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Quality Works

Mark Kaganov established Quality Works in 1990. In early 1990th, the Company was one of the first organizations in the US to capitalize on opening of the former Soviet Union. In a joint venture effort with a Moscow-based software development group "Optimal Programming", Quality Works developed and successfully delivered custom application software for one of the leading medical device manufacturers in the US to manage their international distributor network. Since 1996 Quality Works focuses on consulting, documentation and training in the areas of quality, environmental and health and safety management systems for ISO and other standards..

Our first publication, "ISO 9001 - A Practical Guide for the Development and Implementation of a Quality Manual" was released on the Internet in November 1998. By the end of 1999 this publication was translated into Russian and published by "Standards and Quality" in Moscow. The book became an instant success in Russia. The first book was followed in August of 1999 by "EN 46000 / ISO 13485 - A Practical Guide for the Development and Implementation of a Quality Manual". This book addressed requirements of ISO 9001 and EN 46001 / ISO 13485 standards for medical device manufacturers. In continual effort to serve our customers and provide them with the new updates, in early 1999 Quality Works published the first, to the best of our knowledge, commercial ISO 9001 Quality Manual following the drafts of this standard.

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