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Ark Electronics Receives ISO 13485 Certification for Medical Equipment Manufacturing
October 19, 2023 | Ark ElectronicsEstimated reading time: 1 minute
Ark Electronics, a leading global contract manufacturer specializing in end-to-end electronic manufacturing solutions (EMS) and PCB Assembly, announced that it has earned the Medical Equipment Quality Management Certification from the Geneva, Switzerland-based International Organization for Standards (ISO). This internationally agreed upon and highly sought-after ISO 13485 standard is based on the ISO 9001 process model approach and is a management systems standard specifically developed for the manufacturing of medical devices.
Earning this 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, including design and development, production, storage and distribution, installation, or servicing of a medical device; and design and development or provision of associated activities (e.g. technical support).
“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. In doing so, we easily meet the ISO requirements for medical devices,” said Scott Wiley, President of Irvine, CA-based Ark Electronics. “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’ other ISO Quality Assurance certifications include:
- ISO 9001 – Quality Management System Certification,
- ISO 14001 – Environmental Management System Certification,
- ISO 45001 – Occupational Health & Safety Certification
- ISO 27001 – Info Security Management System Certification
- NQA: IATF 16949 – Automotive Quality Management System Certification
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