Certifications

.decimal® is an ISO 13485:2003, 9001:2008, and 14001:2004 certified company. ISO (International Standards Organization) is a network of the national standards institutes of 156 countries. To maintain certification .decimal® must pass four stringent audits each year that verify that .decimal® is conforming to all of the requirements of each system.

ISO 13485:2003

ISO 13485:2003

An ISO 13485:2003 certification means that .decimal® demonstrates its ability to provide medical devices and related services that consistently meet customer and regulatory requirements.

ISO 9001:2008

ISO 9001:2008

An ISO 9001:2008 certification means that .decimal® focuses on specific quality requirements and applicable regulatory requirements, while working to enhance customer satisfaction and achieve continual improvement in pursuit of these objectives.

ISO 14001:2004

ISO 14001:2004

An ISO 14001:2004 certification means that .decimal® takes steps to minimize harmful effects on the environment caused by our manufacturing activities and works toward continual improvement of our environmental performance.


CE Mark

.decimal® is an ISO 13485:2003, 9001:2008, and 14001:2004 certified company. International Organization for Standardization (ISO) is a network of the national standards institutes of 156 countries. To maintain certification .decimal® must pass four stringent audits each year that verify .decimal® is conforming to all of the requirements of each system. An ISO 13485 certification is a baseline necessity along with the CE-Mark, which is a mandatory conformity mark on products placed in the European Economic Area. The CE-Mark certifies that products have met EU health, safety, and environmental requirements, ensuring consumer safety. .decimal® also holds a Japanese Foreign Medical Manufacturer Certification. These certifications grant .decimal® approval to sell medical devices in many key markets.

Achievement of ISO certifications and the CE-Mark demonstrate a corporate commitment to quality that spans all levels of the organization. They are stringent, globally-recognized standards for medical device manufacturers and service providers and they demonstrate that .decimal® has built a quality system which continuously strives for improvement while maintaining the safety and effectiveness of its medical devices.

The company is also AS9100 compliant and ITAR registered.