Quality

   Committed to Quality, Blatek has achieved the coveted ISO 9001 and ISO 13485 certification in February of 2009. ISO 9001 recognizes the requirements for a good quality management system. ISO 13485 is the internationally recognized standard for quality management in the medical device industry. Blatek has deployed a Quality Management System compliant with ISO 9001 and ISO 13485 developed under the FDA GMP guidelines. Our Quality Management System has been 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 13 years of experience in the Quality field, and also includes a certified Lead Internal Auditor for ISO 13485 by RAB/QSA. The ISO 9001 and ISO 13485 standard for quality management systems will allow us to reach new heights in production efficiency, customer service, and quality.

   Blatek has also instituted a company-wide quality system addressing the FDA regulations governing Current Good Manufacturing Practice (CGMP) 21CFR820. A well structured functional quality system is essential to any company seeking continued growth and success in providing the highest quality goods and services to their customers. To that end, Blatek has set forth to reinforce its long standing position by establishing and maintaining an up to date quality system.