Standards Development Process

Learn more about the steps involved in developing standards, the different kinds of organizations involved in their development, and how you can get involved in the process.


What is a Standards Development Organization (SDO)?

An SDO is an organization focused on developing, publishing, or disseminating technical standards to meet the needs of an industry or field.

Varied topics and specificity

Responsive to the Community: SDOs develop standards in a variety of topic areas in response to industry need, employing a process that involves input and perspectives from a variety of stakeholders, both national and international

Member supported

Member Supported: SDOs are typically member-supported organizations that rely on volunteer participation from experts in relevant fields to draft and review standards

Free and paid offerings

Free and Paid Offerings: While many SDOs charge a fee to access their standards, some offer standards to the public for free


Types of Organizations Developing Standards

SDOs may use consensus-based or non-consensus-based processes.

  • The American National Standards Institute (ANSI) accredits U.S. SDOs that follow a consensus-based process, also known as Voluntary Consensus Bodies (VCSBs).

  • Non-consensus standards are those developed in the private sector but not in the full consensus process (e.g., a standard for a particular company or focusing on a niche topic within a field)

There are five types of organizations that develop standards:

  • ANSI-Accredited SDOs / VCSBs

  • Professional and Scientific Organizations

  • Certification / Accreditation Bodies

  • Pharmacopeia

  • Government Agencies

Learn More

View a comprehensive list of organizations developing standards in the regenerative medicine space.


Attributes of Consensus-Based StandardS Development Processes

According to OMB Circular A-119, the Federal Government prefers the use of Voluntary Consensus Standards (VCS) rather than government-developed standards. VCS are developed by Voluntary Consensus Bodies (VCSB) that have the following attributes:

Openness

Openness: Standards development procedures are transparent and allow anyone with interest to have a voice in the process

balance of interest

Balance of Interest: Standards reflect a broad range of perspectives

Due process

Due Process: Standards development processes are well organized and documented so stakeholders can participate meaningfully and feel confident in the fairness of decisions

Appeals process

Appeals Process: Impartial handling of procedural appeals provides an opportunity for stakeholders to dispute decisions

Consensus

Consensus: Fair, impartial, open, and transparent processes are leveraged to arrive at a general agreement between stakeholders


Process for Developing a Standard

Overview

The standards development process is generally divided into 3 main activities phases:

Pre-development activities

  • Identify needed standards

  • Conduct feasibility assessments

  • Draft an outline of the standard

Standards development organization processes

  • Submission of a proposal to an SDO

  • Drafting and commenting period

  • Draft review by SDO committees and subcommittees prior to publication

Post-publication outreach activities

  • For ANSI-accredited SDOs, this includes a 5-year post-publication review to see if the standard needs to be revised or withdrawn

Process Detail

Although standards development procedures vary among SDOs, the process typically includes the following detailed steps in the phases outlined above:

9-step standards development process
Step 1: Identify Needs

Identify Needs

Identify the need for a written/documentary standard or reference material/physical standard


Step 2: Prioritize Standards

Prioritize Standards

Solicit input from the community to determine which areas of need would have the greatest benefit for the field if standardized


Step 3: Assess Feasibility

Assess Feasibility

Gather experts to discuss the feasibility of developing the standard and confirm whether a standard has the necessary technical foundation and community support to move forward


Step 4: Initiation

Initiation

Present the standard concept to an SDO or other standards developing body and receive acceptance for standard development


Step 5: Initial Drafting

Initial Drafting

Experts within a working group begin to draft the standard



Step 6: Review/Comment

Review/Comment

Drafts of the written standard are circulated for comment, voting, and editing. Reference materials/physical standards may be distributed for testing and certification to ensure that they serve their intended purpose


Step 7: Final Voting

Final Voting

A final round of voting is conducted and the standard is approved for publication


Step 8: Finalization

Finalization

Final changes are incorporated into the standard and it is prepared for publication


Step 9: Ongoing Education and Outreach

Ongoing Education and Outreach

The standard is published and standard champions communicate with the public to raise awareness of its availability and increase understanding of its value and implementation

View any of the SCB project working group pages to see these steps in action.

SDO-Specific Processes

SDO processes may vary. Learn more:

Contact SCB if your SDO has a custom process that should be featured here.


Who Can Participate in Developing a Standard

Anyone who may be impacted by the standard or who has relevant technical knowledge to inform standards development.

3 levels of involvement: minimal, scalable, sustained

The standards development process is open to any individual or organization affected by the standard. Such groups include but are not limited to:

  • Regenerative medicine product developers (e.g., manufacturers of cell therapy, gene therapy, and tissue engineering products)

  • Industry suppliers (e.g., raw material providers, equipment manufacturers, product component developers, or service providers)

  • Contract development and manufacturing organizations (CDMOs)

  • Researchers or representatives of academic institutions

  • Healthcare providers or clinicians

  • Regulators (e.g., FDA) and non-regulatory government agencies (e.g., NIST)

  • Patient advocacy organizations

Participants are volunteers and may choose to participate either as an individual or as a representative of their group or company.

LEARN MORE

Participate in the Standards Development Process includes more information on different ways to get involved in standards development