title: Impact of implementing ISO 9001:2008 standard on the Spanish Renal Research Network biobank sample transfer process.
abstract: BACKGROUND
  Biobank certification ISO 9001:2008 aims to improve the management of processes performed. This has two objectives: customer satisfaction and continuous improvement. This paper presents the impact of certification ISO 9001:2008 on the sample transfer process in a Spanish biobank specialising in kidney patient samples. The biobank experienced a large increase in the number of samples between 2009 (12,582 vials) and 2010 (37,042 vials).
  
  
  METHODS
  The biobank of the Spanish Renal Research Network (REDinREN), located at the University of Alcal&aacute;, has implemented ISO standard 9001:2008 for the effective management of human material given to research centres. Using surveys, we analysed two periods in the &ldquo;sample transfer&rdquo; process. During the first period between 1-10-12 and 26-11-12 (8 weeks), minimal changes were made to correct isolated errors. In the second period, between 7-01-13 and 18-02-13 (6 weeks), we carried out general corrective actions.
  
  
  RESULTS
  The identification of problems and implementation of corrective actions for certification allowed: a 70% reduction in the process execution time, a significant increase (200%) in the number of samples processed and a 25% improvement in the process. The increase in the number of samples processed was directly related to process improvement.
  
  
  CONCLUSIONS
  The certification of ISO standard 9001:2008, obtained in July 2013, allowed an improvement of the REDinREN biobank processes to be achieved, which increased quality and customer satisfaction.
authors.forename: M Alicia
authors.initials: MA
authors.lastname: Cortés
authors.forename: Emanuel
authors.initials: E
authors.lastname: Irrazábal
authors.forename: Andrea
authors.initials: A
authors.lastname: García-Jerez
authors.forename: Lourdes
authors.initials: L
authors.lastname: Bohórquez-Magro
authors.forename: Alicia
authors.initials: A
authors.lastname: Luengo
authors.forename: Alberto
authors.initials: A
authors.lastname: Ortiz-Arduán
authors.forename: Laura
authors.initials: L
authors.lastname: Calleros
authors.forename: Manuel
authors.initials: M
authors.lastname: Rodríguez-Puyol
mesh_terms: D018070:Biological Specimen Banks / Q000458:organization & administration / Q000706:statistics & numerical data; D035843:Biomedical Research / Q000592:standards*; D002568:Certification; D006801:Humans; D009398:Nephrology; D013030:Spain; D013048:Specimen Handling / Q000592:standards* / Q000706:statistics & numerical data; D013997:Time Factors