Quality management

Quality management is briefly described for liquid handling instruments and BLAUBRAND® volumetric instruments.

Quality management at BRAND begins at product conception and continues through the design process and production. Routine checks throughout the entire manufacturing process result in volumetric instruments with the smallest possible deviation from the true volume (accuracy) and narrow scatter of individual values (coefficient of variation). The final step of this Statistical Process Control is random finished product sampling according to DIN ISO 3951.

The quality management system applied at BRAND and certified to DIN EN ISO 9001 is a combination of process monitoring and random checks. The accepted quality level (AQL) is at the very least 0.4., i.e., the limiting values are met with a statistical certainty of at least 99.6 %. All measuring instruments used in quality control are regularly checked and are referenced to the national standards of PTB (The German Federal Institute of Physics and Metrology). Quality management according to DIN EN ISO 9001 is the basis for issuing of calibration certificates (e.g., our certificates of performance).

All test results are documented and filed for 7 years. If the batch or serial number is known, each specific test result on the date of production can be traced. As BRAND manufactures conformity certified volumetric instruments, the quality of products is automatically supervised by the "Eichamt", the German State Office of Weights and Measures. The requirements for monitoring of measuring instruments, traceability to national standards, and staff qualification are fully met.

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

One batch certificate per packing unit!

All reusable BLAUBRAND® volumetric instruments are individually calibrated and are supplied with one batch certificate per packing unit. This facilitates the initial performance verification – also with the monitoring of measuring equipment – as the data can directly be transferred from the certificate. Batch and individual certificates can also be downloaded here.