Overview
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ABSTRACT
More and more public research structures are adopting a process of continuous improvement, up to certification according to the NF EN ISO 9001 standard, in order to display a professionalization of their practice. This article describes the stages of the implementation of a quality approach, from its design up to towards NF EN ISO 9001 certification, in public research structures. The methodology, to build and sustain a management system by quality, is presented, based on examples from lived experiences. The focus is on communication and improvement actions. These two points contribute to the adhesion of the staff.
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Read the articleAUTHORS
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Estelle DONADEI FACCHIN: Head of Quality and Certification Department - CNRS agent at the Montpellier chemistry laboratories (Institut des biomolécules Max Mousseron (IBMM UMR 5247), Institut Charles Gerhardt (ICGM UMR 5253), Institut européen des membres (IEM UMR 5235)) Pôle Chimie Balard, ENSCM, F 34296, Montpellier, France
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Mariette NIVARD: Responsible for quality management, research instrument control/operation Université Rennes, CNRS, IPR (Institut de physique de Rennes)-UMR 6251, F-35000 Rennes, France
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Isabelle PAINTRAND: Université Grenoble Alpes, CNRS, Grenoble INP, LMGP, F-38000 Grenoble, France - The authors are respectively director and deputy director of the Groupement de service accompagnement vers un système de management par la qualité (GDS ASYMU – 2000 CNRS).
INTRODUCTION
The missions of public-sector research and service organizations (joint research units, research federations, technology platforms, etc.) are defined in line with the policies of their supervisory authorities. Evaluation committees are provided with factual data illustrating how these structures operate.
Their main missions are :
carry out all research of interest to the advancement of science and the country's economic, social and cultural progress;
contribute to the application and valorization of research results;
contribute to training in and through research.
Most public research is carried out in response to calls for proposals. It is important to prioritize and assess the relevance of the calls for projects to which research staff respond. Project funders may be public or private, and the funds allocated are managed by one of the laboratory's supervisory bodies. Ultimately, researchers are required to demonstrate the value of their scientific work, justify the expenses incurred and may be required to justify the use of equipment acquired as part of a project. In order to optimize success factors, more and more laboratories and technology platforms are choosing to implement a quality management system (QMS) leading to certification, accreditation or even a label.
The standard NF EN ISO 9001 serves as a benchmark for certification, helping to structure and improve laboratory organization. This standard is internationally recognized.
Technology platforms wishing to establish their skills as calibration and testing laboratories choose NF EN ISO/CEI 17025 accreditation. In France, this accreditation is issued by the French Accreditation Committee (website: COFRAC).
It is important to note that these standards are not mandatory for research laboratories. The choice is therefore a matter for management, who must ensure that staff buy-in is forthcoming.
On the other hand, activities defined by the French Public Health Code are subject to harmonized European standards. Accreditation is mandatory for :
medical biology laboratories (LBM);
French Blood Establishment (EFS) structures;
structures performing biological activities for medically assisted procreation: NF EN ISO 15189 for medical biology laboratories (LBM) and NF EN ISO 22870...
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KEYWORDS
ISO 9001 | management | SMQ
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Laboratory quality and safety procedures
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Quality management and certification for a public research laboratory
Bibliography
Bibliography
Websites
AFNOR https://www.afnor.org/
French National Research Agency (ANR) http://www.agence-nationale-recherche.fr
French Accreditation Committee (COFRAC) https://www.cofrac.fr/
...Standards and norms
- Quality management systems – Requirements - NF EN ISO 9001 - 2015
- Conformity assessment – Requirements for bodies providing audit and certification of management systems – Part 2: Competence requirements for auditing and certification of environmental management systems - NF EN ISO/IEC 17021-2 - 2018
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