ARM 42.39.604

ARM 42.39.604

SupersededLast amended: 2022Length: 173 wordsOfficial source

Cite as Mont. Admin. R. 42.39.604

37.107.307 TESTING LABORATORY QUALITY ASSURANCE PROGRAM (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.
ARM 42.39.604: ARM 42.39.604 | Justis AI