Important Certifications of Contract Electronic Manufacturers

Outsourcing electronic production is a major strategic action. It enables you to concentrate on your core strengths which are design, marketing and sales as professionals address the issues of assembly and production. But to be able to give out your product designs it takes a great deal of faith. What makes you believe that contract electronic manufacturers are up to the task?  

The solution is in certifications.

Certifications are not merely badges on a web site, they are thorough, third-party certifications of the processes, quality levels and compliance of a manufacturer. In the case of the original equipment manufacturers (OEMs), being aware of these standards is the initial safeguard against low quality, regulatory penalties, and supply chain failures.

Important Certifications of Contract Electronic Manufacturers

Not every certification is applicable to each project. Nevertheless, there is no room to discuss a compromise concerning the minimum level of quality control, and particular sectors, such as medical or aerospace, presuppose special compliance. These are the main standards to be considered.

The Quality Management Baseline- ISO 9001

When a prospective partner lacks the ISO 9001 certificate, then probably you should look elsewhere. This is the global Quality Management Systems (QMS).

The ISO 9001 is used to make sure that the manufacturer maintains a uniform process to achieve customer and regulatory demands. It means the commitment to the constant improvement and customer satisfaction. Although it is an overarching requirement that can be applied to all industries, in electronics production it is an indication that the factory floor is not a place where the rule of thumb is applied.

Critical Medical Devices ISO 13485

In the health care case of OEMs, ISO 9001 does not suffice. You require a partner that has certification to ISO 13485.

This standard is specifically in relation to QMS requirements regarding the design and the manufacture of medical devices. It focuses on the management of risks as well as on the sustainability of processes, and not only on continuous improvement. Due to the stakes involved in patient safety and stringent regulations by the FDA or EU MDR, this is a compliance risk that you cannot afford to partner with a CEM without this certification.

AS9100: The Aerospace Standard

When your products will be flying under the air, be it in commercial air transport, defense, or space research, AS9100 is the standard of gold.

Depending on ISO 9001 but incorporating more requirements particular to the aerospace industry, AS9100 pays much attention to product safety, reliability as well as configuration management. It also guarantees that all parts can be traced and the production process is tough to withstand the very harsh environment aerospace products are subjected to.

The IPC Standards: The Electronic Industry Language

Whereas, ISO standards are based on management systems, IPC standards are based on the real workmanship of the electronic assemblies.

·        IPC-A-610: This is a standard of inspection that is most commonly used in printed circuit board (PCB) assemblies. It specifies the acceptable and defective.

·        IPC-J-STD-001: This is a field that deals with the specifications of soldered electrical and electronic assemblies.

A reputable CEM will be not only adhering to these standards, he/she is likely to have in-house trainers (Certified IPC Trainers) to make sure that his/her staff is qualified to implement them flawlessly.

RoHS and REACH Compliance

The world is becoming increasingly strict on environmental regulations.

·        RoHS (Restriction of Hazardous Substances): limits the usage of specific harmful materials that present in electrical & electronic devices (for instance lead & mercury).

·        REACH (Registration, Evaluation, Authorization and Restriction of Chemicals): This is an EU regulation on the production and use of chemical substances.

Compliancy of your CEM to these regulations is crucial in case you have plans to sell your products to the international markets especially the EU.

Conclusion

The strategic choice of a manufacturing partner has to do with risk mitigation. A certification is evidence of the ability of contract electronic manufacturers which has been checked by an external auditor. It offers hard facts that they do not merely claim to value quality, but they do it on a daily basis.

Request to view up to date copies of these certificates before signing a contract. Ensure that they are operational and given by recognized registrars. The mere action will help you to avoid expensive recalls and bad publicity in the future. When you match your product needs with the appropriate manufacturing certifications, you establish a platform of a dependable high quality supply chain.