JIS Q0034-2012
标准物质生产商能力的通用要求

General requirements for the competence of reference material producers

JIS Q0034-2012 发布历史

1.1 This Standard 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. 1.2 This Standard 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. 1.3 This Standard 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. 1.4 This Standard 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 Standard.

JIS Q0034-2012由日本工业标准调查会 JP-JISC 发布于 2012-06-20，并于 2012-06-20 实施。

JIS Q0034-2012 在中国标准分类中归属于: G04 基础标准与通用方法，在国际标准分类中归属于: 03.120.10 质量管理和质量保证,71.040.30 化学试剂。

JIS Q0034-2012 发布之时，引用了标准

• JIS Q0030 *， 2019-01-21 更新
• JIS Q0031 标准物质.证书和标签的内容
• JIS Q0035 *， 2022-03-22 更新
• JIS Q9000 质量管理体系.基本原理和词汇*， 2015-11-20 更新
• JIS Q10012 计量管理体系.测量过程和测量设备要求
• JIS Q17000 Conformity assessment -- Vocabulary and general principles*， 2022-04-20 更新
• JIS Q17025 检测和校正试验室能力的一般要求
• ISO 15189 医学实验室.质量和资格要求*， 2012-11-01 更新
• ISO/IEC Guide 98-3 扩展到任意数量的输出量
• ISO/IEC Guide 99 计量学的国际词汇.基本与一般概念与相关术语(VIM)

* 在 JIS Q0034-2012 发布之后有更新，请注意新发布标准的变化。

JIS Q0034-2012的历代版本如下：

• 1997年03月20日 JIS Q0034-1997 生产标准物质的质量系统指南
• 2001年03月20日 JIS Q0034-2001 标准物质生产商能力的一般要求
• 2012年06月20日 JIS Q0034-2012 标准物质生产商能力的通用要求

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标准号

JIS Q0034-2012

发布日期

2012年06月20日

实施日期

2012年06月20日

废止日期

无

中国标准分类号

G04

国际标准分类号

03.120.10;71.040.30

发布单位

JP-JISC

引用标准

JIS Q0030 JIS Q0031 JIS Q0035 JIS Q9000 JIS Q10012 JIS Q17000 JIS Q17025 ISO 15189 ISO/IEC Guide 98-3 ISO/IEC Guide 99

被代替标准

JIS Q0034-2001

适用范围

1.1 This Standard 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. 1.2 This Standard 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. 1.3 This Standard 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. 1.4 This Standard 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 Standard.

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