Technical File - RoHS2 Technical Documentation

fcowdery · Feb 6, 2015

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

Jen Kirley · Feb 12, 2015

A quick bump...

Can anyone help?

Ronen E · Feb 13, 2015

fcowdery said:
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.

Technical File - RoHS2 Technical Documentation

fcowdery

Starting to get Involved

Jen Kirley

Quality and Auditing Expert

Ronen E

Problem Solver

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