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Standard Interpretation



SIR #: 115
Standard: 2003 NELAC
Section: 5.4.5.4
Link to relevant standard

REQUEST:

What is the documentation needed as the 'record of evidence of compliance'? Our clients are asking for our NELAP certificate, PT results, insurance certificates and QA manual. But we interpret this statement to mean having the NELAP certificate on file.

TNI FINAL RESPONSE:

(Quality Systems Expert Committee and NELAP AC, 11-8-12)

The requirements outlined in 5.4.5.1 refer to a subcontracted laboratory and the tests to be performed. They are 1) the laboratory is accredited under NELAP for the tests or 2) the laboratory meets the statutory or regulatory requirements for performing the tests. In the case of the first requirement, the NELAP Certificate that identifies the accredited test would meet the requirement. If other statutory or regulatory requirements exist, the laboratory must be prepared to provide documentation to indicate that these additional requirements have been met. However, under "Service to the Client" (NELAC 5.4.7), the laboratory shall cooperate with the client "to monitor the laboratory's performance.... provided that the laboratory ensures confidentiality to other clients."