title: [ISO 9001 certification of innovation and clinical research departments: Extending the scope of health assessment].
abstract: BACKGROUND
  The International organization for standardization (ISO) is the world leader in providing industrial and commercial standards and certifications. Beyond medical devices, four French clinical research and innovation departments have received an ISO 9001 certification (the standard for quality management). Simultaneously, medico-economic studies have become increasingly important in the public decision process. Using the clinical research and innovation department from the Léon-Bérard Cancer Center as an example, the purpose of this article is to show how the scope of the ISO 9001 certification has been extended to cover medico-economic studies.
  
  
  METHODS
  All of the processes, procedures, operating modes, documents, and indicators used by the clinical research and innovation department of the Léon-Bérard center were investigated. Literature searches were conducted using Medline keywords. The recommendations from the French national authority for health and other organizations, such as the International society for pharmacoeconomics and outcomes research (ISPOR), were also considered, as well as the recommendations of the General inspectorate of social affairs.
  
  
  RESULTS
  In accordance with the national and international recommendations, two procedures were created and four procedures were revised at this center. Five indicators of quality and an evaluation chart were developed.
  
  
  CONCLUSIONS
  By adopting the ISO 9001 certification into its medico-economic studies, the clinical research and innovation department of the Léon-Bérard center has used an innovative approach in the context of the growing importance of economic studies in decision-making.
authors.affiliation: Département Santé publique, université Aix Marseille 2, 27, boulevard Jean-Moulin, 13005 Marseille, France; Direction de la recherche clinique et de l'innovation, centre de lutte contre le cancer Léon-Bérard, 28, rue Laennec, 69008 Lyon, France.
authors.forename: C
authors.initials: C
authors.lastname: Sambou
authors.affiliation: Direction de la recherche clinique et de l'innovation, centre de lutte contre le cancer Léon-Bérard, 28, rue Laennec, 69008 Lyon, France.
authors.forename: S
authors.initials: S
authors.lastname: Guillemaut
authors.affiliation: Direction de la recherche clinique et de l'innovation, centre de lutte contre le cancer Léon-Bérard, 28, rue Laennec, 69008 Lyon, France; Université Lyon, CNRS, GATE L-SE UMR 5824, 69131 Ecully, France.
authors.forename: M
authors.initials: M
authors.lastname: Morelle
authors.affiliation: Direction de la qualité, centre de lutte contre le cancer Léon-Bérard, 28, rue Laennec, 69008 Lyon, France.
authors.forename: A
authors.initials: A
authors.lastname: Achache
authors.affiliation: Inserm, UMR 912, institut Paoli-Calmettes, 232, boulevard de Sainte-Marguerite, 13009 Marseille, France.
authors.forename: A-G
authors.initials: AG
authors.lastname: Le Corroller
authors.affiliation: Direction de la recherche clinique et de l'innovation, centre de lutte contre le cancer Léon-Bérard, 28, rue Laennec, 69008 Lyon, France.
authors.forename: D
authors.initials: D
authors.lastname: Perol
authors.affiliation: Direction de la recherche clinique et de l'innovation, centre de lutte contre le cancer Léon-Bérard, 28, rue Laennec, 69008 Lyon, France; Université Lyon, CNRS, GATE L-SE UMR 5824, 69131 Ecully, France. Electronic address: lionel.perrier@lyon.unicancer.fr.
authors.forename: L
authors.initials: L
authors.lastname: Perrier
mesh_terms: D035843:Biomedical Research / Q000458:organization & administration / Q000592:standards*; D002568:Certification; D003362:Cost-Benefit Analysis / Q000458:organization & administration* / Q000592:standards; D006801:Humans; D007391:International Cooperation; D062069:Inventions / Q000191:economics* / Q000592:standards*; D007857:Leadership; D017063:Outcome Assessment, Health Care / Q000191:economics / Q000592:standards; D011785:Quality Assurance, Health Care / Q000458:organization & administration* / Q000592:standards; D012015:Reference Standards
keywords: Certification; Economic evaluation; ISO 9001; Innovation; Quality; Qualité; Évaluation économique