1.1 The requirements of this Document serve as a model for national responsible bodies that are considering developing, adopting and implementing regulations employing principles of quality management systems for initial verification of measuring instruments as a part of their national legal metrological control. 1.2 This Document is intended as a guideline for a national responsible body that permits manufacturers to declare conformity of measuring instruments to legal metrological requirements for initial verification, either immediately after production of the instruments or after installation and prior to their use, according to legal metrological regulations. In such cases, the national responsible body shall have in place a means for periodically validating the implementation of a manufacturer’s quality management system. 1.3 This Document provides definitions and guidelines for consideration by manufacturers that choose to implement a quality management program for measuring instruments in accordance with legal metrological requirements. It provides criteria and procedures to be applied by a manufacturer that seeks authorization to declare a newly manufactured instrument to be in conformity with requirements for initial verification according to national laws or regulations for legal metrological control. Note: The criteria and procedures may also be used by the manufacturer for production control of manufactured instruments to ensure that each manufactured instrument meets the performance requirements demonstrated during type evaluation, that is, to ensure that production meets type. 1.4 The national responsible body may recognize an existing manufacturer’s quality management system for use in declaring conformity of a specific category or class of measuring instruments to performance requirements prescribed by regulations. If appropriate and relevant, the manufacturer’s quality management system could be based in part on ISO 9001 [7]. 1.5 This Document does not address any requirements and tests necessary to meet national safety regulations for instrument users. If such regulations exist, the manufacturer shall take the necessary actions to comply.