Tech-Info
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.

 

Conformity Certification 

For volumetric instruments which are kept and used for commercial purposes (e.g., medical and pharmaceutical purposes) the German "Eichordnung" dated 12 August 1988 calls for conformity certification instead of official calibration. This also applies for volumetrically relevant accessories (e.g., pipette tips for piston-operated pipettes). Conformity means: compliance of an instrument with the "Eichordnung", the German Federal Weights and Measures Regulations, Annex 12. The conformity certification procedure is described in DIN 12 600.

The conformity symbol "H" and the manufacturer code designation (for BRAND it is "B") or, on request the "Eichamt" (the German State Office of Weights and Measures, with a separate conformity symbol) certifies the product as complying with the "Eichordnung" for Official Certification and corresponding standards. In general the product itself carries the symbol of conformity or, with disposables, the packaging. (In this case there is no written certification.)

Note:
The conformity certification applies only to volumetric instruments. Therefore, thermometers and density bottles continue to be officially certified.