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Glossary

ISO 13485
A quality standard that covers the manufacture of medical device and complies with the European IVD Directive.

ISO 8 Clean Room
An international standard for the management systems and purity level of clean rooms.

ISO 14001
An international standard for environmental management.

ISO 8655
An international quality standard for the manufacture and testing of piston-operated volumetric apparatus.

ISO 17025
General competence requirements for carrying out tests and calibrations. An accredited pipette calibration laboratory that calibrates pipettes according to precise technical requirements.

Lean management
A production philosophy based on producing goods with lower inputs and to the customer’s requirements. The aim is to ensure that the entire production and logistics chain is as streamlined as possible. It is important that the process as a whole runs smoothly. In practice, this means seeking to minimise lost working time and materials as well as unnecessary processes without negative impacts on the amount and quality of manufactured products. The process thus also yields added value for customers, as they get the products they want at the lowest cost and as fast as possible.

OEM
Original Equipment Manufacturer. The name refers to a company that designs, manufactures or packages the final product under its own name. The product may include third-party components, such as instruments, software or applications.

Performance testing
Pipette calibration verification procedures that employ gravimetrics, photometrics or other methods.

Private label
Products designed and manufactured for another company, which markets the products under its own brand name.

RoHS
Restriction of the Use of Hazardous Substances – an EU Directive that seeks to harmonise member state legislation on limiting the use of hazardous electric and electrical waste.

WEEE
Waste Electrical and Electronic Equipment Directive – an EU Directive that seeks to reduce the generation of electric and electrical waste and to promote its reuse and recycling.