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Combined Interpretations of the 2003, 2009, and 2016 Standards that apply to Volume 1 of the 2016 TNI Standard

Section: 4.3.1

Question:  Is instrument software (or any other software) considered a controlled document?  Are equipment manuals considered controlled documents?

TNI Response:  Software is among the items listed in Section 4.3.1 as a document that must be controlled. Equipment manuals fall under the categories of "procedures, specifications" that are also listed in 4.3.1 as documents that form part of a laboratory's quality system. 4.2.1 and also support having control over the documents, such as software and equipment manuals, that are part of a laboratory’s quality system.  This language is unchanged in the 2009 and 2016 standards.
The SIR is still valid.