(1) The laboratory must have procedure(s) for the selection and purchasing of services and supplies it uses that affect the quality of the tests and/or calibrations. Procedures covering reagents and laboratory consumables must exist for the purchase, receipt, storage, and disposition of expired materials.

(2) The laboratory must ensure that purchased supplies and reagents and consumable materials that affect the quality of tests and/or calibrations are inspected or otherwise verified as complying with standard specifications or requirements defined in the methods for the tests and/or calibrations concerned.

(3) New lots or materials received outside of expected environmental conditions must be documented and validated before use.

(4) Reagents and standards must be inspected, dated, and initialed upon receipt, and upon opening.

(5) Calibration standards and analytical reagents must have an expiration or reevaluation date assigned.

(6) Standards and solutions must be identified with lot number or other assigned unique identifier to trace back to preparation documentation.

(7) Prospective suppliers must be evaluated and selected on the basis of specified criteria.

(8) Processes to ensure that approved suppliers continue to provide acceptable items and services must be established and implemented.