Our management systems

un système de contrôle et de gestion de la qualité

In order to provide the best level of service to our customers, and to ensure that radiochemicals and radiopharmaceuticals of excellent quality are placed on the market, IRE - IRE ELiT has implemented a quality control and management system complying with cGMP, ISO 9001 and ISO 17025 standards.

We are also committed on a daily basis to carrying out our activities with the utmost respect for the environment, and have adopted a responsible environmental policy in accordance with the recommendations of ISO 14001.

ISO 9001

With respect for our global approach to quality management, we operate our services activities in accordance with the ISO 9001 standard, which sets out requirements for a quality management system.

System certification ISO 9001

ISO 9001 certification for our Business Unit “Services” means that we continuously assess and improve our project management processes. This approach ensures that our customers receive an efficient and high-quality service that focuses on their specific needs.

Contact Certification ISO 9001 Quality policy

ISO 17025

Our Laboratory of Radioactivity Measurement has been ISO 17025 accredited since 2011 by BELAC, the Belgian accreditation body. This recognition attests to our expertise in the analysis and measurement of radioactivity on a wide range of sample types (see ISO 17025 certification). Our quality system therefore guarantees that our customers will receive reliable results.

BELAC

In order to maintain the quality of our service and our analysis methods, our laboratory is regularly audited by external experts. We also carry out internal audits several times a year. In addition, we take part every year in numerous inter-comparisons organized by international reference bodies.

These inter-laboratory tests guarantee the validity of our analytical methods and equipment, as well as the accuracy of our results. This also reflects the expertise and quality of our employees.

Contact Certification ISO 17025

ISO 14001

We care about the environment, and we are committed to the development of an environmental policy that aims to reduce the impact of our activities on the environment.

System certification ISO 14001

We are developing an everyday approach with particular focus on:

  • Training employees in the environmental policy
  • Monitoring environmental legislation
  • Improving waste management
  • Reducing energy consumption
  • Reducing the use of consumables (office and laboratory)
  • Implementing and monitoring improvement actions.
Contact Certification ISO 14001 Environmental policy

cGMP

Our manufacturing processes for radiochemical products (Active Pharmaceutical Ingredients) and radiopharmaceuticals comply with the requirements of the regulatory framework for cGMP (current Good Manufacturing Practices).

Good manufacturing practice

The quality of our facilities, the involvement of our employees and our quality management system are our customers’ guarantee that we make products of very high quality that comply with the expected characteristics. The health authorities carry out regular site audits to check that our operations are conducted in compliance with the cGMP standard.

This also enables us to continuously evaluate and improve our production processes.
Our quality management system based on cGMP requirements is your guarantee that you will always obtain the product you deserve.

Contact Certification cGMP

YOUR SATISFACTION

Customer satisfaction is at the center of our concerns.
Please do not hesitate to send us your comments or suggestions for improving our services. We invite you to evaluate our services using the satisfaction form that you can download below and return to us by e-mail.
Any information received will be processed by our Quality Assurance department and will help us with the continuous improvement of our services and products.

Contact Form
IRE - Institute for Radioelements IRE Elit - Environement and lifescience Technology