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29 June 2007
FIND receives ISO 13485:2003 and ISO 9001:2000 certification
Since its launch in 2003, FIND has strived to put in place standard operating procedures in all areas of its operations as a means for achieving quality performance. These processes have enabled FIND to pursue the development of rapid, accurate and affordable diagnostic tests for the developing world in partnership with academia, public and private research institutions, and industry.
On 29 June 2007, these procedures or quality management systems (QMS) were audited by the SWISS TS / TÜV-Süd authority who confirmed that all processes at FIND were structured, organized and documented at a very high level and that ISO standards were being implemented throughout the organizational procedures. FIND will continue to maintain and constantly improve this quality standard of management.
Dr. Giorgio Roscigno, Chief Executive Officer, stated: “This is a very important cornerstone in the history of FIND. We have strived from the very beginning to establish quality management practices that are identical to those used by for-profit industries. We are particularly proud of this achievement, especially because we have implemented these standards in a non-profit diagnostics organization and have established outstanding quality assurance norms.”
In its core business area, FIND’s Project Management was implemented in 2004 with the valuable assistance of Dr. Ralf Linke, who remarked: “ISO certification of FIND’s Project Management is testimony to the concerted efforts and achievements not only of the project management team but also of the Project Leaders who have greatly contributed to the success of our diagnostics pipeline development.”
In view of the fact that the entire organization qualified for certification, the ISO certification underscores FIND’s confirmed QMS with respect to IVD development from proof of concept to evaluation and demonstration.
“The International Standards certification covers FIND’s operations in the areas of Project Management, Finance, Quality Assurance, Logistics, Human Resources and Communications, in other words, all functional departments, and we are very pleased to have received this recognition,” said Dr. Bärbel Porstmann, who is responsible for Quality Management at the foundation.
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