Quality Policy

We, TAUNS Laboratories, Inc., will enrich lives and provide peace of mind through proprietary in vitro diagnostics created based on our diagnostic technologies.

Code of Conducts

  1. Comply with the quality management system, and ensure the quality and safety of products.
  2. Continuously improve the quality management system.
  3. Design and develop products that meet customer requirements, and respond to customer requests promptly and effectively.
  4. Cultivate human resources and corporate culture for the pursuit of quality and safety.
  5. Ensure compliance in all business processes.

ISO13485:2016 Certification

We, TAUNS Laboratories, Inc., have acquired ISO 13485:2016 certification, a quality management system for medical devices, to support our efforts to market in vitro diagnostics worldwide.

Certification BodyTÜV SÜD Product Service GmbH (Germany)
Applied StandardISO13485:2016
FacilityKamishima Factory
Scope of CertificateDesign and manufacture of in vitro test kit for infectious diseases and clinical chemistry

Quality Management System

A Quality Manual has been formulated to ensure proper implementation of the quality management system for products. The purpose of the manual is to ensure the quality and safety of everything that affects the quality of in vitro diagnostics and medical devices manufactured by TAUNS.

Not only ensuring the products we supply meet customer requirements and comply with all applicable legal and regulatory requirements, the manual also covers processes for maintaining and continuously improving the effectiveness of the quality management system. Our quality management system is designed to ensure conformity with all the requirements of our business licenses and approvals for manufacturing and marketing as stipulated by the “Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices” (Japan), as well as all the requirements for European CE marking to sell our products overseas.