What it is
ISO (the International Organization for Standardization) is the global standards body. Its standards span products, materials, test methods and management systems, and many European (EN) standards are adoptions or adaptations of ISO standards.
Why it matters for compliance
ISO standards are valuable evidence of good practice and are often demanded by customers or in procurement — but on their own they do not confer the EU presumption of conformity (only harmonised ENs cited in the Official Journal do). One ISO standard is especially relevant to the discipline itself: ISO 37301, the international standard for compliance management systems, which frames compliance as a managed Plan–Do–Check–Act cycle.
How to use it
- Use ISO standards as good-practice evidence and to meet customer or procurement requirements.
- For EU conformity, rely on the harmonised EN version where one is cited.
- Consider ISO 37301 as a model for building a compliance management system.
Good to know
“We used an ISO standard” supports a safety case but is not the same as a presumption of conformity — check whether a harmonised EN applies to your product and legislation.
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