Impact of implementing ISO 9001:2008 standard on the Spanish renal research network biobank sample transfer process;Impacto de la implementación de la norma ISO 9001:2008 en el proceso de cesión de muestras del biobanco Red de investigación Renal española

Nefrologia

Volumn 34, Issue 5, 2014, Pages 552-560

  Alicia Cortes M ^a   Irrazábal, Emanuel ^b   García Jerez, Andrea ^a   Bohórquez Magro, Lourdes ^a   Luengo, Alicia ^a   Ortiz Arduán, Alberto ^c   Calleros, Laura ^a   Rodríguez Puyol, Manuel ^a  

^a UNIVERSITY OF ALCALÁ   (Spain)

^b Universidad de la Cuenca del Plata   (Argentina)

^c UNIVERSIDAD AUTÓNOMA DE MADRID   (Spain)

Author keywords

Improved biobank; ISO 9001; Quality; REDinREN biobank

Indexed keywords

BIOBANK; CERTIFICATION; HUMAN; MEDICAL RESEARCH; NEPHROLOGY; ORGANIZATION AND MANAGEMENT; SPAIN; SPECIMEN HANDLING; STANDARDS; STATISTICS AND NUMERICAL DATA; TIME FACTOR;

BIOLOGICAL SPECIMEN BANKS; BIOMEDICAL RESEARCH; CERTIFICATION; HUMANS; NEPHROLOGY; SPAIN; SPECIMEN HANDLING; TIME FACTORS;

EID: 84908661270     PISSN: 02116995     EISSN: None     Source Type: Journal    
DOI: 10.3265/Nefrologia.pre2014.Apr.12292     Document Type: Article

References (20)

1. Carter A, Betsou F. Quality Assurance in Cancer Biobanking. Biopreserv Biobank 2011;9(2):157-63.
2. Real Decreto 1716/2011, de 18 de noviembre, por el que se establecen los requisitos básicos de autorización y funcionamiento de los biobancos con fines de investigación biomédica Madrid-España: Boletín Oficial del Estado No 290; 2011. p. 128434-54.
3. García-Merino I, de las Cuevas N, Jiménez J, Gallego J, Gómez C, Prieto C, et al. The Spanish HIV BioBank: a model of cooperative HIV research. Retrovirology 2009;6:27.
4. Liaño F, Torres AM. Biobancos: una nueva herramienta para la investigación clínica. Nefrologia 2009;29(3):193-5.
5. ISO9001. Quality Management Systems Requirements. Geneva: International Organization for Stardardization; 2008.
6. ISO. The ISO Survey of certifications 2009. Available at: http://www.iso.org/iso/survey2009.pdf2010.
7. OECD. OECD Best Practice Guideline for Biological Resource Centres (BRCs). Paris; 2007. p. 1-115.
8. NCI. National Cancer Institute. First-Generation guidelines for NCI-supported Biorepositories. Federal Register 2006;71(82):25184-203.
9. ISBER. 2008 Best Practices for Repositories Collection, Storage, Retrieval and Distribution of Biological Materials for Research International. Cell Preserv Technol 2008;6(1):1-56.
10. ISO 17025:2000. European Standard. General requeriments for the competence of testing and calibration laboratories.
11. ISO/guide 34:2000. General requeriments for the competence of reference material producers.
12. Betsou F, Luzergues A, Carter A, Geary P, Riegman P, Clark B, et al. Towards norms for accreditation of biobanks for human health and medical research: compilation of existing guidelines into an ISO certification/accreditation norm-compatible format. The Quality Assurance Journal 2007;11(3-4):221-94.
13. Chaigneau C, Cabioch T, Beaumont K, Betsou F. Serum biobank certification and the establishment of quality controls for biological fluids: examples of serum biomarker stability after temperature variation. Clin Chem Lab Med 2007;45(10):1390-5.
14. Nederhand RJ, Droog S, Kluft C, Simoons ML, De Maat MPM; Investigators of the EUROPA trial. Logistics and quality control for DNA sampling in large multicenter studies. J Thromb Haemost 2003;1(5):987-91.
15. Lacalamita R, Schirone M, Paradiso A. ISO 9001:2000 applied to a research oncology laboratory: which problems? The experience of National Cancer Institute-Bari. Ann Oncol 2008;19(6):1207-8.
16. Calleros L, Cortés MA, Luengo A, Mora I, Guijarro B, Martín P, et al. Start-up of a clinical sample processing, storage and management platform: organisation and development of the REDinREN Biobank. Nefrologia 2012;32(1):28-34.
17. Ley 14/2007, de 3 de julio, de Investigación Biomédica. Madrid-España: Boletín Oficial del Estado No 159; 2007. p. 28826-48.
18. Bou Llusar JC. Development and validation of a perceived business quality measurement instrument. The Quality Management Journal 2002;9(4):23-38.
19. Reed R, Lemak DJ, Montgomery JC. Beyond Process: TQM Content and Firm Performance. Acad Manage J 1996;21(1):173-202.
20. Arenas MD, Gil MT, Egea JJ, Sirvent AE, Giménez A. Aseguramiento de la calidad y certificación de una unidad de hemodiálisis según normas ISO-9001-2000. Nefrologia 2003;23(1):37-46.