ISO, the International Organization for Standardization, is the largest publisher of standards in the world. Established in October 1946, it is a non-governmental organization of over 160 countries, with one independent member representing each country. ISO develops quality standards for virtually every industry, and the electronics manufacturing industry is no exception. If you have a PCB design and you are looking for a manufacturing partner, you will want to partner with a Contract Manufacturer that is ISO-certified. So, what ISO certifications apply to electronics manufacturing and why is it so important when finding the right partner for your company?

ISO 9001, Quality Management– ISO 9001 is the most common certification in the manufacturing industry. ISO 9001 defines standards for quality assurance, improvement, and customer satisfaction. It helps companies meet customer expectations and improve safety standards.

AS9100, Quality Management: Aerospace- Developed in 1999, this standard builds upon the ISO 9001 and incorporates additional requirements specific to the aerospace industry. The aerospace industry is a high-stakes industry and precision, safety, and reliability are critical. For that reason, AS9100 strives for continuous improvement, defect prevention, and reduction of variation and waste in the supply chain and assembly process. Endorsed by the DoD, FAA, and NASA, AS9100 specifies QMS requirements documented and implemented by organizations that design, develop, and manufacture aerospace products.

ISO 13485, Medical Devices– Like ISO 9001, ISO 13485 is a set of Quality Management standards, but contains more stringent standards. Developed to support medical device manufacturers, it is more detailed and requires a more thoroughly documented Quality Management System. ISO 13485 ensures consistent design, development, manufacture, installation, and delivery of medical devices that are in the context of their intended use.

If you are on the lookout for a manufacturing partner for your printed circuit board and you are evaluating Electronics Manufacturing Services that are ISO-certified, you can expect them to consistently deliver safe, reliable products of superior quality. While ISO certification is not required of all manufacturers, it is recommended that you, as a customer, team up with a manufacturing partner that holds the certification. From an EMS’s perspective, the benefits of getting ISO-certified far outweigh the challenges. It should be noted that cost of implementation, ongoing evaluation requirements, and unclear benefits are among the top reasons cited for not pursuing ISO certification. For those reasons, some manufacturers may claim to be “ISO compliant” as opposed to “ISO -certified.” Being compliant may mean they follow the standards as best as possible, but there is no oversight ensuring that. As a product designer looking at

partnering with an ISO -certified manufacturer, you can see how the benefits to the contract manufacturer would also benefit you, the customer, looking to sell and widely distribute the end product.

An ISO certification confirms the quality of the products and services by the holder, creating added value to the EMS provider. An ISO certification cannot be bought. Knowing that an EMS’s certification was attained as a result of a neutral party confirming the level of quality of services, the customer can have confidence in their product. The implementation of the ISO process is followed by an audit performed by an external accredited body not affiliated with the EMS provider. A manufacturer that is ISO-certified will also have better trained staff. Since the certificate is not indefinite, it must be renewed at specific intervals, which forces the company to continuously implement training for all staff subject to the ISO-certified processes. In addition, the standards allow for clear divisions of responsibility between the departments, resulting in better team organization. Work is performed according to clearly defined norms and standards and the framework within which an employee should operate and perform their duties is clearly defined. At Janco Electronics, we are ISO 13485 certified and will be working toward an AS9100 certification in the coming years.

There can be a lot of noise to work through when deciding who to partner with when your PCB is ready for production. Make sure your criteria for appropriate manufacturing partners include only those that are ISO-certified. By partnering with an ISO-certified EMS provider, you are ensuring product quality, safety, and compliance with global standards. After all, the design of your PCB is just one aspect of the integrity of your product; quality assembly is the other. Customers have sometimes spent years designing, prototyping, and iterating their products before they are ready for production. The decision regarding the electronics manufacturing partner should be made with just as much care and thought.