CE Mark machinery technical file contents

QNET's Machinery Advisory Technical File Contents
The first section of an Advisory Technical File written for our clients contains details of a Hazard and Risk Assessment in which categories of risk are identified. These categories of risk determine the level of action needed to reduce risk, which is a primary requirement of the Machinery Directive. Only then can an Advisory Technical File be written which details how compliance with the Machinery and any related Directives has been achieved. Where risks have already been reduced sufficiently the Advisory Technical File contains statements which carefully explain why. Where further action is needed to reduce risk, the best action to take in order to achieve compliance is identified.
An Advisory Technical File details each Essential Health and Safety Requirement and how compliance has been achieved or the actions needed to achieve compliance with the Machinery Directive. When further action is needed to achieve compliance, recommendations or technical solutions that apply specifically to the machine are offered. It is recognized that different solutions can be implemented to achieve the same result and where possible other options are identified.

Topics Covered in a QNET Machinery Advisory Technical File
There are seven sub-sections in Part 1 of Annex I of the Machinery Directive and these apply to all types of machinery. The seven sub-sections in Part 1 of Annex I of the Machinery Directive have about 48 requirements that need to be addressed. Major topics that are considered, if applicable, are listed below.

The integrity of electrical, pneumatic or hydraulic control systems including fault analysis.
The rating and reliability of components used in electrical, pneumatic and/or hydraulic control systems.
Mechanical handling systems.
Covers, guards, emergency stop and powered failure.
Control devices and their identification.
Operator intervention.
Ergonomics.
Internal lighting.
Requirements for combined machinery.
Stability and mechanical strength.
Lasers and software,
Fire and explosion.
Acoustical noise and vibration.
Control of emissions.
Electrical safety and EMC.
Installation, operating and maintenance instructions.

The Finished Machinery Advisory Technical File
A QNET Advisory Technical File is written in the format of a finished Technical File and can be edited by the manufacturer once the action needed to achieve full compliance with the Machinery Directive has been taken. Finally we cover the following topics:

Identification of the required CE and other marking and any warning labels.
Preparation of a template Declaration of Conformity for use by the manufacturer.

Caution:Once the Advisory Technical File has been converted into a final Technical File it is very similar to a Design Guide and is a valuable document that must held in the strictest confidence. Only a European Government Regulatory body has the authority to request and receive a copy of your complete Technical File.

Don't forget an Authorized Representative is needed for U.S. manufacturers exporting machinery to Europe. For details on how QNET can assist as your EU Authorized Representative go here.