. (ii) The documentation for laboratory tests and examinations must include the results of the testing and examination.