Tosoh Europe N.V. is Committed to Quality

Tosoh Bioscience Certification

ISO 9001/ISO13485

Marketing, distribution, technical service, and customer support of IVD-reagents and kits, as well as related diagnostic instruments. Design, development and manufacturing of IVD-reagents and kits. Distribution of HPLC-columns and separation media. Distribution and technical service of size exclusion chromatography instruments

ISO 9001 »

ISO 13485 »

Approval of conformity certificate schedule for IVD directive Annexe II list B products

For any inquiries about our certification please feel free to contact our external audit company TÜVRheinland »


Member of the European Diagnostic Manufacturers Association

Medtech Europe

Our Quality Policy

Tosoh Bioscience is committed to differentiate itself from its competition by:

  • Fully understanding regulatory and customer requirements
  • Providing high performance solutions to anticipate future needs and provide value to our customers
  • Delivering excellence in the quality of service and support and thereby systematically exceeding its customers' expectations
  • Continuously improving our processes
  • Building a mutually profitable longterm relationship with customers and suppliers
  • Complying with regulatory requirements

Our Quality Management System

Tosoh Bioscience has a long history in Quality. The first ISO 9001 certificate was obtained in 1999 and since then the organisation has further developed a process based quality management system with a focus on the following key areas:

Every employee has a responsibility to ensure the quality of their output meets the required standards. This is ensured by continuously monitoring the efficiency of their activities via measurable process indicators. Each year a new set of goals is proposed to allow continuous refinement of our processes.

Tosoh Bioscience has a team of 3 internal auditors from a number of different departments, HR, QA_RA, and otherdepartments and affiliates, in order to provide an ongoing review of the Quality Assurance (QA) system and to provide an objective evaluation of the processes and procedures used. 

By actively participating in our monthly QA meetings, Tosoh Bioscience's senior management not only demonstrate their commitment to quality, but also ensure any QA issues are discussed fully, allowing continuous follow-up of the efficiency of our QA system.