General requirements

General requirements. (1) Scope. This subchapter establishes personnel, quality assurance, quality control, method selection, sample handling, and documentation requirements for laboratories. (2) Responsibility for quality system. A laboratory shall conduct analytical activities under a quality system that incorporates the provisions of this subchapter. At least one individual within a laboratory’s organization or under the laboratory’s employment shall be identified to the department as responsible for establishing, implementing, assessing, and revising, as needed, a laboratory’s quality system.