SIR #: 79
Standard: 2003 NELAC
Link to relevant standard
X's question for TNI concerns the documentation of the laboratory's scope of accreditation in the test report. In this situation, our laboratory is licensed for a small number of tests in the State of Minnesota, which is adopting the NELAC Standard. Our laboratory is licensed for a full scope of parameters in the State of Arizona, a non-NELAC state. In Section 5.5.10 of the 2003 NELAC Standard, is there a requirement for qualifying data that is not included in the laboratory's scope of accreditation?
If there is a requirement (either directly or implied), how should the laboratory indicate the lack of NELAC licensure on the Arizona-only parameters in order to comply with the NELAC Standard? Is it sufficient to include a disclaimer on the cover page of the reports for Arizona-only work that indicates the data may only be used for compliance purposes in the State of Arizona and not in NELAC states
TNI FINAL RESPONSE:
Based on the standards quoted above, if the laboratory is issuing a NELAC-compliant report and the report has results that are not accredited under NELAC, you must identify those methods that do not meet the NELAC requirements (i.e., methods certified by another accrediting body).
The committee cannot comment on reports that are issued for Arizona compliance purposes.