CISBIO quality management

At CISBIO, quality is considered to be the essential element in ensuring product efficiency and in guaranteeing patient and user safety.

We know that the stakes are high: on-going upgrades of our products and services reinforce our customers' confidence, and in parallel we implement organizational improvements oriented towards customer satisfaction, with higher levels of competitiveness through mastery of our organization and of non-quality costs.

CISBIO is certified ISO 9001 V2008 and ISO 13485 V2003, the latter standard defining the requirements specific to medical devices (and more specifically for In Vitro Diagnosis).

CISBIO management's commitment to quality

CISBIO clearly announced its objective of being the world leader in the field of In Vitro Diagnosis in Radio-Immuno-Analysis. Setting this objective has enabled CISBIO to identify quality as a vital and strategic element in reaching this goal. Therefore, CISBIO has decided to develop a Quality Management System, by optimizing customer relationships and by implementing a management approach adapted to the needs of an international company.

The constant updating of our procedures in conformity with the requirements of international regulations also contributes to the reinforcement of an on-going improvement approach.

CISBIO personnel can be proud of their long experience in the use of quality references, their contribution to the implementation of the Quality Management System and the reaching of these objectives.

The "CE" label

All In Vitro Diagnostics medical devices manufactured by CISBIO and distributed in the European Community carry the CE label, which guarantees that they are in conformity with the strict terms of the European Directive 98/79/CE concerning in vitro diagnostic medical devices.

The products in Appendix II list B (PSA and free PSA) have been certified by an official organization, in conformity with the regulatory obligations.

View the certificates (click to enlarge) :

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