Audits qualité externes de première partie, en recherche scientifique. Quelles sont les écarts/difficultés les plus couramment rencontrées ?

Catherine Chevalier (1) , Vanessa Euthine (2) , Isabelle Jouet (3) , Nelly Lebret (4) , Elisabeth Moreau (5) , Anne Marie Mura (6) , Eva Giesen (7)

1 SFR François Bonamy - Structure fédérative de recherche François Bonamy
2 CarMeN - Cardiovasculaire, métabolisme, diabétologie et nutrition
3 EnVI - Nouvelles Cibles Pharmacologiques de la Protection Endothéliale et de l'Insuffisance Cardiaque
4 IMRB - Institut Mondor de Recherche Biomédicale
5 Essais Therapeutiques et Infection Par Le Vih
6 CIPHE - Centre d'Immunophénomique
7 INSERM, Paris

In quality management, audits are a prime choice for permanent improvement. We used our experience in auditing quality management systems on the bases of ISO 9001 quality management in research, to determine the most currently occurring problems in quality management. The identification of clients, their requirements and satisfaction and the identification of quality-objectives, specific actions and associated indicators appeared to pose the majority of problems. This could partly be interpreted as to be due to a cultural specificity in scientific research, which is largely related to the creation of knowledge and not to a sell and buy relationship. This does however not mean that science is an exception in quality management according to ISO 9001, since the term client is devoid of economic aspects and used to designate the beneficiary of an activity. In the lab, objectives are present but usually treated in an informal way - the respect of the ISO 9001 requirements will lead the labs to a more formal approach with increased traceability and transparency

Mots clés: audit; ISO 9001; recherche scientifique

Domaines: Sciences de l'ingénieur [physics]

Catherine Chevalier, Vanessa Euthine, Isabelle Jouet, Nelly Lebret, Elisabeth Moreau, et al.. Audits qualité externes de première partie, en recherche scientifique. Quelles sont les écarts/difficultés les plus couramment rencontrées ?. QUALITA2013, Mar 2013, Compiègne, France. ⟨hal-00823106⟩