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Documentary Standards

The highest-level international standards, such as those developed by the International Organization for Standardization (ISO), ensure that products and services are safe, reliable and of high quality.  These standards also guide businesses in adopting sustainable and ethical practices and provide safeguards against risks.

NIST Supports efforts by ANSI-accredited standards developers as well as community standardization efforts.  Accreditation by ANSI signifies that an organization's voluntary consensus standards (VCS) development procedures meet's ANSI requirements for openness and due process.   Community standards can often be developed more quickly than international standards through multiparty agreement.  Community standards can still be further developed for broader use and increased consensus.  

Certain industries encourage the use of VCSs.  For example, the U.S. Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) established a Standards Recognition Program for Regenerative Medicine Therapies (SRP-RMT) that recognizes VCSs in order to facilitate the development and assessment of regenerative medicine therapy products that CBER regulates when such VCSs are appropriate.

NIST has led or contributed to many documentary standards promoting innovation and adoption of biotechnology and biomanufacturing.

NIST also publishes protocols in support of further standards development efforts.

Created May 1, 2024