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)
Dr. Donald M. Powers is the ISO/TC 212 chairman, and ISO/TC 212 is divided into four working groups, as follows:
- Working Group 1, Quality and competence in the medical laboratory (convenor – Mr. John James, UK)
- Working Group 2, Reference systems (convenor – Dr. Neil Greenberg, USA)
- Working Group 3, In vitro diagnostic products (convenor – Ms. Kay Setzer, USA)
- Working Group 4, Antimicrobial susceptibility testing (convenor – Dr. James H. Jorgensen, USA)