Guide to Standards Terminology
Standards terminology has a great deal of nuance that can be disorienting for those new to the topic. Below, key standards terms are outlined and the differences between closely related concepts are explained to help make it easier to participate in standards advancement.
How are Standards, Regulations, Guidance, and Best Practices Different?
Standards: Voluntary rules, conditions, characteristics, or physical materials that an organization can adopt to make a process safer, more efficient, or better aligned with the practices of other organizations in their industry. Different standards types include:
Documentary Standards: A document that sets consistent protocols, methodology, technical specifications, or terminology for a product or process.
Standard Reference Materials: Substances or reagents with known properties that are used to calibrate equipment and provide consistency and quality in measurement processes.
Standard Reference Data: Critically evaluated quantitative data related to a measurable physical or chemical property of a substance or system of substances.
Regulations: Have the force and effect of law and are usually mandatory, setting out specific requirements that regulated products and organizations must meet. In the United States, regulations are written in the Code of Federal Regulations and published in the Federal Register.
Guidance: Formal documents issued by a government agency to clarify the agency’s thinking on existing laws or regulations and offer guidelines for how industry can comply with these regulations.
Best Practices: The informal methods most people in a field agree are the best way of accomplishing a goal. These are sometimes published by professional societies in academic journals.
How are Standards Created?
Standards developed following a consensus-based process, which means an organization uses practices that are fair, open, balanced, equitable, accessible, and responsive to stakeholder needs. The American National Standards Institute (ANSI) accredits U.S. standards developing organizations (SDOs) that follow a consensus-based process.
Standards created by any organization that does not follow a consensus-based process. While these standards do not benefit from as wide a range of stakeholder inputs as consensus-based standards, they often raise the level of technical and professional practice within their community.
Who Creates Regenerative Medicine Standards?
View our list of the organizations developing standards for specific examples of each type outlined below.
Standards Development Organizations (SDO)
Organizations focused on developing, publishing, or disseminating technical standards using a consensus-based standards development process.
Professional and Scientific Organizations
Organizations focused on areas of academic or industrial interest; they may create non-consensus standards or informal best practices. This also includes dedicated organizations that focus on developing non-consensus standards and aligning their field under common best practices.
Organizations that offer third-party certification (also called accreditation) programs to confirm that facilities fully meet the process or system requirements of a standard they have chosen to adopt. These organizations may also create non-consensus standards.
Non-consensus standards-developing bodies that may serve as a source for consistent drug manufacturing methods within their country or region. They publish compendial standards—also known as pharmacopeia—which are collected volumes of standards that are often given the force of law by national regulation..