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Anatomy of a Standard
Standards will generally contain the following items:
- Statement of Scope and Application - under what conditions the standard is applicable/to be used
- Definition of Terms
- Referenced Standards and other Documents
- Body of the Standard - may include:
- Equipment needed and calibration requirements
- Procedures, criteria, validation processes
- Training recommendations
- Discussion of Revisions
Typically, standards are very specific - they are limited in scope and seek to avoid specifying any part of an overall process that may be described elsewhere. This helps facilitate version control of interrelated procedures but often means that several standards are needed to fully define a product or procedure.
When evaluating whether a standard is relevant to your project, consider the following:
- Standards should be used only within their defined scope; outside of this, efficacy is unknown. Therefore, always read the Scope and Application sections of the standard before applying.
- Terminology will be specific to the discipline represented in the standard and may not be defined the same as in common language.
- Broad standards (e.g., relating to a class of equipment) will often present high-level information and may not provide the detail you need. Often the detail is found in the referenced standards
Also, since standards are updated regularly, it is essential to determine if the standard is "active" and/or the latest revision. Most standards search engines contain filters to allow you to select only active standards. The designation for the standard generally contains information relating to when the standard was formalized (see Standards 101).