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US Technical Advisory Group (TAG)

CLSI (appointed by ANSI to administer the US TAG for ISO/TC 212) is responsible for ensuring compliance with TAG procedures. 

International Organization for Standardization (ISO)

The International Organization for Standardization (ISO) is an international body composed of representatives from various national standards bodies for the purpose of harmonizing measurement and regulatory practices to facilitate trade and collaboration between countries.

American National Standards Institute (ANSI)

The American National Standards Institute (ANSI) is a US-based accrediting body that designates standards development organizations and related associations, societies, officials, and academic and business institutions to work together to develop or adopt international standards and to represent the needs and views of US stakeholders in standardization forums around the globe.  

CLSI was appointed by ANSI to serve as Secretariat for the International Organization for Standardization (ISO) Technical Committee 212 (ISO/TC 212)—Medical laboratories and in vitro diagnostic systems. ISO/TC 212 is responsible for global standardization and guidance in the field of laboratory medicine and in vitro diagnostic test systems. Visit the ISO website for information on ISO/TC 212 and the ISO standards development process. 
 
CLSI also serves as the administrator for the US Technical Advisory Group (TAG) for ISO/TC 212. This committee is accredited by ANSI and operates in compliance with applicable ANSI requirements for the participation in ISO technical activities.  
 
Participation in a TAG is open to any organization within the United States. A US TAG is the only mechanism through which US organizations and individuals can participate in and influence ISO standards.  
 
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, and pay a participation fee.

In general, the functions and responsibilities of a US TAG are:

  • Recommend registration of ANSI as a P-member or O-member of the technical committee or subcommittee or recommend a change or termination in membership status. 
  • Initiate and approve US proposals for new work items for submission by ANSI for consideration by the technical committee. 
    Initiate and approve US working drafts for submission by ANSI to the technical committee for consideration. 
  • Determine the US position on ISO draft International Standards, draft technical reports, committee drafts, new work item proposals, ISO questionnaires, draft reports of meetings, etc. 
  • Provide adequate US representation to technical committee meetings, designate heads of delegations and members of delegations, and ensure compliance with the ANSI Guide for US
  • Delegates to IEC/ISO Meetings (including preparation and submission of a Head of Delegation report). 
  • Determine US positions on agenda items of technical committee meetings and advise the US delegation of any flexibility it may have on these positions. 
  • Nominate US technical experts to serve on the technical committee working groups. 
  • Provide assistance to US Secretariats of the technical committee or its working groups upon request, including resolving comments on draft international standards, draft technical reports, committee drafts, and new work item proposals. 
    Identify and establish close liaison with other US TAGs in related fields, or identify ISO or IEC activities that may overlap the TAG’s scope. 
  • Recommend to ANSI the acceptance of secretariats for technical committee’s subcommittees or working groups. 
  • Recommend that ANSI invite the technical committees or subcommittees to meet in the United States. 
  • Recommend to ANSI US candidates for the chair of the technical committee, and any subcommittees, and US conveners of the technical committee’s working groups. 

Contribute your expertise to best practice standards and ensure your organization is represented.


Technical advisory groups (TAG) are committees accredited by the American National Standards Institute (ANSI) whose members are eligible to participate in the technical activities of the International Organization for Standardization (ISO). CLSI has been appointed by ANSI to administer the US TAG for the technical committee (TC) on Clinical laboratory testing and in vitro diagnostic test systems (ISO/TC 212), and is responsible for ensuring compliance with TAG procedures.

  • US TAG membership is required if an organization wishes to engage in ISO standards development.
  • The member organization must exhibit a direct and material interest in the TAG’s work.
  • The member organization must pay an administrative fee, and must fulfill relevant obligations including attendance, voting, and correspondence.

Each organization paying the administrative fee is entitled to designate one voting member to serve on the US TAG for ISO/TC 212. The administrative fee covers the costs associated with CLSI support of the US TAG.

TAG Membership Benefits

  • Help determine the US position on ISO draft standards; draft technical reports, committee drafts, new work item proposals, ISO questionnaires, and draft reports of meetings.
  • Provide US representation to technical committee and working group meetings and ensure compliance with the ANSI Guide for US Delegates to meetings of the International Electrotechnical Commission and ISO.
  • Nominate or participate as a US technical expert to serve on the technical committee’s working groups.
  • Initiate and approve US proposals for standards and drafts for submission by ANSI for consideration by the international TC.
  • Determine US position on agenda items for TC meetings and advise the US delegation.

Please use this form to apply for membership or change your organization’s participation on The US TAG to the International Organization for Standardization Technical Committee 212  (ISO/TC 212), Clinical laboratory testing and in vitro diagnostic test systems.

Membership on a US TAG is a formalized mechanism through which US organizations and individuals can participate in and influence ISO standards development. The benefit of global standardization of health care testing and related health care services is better, safer, and more cost-effective patient care worldwide. 

Membership on the US TAG for ISO/TC 212 is open to all US interested parties (organizations, companies, government agencies) who:

  • 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.