SOLUTIONS
Quality Assurance
At Velosity, quality is the cornerstone of our manufacturing culture, driving every action we take—because lives depend on us. From advanced engineering and design to precise manufacturing, quality assurance disciplines are integrated into every phase of our process. Exceptional mold and component fabrication begins with advanced quality planning, customer-approved qualification processes, comprehensive process control plans (Cpk/Ppk studies), and strategies for ongoing production evaluation.
Our cross-functional team performs detailed analyses of each component or assembly to proactively identify and resolve potential failure modes before production begins. By addressing potential challenges upfront, we ensure smoother manufacturing, saving time and resources while delivering repeatable, high-quality outcomes.
Velosity is equipped with state-of-the-art coordinate measuring machines (CMMs) operated by skilled technicians using the latest software for unmatched precision. We also leverage advanced programmable video measurement systems, including OGP, MicroVu, and Keyence, alongside QC-Calc software for data analysis and comparison. These tools and processes allow us to maintain the highest standards in quality assurance.
Our dedication to excellence ensures that the molds and components we manufacture meet or exceed customer expectations, delivering tangible benefits such as:
- Enhanced product life cycles
- Reduced cycle times
- Consistent part dimensional reproducibility
- Interchangeable mold components
With a commitment to quality and innovation, Velosity delivers solutions that exceed industry standards and empower our customers’ success.
CODES & CERTIFICATIONS
Forest Lake
ISO 13485:2016
Brooklyn Park
ISO 13485:2016
Forest Lake
AS9100D
ISO 9001:2015
Brooklyn Park
AS9100D
ISO 9001:2015
UL Recognized
ITAR, JCP/DDTC
& SAM Registered
QUALITY ASSURANCE
Metrology
Velosity makes metrology straightforward and precise with multiple state-of-the-art coordinate measurement machines (CMMs) and advanced vision systems operated by experienced metrology technicians. Our equipment runs on the latest PC-DMIS and Zeiss Calypso software, ensuring cutting-edge accuracy and reliability. Velosity is certified to ISO 13485:2016, ITAR, AS9100D, and ISO 9001:2015 standards by our registrar, TUV America, Inc., reflecting our unwavering commitment to quality and compliance.
QUALITY ASSURANCE
Validation &
Qualification
At Velosity, we understand that uncompromising quality is essential to the success of our customers. The world’s leading medical device companies trust Velosity for the design and production of complex medical device components. Our rigorous quality system informs every step of the process, from supplier selection, inspection, and documentation to comprehensive product validation.
Whether validation protocols are developed by our customers, by Velosity, or collaboratively, our team of experienced experts is ready to support all your validation needs. From metrology and component qualification to full IQ/OQ/PQ validation and PPAP support, Velosity delivers best-in-class results tailored to your protocol requirements.
When your product leaves our facility, you can be confident it will meet all specifications and quality standards you expect from Velosity.
QUALITY ASSURANCE
ISO 9001:2015
Velosity has achieved ISO 9001:2015 certification, demonstrating our commitment to maintaining a robust Quality Management System (QMS). This certification ensures that our processes are both appropriate and effective, enabling us to deliver products and services of consistent, high quality.
ISO 9001:2015 emphasizes customer satisfaction and continuous improvement, requiring organizations to identify and implement enhancements that meet customer needs as well as statutory and regulatory requirements. ISO 9001:2015 provides a framework for meeting the expectations of customers and stakeholders while upholding the highest quality standards.
QUALITY ASSURANCE
AS9100D
AS9100D is a widely adopted and standardized quality management system tailored for the aerospace industry. It includes robust recommendations to help prevent counterfeit parts, such as training employees to recognize and avoid counterfeit components and implementing stringent controls to ensure parts and materials are sourced only from original or authorized manufacturers.
Velosity has fully integrated AS9100D into our internal processes, reinforcing our commitment to delivering high-quality products with exceptional safety and reliability throughout our organization.
QUALITY ASSURANCE
ITAR, JCP/DDTC & SAM Registered
Velosity complies with the United States regulations as a manufacturer of defense-related products. Velocity is fully International Traffic in Arms Regulations (ITAR) registered and holds the necessary Joint Certification Program/Directorate of Defense Trade Controls (JCP/DDTC) and System for Award Management (SAM) registrations.
Additionally, Velosity has been approved by both the IRS and the Defense Logistics Agency (DLA) to work directly with the Federal Government. This ensures we are prepared to support strategic partnerships within the defense and aerospace industries, providing seamless support for all product manufacturing requests without delays associated with licensing requirements.
QUALITY ASSURANCE
ISO 13485:2016
Velosity has met the requirements for ISO 13485:2016: Quality Management System for Medical Device Manufacturing. ISO 13485:2016 is the medical industry’s optimal medical device standard, which ensures that all medical devices meet the proper regulatory compliance laws and customer needs.
QUALITY ASSURANCE
UL Recognized
Velosity produces various parts and assemblies which are classified or listed by Underwriters Laboratories.
Professional Associations
Velosity maintains several professional associations, including Manufacturers Association for Plastics Processors (MAPP), The National Armaments Consortium (NAC), Defense Alliance, Manufacturers Alliance, and Minnesota Precision Manufacturing Association (MPMA).
