Conformity assessment - Supplier declaration of conformity - Part 1: General requirements
Sets the general content of a supplier declaration of conformity. FDA says its declaration elements are consistent with this standard.
The text of this standard is sold by ISO/IEC and is not reproduced here. This page gives the code, edition, scope and what each market says about it.
Whether the market recognizes, harmonizes or adopts this standard, and which edition it accepts
| Market | Status | Edition accepted | National code | Details |
|---|---|---|---|---|
| United States | Referenced | - | - | Voluntary: a submitter may format a declaration of conformity using this standard. |
Open the market page and its pathway pages for the full requirement, protocol and report content
Related standards: Q5A(R2), Q5B, Q5D, Q5E, Q8(R2), Q11, Q12, Q13, AS/NZS 3551, UN Manual of Tests and Criteria, section 38.3. See all standards.
Not legal or regulatory advice. Check the current official rules before you act. Parts of the approvals data are official open data reused under open licences. Data sources.