Combined Interpretations of the 2003, 2009, and 2016 Standards that apply to Volume 1 of the 2016 TNI Standard
Question: The standard does not explicitly state that a laboratory must have a legitimate copy of the TNI standard. However section 4.3.1 indicates laboratories must "control all documents that form part of its management system" and specifically mentions standards. Section 4.3.2.2(a) states "authorized editions of appropriate documents are available." Do these two sections effectively ensure that laboratories must have a copy of the TNI standard? Note: Chris Gunning of A2LA uses these sections to require laboratories they accredit to have a copy of ISO 17025 or the TNI standard depending on which accreditation the laboratory is seeking. TNI Response: Because the TNI standard contains specific requirements that laboratories must address, and because these requirements are not universally available from other sources, yes, an authorized edition of the appropriate TNI standard revision under which the lab holds accreditation must be available within the laboratory's controlled document system.
MODULE 2: QUALITY SYSTEM GENERAL REQUIREMENTS
Section: 4.3.1 and 4.3.2.2