1. (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:

   1. (a) quality control procedures;
   2. (b) testing laboratory organization and employee training and responsibilities;
   3. (c) quality assurance objectives for measurement data;
   4. (d) traceability of data and analytical results;
   5. (e) instrument maintenance, calibration procedures, and frequency;
   6. (f) performance and system audits;
   7. (g) corrective and preventative action procedures;
   8. (h) steps to change processes when necessary;
   9. (i) record retention and document control;
   10. (j) laboratory test sample retention and disposal;
   11. (k) test procedure standardization; and
   12. (l) method validation.
2. (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. (3) All testing laboratory personnel shall review the quality manual upon revision or at least annually.

Authorizing statute(s): 16-12-202, 16-12-209, MCA

Implementing statute(s): 16-12-202, 16-12-209, MCA

History: NEW, 2019 MAR p. 1868, Eff. 10/19/19; AMD, 2022 MAR p. 58, Eff. 1/15/22; TRANS, from ARM 37.107.307, 2023 MAR p. 570, Eff. 7/2/23.