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Implementation and certification of ISO 9001:2015 seal in human tissue bank HCFMRP-USP
Cell and Tissue Banking ( IF 1.5 ) Pub Date : 2020-10-13 , DOI: 10.1007/s10561-020-09852-1
Carlos Alexandre Curylofo Corsi 1 , Mitsuhisa Shoji 2 , Katia Carmen Gabriel Scarpelini 1 , Rodolfo Leandro Bento 1 , Christiane Becari 1 , Alan Vinicius Assunção-Luiz 3 , Álefe Saloum Cintra 3 , Luís Gustavo Gazoni Martins 1
Affiliation  

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 Ribeirão Preto Clinical Hospital (HCRP) at the University of São Paulo (USP) at Ribeirão 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 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.



中文翻译:

ISO 9001:2015 印章在人体组织库 HCFMRP-USP 中的实施和认证

质量管理体系是一种管理技术,用于保证给定组织的过程和产品的质量。因此,ISO 9001:2015 认证有助于希望开发、实施、维护和改进质量管理体系的组织,以实现流程改进和评估,以满足其客户的需求。本经验报告介绍了巴西里贝朗普雷图医学院 (FMRP) 圣保罗大学 (USP) 里贝朗普雷图临床医院 (HCRP) 人体组织库中 ISO 9001:2015 质量管理印章的实施和认证. 2018 年,人体组织银行与 HCRP 合作,接受了 PRIMEMODE 的咨询。咨询包括向组织银行员工阐明流程的访问,使他们能够阐明标准所有项目的适用性。2019 年 3 月,组织银行接受了审计访问,并获得了 Carlos Alberto Vanzolini 基金会的 ISO 9001:2015 认证。组织库旨在为器官捐赠者的移植和研究提供人体组织。它具有符合所需健康和法律标准的复杂物理结构。此外,现在它有质量管理印章。该认证保证了所提供纸巾的流程组织和高质量标准。它具有符合所需健康和法律标准的复杂物理结构。此外,现在它有质量管理印章。该认证保证了所提供纸巾的流程组织和高质量标准。它具有符合所需健康和法律标准的复杂物理结构。此外,现在它有质量管理印章。该认证保证了所提供纸巾的流程组织和高质量标准。

更新日期:2020-10-13
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