Module D refers to a quality assurance system used to demonstrate conformity with EU product regulations, such as the 2024/370 Drinking Water Directive (DWD), the EU Fertilising Products Regulation (FPR), the Machinery Directive, or the Construction Products Regulation. It is one of several conformity assessment modules defined in the New Legislative Framework (NLF).
In essence, Module D requires a manufacturer to operate a quality system—under the supervision of a Notified Body—that demonstrates the ability to consistently meet all regulatory requirements for the product. In the case of Module D1, the system must also cover product design. This means the manufacturer can design and place new products on the market, operating “as their own Notified Body” under continuous oversight. Such situations also require additional documented procedures to control design activities.
Generally, Module D requires quality management throughout the full production chain. ISO 9001 is the harmonised standard that corresponds to Module D and is often the basis for demonstrating conformity.
The following topics may be addressed during a Module D audit. Audits can be extensive, so feel free to reach out to us for support:
- Supplier and raw material control – ensuring only approved suppliers and substances are used (including compliance with Positive Lists).
- Traceability – confirming each production batch can be traced to its materials, testing, and release decision.
- In-process and final checks – verifying that production monitoring and inspection processes are consistent, including analytical checks.
- Non-conformity handling – how deviations are detected, documented, investigated, and corrected.
- Record-keeping – ensuring that logs, certificates, and reports are properly maintained and accessible.
- Internal audits – confirming that internal audits are performed and that follow-up actions are implemented.
- Production controls – standardised, repeatable rules governing each relevant stage of production.
- Staff policy – ensuring competency, training, and responsibilities are clearly defined.
- Other quality elements required under the regulation or based on product-specific risks.