International

Three primary objectives drive U.S. participation in the development of international healthcare organization management standards:  

  1. Impart unique and substantial U.S. best practices into the content of standards to improve their global relevance and efficacy,
  2. Ensure that U.S. interests are voiced and included within internationally published standards,
  3. Create a common healthcare language through which global stakeholders may have the confidence that healthcare organizations throughout the world are adopting the same level of standardization.

The Healthcare Standards Institute (HSI) is a member of the U.S. Technical Advisory Group for ISO Technical Committee 304 (Healthcare Organization Management), and follows the ANSI model procedures that meet the requirements for due process and criteria for participation in international standardization activities, as described in the ANSI Procedures for U.S. Participation in the International Standards Activities of ISO (current ed.).  ISO TC 304 follows the ISO Directives that meet the requirements for due process and criteria for approval and withdrawal of ISO Standards, as described in the ISO Directives Parts 1 and 2 (current ed.), the ISO Vienna Agreement, and any other current official ISO requirements.

FAQ's

What is ISO’s relationship to governments?
The International Organization for Standardization (ISO) is a non-governmental organization (NGO). Therefore, unlike the United Nations, the national members of ISO are not delegations of the governments of those countries. These national members are the national standards bodies, or equivalent organizations, in their respective countries. Some of them are wholly private sector in origin, others are private sector organizations but have a special mandate from their governments on matters related to standardization, and others are part of the governmental framework of their countries. In addition to private experts, government experts often participate in ISO's standards' development work. While ISO is an NGO, it receives input from both the public and private sectors.

What are international standards?
Much like their domestic versions, international standards are documents that describe the specifications, metrics, and procedures necessary to produce repeatable and reliable measurements, methods, processes, services, procedures and/or products that are used by organizations and individuals.  They often start with an idea, a past or current practice, or some written document that describes effective or best-in-class performance.

What are the benefits?
Standards serve as a foundation for services, processes, or product development. They facilitate improvement, reduce business risks, encourage innovation, and support sustainable practices. They are a tool for consumers to understand and compare competing products and services, and often lead to a competitive edge. Finally, standards can be nationally or globally adopted, facilitating domestic and international trade.

Why international healthcare management standards?
A report from Deloitte in 2019 states that, global healthcare expenditures continue to escalate, shining a light on health systems’ need to reduce costs and increase efficiency. Spending is projected to increase at an annual rate of 5.4 percent in 2017–2022, from $7.724 trillion USD to $10.059 trillion USD, although cost-containment efforts combined with faster economic growth should maintain the share of GDP devoted to healthcare at around 10.4 percent over the five-year period to 2022.

The proper application of international, voluntary standards in healthcare organization management can dramatically reduce the cost of non-clinical management functions that support an organization’s principal operations, while at the same time improving patient satisfaction and clinical outcomes.

Are there organizations already creating healthcare management standards?
There are a few organizations who include a limited number of healthcare management subjects in their healthcare standards portfolios, however these programs tend to focus on clinical services, devices, and metrics.  Our focus is exclusively on the less well understood organizational practices, activities and measures that are essential for a healthcare organization to operate in the modern healthcare environment.

What is the International Organization for Standardization (ISO)?
ISO is an independent, non-governmental international organization with a membership of 165 national standards bodies. Founded in 1946 and based in Geneva, Switzerland, ISO brings together experts to share knowledge and develop voluntary, consensus-based, market relevant International Standards that support innovation and provide solutions to global challenges.

How does the international standards development process work?
ISO Technical Committee 304 establishes, maintains, and oversees the global committee of international experts on  behalf of ANSI, who represents the United States to ISO.  Global Technical Committees (“TC”) are led by a chairperson who oversees the development of standards in numerous subgroups called “Working Groups.”  These Working Groups are led by “Convenors” who guide the members as they write the draft standards.  The Convenors also lead discussions about the technical content of the document and help the Working Group of experts arrive at a consensus.  Once consensus has been achieved, the document is sent to the entire TC for feedback and a vote on whether to proceed to the next step.  Upon receipt of the TC’s comments and vote, the Working Group reviews this feedback and makes changes based on the nature of the feedback.  

If the TC has voted to proceed with the document’s development, it is sent to the entire 165+ membership of ISO for global public comment and a vote to proceed.  Depending on these comments and the vote from the ISO membership, the document may be revised further and given a final vote by the TC, or it may move directly to publication.  ISO then publishes the standard for consumers to purchase and adopt.

How long does the standards development process take?
Depending on the complexity of the subject matter, standard development may take between 18 and 36 months.  The length of time is also dependent on the number of public comments and how long it takes to resolve them.

What types of standards projects are possible?  
The scope of work includes all non-clinical, functional activities that support the operation of a healthcare organization.  As the scope states:

Standardization in the field of healthcare organization management including classification, terminology, nomenclature, management practices and metrics that comprise the non-clinical operations in healthcare entities.  

Therefore, projects may emerge on any topic that falls within the above scope.  HSI allows the healthcare management marketplace to provide direction on what the priority should be for project committees.  

How does ISO decide which standards to develop?
At ISO, it is the actual community and interested parties who decide the need for a standard. An industry or business sector can communicate its desire for a standard to their national ISO member. The country standard body then communicates this desire to ISO. 

If accepted, the project is assigned to an existing technical committee. Proposals may also be made to establish technical committees (TCs) to cover new scopes of technological activity. ISO only develops new standards for which there are clear market requirements.

How can someone join a committee?
Once a country decides to participate in the development of an international standard, it must form a domestic committee of experts who the country will designate to serve on Working Groups.  The United States calls its committee of experts the U.S. Technical Advisory Group (U.S. TAG) for ISO TC 304. U.S. TAG members must approve applicants or project ideas for membership or consideration.  Besides reviewing applications for an expression of genuine interest in the TC’s work, the U.S. TAG has a duty to ensure that the U.S. participants are true experts and that they represent the interests of the United States in international meetings. Balancing individual expertise while upholding national U.S. interests during international meetings is a dynamic process in standards development.

What is the time commitment for me to participate on a Working Group?
Committee meetings for the foreseeable future will be virtual.  They usually occur monthly and last for approximately 90 minutes.  Smaller project teams may meet more frequently to write and discuss sections of the document.  The amount of time involved is approximately two hours per month but may vary based on the complexity of the standard, level of desired involvement, and the number of participants in a Working Group.

How many people are in a Working Group?
There is no predetermined number of participants. the TC Chair works with the Convenor of each Working Group to determine how many experts must be recruited and deployed to a specific project.  

How do I get started?
Contact [email protected]