(1) The testing laboratory shall develop and implement a quality assurance program to assure the reliability and validity of the analytical data produced by the testing laboratory. The quality assurance program shall, at a minimum, include a written quality manual that addresses the following:
(a) quality control procedures;
(b) testing laboratory organization and employee training and responsibilities;
(c) quality assurance objectives for measurement data;
(d) traceability of data and analytical results;
(e) instrument maintenance, calibration procedures, and frequency;
(f) performance and system audits;
(g) corrective and preventative action procedures;
(h) steps to change processes when necessary;
(i) record retention and document control;
(j) laboratory test sample retention and disposal;
(k) test procedure standardization; and
(l) method validation.
(2) The scientific director shall annually review, amend if necessary, and approve the quality manual both when it is created and when there is a change in methods, laboratory equipment, or the scientific director.
(3) All testing laboratory personnel shall review the quality manual upon revision or at least annually.