Companies require quality injection molded components consistently. Today quality is what makes all the difference. Below are quality certifications, tools and equipment to help achieve the highest level of quality plastic components and devices.
Quality Certifications & Registrations
Quality assurance is a program for the systematic monitoring, evaluation and documentation of the various aspects of a project to ensure critical standards of quality are being met.
ISO 9001 - ISO: International Organization for Standardization, a third party organization providing confirmation that companies meet requirements for the ISO certifications. The ISO 9001:2008 certification for quality management systems are designed to help companies meet customer needs. This manufacturing certification standard is recognized globally.
ISO 13485 - ISO 13485:2003 quality certification is for companies manufacturing medical devices. Companies that achieve ISO 13485 certification are in line with the Food and Drug Administration’s QSR standards and are globally recognized for conforming to the medical device regulatory requirements. This gives the injection molding company the benefit of increased efficiency, accomplishing regulatory requirements and monitoring the effectiveness of the supply chain. ISO 13485:2003 is also a manufacturing standard respected worldwide.
FDA Registered - With FDA registration your injection molder can manufacture not only components that are distributed to a finished device manufacturer; but to manufacture finished goods device or components that are packaged or labeled for commercial distribution for health related purposes to an end user. This also means the Quality Management System has to be in compliance with the rules established under FDA quality System Regulation (QSR) as established under the 21 Code of Federal Regulation (CFR) Part 820 (Medical Devices).
ITAR - ITAR: International Traffic in Arms Regulations set by the United States government. This set of US government regulations controls the export and import of defense related product and services on the United States Munitions list, which is a list the US government deems as defense related goods, services and technology. This means your injection molder has control over the following: all employees must be able to work in the United States legally, all product identified as ITAR must be controlled, identified and secured, technical information must be identified and secured including electronic data, blue prints, BOM’s, work instructions, and email, and all facilities must be secured at all points of access as well as visitors must be escorted after access is granted.Read More