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Combined Interpretations of the 2003, 2009, and 2016 Standards that apply to Volume 1 of the 2016 TNI Standard

Section: 4.3.2

Question: requires documents to be reviewed "periodically". I have interpreted this to mean that NELAC wants the documents reviewed but requires the lab to establish the frequency. NELAC further supports this position by specifically requiring data integrity procedure to be reviewed annually ( However, some assessors with whom I work take the position that since 4.14.1 and 4.14.5 require labs to annually review "testing activities" and conduct audits on "all elements of the management system" that these are inferred or indirect requirements to annually review all procedures. Since addresses the issue directly, I take the position that it prevails over any indirect or inferred interpretation of the standard.

TNI Response:  The internal audits must show compliance with the laboratories policies and procedures. This is a procedural review for compliance and suitability. The periodic review of SOPs is set by the lab and does require that technical management review current procedures. This can be done with internal method audits. If the AB finds issues that would indicate that periodically has been stretched too long, then the AB could impose a finding that would require the timeframe be shortened. Also, support procedures can be allowed to have longer periods between review, such as when changes are needed due to a change in laboratory practice.