Quality management
By quality we mean the expert performance, free of faults, of our products and services, with due regard for all the requirements and conditions that you may have as a customer and in a manner which is pleasant to you.
Our aim is to realise this to the greatest extent possible. For this reason, a comprehensive and uniform quality management system has been established in QInstruments, which represents the basis for EN ISO 9001 ff compliant development and production, for numerous accreditations, certifications and licences.
Moreover, it is a matter of great importance that technical and personal development is ongoing, so as to enable our company to achieve its quality targets. Our personnel develop their competence by concentrating on recognising customer requirements correctly and completely and performing the services required in accordance with the customer's wishes.
Our daily contact with environmental matters has made us sensitive to the need of protecting our resources. For this reason, our quality management system has in some locations been augmented by the addition of an environmental management system.
The compliance with the EG-Directive 2011/65/EU - RoHS ("Restriction of the use of certain Hazardous Substances") - is our top priority.
Quality Control
The quality management process of Q.Instruments guarantees a constant quality of manufactured products. In order to realize this policy we have introduced a quality management system, that controls and evaluates all products and processes in the company and takes care of all necessary corrections and adjustments.
The verification of these facts is assured through the operation of a control and inspection system:
- ID-Tracking of all parts and assemblies through bar code labels
- Batch tracking of all parts and assemblies
- Serial number tracking of all products
- Inspection of incoming goods
- Inspection during production/assembly process
- Calibrations and adjustments (automated and semi-automated)
- Life time tests
- Development of test and verification tools for temperature and mixing parameters
- QC analysis and documentation (QC database, final test reports, certificates, etc.)
- QC Audits through Key Account Customers
- Continuous improvement processes
- Safety tests and CE approvals
Inspection and CE marking
Each manufacturer of laboratory instruments and medical devices bear a heavy responsibility for its products. These have to comply with legal requirements and EU regulations.
The products under the labels QInstruments and BioShake be developed and produced according to applicable European directives and requirements in conformity with legal provisions, such as the WEEE/RoHS2 directive and product safety law (GPSG). The sign GS (tested safety) and CE (Conformité Européenne) are the only statutory marks in Europe for product safety.
CE Declaration of Conformity
BioShake devices meet the basic health and safety requirements and applicable EC directives/standards of:
- 2014/30/EU – The Electromagnetic Compatibility Directive
- 2011/65/EU – Restriction of Hazardous Substances Directive
- 2015/863/EU amending Annex II to Directive 2011/65/EU
- DIN EN 61010-1:2020-03
- DIN EN 61010-2-010:2015-05
- DIN EN 61010-2-051:2016-02
- DIN EN 61326-1:2013-07
- DIN EN IEC 63000:2019-05