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Standard Interpretation



SIR #: 396
Standard: 2016
Section: V1M4, Section 1.6.3


REQUEST:

V1M4: 1.6.3.1 seems to allow the laboratory to determine their own on-going DOC procedure/approach.

V1M4: 1.6.3.2 states that the “ongoing DOC ‘may’ be one of the following…” and then further states in Section 1.6.3.2.e) that only if items a) through d) are not feasible can a laboratory use the option of e) for the ongoing DOC.

Does an on-going DOC need to be one of the examples listed in V1M4: 1.6.3.2.a) through e) or are other approaches acceptable?

TNI FINAL RESPONSE:

Other approaches to on-going DOC would be acceptable if the laboratory has documented those approaches and shown those approaches to be adequate per V1M4 1.6.3.1 as well as met the definition of DOC as listed in V1M2.