Greetings team members,


I seem to recall somewhere either in a directive or the blue guide where it
states (or implies) that part of the CE marking requirements entails that
the manufacture must have a product quality system/production
control..........and this is where I need clarification: Does it imply that
the quality system entail that *one must conduct an internal product safety
audit (or the like) *to reassure themselves that there has been no
deviation to the product design/documentation that originally supported
their CE marking testing/declaration.



*Note that I am not referring to the module conformity assessment protocol
which involves a notified body, but just the simple self-declaration
scheme. My search always seems to point me towards the notified body
modules section, where they say that the 3rd party conducts factory audits,
etc. but there is nothing that states this for the non-notified body
involvement.*



If there is no such production verification audit required, would it not be
prudent to do this? ….just like the NRTL program? My experience indicates
that most manufacturers do not conduct internal product audits relating to
CE marking unless they forced to because they also have a certification
mark on the product (i.e. NRTL program or other certification scheme via a
Notified Body).


Thanks for any help you can provide me with an official exact
clause/text/excerpt from the OJ, guides and/or directives.


Regan Arndt

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