International Certification

Commitment to Quality and the Pursuit of International Certification Excellence

Since becoming one of the industry pioneers to receive the ISO 9001 certification from SGS UK in 1996, Pan Taiwan Enterprise has embedded the spirit of continuous improvement and pursuit of excellence into every aspect of its operations and product development.

We believe that quality is not merely the outcome of product inspection, but the result of every team member's consistent commitment to process integrity and attention to detail.

Expanding Certification Scope to Meet Global Compliance Standards

In response to increasingly stringent international compliance requirements, Pan Taiwan continues to expand the scope and level of its certifications:

Compliance with U.S. FDA standards, ensuring that our medical products meet the highest safety requirements for the American market.
Approval from Taiwan’s Ministry of Health and Welfare, demonstrating full compliance with local regulations and our strong sense of responsibility to the domestic market.
ISO 13485 certification for medical device quality management, with a dedicated focus on the design, development, manufacturing, and quality assurance of healthcare products.

Beyond Quality: Commitment to Corporate Social Responsibility (CSR)

In addition to stringent control over product and process quality, Pan Taiwan places high importance on fulfilling its corporate social responsibilities (CSR).

Since 2017, we have consistently passed BSCI (Business Social Compliance Initiative) audits, conducted by SGS based on EU standards.
In 2024, we were awarded an "Outstanding" rating, the highest possible level, in recognition of our performance in labor rights, workplace safety, ethical business conduct, and sustainable development.

Asia Connection: Certified Quality through Rigorous FDA Audits

Our subsidiary, Asia Connection, successfully passed multiple on-site inspections by the U.S. FDA in 2014, 2018, and other years without any nonconformities.
These achievements are a testament to the strength of our quality systems and have further solidified long-term trust with our global customers.

Looking Ahead: Quality as the Foundation of Sustainable Growth

Pan Taiwan will continue to set ever-higher internal standards—not only focusing on product excellence, but also treating international certifications as pillars of corporate governance and sustainable growth.

We firmly believe that only by continually advancing every aspect of quality and accountability can we grow together with the global market and create enduring value for our customers, employees, and society.