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F. Sistani, U.H. Steinhorst; A Comparison of the European and American Models for Quality Management Applicable in an Eye Bank . Invest. Ophthalmol. Vis. Sci. 2003;44(13):4707.
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© ARVO (1962-2015); The Authors (2016-present)
Purpose: In the past years it has become mandatory for every German Cornea Bank to establish a quality management system (QMS). Legal and social requirements and requirements of the interested parties are increasing steadily. Any mistake could be fatal, specially in this era of transmissible diseases like HIV, Hepatitis or Creutzfeld-Jacob disease. The purpose of this work was to point out the importance of a QMS in an eye bank and to present a suitable model of application of a QMS in a cornea bank. Methods: There are many different models for a quality management. Two of the most common models applied in health care organizations were compared. The ISO 9000 family of standards (most common among European eye banks) and Total Quality Management (TQM), which is the most common model of quality management in the USA were evaluated and compared with each other for their suitability as models of quality management in a helath care organization such as an eye bank. Results: Quality management takes place in 4 operative levels: Planning, control, assurance and improvement of the quality of our work. A QMS increases the quality and the transparency of our activities, it helps to prevent non-conformities or to detect possible non-conformities and correct them. Quality management assures a continual improvement and prevention of potential mistakes.The ISO 9000 family of standards describes the fundamentals of quality management, specifies requirements and provides guidelines for more efficiency of the quality management system. Every organization fulfilling these requirements receives a certificate of accreditation. The model of Total Quality Management (TQM) is a complete model of quality management respecting all aspects of quality management. An easy way to establish a functioning QMS is to start with the ISO model and to expand it to the level of TQM Conclusions: Every person working in an eye bank, like all other branches in transplantation medicine has a big responsibility supplying patients with high quality grafts. Establishment of a QMS is very important to assure an excellent and safe supply of the patients with corneal grafts. A combination of both ISO 9000 family and the TQM is certainly the best way of establishing a quality management system in a cornea bank
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