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ISO 9001:2015 Certified

ISO 9001:2015 — Quality management systems

 

Our quality management system is based on ISO standards, helping us exceed our customers’ high standards while adhering to regulatory requirements. BIX Shanghai is ISO 9001:2015 certified— ensuring quality and excellence, on every order.

 

EN ISO 13485:2015 — Medical devices - Quality Management Systems

 

BIX already received EN ISO 13485 certification that is sometimes required for integration into medical devices. 

ISO 13485 

ISO 13485:2016 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 and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.