IRVINE, Calif.—Ark Electronics recently received the Medical Equipment Quality Management Certification from the Geneva, Switzerland-based International Organization for Standards (ISO), the company said in a release.
The highly sought-after ISO 13485 standard is based on the ISO 9001 process model approach. It is a management systems standard specifically developed for the manufacturing of medical devices.
Ark Electronics is an Irvine-based global contract manufacturer that specializes in end-to-end electronic manufacturing services (EMS) and PCB Assembly. Its ISO 13485 certification confirms that Ark Electronics has met all the requirements for a quality management system and demonstrated its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. These include design and development, production, storage and distribution, installation, or servicing of a medical device; and design and development or provision of associated activities, such as technical support, the company said.
“Safety and quality are non-negotiable in the medical devices industry. That’s why we developed the highest-quality manufacturing processes and utilize the most rigorous standards, with a zero-tolerance policy for defects,” said Scott Wiley, president of Ark Electronics, in a statement. “In doing so, we easily meet the ISO requirements for medical devices. This ISO certification, along with the many other ISO and independent third-party certifications we have received, gives our clients the assurances they value and deserve when it comes to the quality manufacturing and delivery of their products.”
Ark Electronics said it has earned several other IOS Quality Assurance certifications, including
ISO 9001 Quality Management System Certification; ISO 14001 Environmental Management System Certification; ISO 45001 Occupational Health and Safety Certification; ISO 2700 Information Security Management System Certification; and NQA: IATF 16949 Automotive Quality Management System Certification.
With locations in North America, China, and Europe, Ark Electronics serves major consumer electronics, mobile communications, automotive, and industrial IoT companies. The company said it combines technical expertise with agile manufacturing and supply chain processes, enabling its customers to “create and supply original products and solutions at scale to their global OEM customers.”