(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.