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Standard Interpretation

Standard: 2003 NELAC


Identification of controlled documents.

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

Are equipment manuals considered controlled documents?


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

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