Technical File - RoHS2 Technical Documentation

fcowdery

Starting to get Involved
#1
We are currently preparing a Technical File for our Notified Body to review.
Directive 768/2008/EC Annex II, Module A discusses a requirement for an internal production control procedure.

Is this a shell document serving as a pointer file to QMS and product documents already in existence.

If not, can anyone share a template of this document?

Thanks in advance for your feedback
 
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Ronen E

Problem Solver
Staff member
Moderator
#3
We are currently preparing a Technical File for our Notified Body to review.
Directive 768/2008/EC Annex II, Module A discusses a requirement for an internal production control procedure.

Is this a shell document serving as a pointer file to QMS and product documents already in existence.

If not, can anyone share a template of this document?

Thanks in advance for your feedback
768/2008/EC is not a Directive. It is an EC Parliament and EC Council joint Decision. Since it is not addressed to any specific body, it has no direct applicability. It's main role is to guide the EC legislators in drafting future (applied) law. It is a framework.
 
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