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Application of module D Quality assurance Under directive 2014/32/EU (MID)  or directive 2014/31/EU (NAWID) 


May 2007
Issue 1

Addendum to the WELMEC guide 8.4

ADDENDUM DATE: May 2009, Issue 1


This guide is one of those which complete the general guide on the assessment and operation of notified bodies performing conformity assessment in application of the Measuring Instruments Directive (2014/32/EU; MID) and the directive on non-automatic weighing instruments (2014/31/EU; NAWID). Several guides have been established for the detailed application of some modules of MID. These guides should not be read without taking into consideration all relevant aspects in all the guides related to a module. In order to facilitate the understanding of the whole set of guides, a table is provided in Annex 1 of WELMEC 8.0. 

This guide is intended to provide guidance to all those concerned with the application of Annex II Module D (for simplicity referred to as Module D) of MID and NAWID. It provides guidance for manufacturers, notified bodies responsible for conformity assessment and the notifying authorities. 

For more information on the requirements applicable to the quality systems of manufacturers, the specific WELMEC Guide 8.6 Presumption of conformity of the quality system of manufacturers with Modules D or H1 when EN ISO 9001:2015 is applied should  be considered. 

The Guide is purely advisory and does not impose any restrictions or additional technical requirements beyond those contained in the MID or NAWID. Alternative approaches may be acceptable, but the guidance provided in this document represents the considered view of WELMEC as to the best practice to be followed. However it is intended that the procedures as described in the guide must be followed if it is to be claimed that the guide has been applied. 

In many cases the manufacturer will already have an appropriate quality system in place. The task for the notified body will then be to build on the work done by the body certifying the quality system, taking into account all the specific requirements of Annex II Module D, and to have a particular focus on the legal metrology application. In this way the notified body will avoid duplicating work that already has been done by a certification body. (See WELMEC Guide 8.6 Presumption of conformity of the quality system of manufacturers with modules D or H1 when EN ISO 9001:2015 is applied)

AUTHORED BY: Working Group 8

Unless otherwise stated, the English version of each publication should be taken as the official version.

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