You have many things to consider when choosing an electronics contract manufacturer. Although you’ll probably spend some time negotiating price and other important aspects of your contract, electronic manufacturing certifications should remain non-negotiable. These important industry certifications ensure the CM you work with meets rigorous quality expectations as required by the industries they serve. Without proper certification, the CM simply cannot guarantee quality or that the product produced meets industry-specific regulatory compliance standards.
General Certification – ISO 9001
The International Organization for Standardization (ISO) 9001 certificate shows that the contract manufacturer has implemented and maintained a quality management system. This certification is internationally accepted and proves that the CM consistently meets customer requirements and continues to strive to improve product quality.
Medical Device Industry Certification – ISO 13485
ISO 13485 is required for a CM to design and/or produce devices for the medical industry. This important certification ensures the CM has effectively implemented and maintained its quality management system. It also ensures the CM implements certain controls and protocols to ensure product safety.
I order to achieve ISO 13485 certifications, contract manufacturers must meet specific requirements for testing, inspection, and product traceability.
Aerospace Industry Certification – AS9100
Aviation Space (AS) 9100 certification encompasses all requirements for ISO 9000 as well as additional aerospace industry-specific quality and safety standards. In order to receive AS9100 certification, a CM must display an emphasis on risk management, adopt proven production processes, and pass an AS9100 audit.
When selecting a CM, it never hurts to ask to see their certification documents. CMs that have taken the time to obtain industry-specific certification are generally happy to provide this information on request. If the CM tells you otherwise, or fails to provide the appropriate documentation, it’s probably best to take your business elsewhere.
Means Engineering offers contract manufacturing services to organizations across a wide range of industries. We are proud to hold several industry-specific certifications including ISO 9001, ISO1 3485, and AS9100. Please contact us for more information about our contract manufacturing services.