ISO/IEC Guide 99:2007 provides a set of definitions and associated terms, in English and French, for a system of basic and general concepts used in metrology, together with concept diagrams to demonstrate their relations. Additional information is given in the form of examples and notes under many definitions.
This Vocabulary is meant to be a common reference for scientists and engineers, as well as teachers and practitioners, involved in planning or performing measurements, irrespective of the level of measurement uncertainty and irrespective of the field of application. It is also meant to be a reference for governmental and inter-governmental bodies, trade associations, accredi�tation bodies, regulators and professional societies.
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Guide 34:2009 specifies general requirements in accordance with which a reference material producer has to demonstrate that it operates, if it is to be recognized as competent to carry out the production of reference materials.
Guide 34:2009 is intended for the use by reference material producers in the development and implementation of their management system for quality, administrative and technical operations. Reference material customers, regulatory authorities and accreditation bodies may also use it in confirming and recognizing the competence of reference material producers.
Guide 34:2009 is not intended to be used as the basis for conformity assessment by certification bodies.
Guide 34:2009 sets out the management system requirements in accordance with which reference materials shall be produced. It is intended to be used as part of a reference material producer's general quality assurance (QA) procedures.
Guide 34:2009 covers the production of certified and non-certified reference materials. For non-certified reference materials, the production requirements are less stringent than for certified reference materials. The minimum requirements for the production of non-certified reference materials are specified throughout the Guide.
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ISO Guide 80 outlines the essential characteristics of reference materials for quality control (QC) purposes, and describes the processes by which they can be prepared by competent staff within the facility in which they will be used (i.e. where instability due to transportation conditions is avoided). The content of this Guide also applies to inherently stable materials, which can be transported to other locations without risk of any significant change in the property values of interest.
The primary audience for this Guide is laboratory staff who are required to prepare and use materials for specific in-house quality control applications. Preparation of QCMs, where transportation is a necessary component of the supply chain, such as laboratory sites at different locations or for proficiency testing schemes, should conform to the relevant requirements of ISO Guides 34 and 35.
The description of the production of reference materials (RMs), as detailed in ISO Guide 34 and ISO Guide 35 is also applicable to the preparation of quality control materials (QCMs). However, the requirements for "in-house" QCMs are less demanding than those for a certified reference material (CRM). The preparation of QCMs should involve homogeneity and stability assessments, and a limited characterization of the material to provide an indication of its relevant property values and their variation, prior to use. This document provides the quality criteria that a material should fulfil to be considered fit-for-purpose for demonstrating a measurement system is under statistical control. Guidance on uses of such materials is not included in this Guide.
The layout and structure of this Guide provides general information on the preparation of QCMs in the main chapters, with specific case studies covering a range of sectors in the annexes. The case studies are not complete "process manuals" but are included to highlight some of the key considerations when preparing QCMs. The case studies vary in complexity and detail, including sector specific terminology, but provide a range of information for laboratory staff to draw from.
It is expected that those involved in QCM preparation will have some knowledge of the type of material to be prepared and be aware of any potential problems due to matrix effects, contamination, etc.
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ISO/TR 10989:2009 covers:
the results of a study into, and comparison between, existing classification and categorization schemes for reference materials,
the development of reference material (RM) features and characteristics upon which a harmonized and consistent categorization scheme could be based, and
approaches for making the categorization scheme adaptive to new RM needs and developments.
The development of a harmonized categorization scheme aims at facilitating a transparent and comparable presentation of reference materials by producers, and the identification of reference materials by users. The intended categorization scheme was conceived to meet the needs of modern forms of information presentation and retrieval, i.e. internet-based catalogues and databases, and has been developed specifically with the view to being used this way.
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