An introduction to electronics manufacturing certifications for contract manufacturing

When a company embarks on the journey of outsourcing electronics manufacturing, it’s paramount to ensure that the chosen manufacturing partner adheres to industry-recognized certifications that guarantee product quality, safety, and compliance with global standards. These certifications serve as a testament to the commitment of the manufacturer to uphold the highest levels of excellence in their processes. It also ensures the electronic products you entrust to them meet or exceed regulatory requirements.

The Compliance Possibilities

There is a wide range of certifications available to Electronic Manufacturing Service (EMS) providers. Knowing which ones are relevant to a company’s products is necessary to make sure the EMS can provide the quality needed in the right areas of the product. These certifications can be broken down into six groups, as listed below.

Quality Management Certifications

At the core of a reputable manufacturing process is a robust Quality Management System (QMS). The International Organization for Standardization’s (ISO) ISO 9001 certification is a gold standard in affirming that the manufacturing partner follows stringent quality management principles. This certification assures you that the entire production cycle is finely tuned to consistently deliver electronic products of superior quality.

Many firms have gone beyond the ISO 9001 standard and adopted greater quality standards, as well as specialized ISO certifications that may be more important for your products than what is now the baseline 9001 standard. Learn more about the ISO 9001 family.

Environmental Responsibility and Compliance

Environmental sustainability is an increasingly important aspect for electronic manufacturing practices. Certifications such as ISO 14001 and RoHS Compliance underscore a commitment to eco-friendly production. Each certification centers on specific aspects. ISO 14001 focuses on minimizing environmental impact, while RoHS compliance ensures that hazardous substances are restricted, contributing to a greener and more sustainable manufacturing process. Understanding what each certification is aimed at helps make sure the target compliance aspect is achieved at the CM. Learn more about RoHS and ISO 14001 environmental and management certifications.

Regulatory Compliance for Global Markets

Navigating global markets requires adherence to specific regulatory standards. The CE Marking indicates compliance with European Union regulations, CSA mark indicates similarly for Canada while FCC compliance ensures conformity with electromagnetic interference and radio frequency interference standards in the United States. These certifications facilitate market access, enabling your products to meet the diverse regulatory requirements of different regions.

Product Safety Standards

The safety of electronic products is paramount, especially when they involve electrical components. Certifications like UL (Underwriters Laboratories) and IEC Standards affirm that products undergo rigorous testing to meet safety benchmarks. These standards can vary from industry. This not only ensures the safety of end-users but also instills confidence in the reliability of the manufacturing process. Many contract manufacturers help provide product testing capabilities to help companies meet these certifications. If the market requires the product to have UL, CE, CSA, or other certifications, this is an important aspect to make sure your EMS has.

Industry-Specific Certifications

For electronic products in specialized fields, such as medical devices, the ISO 13485 certification is essential. It attests to the adherence to stringent quality standards specifically designed for the design, production, and servicing of medical devices. This certification provides the assurance that your products meet the unique demands of the healthcare industry. When building aerospace electronic products, the AS9100 standard may need to be followed to make sure the product meets the needs of these manufacturers. 

To be sure, there are more certifications for medical devices beyond ISO 13485 and AS9100 for aerospace. Careful research will need to be done to make sure that the products produced fit within the regulations of these industries, and others that may have different needs and requirements.

Government-Specific Certifications

When a company is building products for government organizations, another set of more specialized certifications and compliance policies are needed. How far into the supply chain these standards need to go can vary according to customer and product type. 

For more sensitive projects in the US government, it can go beyond part and product quality certifications.  In these cases, maintaining the security of information on the product is needed. Sometimes International Traffic in Arms Regulations (ITAR) compliance, NIST SP 800-171 compliance or other regulations may be required for the company as well as its vendors. Other governments have similar certification needs with different requirements and qualifications and may require strict siloing of information even on similar products.

Keeping record of which parts require specific certifications is critical as these organizations sometimes audit companies for compliance, as well as how this information is transmitted to outside organizations. These aspects also extend to a company’s contract manufacturers and suppliers. 

Learn more about ITAR and Protecting Controlled Unclassified Information in Nonfederal Systems (PDF)

Managing certifications effectively

As touched on above, there are essentially three sets of certifications that a company must manage: individual part certifications that go into the product, the various certifications of the manufacturing process, as well as the overall certifications the product itself must maintain for the industry and market it serves. This can be a lot of information for a company to track. It also can be difficult to make sure each of these are found when production decisions are being made. That’s why it’s almost a requirement to utilize purpose-built software to manage these details. 

For small- and medium-sized businesses, a fully featured Material Requirements Planning (MRP) system provides several tools to help manage compliance aspects. Systems like Aligni MRP are designed to manage the requirements for parts, vendor capabilities and the end product’s specifications – this includes certifications and compliance needs. MRP systems are also built to make it easy to communicate these aspects to everyone inside the organization, as well as to suppliers like EMS providers. This communication capability combined with its single point of information storage gives MRP systems considerable advantages over homegrown spreadsheet-based systems. 

Bringing it all together

Certifications collectively serve as a comprehensive framework for excellence in electronics manufacturing. They signify a commitment to quality, safety, environmental responsibility, and regulatory compliance, but they also require in-depth research and stringent process management for both you and your vendors. As you explore outsourcing partnerships, prioritizing manufacturers with these certifications ensures that your electronic products not only meet but exceed the highest industry standards.

If you’re looking to manage compliance and certification aspects within any part of your supply chain – or the entire chain – then it’s time to move to a software system that can help reduce errors, streamline communication, and accelerate operations. It’s time to migrate to Aligni MRP.