At the SK-Electronics Group, we are committed to continuously enhancing the products and services we provide, driven by our core principles of “Customer Focus” and “Quality First.”

Quality Policy

To deliver quality and services that satisfy our customers, and based on our corporate philosophy of “Creation and Harmony,” we will promote the following initiatives by leveraging the advanced production technologies we have cultivated over many years and through the continuous pursuit of original technological development:

  1. 1Commitment to Improving Customer Satisfaction
  • Capture changes in the market in a timely manner and conduct marketing activities that respond to customer needs.
  • Strengthen our technological capabilities and production capacity to accurately respond to customer requirements.
  1. 2Improve the “Quality of Work” Through Continuous Improvement
  • Improve productivity through the “visualization” of information.
  • Improve quality and cost through Review & Release.
  • Provide high-quality products through improvement activities that emphasize processes.
  1. 3Ensure Global Quality Across Domestic and Overseas Sites
  • Strengthen our quality assurance structure.
  • Share quality-related information.
  • Enhance our quality management system (QMS).
  1. 4Ensure the Effectiveness of the Quality Management System
  • Provide products that comply with applicable laws and regulations.
  • Meet the requirements of applicable quality standards.
  • Conduct reviews to maintain the effectiveness and validity of the QMS.

Quality Assurance Activities

At SK-Electronics, each business division and group company establishes a Quality Manual in line with the Quality Policy to maintain a robust quality management system.

Conducting Quality Audits to Ensure Reliable Quality Assurance

Our two manufacturing sites in Japan (Kyoto Plant and Shiga Plant), as well as our overseas group plant (Finex Plant (Tainan, Taiwan)), are certified to the international standard ISO 9001 for quality management systems. Each organization thoroughly implements the PDCA cycle—planning improvement, implementing improvement, and evaluating results—to ensure product quality, drive continuous improvement, and prevent quality issues before they occur. We also continue to conduct audits to verify the effectiveness of our QMS.

  • Internal audits conducted by trained internal quality auditors (once per year)
  • Recertification and surveillance audits conducted by external certification bodies (once per year)
  • Regular verification of quality assurance structures at each site

Supplier Quality Audits to Ensure Reliable Quality Assurance Activities

Our Quality Assurance Division maintains a global framework to drive quality improvement. For example, for purchased parts and materials, we operate a supplier qualification program—together with the procurement functions of each business division—to evaluate and certify suppliers’ process quality in order to ensure global quality.

Early Detection and Prevention of Critical Complaints and Preparedness for Potential Incidents

We manage customer inquiries and nonconformance information to enable the early detection of critical quality issues and to prevent similar issues from occurring.

Quality Meetings to Ensure Effective Quality Assurance Activities

Quality meetings are held to share quality-related information and to discuss and decide important matters related to corrective and preventive actions.

System Improvement Committee to Strengthen the QMS

The System Improvement Committee discusses and decides important matters related to the exchange of information and implementation of measures in order to align understanding across departments when establishing, revising, or discontinuing QMS-related standard documents that span multiple departments.

Quality assurance system

Quality system, etc., acquiring status

1997 A head office to acquire ISO9000 was established
1999 Acquired ISO9002 (SHASHIN KAGAKU: Existing Kyoto Plant)
2001 SK-Electronics CO., LTD. was established
2002 Certification upgraded to ISO9001: 2000
2002 FINEX Co., LTD. established
2004 Acquired ISO9001 (Finex Co., LTD.)
2008 Shiga Plant was established
2010 Certification upgraded to ISO9001: 2008 (Kyoto Plant, Shiga Plant, and FINEX Co., LTD.)
2014 Acquired second class medical equipment manufacturing and distribution license (GQP/GVP system of medical devices)
2015 Registered as medical equipment manufacturer (Medical equipment QMS)
2016 Acquired a license for selling and leasing specially controlled medical devices (medical device QMS)
2016 Certification upgraded to ISO9001: 2015 (FINEX Co., LTD.)
2018 Certification upgraded to ISO9001: 2015 (Kyoto Plant, Shiga Plant)
2019 Acquired ISO13485 (Head office, Kyoto Plant).Certification ended in February 2026.
2020 Renewed license for manufacturing and selling class-2 medical equipment (GQP/GVP system for medical equipment)
2022 Renewed license for selling and leasing specially controlled medical devices (medical device QMS)
2026 Commencement of QMS operations in accordance with the Medical Device QMS Ordinance