.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 .decimal®'s 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.
