PSNet
Regarding whether or not one must have an ISO 9000 registered quality
system to apply the CE mark, some specifics are laid out for us...
In the LVD, including the modifications by the CE marking amendment
93/68, states in concluding Annex IV - Internal Production Control: 5) The
manufacturer must take all measures necessary in order that the manufacturing
process shall ensure compliance of the manufactured products with the technical
documentation referred to in point 2 and with the requirements of this Directive
that apply to them.
The manufacturer must, therefore, have some sort of a control process in
place. It does not specifically require that it be ISO 9000 registered.
However, if a manufacturer is questioned regarding his ability to control the
manufactured product, I believe that ISO 9000 will be used as the basis for
evaluation of the control process. My point is that even if your process is not
registered, it ought to be good enough to be registered - that's the litmus
test... So use ISO 9000 as the basis for your Quality System...
:>) br, Pete Perkins
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Peter E Perkins, PE
Principal product safety consultant
Tigard, ORe 97281-3427
503/452-1201 phone/fax
[email protected]
visit our www homepage:
http://ourworld.compuserve.com/homepages/peperkins
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