Summit Imaging, a technology-focused ultrasound medical equipment support company, announced that it has earned ISO 13485:2003 and ISO 9001:2008 certifications from the National Standards Authority of Ireland (NSAI) for its repair and support services of ultrasound medical equipment.
To earn the certifications, Summit underwent an extensive development and implementation process of the Quality Management System (QMS), culminating in a multi-day certification audit by NSAI. The International Organization for Standardization (ISO) is the world’s largest developer and publisher of international standards for the implementation of QMS and various other technical and operational procedures. Both certifications recognize Summit’s dedication to operating at the highest business standard possible and providing quality repair and support service.
The ISO 13485:2003 certification specifies the requirements an organization’s QMS must meet to demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements.
The ISO 9001:2008 certification is presented to an organization with a QMS that aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system, and the assurance of conformity to customer and regulatory requirements. The company reports that earning both ISO 13485:2003 and ISO 9001:2008 certifications became a strategic priority in 2013.
Summit Imaging’s services include end-to-end customer support, including hands-on training courses, repairs, parts replacement, free 24/7 technical support, an extended warranty on parts and services, and the ability to diagnose most problems over the phone in under nine minutes. For more information about the company’s ultrasound equipment support resources, visit the Summit Imaging website.