ISO Standards Frequently Asked Questions

What is ISO?

The International Organization for Standardization (ISO), established in 1947 and based in Geneva, is a non-governmental, worldwide federation of national standards bodies. The member bodies are from more than 160 countries, with each national standard body representing their respective country as a member. In the case of the United States, the American National Standards Institute (ANSI) is the US member of ISO.

ISO's mission is to promote the development of standardization and related activities in the world, with a view to facilitating the international exchange of goods and services and to developing cooperation in the spheres of intellectual, scientific, technological, and economic activity. ISO's work results in international agreements, which are published as International Standards and other types of ISO deliverables.

ISO has put together groups of experts that represent every sector imaginable from soaps to spacecraft. These expert groups are referred to as Technical Committees. There are more than 250 technical committees.

What is ISO Technical Committee 212—Medical laboratories and in vitro diagnostic systems?

ISO/TC 212—Medical laboratories and in vitro diagnostic systems is the ISO Technical Committee whose efforts are focused on standardization and guidance in the field of medical laboratories and in vitro diagnostic systems. This includes, for example, quality management, pre- and postanalytical procedures, analytical performance, laboratory safety, reference systems, and quality assurance.

How did CLSI gain responsibility for administering ISO/TC 212? 

In forming ISO/TC 212, ISO’s Technical Management Board 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.

Who conducts the work of ISO/TC 212?

The ISO/TC 212 chairman oversees the work program of the technical committee, and the TC’s work is divided into five working groups. These working groups are:

• Working Group 1, Quality and competence in the medical laboratory
• Working Group 2, Reference system)
• Working Group 3, In vitro diagnostic products
• Working Group 4, Microbiology and molecular diagnostics 
• Working Group 5, Laboratory biorisk management

Does ISO/TC 212, Medical laboratories and in vitro diagnostic systems, have an advisory group?

Yes, this group is referred to as the US Technical Advisory Group (TAG) for ISO/TC 212.

What do US Technical Advisory Group members do?

The primary purpose of US TAGs is to develop and transmit, via ANSI, US consensus positions and comments on activities and ballots of the International Organization for Standardization (ISO) Technical Committee 212. These activities and ballots include the approval, reaffirmation, revision, and withdrawal of applicable ISO standards.

The US TAG for ISO/TC 212 is also responsible for deciding on the delegates and experts to represent the US at ISO/TC 212 committee meetings. The US TAG can submit New Work Item Proposals (NWIPs) for consideration and ISO member voting regarding the development of new standards in ISO/TC 212.

How do US Technical Advisory Group members benefit from participation?

As a member of the US Technical Advisory Group (TAG) to ISO/TC 212, you automatically get a leg up on emerging issues and obstacles that affect your area of interest. You will gain early knowledge and access to information that will help you shape your company or organization’s agenda, develop networks, and act on priority areas. By contributing to the standards development process you will have the chance to ensure your voice is heard—both domestically and internationally—and participate in decisions that impact your area of interest.

Additionally, you will be seen as a leader and expert in your field—both as an individual and for the organization you represent. Members are recognized on an international stage, and being involved in the standardization process is a way to display your involvement in the industry.

Who is eligible to participate?

Participation in the US Technical Advisory Group (TAG) for ISO/TC 212 is open to any organization or individual within the United States. 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. Typically, large and small industry, government agencies, professional societies, health care facilities, and individuals with a direct and material interest in the TAG’s work make up the US TAG’s membership.

See the TAG Registration form for more details.

Are there requirements for joining the US Technical Advisory Group for ISO/TC 212? To participate:

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.

What is CLSI’s role in ISO?

CLSI serves as the American National Standards Institute (ANSI)-accredited administrators of the US Technical Advisory Group (TAG) for ISO Technical Committee (TC) 212. In its capacity as an administrator, CLSI manages the work of the Technical Committee’s working groups on creative solutions to emerging issues and obstacles that affect the medical laboratory community.

How do I get involved?

To apply for membership on the US TAG for ISO/TC 212, please complete the registration form.