Worldwide leader in diagnostics.

Quality Policy

The employees and top management of Fujirebio Diagnostics, Inc. (FDI) are committed to enhancing customer satisfaction by providing quality products to our customers, and to complying with the regulations and requirements of all of the countries in which we operate. We define quality products as products that are safe and effective, and that meet our customers’ expectations as well as our own established acceptance criteria.

We strive for quality leadership in all of our product lines and activities.

We foster and maintain an attitude of quality awareness throughout all functional groups and activities of the Company. We ensure control over all outsourced processes deemed to affect product conformity to requirements.

We strive to continually improve the effectiveness of our Quality Management System by establishing quality goals in measurable terms, through continuous assessment of our progress, and by ensuring the availability of resources to achieve these goals.

Top management leads by ensuring that all employees, at all levels within the organization, understand this commitment to quality and are suitably trained to implement and maintain FDI’s commitment to quality as expressed by this policy.

We strive for excellence in all phases of our business beginning with product design and development, culminating only when our customers’ expectations and requirements have been met or exceeded.

We are committed to maintaining a Quality Management System, which complies with the requirements of 21 CFR Section 820 (1996) Quality System Regulation, applicable quality system standards, and any other documentation specified by national or regional regulations.