ISO 13485 Certification

Certification Highlight – ISO 13485

Saline Lectronics Blog

Certifications are important in electronics contract manufacturing. The best electronics contract manufacturers (CMs) possess industry certifications that prove their compliance with accepted standards, as well as a dedication to excellent business practices. Only trust your printed circuit board assembly (PCBA) project to a CM that can show you a list of certifications. Otherwise, you’ll have no quality or compliance assurance. Here’s a breakdown of one electronics contract manufacturing quality certification: ISO 13485.

What Is ISO 13485 And Who Does It Apply To?

What Is ISO 13485 Certification

The ISO 13485 certification refers to specific Quality Management System (QMS) requirements for medical device manufacturers by the International Organization for Standardization (ISO). ISO 13485 deals specifically with medical devices and related regulatory requirements. The purpose of ISO 13485 is to make the quality of medical devices more consistent across manufacturing facilities. It applies to manufacturers of medical devices and related services, as well as any organization involved in the lifecycle of medical device development.

Every organization that obtains the ISO 13485 certification abides by approved methods during all stages of the medical device manufacturing lifecycle: design, development, manufacturing, distribution, storage, and installation. This can be a tall order to fill, which is exactly why possessing the ISO 13485 certification is such an impressive mark of quality. Without a certification like ISO 13485, there would be no proof that an organization knows or abides by accepted industry quality standards. Lack of certification often means that the facility does not manufacture medical devices according to industry requirements.

Certifications are especially important in the medical field, as the quality and performance of a device could literally mean life or death. Always search for the ISO 13485 certificate before you sign with an electronics CM if you want consistent quality management. Otherwise, you could end up dealing with serious manufacturing defects and inefficiencies that cost you money, thanks to the low-quality performance of the manufacturer. An ISO 13485 certification greatly increases the odds that end products will be of the highest quality when purchasing custom medical devices.

How Does a CM Obtain an ISO 13485 Certification?

How to get ISO 13485 Certification

Contract manufacturers must demonstrate the ability to design, develop, and manufacture medical devices that meet the ISO requirements to receive the ISO 13485 certification. ISO requirements change year by year. Manufacturing plants must keep up with the most recent ISO certifications to adhere to the latest industry expectations. As of today, an electronics CM’s QMS must fulfill the following requirements to obtain ISO 13485:2016 certification – the latest available:

  • Documentation requirements. Organizations that wish to obtain the certification must fulfill documentation requirements, including having a Quality Manual, Required Procedures, Required Forms and Records, Control of Documents, and Control of Forms.
  • Management requirements. Managers in QMS must fulfill certain requirements for ISO 13485 certification. These requirements address Management Responsibility, Quality Policy and Objectives, Customer Focus, Customer Satisfaction, and Management Review.
  • Production requirements. Medical device production must fulfill strict requirements in terms of planning, customer relations, design, purchasing, supply chain, process control, traceability, and customer property.
  • Monitoring requirements. An organization must show that its QMS has testing, measurement, analysis, and monitoring processes in place to constantly improve medical device manufacturing. Process monitoring should serve the purpose of ensuring customer satisfaction, complying with standards, and preventing defects.

These standards apply to all manufacturers of medical devices regardless of their size and type (except where the standards explicitly state otherwise). Establishments have to demonstrate an ongoing commitment to quality to renew their ISO 13485 certifications year by year. Only if an organization’s QMS fulfills all of the comprehensive and demanding requirements of ISO 13485 can it achieve certification.

Examples of How Organizations Use ISO 13485 Certification

How Organizations Use ISO 13485 Certification

Saline Lectronics is an example of an organization that carries ISO 13485 certification. We manufacture medical printed circuit board assemblies (PCBAs) for the medical industry. All of the business we do in the healthcare market must adhere to the requirements of the ISO. This includes PCB assembly, heart monitors, diagnostic devices, and more.

Saline Lectronics qualifies for the ISO 13485 certification each year thanks to our dedication to continuously improving the benchmark for high quality. The systems we have in place for QMS and quality assurance help us control the performance of our finished products. Systems such as Cogiscans’s Track, Trace and Control (TTC) System help Saline Lectronics trace medical PCB assembly from beginning to end – enabling us to comply with the requirements for ISO 13485 certification.

Embracing the latest technologies in medical PCB assembly allows us to assemble high-quality medical electronics for customers. ISO 13485 is just one of many manufacturing certifications Saline Lectronics is proud to possess. Learn more about our industry certifications here.