QNET's European Design Engineers can quickly assist you in identifying practical design solutions that satisfy the requirements of EU Directives such as the Machinery, Noise, Pressure Equipment and ATEX Directives. This avoids expensive research into EU requirements, ensures access to the best design concepts, detailed solutions and attention to safety at the development stage to avoid design changes later. European Directives are not meant to be restrictive and with a good design approach manufacturers can be highly innovative.
In this introductory presentation participants learn that CE-Marking is based on EU Directives. how and by whom these directives are developed. What type of products may follow the self-certification process of these directives or if they need to be certified by a European Notified Body. How and when standards fit into this process and if a quality management system is required (ISO 9001). Compliance with WEEE and ROHS environmental directives for electrical and electronic equipment will also be covered.
Machinery Directive - Hazard & Risk Analysis Training - 2 Days
Machinery Directive - Hazard & Risk Analysis & Essential Health and Safety Requirements (EHSR) Training - 3 Days
This training is designed to provide a core group of Engineers with a more in-depth understanding of the Machinery Directive Essential Health and Safety Requirements (EHSR) for the purpose of CE marking. The focus is on teaching attendees in performing a hands-on Hazard and Risk Analysis on their equipment, based on well tried techniques that reveal realistic assessments and how the results apply when addressing EHSR. The format will be a small group presentation with PowerPoint visual aids and hands-on involvement. If possible the attendees should include at least one representative from the following groups; mechanical engineering, electrical engineering, service engineering, users, sales and marketing and at least two dissimilar products should be considered.
Advisory Technical File Writing.
This CE marking service consists of the development of an Advisory Technical File that QNET has used successfully for machinery, ranging from simple to sophisticated, since 1997. It meets the needs of small/medium size manufacturing companies that place equipment on the EU market.
The Advisory Technical File covers each of the Essential Health and Safety Requirements of Machinery Directive 2006/42/EC as they appear in the Directive followed by statements suggesting how compliance can be achieved. To convert this document into a finished Technical File clients need to do the following:
Locate all the documents that substantiate the statements we have made.
Enter each document in the section suggested, making reference to a document number if this is how documents are identified in the company record system.
There are two components to a Technical File. statements of how compliance has been achieved and support documents that verify the statements. Together these must confirm that compliance with the Essential Health and Safety Requirements of the directive has been achieved.
On the last page of this document is a draft of the Declaration of Conformity or Incorporation that must be prepared to confirm compliance with the directive.
Companies typically complete the CE marking process of a machine within 3 to 4 months.
QNET Advisory Technical File Consulting services have assisted more than 200 companies CE mark their machinery, including self-certification and ANNEX IV (Third party/Notified Body certification) machines in accordance with the following directives:
Machinery Directive 2006/42/EC
Pressure Equipment Directive 97/23/EC
ATEX Directive 94/9/EC
EU Authorized Representative
In accordance with the requirements of the Machinery , RoHS and Medical Device directives.
U.K. Notified Body Interaction and Negotiations
QNET engineers provide assistance with preparation and submission of a Notified Body application.
Management of negotiations between Notified Body and Manufacturer in response to any questions or issues raised by the Notified Body that need to be resolved, providing QNET was involved in the CE marking process.
For additional information please contact Yvonne Halpaus at: qnet@ce-mark.com
