It is our policy to promote, with the leadership of our management, a total commitment to quality by each individual throughout our organization worldwide. It is our goal that this commitment to quality will result in complete customer satisfaction with both our products and our services. For this purpose, we have established and implemented a formal quality system. Performance of our quality system is monitored to ensure that we are meeting our customers’ requirements and that we continually improve the effectiveness of the system and our progress in achievement of our goal.
ISO 9001 Certification
At Gilson, we are committed to quality . . . and it shows in everything we do—from design to manufacturing, from technical support to training. Due to our commitment to quality and customer satisfaction, Gilson has consistently been awarded ISO 9001 certification. As a result of audits conducted by an independent third party registrar, you can be assured that our products are the result of well defined and controlled processes. Gilson, Inc., Gilson S.A.S., Gilson International B.V., Gilson (Schweiz) AG, and Gilson UK are ISO 9001 certified.
ISO 13485 Certification
ISO 13485 certification defines Gilson’s robust Quality Management System demonstrating our capability to meet both customer and regulatory requirements. Achieving and maintaining this certification is a strategic decision by Gilson to further enhance our existing ISO9001 Quality System in the areas including, but not limited to, traceability, risk management, and design processes in a highly regulated market.
Accreditation of the Gilson Pipette Calibration Laboratory in France
Many countries around the world have one or more organizations responsible for the accreditation of their nation’s laboratories. Most of these accreditation bodies have now adopted an international guide, called ISO 17025.
The ISO 17025 contains “all the requirements that testing and calibration laboratories have to meet if they wish to demonstrate that they operate a quality system, are technically competent, and are able to generate technically valid results.” ISO 17025-2005
In France, the recognized accredited organization is called COFRAC, in the United Kingdom it is called UKAS and in the USA there are several accredited organizations called ANAB, A2LA, and NVLAP.
Accreditation by COFRAC ensures that the Gilson pipette calibration laboratory in France respects the ISO 17025 management and technical requirements and applies the ISO 8655 for pipette calibration by using the gravimetric method.
The calibration laboratory in France is considered an independent metrological laboratory. It is allowed to issue calibration certificates for pipettes with the COFRAC logo. The COFRAC logo proves that the measurements are linked to the International System Units.
Gilson’s Pipette calibration laboratory in France enables the Gilson service centers around the world to offer customers a new service for certified pipette calibration by using either of the two following methods recognized by the COFRAC:
- Standardized ISO 8655-6 3 x 10 measurements method without changing tips.
- Gilson gravimetric 3 x 4 measurements method.
Gilson Pipettes, CE Marking and the European IVD Directive
The products, listed on Gilson’s Certificate of CE Declaration of Conformity (attached), comply with the EC Directive (98/79/EC) for In Vitro Diagnostic (IVD) Medical Devices. We have started the process of marking our products, packaging, etc. with the CE mark.
What is the CE mark and what does it imply?
You will find CE marks on medical devices and electrical equipment.
- CE marking on a product is a manufacturer's declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislations.
- CE marking on a product indicates to governmental officials that the product may be legally placed on the market in their country.
- CE marking on a product ensures the free movement of the product within the EFTA & European Union (EU) single market (total 28 countries).
- CE marking on a product permits the withdrawal of the non-conforming products by customs and enforcement authorities.
What is the IVD Directive (98/79/EC)?
The In Vitro Diagnostic (IVD) Medical Device Directive (98/79/EC) is the third in a series of European Directives on medical devices intended to provide regulations for the safe manufacture, supply and use of devices in Europe. It applies to all devices that meet the following definition.
‘In Vitro Diagnostic Medical Device’ means any medical device that is reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:
- Concerning a physiological or pathological state, or
- Concerning a congenital abnormality, or
- To determine the safety and compatibility with potential recipients, or
- To monitor therapeutic measures
Caution! This means that the Gilson products can be used for in vitro diagnostic tests in laboratories. It does not imply that Gilson products may be used directly on human beings for any medical or clinical purposes.
Click on the pdf link below to download the certificate of CE Declaration of Conformity (LT801500) for your records, in accordance with Good Laboratory Practice.