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Standard Interpretation



SIR #: 124
Standard: 2003 NELAC
Section: 5.5.6.4
Link to relevant standard

REQUEST:

For subsection a), I would like an interpretation of the requirement to obtain the manufacturer's Certificate of Analysis for reagents. Does this mean just "ready-made" reagents (e.g. the color reagent for a test) or does this also include pure chemicals (e.g. a bottle of sodium chloride crystals)?

TNI FINAL RESPONSE:

(Quality Systems Expert Committee and NELAP AC, 3-31-13)

The standard requires that Certificates of Analysis be obtained for all reagents. This does not mean that the C of A is automatically supplied. In some cases, you may need to request such information from a manufacturer. This includes both "ready-made" and pure (neat) chemicals.