The situation over "self-verification" under the NAWI Directive is becoming clearer, although sadly it is not turning out the way we would like. You may remember we explained the problem in some detail in the March issue of Weighlog, but let's just recap on it.
Under the NAWI Directive there are three options for "verification"; the traditional verification by a Trading Standards Officer (if you can find one that is authorised to do it!), unit verification where the verification and the Type Approval are combined (available for unique installations and one-off systems, only one or two such verifications have been made since the Directive came into force in January 1993) and "self-verification" available for manufacturers with a quality system accredited by a Notified Body. (The correct name for this is "EC Declaration of Type Conformity (guarantee of production quality)" but we will use "self-verification" or "SV" as shorthand).
The Directive makes it clear that only the manufacturer can be accredited to self-verify. The manufacturer can allow others to operate under his accreditation but they must follow his procedures, meet all the requirements of his accreditation, and work under his control as far as verification is concerned.
Over the years a number of UKWF Members have been accredited to carry out SV and have been allowed by the Notified Bodies to include in the scope of their accreditation weighing equipment manufactured by others. The Notified Bodies have now realised that they went further than they should have in allowing this and that they had no legal authority to do what they did. As a result a number of Members are now facing the prospect of having the scope of their accreditation reduced by the removal of any equipment that they are not the manufacturer of from the list of equipment that they are allowed to verify.
So who or what is the manufacturer? This was the subject of a meeting between NWML, the Notified Bodies and the UKWF last month. In general terms the meeting agreed, after a long and intense discussion that the manufacturer is:
The organisation that undertakes the physical task of making or manufacturing an instrument, or
The organisation that places an instrument on the market under its own name and takes legal responsibility for the item. (In this case the organisation must have some level of control of the manufacturing process).
In order to help understand who is or is not a manufacturer, NWML have published a document with the title "Guidance on the Designation of Manufacturers". This Guidance, together with a flow chart type decision tree is available on the UKWF web-site. Members are encouraged to use the Guidance and the flow chart to see how they are affected by the definition of manufacturer, and to contact the Federation if they have any questions.
These are some examples that might help.
A distributor or dealer who buys in a complete self contained weighing machine (e.g. a retail counter scale or a bench scale) from a supplier cannot be regarded as the manufacturer of that machine even if he marks it with his own brand name, because he has no level of control over the manufacturing process.
A distributor buys in a self contained weighing machine from a supplier and then modifies it in such a way that it is now a "different" machine from the one he originally purchased, e.g. he adds another load receptor or incorporates the machine into another system. He can be regarded as the manufacturer if he marks the machine with his own name and issues an EC Declaration of Conformity for the "new" machine or system.
A dealer buys in an indicator and load cells. He then has a bottomwork built, - it may be anything from a small platform to a weighbridge- and incorporates the load cells into it and connects it to the indicator. The dealer is the manufacturer. He must put his name on the machine and issue the EC Declaration of Conformity.
So where do we go from here? The Federation is acting on two fronts. Firstly we have asked NWML to introduce amendments to the existing Regulations as a matter of urgency. Whilst NWML cannot do anything that is not permitted by the Directive and therefore cannot allow organisations that are not manufacturers to carry out self-verification on new machines, they can, with an amendment to the Regulations, allow installers, dealers and repairers to carry out re-verification after the machines have been placed on the market and taken into service. NWML have indicated that they are sympathetic to this and will explore how quickly the amendments can be introduced, although they are committed to dealing with all the necessary legislation to implement the Measuring Instruments Directive as their first priority.
Secondly, through CECIP the Federation is contacting the European Commission to see if it is possible to get the Directive modified. CECIP raised the question about the definition of manufacturer at the last WELMEC Working Group 2 meeting in June. The Commission were represented at the meeting, and advised CECIP to write to the Commission Group that is currently looking at how Directives are implemented. The Commission representative also said that it was time that the NAWI Directive was reviewed, as it is now 15 years old, and that this topic could form part of that review. Any such review is however likely to be a long process.
Both NWML and the Notified Bodies are aware of the problems that this change of interpretation will cause for UKWF Members. They are committed to adopting as wide a definition of manufacturer as they possibly can whilst staying within the limits set down in the Directive, and they will deal with all questions and queries as sympathetically as possible. The Federation will continue to work towards getting the facility to carry out verification available to as many Members as possible. It will however take time. Please bear with us; this will be at the top of our agenda until it is resolved. |