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Standard Interpretation



Standard: 2003 NELAC
Section: 5.4.3.1


REQUEST:

Identification of controlled documents.

Is instrument software (or any other software) considered a controlled document?

Are equipment manuals considered controlled documents?

TNI FINAL RESPONSE:

(Quality Systems Expert Committee and NELAP AC, 4-7-14)

Software is among the items listed in Section 5.4.3.1 as a document that must be controlled. Equipment manuals fall under the categories of "procedures, specifications" that are also listed in Section 5.4.3.1 as documents that form part of a laboratory's quality system. NELAC 5.4.2.1 and 5.4.2.3.m also support having control over the documents, such as software and equipment manuals, that are part of a laboratory�s quality system.