Our Quality Policy:

Tosoh Bioscience is committed to differentiate itself from its competition by fully understanding regulatory and customer requirements, providing high performance solutions,  delivering excellence in the quality of service and support and thereby systematically exceeding its customers' expectations.

Our Quality Management System:

Tosoh Bioscience has a long history in Quality.  The first ISO 9002 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:

Shared Responsibilities

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.

An Efficient Internal Audit Team

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

Commitment of Senior Management

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.

Tools & Infrastructure

Tosoh Bioscience is continuously investing in the necessary tools and infrastructure to support all process owners in making the most of their careers.

 ISO 9001/ ISO13485

Distribution and support of diagnostic reagents, IVD kits for human and animal applications, as well as the equipment necessary to make use of the said reagents and kits. 

Manufacturing of diagnostic reagents.

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

For any inquiries about our certification please feel free to contact our external audit company Lloyd’s Register Quality Assurance UK: info@lrqa.com

 Member of the European Diagnostic Manufacturers Association