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Standard Interpretation



SIR #: 70
Standard: 2003 NELAC
Section: 5.4.13.1
Link to relevant standard

REQUEST:

This section deals with the annual Quality Audit. 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 FINAL RESPONSE:

(Quality System Expert Committee/NELAP Accreditation Council, 3-x-11)

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. NELAC 5.5.2.6 states that the lab management defines the minimal level of qualifications for all positions.