Implementation and certification of ISO 9001:2015 seal in human tissue bank HCFMRP-USP
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Implementation and certification of ISO 9001:2015 seal in human tissue bank HCFMRP-USP Carlos Alexandre Curylofo Corsi . Mitsuhisa Shoji . Katia Carmen Gabriel Scarpelini . Rodolfo Leandro Bento . Christiane Becari . Alan Vinicius Assunc¸a˜o-Luiz . ´ lefe Saloum Cintra . Luı´s Gustavo Gazoni Martins A
Received: 7 January 2020 / Accepted: 22 July 2020 Springer Nature B.V. 2020
Abstract The Quality Management System has been a management technology applied to guarantee the quality of processes and products of a given organization. Thus, ISO 9001:2015 certification assists organizations that want to develop, implement, maintain, and improve a quality management system to enable process improvements and assessments to meet the needs of its customers. This experience report addresses the implementation and certification of the ISO 9001:2015 quality management seal at the Human Tissue Bank of the Ribeira˜o Preto Clinical Hospital (HCRP) at the University of Sa˜o Paulo (USP) at Ribeira˜o Preto Medical School (FMRP)—Brazil. In 2018, the Human Tissue Bank, in partnership with HCRP, received consultancies from PRIMEMODE. The consulting consisted of visits that elucidated the processes to the employees of the Tissue Bank, enabling them to clarify the applicability of all items of the standard. In March 2019, the Tissue Bank
C. A. C. Corsi (&) K. C. G. Scarpelini R. L. Bento C. Becari L. G. G. Martins Ribeirao Preto Medical School, University of Sa˜o Paulo, Sa˜o Paulo, Brazil e-mail: [email protected] M. Shoji Foundation Carlos Alberto Vanzolini, Sa˜o Paulo, Brazil ´ . S. Cintra A. V. Assunc¸a˜o-Luiz A Ribeira˜o Preto Nursing School, University of Sa˜o Paulo, Sa˜o Paulo, Brazil
received the audit visit and was certified with the ISO 9001:2015 Seal by the Carlos Alberto Vanzolini Foundation. The Tissue Bank aims to provide human tissues for transplantation and research from organ donors. It has a complex physical structure within the required health and legal standards. Also, now it has a quality management seal. The certification guarantees the process organization and the high quality standard of the supplied tissues. Keywords Certification Human tissue bank Health quality management system ISO 9001:2015
Introduction The Quality Management System (QMS) can be understood as a management technology, applied to guarantee the quality of processes and safety of products and particular organization services, whether it comes from any sector (Andrade et al. 2018). Thus, certifications through technical standards help organizations that want to develop, implement, maintain and improve quality management systems to enable process improvements to meet the needs of their customers (ABNT 2015; Fe´lix et al. 2018). The ‘‘International Organization for Standardization’’ (ISO) is an international organization based in Geneva, Switzerland, whose main scope and policy is standardization. The word ISO origin is Greek and
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