HOME    SEARCH    ABOUT US    CONTACT US    HELP   
           
Rule: 37.107.307 Prev     Up     Next    
Rule Title: TESTING LABORATORY QUALITY ASSURANCE PROGRAM
Add to My Favorites
Add to Favorites
Department: PUBLIC HEALTH AND HUMAN SERVICES
Chapter: MARIJUANA REGISTRY
Subchapter: Testing Laboratories
 
Latest version of the adopted rule presented in Administrative Rules of Montana (ARM):

Printer Friendly Version

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.

 

History: 16-12-202, 16-12-209, MCA; IMP, 16-12-202, 16-12-209, MCA; NEW, 2019 MAR p. 1868, Eff. 10/19/19; AMD, 2022 MAR p. 58, Eff. 1/15/22.


 

 
MAR Notices Effective From Effective To History Notes
37-967 1/15/2022 Current History: 16-12-202, 16-12-209, MCA; IMP, 16-12-202, 16-12-209, MCA; NEW, 2019 MAR p. 1868, Eff. 10/19/19; AMD, 2022 MAR p. 58, Eff. 1/15/22.
37-889 10/19/2019 1/15/2022 History: 50-46-344, MCA; IMP, 50-46-304, 50-46-311, 50-46-326, 50-46-344, MCA; NEW, 2019 MAR p. 1868, Eff. 10/19/19.
Home  |   Search  |   About Us  |   Contact Us  |   Help  |   Disclaimer  |   Privacy & Security