SIR #: 101
Standard: 2003 NELAC
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 126.96.36.199 as a document that must be controlled. Equipment manuals fall under the categories of "procedures, specifications" that are also listed in Section 188.8.131.52 as documents that form part of a laboratory's quality system. NELAC 184.108.40.206 and 220.127.116.11.m also support having control over the documents, such as software and equipment manuals, that are part of a laboratory’s quality system.