Certifications
The ISO 9001:2000 and ISO 13485 certifications give ART the ability not only to meet customer and regulatory requirements for SoftScan, but also to enhance organizational performance.
ISO 9001:2000
ISO 9001 certification demonstrates that ART’s quality management system complies with ISO requirements and assures customers and partners that the company has the appropriate business processes in place to meet customer and regulatory requirements.
ISO 13485
ISO 13485 is the international quality management standard for designers and manufacturers of medical devices and related services, and is harmonized with the U.S. FDA’s good manufacturing practices. ART has actively pursued this certification as part of an ongoing commitment to comply with regulatory requirements in response to the needs of the medical community worldwide.