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Standard Interpretation



Standard: 2016
Section: V1M2, Section 5.5.13.1 (e)


REQUEST:

As written section 5.5.13.1.e appears to contradict itself in that section e reads: "glass microliter syringes and Class A glassware are exempt from any verification requirements beyond what is stated in Section 4.6.2." Then, upon reading section 4.6.2 states: "The laboratory shall ensure that purchased supplies and reagents and consumable materials that affect the quality of tests and/or calibrations are not used until they have been inspected or otherwise verified as complying with standard specifications or requirements defined in the methods for the tests and/or calibrations concerned. These services and supplies used shall comply with specified requirements. Records of actions taken to check compliance shall be maintained."

Can you clarify, per the Standard, if Class A glassware and glass microliter syringes have to be verified for accuracy upon receipt? Section e seems to indicate that these are accepted for accuracy; until you refer to section 4.6.2 which requires verification to specifications upon receipt.

TNI FINAL RESPONSE:

Volumetric verification is not required for glass microliter syringes or Class A glassware. Glass microliter syringes and Class A glassware are required to be inspected as complying with any specifications or requirements prior to first use. The laboratory decides how to perform the inspection or verification mentioned in 4.6.2 and must retain records of actions to check compliance.