K Technology Corp. | Electronics R&D for Automotive, Medical, Communications
Accredited certification
certification to ensure high quality
Acquisition and Compliance with Certifications
We have obtained IATF 16949 (formerly ISO/TS 16949), a global quality management standard for the automotive industry, as well as ISO 13485 certification, and we rigorously implement these processes to ensure and maintain high levels of safety and quality.
IATF 16949 (formerly ISO/TS 16949) is an international sector-specific standard for the automotive industry. It evolved from QS-9000, a parts procurement standard developed by the U.S. Big Three automakers, combined with various European automotive quality system standards, and is now widely recognized as the benchmark for quality in the automotive sector.
ISO 13485 is an international standard for quality management systems for medical devices, designed to ensure product safety and effectiveness. It requires strict processes for risk management, documentation, and corrective/preventive actions across all stages—from design and development to manufacturing and post-market services—supporting continuous quality improvement and compliance with regulatory requirements.
Our strength lies in being certified under both automotive and medical industry quality management systems, where safety and reliability are paramount.
IATF 16949 (formerly ISO/TS 16949)
IATF 16949 is an international quality management system standard for the automotive industry. Based on ISO 9001, it incorporates industry-specific requirements to ensure consistent quality assurance throughout design, development, production, assembly, and service. Widely adopted by automakers and suppliers worldwide, it supports customer satisfaction and high quality through defect reduction, process standardization, and continuous improvement.
ISO 9001
ISO 9001 is an international standard for quality management systems (QMS) established by the International Organization for Standardization (ISO).
Its objective is to enhance customer satisfaction by defining requirements for organizations to build and operate systems that consistently deliver quality. It emphasizes a process-based approach, risk-based thinking, and continuous improvement.
ISO 14001
ISO 14001 is an international standard for environmental management systems (EMS) established by ISO.
It provides a framework for organizations to reduce environmental impact, comply with regulations, and pursue sustainable business operations. Based on the PDCA cycle (Plan–Do–Check–Act), it promotes setting and achieving environmental objectives and continuous improvement.
ISO 13485
ISO 13485 is an international QMS standard specifically for the design and manufacture of medical devices.
While based on ISO 9001, it strengthens regulatory and risk management requirements to ensure safety and effectiveness of medical devices.
At our company, it has been applied in the manufacturing of:
Controllers for extracorporeal circulation centrifugal pump devices
Equilibrium function measurement systems
ECG (electrocardiograph) boards and unit assemblies
These efforts ensure the delivery of high-quality and safe medical devices.
Medical Device Manufacturing License
(Registration No.04BZ200065)
Medical device manufacturing registration is a system required of companies engaged in the manufacture or processing of medical devices, based on the Pharmaceuticals and Medical Devices Act (PMD Act).
Manufacturers must comply with QMS Ordinance standards for manufacturing and quality management, and maintain appropriate facilities and systems. Registration legally authorizes the manufacture and shipment of medical devices.