SGS Tekniks is proud to announce that we are now EN ISO 13485:2012 certified. To become EN ISO 13485:2012 certified, SGS Tekniks underwent an evaluation process that included: quality management system development, a management system documentation review, pre-audit, certification assessment, and clearance of non-conformances, all of which work to identify and implement counter measures that eliminate non-conformance to the quality management standard.
ISO 13485:2003 & EN ISO 13485:2012 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 regulatory requirements.
SGS Tekniks’s decision to become EN ISO 13485:2012 certified is a proactive one that not only anticipates the demands of our customers, but also demonstrates a commitment to providing quality products and services to all current and future customers. To maintain our certification, SGS Tekniks will perform audits to ensure compliance and to assess initiatives for continued improvement.
This certification further strengthens our commitment to our customers and our Company Quality Policy.
Click here to download our ISO 13485:2003 & EN ISO 13485:2012 certificate