CILcare, a CRO specialized in hearing disorders, announced that it has been awarded the ISO 9001:2015 certification for its quality management system that includes the conduct of pharmacokinetics, efficacy, tolerance, and ototoxicity studies of drugs, gene and cell therapies, and implantable devices.

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“We are elated with our ISO 9001 certification which wholly reflects our high-quality policies,”  said Celia Belline, CILcare’s CEO. “Quality is an essential building block in CILcare’s overall strategy and part of our DNA. The ultimate goal of CILcare’s activity is to provide health solutions to improve the lives of patients, by protecting or restoring an essential sense: hearing. This mission is intrinsically linked to a strong public health issue, and at every level of the company, we measure the responsibility we have towards patients.”

Building on this commitment, CILcare achieved what it describes as a “novel milestone with its ISO 9001 certification, further strengthening its ability to offer customers and partners the best R&D services.”

“We want CILcare to be responsible and sustainable. We believe that this goal can only be achieved with a strong quality system and a fair and ambitious performance management process,” said Marie-Pierre Pasdelou, Chief Regulatory Officer.

ISO 9001:2015 is an internationally recognized standard for creating, implementing, and maintaining a quality management system. It helps businesses prove their ability to consistently provide products and services that meet customer and regulatory requirements. The certification aims to enhance customer satisfaction through the effective application of a company’s system, including processes for continual review and improvement.

This certification, obtained after an extensive external audit performed by Bureau Veritas, an ISO certification organization, reflects the willingness of CILcare to “always operate in a high-quality environment with a continuous improvement mindset, since its inception.” CILcare’s ISO 9001:2015 audit was performed in September 2021.

“It was a fantastic team effort. The certification is the clear proof of CILcare’s robust Quality Management System (SMQ), which will set the stage for long-term growth,” said Philippe Larroze-Chicot, Quality Director at CILcare.

Source: CILcare