ISO 9001 is defined as the international standard that specifies requirements for a quality management system (QMS). Organizations use the standard to demonstrate the ability to consistently provide products and services that meet customer and regulatory requirements. It is the most popular standard in the ISO 9000 series and the only standard in the series to which organizations can certify. ISO 9001 helps organizations ensure their customers consistently receive high quality products and services, which in turn brings many benefits, including satisfied customers, management, and employees.
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.
Recognition is the process whereby the FDA identifies standards to which manufacturers of medical devices may submit a declaration of conformity to demonstrate they have met relevant requirements in the Federal Food, Drug, and Cosmetic Act (FD&C Act)
ITAR compliance means that organizations (wholesalers, contractors, software/hardware/technology vendors, third-party suppliers) which sell, manufacture, and distribute services or products must abide by the rules and specifications set forth by the International Traffic in Arms Regulations (ITAR).
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