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ISO / Technical Committee 212

CLSI manages the committee’s program of work through the ISO consensus process according to the ISO Directives, and provides administrative support.

The scope of ISO/TC 212 is: “Standardization and guidance in the field of laboratory medicine and in vitro diagnostic test systems. This includes, for example, quality management, pre- and post-analytical procedures, analytical performance, laboratory safety, reference systems and quality assurance.”

The following is excluded:

  • Generic quality management standards addressed by ISO/TC 176
  • Quality management standards for medical devices addressed by ISO/TC 210
  • Reference material guidelines addressed by the ISO Committee on Reference Materials (REMCO)
  • Conformity assessment guidelines addressed by the ISO Committee on Conformity Assessment (CASCO)

Jesus Rueda Rodriguez is the ISO/TC 212 chairman, and ISO/TC 212 is divided into five working groups, as follows:

  • Working Group 1, Quality and competence in the medical laboratory (convenor – Ms. Sheila Woodcock, Canada)
  • Working Group 2, Reference systems (convenor – Dr. Hubert Vesper, USA)
  • Working Group 3, In vitro diagnostic products (convenor – Dr. Kira Meyerovich (Belgium)
  • Working Group 4, Microbiology and molecular diagnostics (convenor – Dr. Uwe Oelmueller, Germany)
  • Working Group 5, Laboratory biorisk management (convenor – Patty Olinger (USA)