Animation Quality

Le GIS Biogenouest supports the network's core facilities in deploying a quality approach or improving their quality management system. Thus, the Quality coordinator of the GIS Biogenouest helps the core facilities with their quality procedures. It offers support, provides advice and coordinates the internal network of quality specialists.

To date, 12 core facilities or technical core facilities are certified. A variety of quality certifications can be obtained by exchanging with quality specialists, accompanying you in your approach.

Being a certified core facility is very useful for setting up processes that will allow you to increase the efficiency of your teams.

In Biogenouest network, 3 different certifications are held by our core facilities:

Certified core facilities

ISO 9001 certification - 2015

The ISO 9001:2015 standard specifies requirements for a quality management system when an organization:

  • Must demonstrate ability to consistently deliver products and services that meet customer requirements and applicable legal and regulatory requirements.
  • It should also aim to increase customer satisfaction through the effective application of the system, including processes for improving the system and ensuring compliance with customer requirements and applicable legal and regulatory requirements.

Certification ISO 9001 - 2015 and
NFX 50-900 - 2016

The NFX standard specifies the requirements relating to the management system integrating a QMS when an organization such as the Technological Research core facilities in Life Sciences:

  • must demonstrate its ability to fulfill its scientific and technological research missions,
  • must demonstrate its ability to consistently provide products and services that meet customer requirements and applicable legal and regulatory requirements,
  • and aims to increase customer satisfaction through the effective application of the system, including processes for improving the system and ensuring compliance with customer requirements and applicable legal and regulatory requirements.

ISO 9001 - 2015 certification and Good Manufacturing Practice

Good Manufacturing Practices (GMP) are established by states or by the European Commission as part of the development of quality procedures and apply to the manufacture of medicinal products for human use.

GMPs constitute an enforceable regulatory reference during inspections of pharmaceutical establishments by their supervisory authorities.

The Quality network within the GIS Biogenouest

The network allows personnel involved in quality actions or approaches to discuss and share their know-how, experiences and documents. Internal tools are deployed to easily collaborate within the network. (Reserved only for Biogenouest members)

To continue conservation, join us on the Cesgo Quality Chat!

A network connected with the other Quality networks

The Biogenouest Quality network is linked to other major networks developed by members, supervisory bodies or organizations in France. For more information on the other networks, you can visit their web pages:

Testimonials from Recently Certified core facilities

If you want to discover testimonials from recently certified core facilities, we invite you to read them here:

Your core facility was recently certified, qWhat steps have you taken to implement your quality management system?

 

Mathilde Grand, Quality Management Manager:

Our quality approach takes place in several stages.

In 2018, the former Head of the core facility was already keen to implement an approach that I had initiated with him. The scope was different because it included the research team adjoining the core facility. We started with the perimeter, identified the processes and the pilots. During 2019, I went on maternity leave and the site took a long break. People who were already busy were not able to continue this project during my absence.

In 2020, two members of Ceisam undertook to make an inventory of the core facility RMN which led to its reorganization with a new manager and deputy managers. Quality was immediately identified as an important project.

In 2021, we have chosen to get help from a consultant. We collaborate with a consultant who already works with other NMR core facilities. Our work is not unknown to him. This work in pairs enabled us to obtain our ISO 9001 certification in November 2022.

 

Patrick Giraudeau, Manager core facility :

After having tried unsuccessfully to set up the quality approach ourselves for several years, we called on a consultant specialized in its implementation on academic core facilities (Gilles Corberand, Indiceo Conseil). After having trained us, he led us to appropriate the quality approach, and to adjust our daily functioning. The process lasted a little over a year, and after an initial certification obtained in November 2022, we are now autonomous in the management of our Quality Management System (QMS).

 

 

What difficulties did you encounter? How did you overcome the main obstacles?

 

Matilda Grand, Quality Management Manager :

The first difficulty is to fully understand the standard and to correctly translate the action or tool that must be implemented to meet the requirements of the standard. Working with a consultant has greatly helped us in this understanding and its obligations.

 

Patrick Giraudeau, Responsible core facility :

The first difficulty was trying to implement the approach ourselves, without outside support. We overcame it thanks to the help of a consultant who was able to understand the specificities of our core facility. We also encountered the classic difficulty of the initial reluctance of the core facility's staff when faced with an approach involving quality management. Indeed, our core facility was previously in a self-managed mode of operation which was technically very solid, but led to certain malfunctions. Faced with this initial apprehension, everyone played the game and provided a considerable amount of work to change our collective mode of operation.

 

 

How has this approach changed your work?

 

Matilda Grand, Quality Management Manager :

We have set up a cloud space for the core facility, use a tool to manage tasks, Trello, which allows you to see and follow the different actions to be taken, the progress reports. We have improved our daily lives and reduced our mental load. A fortnightly meeting is set up. The technical team meets weekly. We have put in place tools that make us gain in communication and efficiency.

 

Patrick Giraudeau, Responsible core facility :

The implementation of the quality approach has profoundly changed our daily mode of operation. The central element is the establishment of a fortnightly operational committee (bringing together all the core facility staff), as well as a weekly meeting of the three technical engineers in charge. This allows a very high responsiveness to requests from users, customers and guardians, which are growing rapidly.

 

What are the benefits of this certification?

 

Matilda Grand, Quality Management Manager :

From my point of view Quality Management Manager, the benefits of certification relate to the organization, quality and quantity of work and the proper functioning of the core facility. Even if at the beginning we sometimes had the feeling of doing a lot of “paperwork”. We have set up documents in case of absence of an engineer for example. Today, if one of the engineers is absent, we know how and who can take over, for which skill, for example.

 

Patrick Giraudeau, Responsible core facility :

Certification allows us first of all to be part of a process of continuous improvement, which we hope will benefit our users and customers. The first two satisfaction surveys carried out in 2022 and 2023 seem to go in that Sens. Internally, management through a quality approach allows us to communicate better and avoid possible misunderstandings and malfunctions, as may have been the case in the past. This also allows us to better manage contingencies (breakdowns, absence of staff, etc.). Finally, certification of course brings recognition vis-à-vis our supervisory authorities and funders.

 

Une information or an element that you want to highlight?

 

Matilda Grand, Quality Management Manager :

In 2020-2021, when we were discussing the implementation of our quality approach, we thought for a long time about taking on a CDD or a consultant. When we spoke with different people, we sometimes had very clear opinions on the subject. Today, we do not regret having chosen to collaborate with a consultant who helped us, supervised so that we individually appropriated the system and our responsibilities.

 

Patrick Giraudeau, Responsible core facility :

In 2024-2025, the RMN CEISAM-Corsaire-MetaboHub core facility will benefit from a major renewal of the instrument park and a complete redevelopment, as part of the CPER UltraOmics project. This operation requires excellent coordination between the many parties involved (core facility staff, supervisory services, funders, design offices, equipment manufacturers, etc.). Having implemented the Quality Management System (QMS) beforehand will be a key ingredient in the success of this major project.