Chengdu Corder Optics & Electronics Co., Ltd.

Introduction

Chengdu Corder Optics and Electronics Co.,Ltd. has got various certificates,such as ISO 13485:2003 Quality Management System ("QMS"), ISO 9001:2000 QMS,China Registration Certificate For Medical Device (SFDA) and so on.

YY/T 0287-2003 idt ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
All requirements of ISO 13485:2003 are specific to organizations providing medical devices, regardless of the type or size of the organization.
The processes required by ISO 13485:2003, which are applicable to the medical device(s), but which are not performed by the organization, are the responsibility of the organization and are accounted for in the organization's quality management system.
GB/T 19001-2000 idt ISO 9001:2000 which gives the requirements for quality management systems, is now firmly established as the globally implemented standard for providing assurance about the ability to satisfy quality requirements and to enhance customer satisfaction in supplier-customer relationships.

China Registration Certificate For Medical Device is an approval which was awarded by China State Food And Drug Administration (SFDA).