The tissue bank at the Instituto Nacional de Investigaciones Nucleares: ISO 9001:2000 certification of its quality management system.
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.
Martínez-Pardo
María Esther
ME
Instituto Nacional de Investigaciones Nucleares, Apdo. Postal 18-1027, Col. Escandón, 11801, Mexico, D.F., Mexico. memp@nuclear.inin.mx
Mariano-Magaña
David
D
D000818:Animals; D046148:Donor Selection; D006801:Humans; D008800:Mexico; D011785:Quality Assurance, Health Care / Q000592:standards*; D014015:Tissue Banks / Q000592:standards*; D009927:Tissue and Organ Procurement; D017749:Total Quality Management / Q000592:standards*