Quality assurance is a program for the systematic monitoring and evaluation of the various aspects of a project, service or facility to ensure standards of quality are being met, these should be critical for your plastic injection molder.   This begins with ISO certifications like ISO 9001:2008 and ISO 13485:2003.  Companies manufacturing defense and military related products are required to operate under ITAR, which is a set of regulations by theU.S.government for defense related services and product.  Below is a detailed description of each certification.

 ISO 9001

ISO stands for the International Organization for Standardization, which is a third party organization that provides confirmation that companies meet the requirements of the ISO certifications.   The ISO 9001:2008 certification for quality management system is designed to help companies meet the needs of their customers.  You should verify that your injection molder is ISO 9001:2008 certified.  This certification is a manufacturing standard recognized by companies worldwide.

 ISO 13485

ISO 13485:2003ISO 13485:2003 quality certification is for companies who manufacture medical devices.  This certification has special requirements not covered in the ISO 9001:2008 certification.  Companies that achieve ISO 13485 certification are in line with the Food and Drug Administration’s QSR standards and is globally recognized for conforming to the medical device regulatory requirements.  If you need plastic injection molding for the medical or pharmaceutical industry verify that your injection molder is ISO 13485:2003 certified.  This gives the injection molding company the benefit of increased efficiency, meeting regulatory requirements and helps monitor the effectiveness of their supply chain.  Just like the ISO 9001:2008 certification, ISO 13485:2003 is a manufacturing standard this is globally recognized.

 ITAR

ITAR which stands for the International Traffic in Arms Regulations set by theUnited Statesgovernment.   This set ofU.S.government regulations controls the export and import of defense related product and services on the United States Munitions list, which is a list that theU.S.government deems as defense related goods, services and technology.  These regulations dictate information and material pertaining to defense and military related technologies may only be shared withU.S.personnel unless authorization from the State Department is received.   The benefits of being ITAR certified is the ability to compete on a global level, work with companies in the military and space supply chain, provides a mechanism for the security of your facility and employees.  When your company achieves ITAR it means you have 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. 

With the defense related certification there is also the ability to acquire a JCP number, JCP stands for Joint Certification Program, which is an agreement between theUnited StatesandCanadato consult and cooperate on the development of common industrial security procedures and technology control in the joint defense ofNorth America.  If your company has attained a JCP number you can work with companies that fall in this parameter of operation.

Crescent Industries a custom injection molder and mold builder providing plastic components to the medical/pharmaceutical, defense, safety and aerospace industries, has achieved and operates under the ISO 9001:2008, ISO 13485:2003, ITAR and JCP certifications.   For more information on Crescent’s quality certifications, please click here.

 What quality certifications are important to your company?

 

 

 

Topics: Quality