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Chinese Journal of Cell and Stem Cell(Electronic Edition) ›› 2019, Vol. 09 ›› Issue (05): 309-313. doi: 10.3877/cma.j.issn.2095-1221.2019.05.009

Special Issue:

• Review • Previous Articles     Next Articles

Construction of quality management system for perinatal stem cell banks

Dehai Wang1, Tianjun Li1, Jian'en Gao1, Lei Yu1, Guifu Zhang1, Xu Ma1,()   

  1. 1. National Research Institute for Family Planning, Beijing 100081, China
  • Received:2019-06-18 Online:2019-10-01 Published:2019-10-01
  • Contact: Xu Ma
  • About author:
    Corresponding author: Ma Xu, Email:

Abstract:

Constructing a quality management system (QMS) is the basic part to ensure the quality of the stem cell products and the development of service. By comparing the structure, content and emphasis of standards established by American Association of Blood Banks (AABB) , Foundation for the Accreditation of Cellular Therapy (FACT) and ISO9001, this article discusses the methods, steps and reference model of constructing a QMS for stem cell banks. It not only helps ensure the construction and managment of perinatal stem cell banks are standardized, normalized and scientific by reference these standards, but also helps improve the ability and level of trust of banks. A good QMS can also accelerate the promotion of strategic emerging industries like stem cells and precision medicine, and provide the motive force to build healthy China.

Key words: Perinatal, Stem cell banks, Quality management system, Building, Improvement

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