Thursday, May 28, 2009

Reference Materials for Genetic Testing ISO Standardization

Reference Materials for Genetic Testing ISO Standardization
by : Klaus Stinshoff
Digene Switzerland Sarl

ISO Standardisation

Classes of Standards:

  • horizontal standards: Standards indicating fundamental concepts, principles and requirements with regard to general aspects applicable to all kinds or a wide range of products and/or processes (e.g. ISO 17511:2003)
  • semi-horizontal standards : Standards indicating aspects applicable to families of similar products and/or processes making reference as far as possible to horizontal standards (e.g. ISO 18153:2003) and
  • vertical standards : Standards indicating necessary aspects of specific products and/or processes, making reference, as far as possible, to horizontal standards and semi-horizontal standards
(GHTF, SG1/N044R4, 2002)

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