SOLUTIONS
Quality Assurance
Quality is at the forefront of everything that we do because lives depend on us. We maintain a manufacturing culture of quality and compliance. Our quality vision ensures consistent high quality and compliance on every project, at every stage of the product manufacturing cycle. (Carolina precision)
Repeatable outcomes. Measurable performance benchmarks. Consistent quality standards. At Velosity we do not start a project without conducting advanced quality planning, establishing a qualification process, creating a process control plan (Cpk/Ppk studies) and planning for ongoing production evaluation. (Team site)
Our cross functional team performs a detailed analysis to look for potential failures before we begin–that helps us solve problems up-front rather than during the manufacturing process where it can cost you time and money.
Velosity offers multiple state-of-the-art coordinate measuring machines (CMMs) run by experienced technicians and all of our CMMs operate with the most current version of PC-DMIS software. Velosity also uses a programmable video measurement system with QC-3000 software. We use QC-Calc software for data comparison.
CODES & CERTIFICATIONS
UL Recognized
FDA Registered
Number: 2183970
ITAR, JCP/DDTC
& SAM Registered
QUALITY ASSURANCE
Metrology
Velosity makes metrology easy with multiple state-of-the-art coordinate measurement machines (CMMs) and vision systems run by experienced metrology technicians. All of our CMMs operate with the most current version of PC-DMIS software. Velosity is ISO, ITAR, and AS100 certified by our registrar, TUV America, Inc.
Our 111,000-square-foot, climate-controlled facility is registered with the FDA and operates under Current Good Manufacturing Practices (CGMP). Whether you have ultra-small or large format inspection requirements, we have the equipment and personnel available to assist you with all your metrology needs.
QUALITY ASSURANCE
Validation &
Qualitification
Velosity recognizes that uncompromising quality is imperative to the success of our customers. The world’s leading medical device companies collaborate with Velosity for the design and production of complex medical device components. Our rigorous quality system drives every aspect of the process, from supplier selection, inspection, and documentation to product validation. Whether validation protocols are developed by our customers, by Velosity, or preferably in concert with our customers, our experienced team of experts can support all of your validation requirements. From metrology to component qualification to full IQ/OQ/PQ validation, Velosity provides best-in-class validation results. Be assured that when your product leaves our facility, it will meet all specifications you expect from Velosity.
QUALITY ASSURANCE
ISO 9001:2015
Velosity has met the requirements for ISO 9001, which defines an ISO 9001 Quality Management System (QMS). ISO 9001 evaluates whether your Quality Management System is appropriate and effective while forcing you to identify and implement improvements. The ISO 9000 family is a set of five quality management systems standards that help organizations meet customer and other stakeholder needs within statutory and regulatory requirements related to a product or service.
QUALITY ASSURANCE
AS9100D
AS9100 is a widely adopted and standardized quality management system for the aerospace industry. To help prevent counterfeit parts, AS9100D makes recommendations, including the appropriate training of employees to recognize and prevent the use of counterfeit parts and developing controls to ensure parts and components were sourced from the original or authorized manufacturers.
Velosity has made AS9100 part of the internal process to maintain high-end quality product safety and reliability throughout the organization.
QUALITY ASSURANCE
ISO 13485:2016
Velosity has met the requirements for ISO 13485: Quality Management System for Medical Device Manufacturing. ISO 13485 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.
FDA Registered
As a contract manufacturer of medical device components and finished devices, Velosity is FDA Registered.
QUALITY ASSURANCE
ITAR, JCP/DDTC and SAM Registered
The United States government requires all manufacturers of defense products and services be International Traffic in Arms Regulations (ITAR) compliant. Velosity is ITAR compliant and carries the necessary JCP/DDTC and System for Award Management (SAM) registrations. Velosity has been approved by the IRS and the DLA to work directly with the Federal Government to sell products and/or services, and stands ready for strategic partnerships in the defense and aerospace industries, supporting all product manufacturing requests without the delay of not having these necessary licenses.
Professional Associations
Velosity maintains several professional associations, including Manufacturers Association for Plastics Processors (MAPP), The National Armaments Consortium (NAC), Defense Alliance, Manufacturers Alliance, Minnesota Precision Manufacturing Association (MPMA), and Medical Alley.
