- (a) The laboratory shall prepare and maintain a quality systems manual that meet the requirements specified in Volume 1, Module 2, Sections 4.2.8.3 and 4.2.8.4 of the TNI standards.
(b) The quality systems manual shall:
- (1) Represent the laboratory’s normal day to day operating procedures and policies;
- (2) State that all laboratory staff must follow all specified procedures and policies;
- (3) Describe or reference the procedures for the development of in-house limits for analytical method quality control standards when not defined by the reference method; and
- (4) Describe or reference the procedures for reviewing and validating analytical method support activities, analytical results, and reported analytical results.
- (c) The quality systems manual shall either include the standard operating procedures (SOPs) or reference where the SOPs are maintained.
Source. (See Revision Note at chapter heading for Env-C 300) #12065, eff 1-1-17; ss by #13291, eff 11-23-21