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普兰德 : 技术信息 : 质量管理


简要介绍移液产品以及BLAUBRAND® 体积测量仪器的质量管理

BRAND 的质量管理始于设计产品伊始的理念、产品设计过程以及生产过程。贯穿整个生产过程的例行监控确保我们的体积测量仪器相对其真实测量体积拥有最小的偏差 (Accuracy) 以及最小的离散度 (Coefficient of Variation)。最后根据DIN ISO 3951 标准的统计学处理要求进行随机抽样检查。

BRAND 采用的质量管理体系正如 DIN EN ISO 9001 认证要求的那样结合了生产过程监控以及随机抽样检测。可接受质量水平 (AQL) 小于等于 0.4,也就是说统计学确定性至少为99.6%。所有在质控时使用的测量仪器均进行定期检查并符合 PTB(德国物理技术研究院)的国家标准。依照 DIN EN ISO 9001 的质量管理体系是出具校准证书(比如:性能认证证书)的基础。

所有测试结果全部具有书面记录,并且可追溯7年。只要知道批号 (batch number) 或序列号 (serial number),任何生产时的测试结果都可以被追溯。

当 BRAND 生产 conformity认证的体积测量仪器时,产品质量自动由德国国家计量局 “Eichamt” 监督。检测仪器的监测、根据国家标准的可追溯性以及员工素质可完全达标。

Legal regulation of volumetric instruments in Germany

Regarding: Volumetric instruments of glass or plastic (class A/AS only) and piston-operated volumetric instruments 

German Calibration Regulation valid until December 31. 2014

For volumetric instruments to be ready for use in legally regulated areas such as the medical and pharmaceutical fields (manufacture and testing of medicinal products), the German Calibration Regulation requ ires a Certificate of Compliance from the manufacturer. This is certified with the mark "H" and the manufacturer's code- here, "B" for BRAND.

German Measurement and Calibration Regulation valid startinq January 1, 2015
(the replacement for the Calibration Regulation)

For volumetric instruments to be ready for use in legally regulated areas such as the medical and pharmaceutical fields (manufacture and testing of medicinal products) , the German Measurement and Calibration Regulation requires a Declaration of Compliance from the manufacturer. This is met with the mark "DE-M".

Transition on January 1, 2015:

BRAND will change the mark on volumetric instruments from "H" to "DE-M" starting January 1, 2015. A complete conversion will take place over 2015. Since our volumetric instruments have historically been sold with a simple manufacturer's test and not with official calibration, our production and testing methodology will remain the same. As always , we will comply with applicable standards. As in the past, no regular official calibration during the usage phase is planned. The marks "H" and "DE-M" can be considered equivalent and both are valid for an unlimited period.            Download the Statement as PDF-file

每个包装一份批次认证证书

所有可重复使用的BLAUBRAND® 体积计量设备都随包装带有一份批次认证证书。便于初次使用时确认仪器性能 — 也可用于监测计量设备 — 可直接取证书数据。相关证书也可通过网站 www.brand.de 下载。




Titel: 质量管理

Link: https://www.brand.de/cn/tech-info/quality-management/?US=title%252525252525252525252525252525252525252525253dIsrael


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