BioChain is Proud to Announce ISO 9001:2008 and ISO 13485:2003 Recertification

At BioChain we are committed to delivering exceptional products to our customers. Our production undergoes rigorous Quality Control and Quality Management to provide consistent quality products. The international criteria and standardization of quality management is set forth by ISO 9001:2008; however, this certification is not a mandatory requirement for all organizations. BioChain has pursued this standard since 2008 which further exemplifies our commitment to quality.

Recertification of ISO 9001:2008 signifies our continuous improvement of the quality management system and process. This qualification is based on multiple principles such as strong customer focus, involvement of top management, process approach, continual improvement, and fact-based decision making. With BioChain’s commitment to standardized auditable processes and procedures, we provide a level of excellence and transparency that our customers can depend on.

ISO 13485:2003 is another internationally recognized standard that specifies requirements for a quality management system for medical device manufacture and related services. This recertification further establishes our assurance to meet customer and applicable regulatory requirements. Recertification of these two doctrines (ISO 9001, and 13485) demonstrates BioChain’s proven commitment to quality through an internationally recognized standard.

We are driven to continually enhance and upgrade our quality system and to invest necessary resources in personnel training. By striving to employ adequate equipments and test assays, we further advance our competence levels and performances. At BioChain we are proud to pass these qualifications and are confidently positioned to serve our customers with their needs.



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