【国外标准】 Standard Practice for Competency Requirements of Reference Material Producers for Water Analysis

4.1 This practice is for the use by RM producers in the development and implementation of their quality system and by those concerned with assessing the competence of RM producers. It should be recognized that a RM needs to be characterized mainly to the level of accuracy required for its intended purpose (that is, appropriate measurement uncertainty). The RM producer shall describe the procedure for establishing the quality of materials as a component of the quality system.4.2 This practice is for the use of RM users in the establishment if a RM producer has a quality system adequate to produce high quality RMs. It can be used by users to determine if the scientific and technical competence of a RMs producer is adequate to ensure the quality of RMs. This practice is consistent with the requirements for RM producers established in ISO Guide 34.4.3 This practice does not specify specific protocols for the contents of RMs certificates of analysis, for calibration in analytical chemistry and use of certified RMs and for certification of RMs. For this information, users are referred to Practice D6362, ISO Guide 32, and ISO Guide 35.1.1 This practice establishes the general requirements with which a reference materials (RM) producer has to demonstrate that it operates, if it is to be recognized as competent to produce RMs used for water analysis.1.2 This practice establishes the quality system requirements in accordance with which waters RMs shall be produced. It is intended to be used as part of a RM producer’s general quality assurance (QA) procedures. RM producers shall define their scope in terms of the application, the measurement methods used in the homogeneity, stability, and characterization studies.1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.