INTRODUCTION AND OPERATION OF ISO9002 FOR CORD BLOOD BANK

DOI 1 Citations
  • Takada Kei
    Division of Cell Processing, The Institute of Medical Science, The University of Tokyo
  • Nagamura-Inoue Tokiko
    Division of Cell Processing, The Institute of Medical Science, The University of Tokyo
  • Sugo Michiko
    Division of Cell Processing, The Institute of Medical Science, The University of Tokyo
  • Shioya Mika
    Division of Cell Processing, The Institute of Medical Science, The University of Tokyo
  • Takahashi Atsuko
    Division of Cell Processing, The Institute of Medical Science, The University of Tokyo
  • Cui Yan
    Division of Cell Processing, The Institute of Medical Science, The University of Tokyo
  • Hirai Masako
    Division of Cell Processing, The Institute of Medical Science, The University of Tokyo
  • Taguchi Atsushi
    Division of Cell Processing, The Institute of Medical Science, The University of Tokyo
  • Watanabe Nobukazu
    Division of Cell Processing, The Institute of Medical Science, The University of Tokyo
  • Takahashi Tsuneo A.
    Division of Cell Processing, The Institute of Medical Science, The University of Tokyo

Bibliographic Information

Other Title
  • さい帯血バンクにおけるＩＳＯ９００２品質保証システムの導入と運用

Abstract

Quality assurance is becoming important for the cellular products in cell therapy and blood transfusion. “The International Organization for Standardization (ISO) 9002” is an International standard for quality management systems. We designed and implemented an ISO9002 system for cord blood banking. In March 2001, The Facility for Cell Processing and Preservation of the Tokyo Cord Blood Bank obtained ISO9002: 1994 from the external attestation organization as the first such of cell processing laboratory and cord blood bank in Japan.<br>The introduction of ISO to cord blood banking ranged from reception of cord blood units, various tests, cell processing, cryopreservation, shipping and data analysis.<br>The document system consisted of the “Quality Manual”, “General Procedure” and “Standard Operation Procedures”. The system was audited by internally and then an external attestation organization.<br>After implementation of the ISO, several advantages were recognized including an increase in nuclear cell recovery and in the rate of medical inquiries from mothers.

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Details 詳細情報について

  • CRID
    1390001204908428672
  • NII Article ID
    130003707056
  • DOI
    10.3925/jjtc1958.49.473
  • ISSN
    18838383
    05461448
  • Text Lang
    ja
  • Data Source
    • JaLC
    • Crossref
    • CiNii Articles
  • Abstract License Flag
    Disallowed

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