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Standard Interpretation

SIR #: 308
Standard: 2009 TNI
Section: V1M2, Section 4.14.1


Per Clause 4.14.1, the internal audit program shall address all elements of the management system, including the testing and/or calibration activities. It is unclear if all test methods need to be audited annually since 4.14 never uses the word "methods" but rather "areas" or "activities".

The question is this: Can the test methods be grouped by technology (i.e. GC/MS, ICP/MS, ICP, Spectrophotometry, Gravimetry, Meters, Titrimetry, SFIA, etc.) or does every method have to be audited annually? If grouped by technology, can different test methods within each technology be scheduled annually? The schedule beyond one year would show that tests are rotated for internal audits over time.


No, not every method needs to be assessed annually in the laboratory's internal audits.

Yes, different methods within each technology may be assessed on an annual basis.