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

Section: 4.14.1

Question:  One sentence reads:  "Such audits shall be carried out by trained and qualified personnel who are, whenever resources permit, independent of the activity to be audited." What is the meaning of "trained and qualified" as used in the sentence? Trained and qualified in environmental matters, auditing techniques etc.?

TNI Response:  Since "trained and qualified" is not defined, it would be up to the laboratory to state what their requirements are. It would be expected that the person performing the audit has a knowledge of the portion of laboratory operations that are being audited. states that the lab management defines the minimal level of qualifications for all positions.


Question:  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".  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.

TNI Response:  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.