Globalink’s Medical Division Pursuing ISO 13485:2003 Certification

Globalink Manufacturing Solutions promises to deliver quality products that match the exact specifications of our clients. We are continually striving to enhance the level of quality that we deliver and we are currently working towards receiving our ISO 13485:2003 certification.
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.
The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements.
We are confident that this enhancement to our already strong quality management process will add to the value that we can provide out clients.