The outcome of the first surveillance audit for the continuation of our ISO 13485: 2003 Quality Management System Certification is positive. The audit was performed by Lloyds Register Quality Assurance (Houston, TX).

Based on the areas of the quality management system assessed during this 1st Surveillance visit, The internal audit process and the quality management system of Eye Dynamics, Inc. in Torrance, CA, US meets the requirements of ISO 13485:2003 and ISO 13485:2003 under CMDCAS; therefore continued certification to ISO 13485:2003 and ISO 13485:2003 under CMDCAS is recommended.

ISO (International Organization for Standardization) is a global network that identifies what International Standards are required by business, government and society, develops them in partnership with the sectors that will put them to use, adopts them by transparent procedures based on national input and delivers them to be implemented worldwide.

ISO standards distil an international consensus from the broadest possible base of stakeholder groups. Expert input comes from those closest to the needs for the standards and also to the results of implementing them. In this way, although voluntary, ISO standards are widely respected and accepted by public and private sectors internationally.

ISO has a current portfolio of over 15 thousand standards that provide practical solutions and achieve benefits for almost every sector of business, industry and technology. ISO’s has specific standards for medical devices, information and communication technology as well as standards for services.

ISO standards level the playing field. They make transparent the requirements that products must meet on world markets, as well as the conformityassessment mechanisms for checking that those products measure up to standards.

The ISO 9000 family of management system standards include managerial and organizational practice. Complementing the above is a toolbox of ISO standards and guides for conformity assessment – covering all aspects from supplier’s declaration of conformity to third-party certification and accreditation – which is becoming a vital component of business transactions, global trade and regulatory requirements.

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