The tissue bank at the Instituto Nacional de Investigaciones Nucleares: ISO 9001:2000 certification of its quality management system |
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Authors: | María Esther Martínez-Pardo David Mariano-Magaña |
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Institution: | (1) Instituto Nacional de Investigaciones Nucleares, Apdo. Postal 18-1027, Col. Escandón, 11801 Mexico, D.F., Mexico |
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Abstract: | Tissue banking is a complex operation concerned with the organisation and coordination of all the steps, that is, from donor
selection up to storage and distribution of the final products for therapeutic, diagnostic, instruction and research purposes.
An appropriate quality framework should be established in order to cover all the specific methodology as well as the general
aspects of quality management, such as research and development, design, instruction and training, specific documentation,
traceability, corrective action, client satisfaction, and the like. Such a framework can be obtained by developing a quality
management system (QMS) in accordance with a suitable international standard: ISO 9001:2000. This paper presents the implementation
process of the tissue bank QMS at the Instituto Nacional de Investigaciones Nucleares in Mexico.
Objective: The objective of the paper is to share the experience gained by the tissue bank personnel radiosterilised tissue bank (BTR)]
at the Instituto Nacional de Investigaciones Nucleares (ININ, National Institute of Nuclear Research), during implementation
of the ISO 9001:2000 certification process. At present, the quality management system (QMS) of ININ also complies with the
Mexican standard NMX-CC-9001:2000. The scope of this QMS is Research, Development and Processing of Biological Tissues Sterilised
by Gamma Radiation, among others. |
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Keywords: | Tissue processing Quality management system Quality documents ISO 9001:2000 |
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