Processes as complex as printed circuit board assembly (PCBA) benefit from standardization. Without guidance from international regulations, different electronics contract manufacturers (CMs) would have free rein to produce PCBs according to whatever standards suited their needs – not those of the customer. Standardization regulates the industry and benefits customers.
In an effort to improve quality consistency and customer service in electronics manufacturing, the International Standardization Organization (ISO) has stepped in to present guidelines and special industry certifications. Some of the best-known ISO standards exist in the ISO 9000 family – the set of standards that addresses quality management systems and processes. This article expands on one certification in this family: ISO 9001.
What Is the ISO 9001 Certification?
CMs should be able to provide some type of guarantee for customers in terms of quality assurance and long-term PCB performance. Otherwise, customers could waste time and money investing in a CM that produces subpar or low-quality end products. ISO 9001 helps to provide this quality guarantee to customers. ISO 9001 is the international requirement list for top-tier, Quality Management Systems (QMSs). The posterity of a manufacturer’s QMS can decide how well or how poorly the CM adheres to expected quality standards in ISO 9001.
According to the ISO website, ISO 9001 focuses on a few main goals within an organization: “strong customer focus, motivation and implication of top management, process approach, and continual improvement.” ISO 9001 encourages organizations to improve efficiency and customer satisfaction through compliance with specific requirements. These requirements change periodically to adjust to changing technologies and customer needs. The most current version of the certificate is ISO 9001:2015. ISO 9001:2015 is the only standard in the ISO 9000 family that can come in the form of a certification.
ISO 9001:2015 certification is not a manufacturing requirement. Instead, it is an additional achievement a CM can receive if it meets all the stringent quality and QMS requirements. The ISO 9001:2015 certification applies to any manufacturing company that wants to establish itself as a trusted provider in its industry. Large and small organizations, regardless of type or industry, can get the ISO 9001:2015.
What Standards Must a CM Have to Obtain ISO 9001 Certification?
More than one million organizations in more than 170 countries are currently ISO 9001-certified. Having this certification is a sign that an electronics CM is willing to go above and beyond to ensure high-quality PCBA. It can serve as a quality guarantee for customers. Obtaining ISO 9001 certification as an electronics contract manufacturer requires adherence to specific QMS guidelines and regulations, including:
- Focusing on the customer in all manufacturing processes
- Engaging leadership and staff members
- Constantly striving toward improvement
- Making decisions based on evidence and data
- Managing relationships properly
- Risk-based thinking
- Implementing plans to address risks and opportunities
- Preventing repeat mistakes
- Auditing systems regularly
- Selecting the right QMS consultants
- Documenting QMS
- Testing products and recording results
- Creating and adhering to quality plans
- Using information to improve processes in the future
Always select a CM with this certification if you want to feel confident in the capabilities of your PCBA manufacturer. Organizations with ISO 9001 certification have proven they have the ability to consistently meet customer, statutory, and regulatory requirements in the products and services they provide. This certificate shows a CM’s commitment to enhancing customer satisfaction, managing risks, and addressing opportunities that arise during the PCB lifecycle. It also demonstrates an ability to conform to QMS requirements.
Specific Certifications Under ISO 9001
ISO 9001 is a general set of standards. Within ISO 9001 are additional sector-specific applications. There are ISO 9001 adaptations for the medical device manufacturing industry, government electoral organizations, local governments, business management systems for the rail industry, petroleum and natural gas industries, and software engineering. Look for certifications in a specific ISO 9001 subclass according to your unique needs and industry.
Saline Lectronics, for example, has the ISO 13485 certification for medical PCB assembly. Saline Lectronics uses its ISO 9001 and ISO 13485 certifications to comply with current industry and market standards in PCBA. We use ISO 9001 to show that we have the processes it takes for effective QMS and strong customer service, while the ISO 13485 demonstrates our exceptional capabilities within medical PCBA. Although these certificates are not requirements, we recognize their importance to customers.
ISO 9001 certification proves a CM is ready and willing to address future needs and manufacturing expectations. It is proof that a CM doesn’t back down from a challenge. If you need to feel confident in your CM’s QMS, customer service, and the quality of the finished products, look for a provider with ISO 9001:2015 certification. Saline Lectronics consistently updates and renews all certifications to prove its lasting dedication to quality. Contact us for more information about our certifications and PCBA services.