Does a quality system (D) just cover production, or does it mean I need to assess the design of products before they are placed onto the market?

H2O
H2O Register
Chemical Registration Expert
3 min read

Broadly speaking, no.


Module D is production quality assurance. Its purpose is to ensure that every tap, pipe, or valve leaving your production line is identical to the approved type that passed Module B (EU-type examination). The Notified Body audits your production quality management system to verify that:

  • Only approved raw materials and formulations are used.

  • Each batch is traceable back to suppliers and test results.

  • In-process controls and final inspections are consistent.

  • Deviations are detected, recorded, and corrected.


In other words: Module D looks at how you build products, not how you design them. The Notified Body assesses the design separately during Module B. At that stage, the NoBo reviews the formulation, positive-list compliance, and migration testing of a representative sample. Once Module B approval is granted, the design is “locked.” Module D then ensures that production never deviates from that approved design.


 It’s important not to confuse Module D with Module D1. Under the NLF toolbox, Module D1 can cover both design and production quality assurance (as is the case under some other directives). But for the DWD, only Module D applies. This means your quality system does not need to include a design-control function — the design is handled entirely under Module B, while production is overseen under Module D. 


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