Module D
5 articles
What does it mean to have a quality system under Module D/D1?
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 Fertilisin...
Can unwritten, or informal procedures be used?
Usually, within a quality system, Notified Bodies will require documented procedures so they can clearly establish compliance against the requirements of the specific regulatio...
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?
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 ap...
Is ISO 9001 required?
Module D is based on international standards for management systems, and indeed ISO 9001 is an EU harmonised standard for proving compliance against quality management requir...
How to ensure quality assurance of a laboratory that I use?
Most laboratories that delivery quality results will be working under an ISO 17025 accreditation and will be accredited. In this case you have a quality system setup to control...