.decimal Obtains ISO 13485:2003 Certification for Medical Device Quality Management System
Today’s announcement highlights .decimal’s commitment to achieving the highest degree of quality while supporting the company goal of exceeding customer expectations. By obtaining the ISO 13485 certification, .decimal meets global quality design and manufacturing requirements for medical devices. An ISO 13485 certification is a baseline necessity for approval to sell medical devices in many key markets and therefore supports .decimal’s plans to offer its products to nations around the globe.
Achievement of the ISO 13485 certification marks a corporate commitment to quality that spans all levels of the organization. It is a stringent, globally-recognized standard for medical device manufacturers and service providers. This great accomplishment affords .decimal a competitive edge in the market by ensuring superior service and quality products to its customers. It demonstrates that .decimal has built a quality system which continuously strives for improvement while maintaining the safety and effectiveness of its medical devices.
ISO 13485:2003 requires monitoring and maintaining of the quality system and its related processes and procedures. These requirements ensure increased focus on our primary goal of patient safety by delivering
- The right part,
- To the right patient,
- At the right time.
.decimal will also continue to maintain its ISO 9001 quality management system certification and its ISO 14001 environmental management system certification. All three certifications are internationally-recognized standards.
For more information on .decimals certified Quality and Environmental Management Systems please contact the Quality Department at quality@dotdecimal.com or via phone at 1.800.255.1613. Click here to view our ISO certificates.