Administrative Rules of Montana
Department 37 - PUBLIC HEALTH AND HUMAN SERVICES
Chapter 37.12 - LABORATORIES
Subchapter 37.12.3 - Licensure of Laboratories Conducting Analyses of Public Water Supplies
Rule 37.12.336 - QUALITY ASSURANCE
Current through Register Vol. 6, March 22, 2024
(1) A licensed laboratory must develop and implement a quality assurance program that is an integrated system of activities involving planning, quality control, quality assessment, reporting, and quality improvement to ensure that its services meet its standards of quality with its stated level of confidence.
(2) The quality assurance program must address the type of testing activities the licensed laboratory undertakes and how quality assurance activities may change with changes in sample volumes. The quality assurance program must include a quality assurance plan and documentation of quality assurance activities.
(3) As part of its quality assurance program, each licensed laboratory must develop and adhere to a quality assurance plan. The laboratory must include and address the following essential items in the quality assurance plan:
(4) For chemistry laboratories the plan must also include:
(5) As part of the quality assurance program, the laboratory must document and retain records for a period of five years demonstrating that it has maintained compliance with its quality assurance program. The laboratory may be requested by the department to provide quality assurance data to monitor compliance.
50-1-202, MCA; IMP, 50-1-202, 75-6-106, MCA;