A STRONG COMMITMENT

TO THE QUALITY AND SAFETY OF OUR SOLUTIONS SINCE 1997

Standards and certifications

In immunohaematology, enhanced safety research is an essential requirement. DIAGAST mobilizes to listen to the market, pre-empt its needs and respond to new regulations in terms of Quality and Safety.

Our solutions meet the new regulations and quality standards applicable in France and abroad. Thus, from their design stage until their installation and after-sales service, they are subject to strict compliance with the quality management system specific to in vitro diagnosis medical devices (IVDMD).

At a glance

1997: ISO 9001 NF certification Certification NF EN ISO 9001

2003: CE marking and ISO 13485 NF certification

2008: First US FDA approvalPremier agrément US FDA

2012: GMP ANVISA certification (Brazilian Health Surveillance Agency) and GMP KFDA certification (South Korean Health Surveillance Agency)

2018: Renewall of the NF EN ISO 13485 :2016 certification for EC marking and MDSAP certification for Canada, Brazil and Australia.

Quality Assurance and Quality Control

The quality of our products and services is a daily commitment from each employee and is measured through quality indicators. Quality Assurance establishes and develops the general provisions to be made to control our processes, manage risks and drive the continuous improvement of our organisation, infrastructures and practices. These provisions, grouped under the term Quality Management System, meet very strict international regulatory requirements.

In accordance with established specifications, quality inspections are performed at each production stage, from raw materials to in-process inspections and finished products. The traceability of each production is achieved by the use of a batch record. Each batch record as well as the conformity of the quality inspections are checked by the quality department in order to authorize the release for sale of the batches.