Quality Management

Quality Management at IQ Corporation

IQ Corporation BV's vision for quality management is to develop and consistently deliver high-quality innovative products for diagnosis and therapy. Quality is the basic requirement for the satisfaction of our customers and the resulting competitiveness and economic success of IQ.

Quality system
IQ’s quality system is based on ISO 13485, published in 2003, and dictates quality-management standards and requirements for a comprehensive management system for design and manufacture of medical devices. IQ has met ISO 13485 conditions as well as 21 CFR 820 corresponding subparts. The company is ISO13485:2003 certified by KEMA for all activities, including research & development within both subsidiaries of IQ and in manufacturing, marketing & sales within IQ Products. All documents which are related to the quality management system of IQ are electronically kept in the software program Q-Pulse. By internal and external audits we actively maintain and improve our quality system. Our most recent external audit was performed on January 2010. Our current certificate is dated on April 09, 2010 and will be valid until February 18, 2013. Registered diagnostic products
In accordance with the guideline 98/79/EC by the European Parliament for In-Vitro-Diagnostics (IVD guideline), IQ has obtained the CE mark for its in-vitro-diagnostic products. The CE mark guarantees the highest level of safety and healthy for patients, users and third parties. For the CE mark on Cytomegalovirus (CMV) kit, IQ co-operated with the Dutch Notified Body KEMA (identification number 0344) and acquired CE certification. The Fetal Cell Count™ kit, the Leuko64™ kit and most CD monoclonal antibodies (used for diagnostic purposes) have been extensively documented and meet the requirements of the IVDD. The Technical Documentation includes detailed product descriptions, stability data, validations and descriptions of the quality management system. FDA registered facility
IQ Corporation BV is registered as a medical device establishment, performing the manufacturing of the CMV Brite™ Kit -510(k) number K951550 and the CMV Brite™ Turbo kit -510(k)number K991650.