ISO Standards Frequently Asked Questions

ISO/TC 212 is responsible for “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 areas are excluded from TC 212's scope of work:

• 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) 

CLSI proposed the formation of a new international standards technical committee, focused on the coordination of international standardization in the clinical laboratory testing field, to the American National Standards Institute (ANSI). ANSI brought the proposal to the ISO Technical Management Board (TMB). In 1995, the TMB approved the proposal and created the technical committee, designated ISO/TC 212, Clinical laboratory testing and in vitro diagnostic test systems.

In forming ISO/TC 212, the TMB granted the Secretariat to ANSI, which in turn delegated the Secretariat responsibility to CLSI. CLSI manages the committee’s program of work through the ISO consensus process and provides administrative support.

ISO/TC 212 has a chairman, Dr. Jack Zakowski of the United States, who oversees the work program of the technical committee, and the TC’s work 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. Neil Greenberg, USA)
• Working Group 3, In vitro diagnostic products (convenor – Ms. Karen Roberts, USA)
• Working Group 4, Microbiology and molecular diagnostics (convenor – Dr. Uwe Oelmueller, Germany)
• Working Group 5, Laboratory biorisk management (convenor – Dr. Gary Burns, UK)

The ISO consensus process is prescribed in the ISO Directives, which outline the procedures for:

• Authorization of a new work item (or project)
• Working group formation and participation in the development of the standard
• Document structure, format, and essential clauses
• Voting at the Committee Draft (CD), Draft International Standard (DIS), and Final Draft International Standard (FDIS) stages
• Addressing comments received
• Final publication of the Standard 

Each country has its own procedure for selecting experts to work on ISO standards projects. If you would like to be involved, contact your member body to express your interest in participating. 

US Technical Advisory Groups (TAGs) are committees accredited by ANSI for participation in ISO technical activities or appointed by the USNC for participation in IEC technical activities, which operate in compliance with the ANSI Criteria for the Development and Coordination of US Positions in the International Standardization Activities of the ISO and IEC. Such US TAGs are administered by US TAG administrators, who are appointed by ANSI to be responsible for ensuring compliance with TAG procedures.

To serve as a member of the US TAG for ISO/TC 212 the member must:

• Have a direct and material interest in the TAG’s work
• Participate actively by fulfilling attendance, voting, correspondence, and other relevant obligations
• Pay an administrative fee 

There are currently 33 participating P-member countries which include the following: