title: Evaluation of a fungal collection as certified reference material producer and as a biological resource center.
abstract: Considering the absence of standards for culture collections and more specifically for biological resource centers in the world, in addition to the absence of certified biological material in Brazil, this study aimed to evaluate a Fungal Collection from Fiocruz, as a producer of certified reference material and as Biological Resource Center (BRC). For this evaluation, a checklist based on the requirements of ABNT ISO GUIA34:2012 correlated with the ABNT NBR ISO/IEC17025:2005, was designed and applied. Complementing the implementation of the checklist, an internal audit was performed. An evaluation of this Collection as a BRC was also conducted following the requirements of the NIT-DICLA-061, the Brazilian internal standard from Inmetro, based on ABNT NBR ISO/IEC 17025:2005, ABNT ISO GUIA 34:2012 and OECD Best Practice Guidelines for BRCs. This was the first time that the NIT DICLA-061 was applied in a culture collection during an internal audit. The assessments enabled the proposal for the adequacy of this Collection to assure the implementation of the management system for their future accreditation by Inmetro as a certified reference material producer as well as its future accreditation as a Biological Resource Center according to the NIT-DICLA-061.
authors.affiliation: Fiocruz - Fundação Oswaldo Cruz, Instituto Nacional de Controle de Qualidade em Saúde (INCQS), Rio de Janeiro, RJ, Brazil; Fiocruz - Fundação Oswaldo Cruz, Instituto Nacional de Controle de Qualidade em Saúde (INCQS), Postgraduate Program in Health Surveillance, Rio de Janeiro, RJ, Brazil.
authors.forename: Tatiana
authors.initials: T
authors.lastname: Forti
authors.affiliation: Fiocruz - Fundação Oswaldo Cruz, Instituto Nacional de Controle de Qualidade em Saúde (INCQS), Rio de Janeiro, RJ, Brazil.
authors.forename: Aline da S S
authors.initials: Ada S
authors.lastname: Souto
authors.affiliation: Fiocruz - Fundação Oswaldo Cruz, Instituto Nacional de Controle de Qualidade em Saúde (INCQS), Rio de Janeiro, RJ, Brazil.
authors.forename: Carlos Roberto S
authors.initials: CR
authors.lastname: do Nascimento
authors.affiliation: Fiocruz - Fundação Oswaldo Cruz, Instituto Nacional de Controle de Qualidade em Saúde (INCQS), Rio de Janeiro, RJ, Brazil.
authors.forename: Marilia M
authors.initials: MM
authors.lastname: Nishikawa
authors.affiliation: Fiocruz - Fundação Oswaldo Cruz, Instituto Nacional de Controle de Qualidade em Saúde (INCQS), Rio de Janeiro, RJ, Brazil.
authors.forename: Marise T W
authors.initials: MT
authors.lastname: Hubner
authors.affiliation: Fiocruz - Fundação Oswaldo Cruz, Instituto Nacional de Controle de Qualidade em Saúde (INCQS), Rio de Janeiro, RJ, Brazil.
authors.forename: Fernanda P
authors.initials: FP
authors.lastname: Sabagh
authors.affiliation: Fiocruz - Fundação Oswaldo Cruz (Fiocruz), Instituto Oswaldo Cruz (IOC), Rio de Janeiro, RJ, Brazil.
authors.forename: Rosane Maria
authors.initials: RM
authors.lastname: Temporal
authors.affiliation: Instituto Nacional de Metrologia, Qualidade e Tecnologia (Inmetro), Divisão de Metrologia Química (DiQuim), Rio de Janeiro, RJ, Brazil.
authors.forename: Janaína M
authors.initials: JM
authors.lastname: Rodrigues
authors.affiliation: Fiocruz - Fundação Oswaldo Cruz, Instituto Nacional de Controle de Qualidade em Saúde (INCQS), Postgraduate Program in Health Surveillance, Rio de Janeiro, RJ, Brazil; Fiocruz - Fundação Oswaldo Cruz (Fiocruz), Vice-Presidência de Pesquisa e Laboratórios de Referência (VPPLR), Rio de Janeiro, RJ, Brazil. Electronic address: manueladasilva@fiocruz.br.
authors.forename: Manuela
authors.initials: M
authors.lastname: da Silva
mesh_terms: D001938:Brazil; D005658:Fungi / Q000145:classification* / Q000235:genetics / Q000302:isolation & purification; D009172:Mycology / Q000458:organization & administration* / Q000592:standards; D011309:Preservation, Biological / Q000592:standards*; D011786:Quality Control
keywords: ABNT NBR ISO/IEC 17025; Biological Resource Center; Certified reference material; Fungal collection; NIT-DICLA-061