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Standard Interpretation

Standard: 2009 TNI
Section: V1M2, Section


My question is about documentation and traceability of consumables. Are environmental labs required to maintain records (ie Certificate of Analysis, storage, date of receipt, etc.) for such consumables as carrier gasses used for MassSpec or Spec type instrumentation?


(Quality Systems Expert Committee and NELAP AC, 2-24-14)

V1M2 requires documentation for "standards, reagents, reference materials, and media". Carrier gasses are not referenced within this section. However, a carrier gas is a laboratory consumable material that affects the quality of tests, and is subject to the policy and procedure requirements described in V1M2 4.6.