ISO Guide 34:2009 标准样品生产者能力的通用要求

标准编号：ISO Guide 34:2009

中文名称：标准样品生产者能力的通用要求

英文名称：General requirements for the competence of reference material producers

发布日期：2009-12

标准范围

指南34:2009规定了标准物质生产商必须证明其有能力进行标准物质生产的一般要求。指南34:2009旨在供标准物质生产商在制定和实施其质量、行政和技术操作管理体系时使用。标准物质客户、监管机构和认证机构也可以使用它来确认和认可标准物质生产商的能力。指南34:2009不打算用作认证机构合格评定的依据。指南34:2009规定了标准物质生产所依据的管理体系要求。本标准旨在作为参考材料生产商一般质量保证（QA）程序的一部分。指南34:2009涵盖了认证和非认证标准物质的生产。对于非认证标准物质，其生产要求不如认证标准物质严格。本指南规定了非认证标准物质生产的最低要求。

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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