ISO 9001 Certification

What Certifications Are Critical for Your Contract Manufacturer to Have?

Saline Lectronics Blog

Industry certifications should be non-negotiable requirements when it comes to selecting the ideal electronics contract manufacturer. Electronics manufacturing certifications exist to ensure CMs meet rigorous quality expectations according to the industry. Without the proper certifications in your industry or niche, a CM cannot guarantee product quality or consistency. If you come across a CM without the following certifications (based on your specific industry), we suggest you keep searching. Certifications are your way to safeguard your rights as a customer, even if they are not an official electronics CM requirement.

  1. Medical Device Industry Certification – ISO 13485

Medical Device Industry Certification – ISO 13485

International Organization for Standardization (ISO) 13485 is the standard for quality management systems in medical device manufacturing. ISO 13485 came into existence in 1996. It lists the requirements for quality management systems in the design and manufacturing of all medical devices. In the medical industry, a CM with ISO 13485 certification is absolutely a must. Without it, a manufacturer is not qualified to produce the item. An ISO 13485 shows that the manufacturing facility has met the following requirements:

  • The organization demonstrates that it has effectively implemented and maintained its manufacturing quality system.
  • It ensures product safety by implementing certain controls and protocols in the manufacturing environment.
  • It engages in risk-management activities and design control during product development.
  • It has specific requirements for testing, inspection, and product traceability in implantable medical devices.
  • It has requirements for documentation and validation that medical devices are sterile.
  • It has requirements to ensure the effectiveness of preventive and corrective actions.

The certificate of registration for ISO 13485 should state the CM’s name and the scope of the certification. Ask to see the certification and check for yourself if it expands to the area of expertise you specifically need, such as electronic printed circuit board assemblies or box builds. Also, check the certification expiration date to make sure the CM has re-registered on time. Finally, the certificate should bear the signature of the registrar president as a sign of its authenticity.

  1. Aerospace Industry Certification – AS9100

Aerospace Industry Certification – AS9100

The Aviation Space (AS) 9100 certification is the standardized quality management system for electronic manufacturers in the aerospace industry. AS9100, released in 1999, is now widely adopted as a replacement of the AS9000. AS9100 also encompasses all requirements for ISO 9000, as well as adding new quality and safety standards. A CM with AS9100 certification has the credentials to complete projects for major aerospace OEMs and suppliers according to high industry standards and expectations.

A CM can only obtain the aerospace PCB assembly certification if it displays an emphasis on risk management, meets special requirements, adopts proven production processes, eliminates issues, and passes any audits (Saline Lectronics earned a Best in Class honor during its AS9100 audit in the past). AS9100 is the globally recognized standard for aerospace industry electronics production and manufacture.

  1. Defense Industry Certification – ITAR

Defense Industry Certification – ITAR

The defense industry certification, International Traffic in Arms Regulation (ITAR), controls defense and military technologies to ensure national security. To import and export any electronics involved in the defense industry, a military PCB assembly manufacturer must have valid ITAR certification. To achieve this certification, a CM must meet strict registration requirements, such as maintaining manufacture records and documentation. The U.S. Department of State is in charge of approving registration requests and certifying qualifying contract manufacturers.

  1. General Certification – ISO 9001

General Certification – ISO 9001

The ISO 9000 family of certificates deals with general quality management across multiple industries and business sizes. ISO 9001 is accepted around the world as the quality management system standard necessary to show that a manufacturer has implemented and maintained an effective and efficient quality management system. ISO 9000 registration requires proof that the CM consistently meets specific customer requirements, and that the company is always striving to improve and optimize product quality.

The Takeaway: Always Ask to See Certifications Before Signing a Contract

If the CM will not let you see a certification, this is a major red flag. Take this to mean that the CM doesn’t actually have the appropriate documentation and does not meet the quality requirements for your stringent medical, aerospace, or defense industry products. Hiring a CM without manufacturing certifications means setting yourself up for poor quality products, broken industry standards, and even potential consumer lawsuits against your company. Always check for certifications before signing your rights away in a legally binding contract.

Saline Lectronics always makes its list of certifications available to the public and is happy to answer industry-specific certification questions when you contact us.