 Blatek is currently deploying a Quality Management System compliant with ISO 13485 and is being developed under the FDA GMP guidelines. We have made the commitment to achieve the coveted ISO 9001 and ISO 13485 quality standards by Quarter
4 of 2007. ISO 13485 is the internationally recognized standard for quality management in the medical device industry. The new Quality Management System is being developed and deployed by a team that is dedicated to Quality initiatives with full support from the management team. Blatek has a development team led by the Quality Manager, who has 19 years of experience in the Quality field, and is a certified Lead Internal Auditor for ISO 13485 by RAB/QSA. The ISO 13485 standard for quality management systems will allow us to reach new heights in production efficiency, customer service, and quality.
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