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CE marking for exporters to Europe PDF Stampa E-mail
A product manufactured in conformity with EU legislation in one member State will be guaranteed automatic access to the markets of all the other member States.
Manufacturers are responsible for the application of the CE marking to their products.
T PRISMA offers a complete range of services ensuring that products comply to the CE marking regulations.
Our Professionals have in-depth expertise and an extensive working experience in a wide industrial spectrum.


SERVICES
T PRISMA offers technical advice in the CE marking process, including:
• Guidance in identifying applicable Directives and Harmonised Standards.
• Product evaluations in accordance with applicable European Harmonised Standards.
• Hazards identification and risks assessment.
• Assistance in application of the Directives and in determining the appropriate measures to meet with CE marking regulations.
• Access to Notified Bodies, where "third part" involvement is desired or required.
Obtain competitive quotes from " Notified Bodies".
• Design and assistance in implementation of Quality System, in accordance with ISO 9001:2000, when required by the Directive or desired by the manufacturer.
• Assistance in preparing the Declaration of Conformity and Technical File.
• Authorized representative services.


CE MARKING APPLIANCES
• Machinery
• Pressure vessels and pressure equipments
• Air refrigeration equipments
• Personal protection devices
• Boilers
• Lifts
• Boats
• Construction products
• Process plants and factories

CE marking of plants is more than a "sum" of CE mark for each component.
T PRISMA's experienced design engineers can assist in complying with the above types of situations.
Our Professionals have extensive experience of mechanical, electrical, structural, electronic circuit, software design and industrial plant engineering, with particular knowledge on health & safety matter.
• Application of Noise, Low Voltage and Electromagnetic Compatibility Directives
• Medical and in vitro diagnostic devices

CONTENTS OF CE MARKING TECHNICAL ADVICE

• Directive & Standards Identification
• Technical Consulting Service:
  - Advice on compliance and conformity of products (or plants)
  - Review under the "Essential Health & Safety Requirements"
  - Safety and risk rating
  - Suggestions for risk reduction in compliance with EU Standards and Directives.
  - Purchasing Standards (as requested).
• Compliance Testing arrangement
Obtain competitive quotes from "Approved Bodies" where "third part" testing is required
• Technical Documentation Service
  - Assistance in preparing Technical Files
  - Guide to Declaration of Conformity
• Document Translation (as requested)
  - Users Manual and Installation Instructions
  - Labeling Advice


CONTENTS OF CE AUTHORISED REPRESENTATION
Through its Italy office, T PRISMA offers Authorized Representative Services in accordance with the requirements of the Medical and In-Vitro Diagnostic Directives.
We can act as EU authorized representative: register products in Italy, get products' Certificate of Registration for CE Marking and keep the necessary documents available for being immediately verified by vigilance authorities.
As Authorised Representative T PRISMA offers the following services:
• Use of T PRISMA's name and registered address in Italy (or Europe);
• Registering of CE-marked devices with the appropriate Competent Authorities;
• Keep (confidentiality) Technical Files and makes them available, as required, for being immediately verified by vigilance authorities;
• Legislation monitoring;
• Interfacing between manufacturers and Authorities, Notified Body, distributors or end-users.
• Technical representation, assistance, and reporting in case of incidents or claims.
• Notification of the competent Authorities of serious incidents.
• Assistance in Product Recalls and Advisory Notices;
• An annual review of technical file content with a reminder to update or change existing documentation.


HOW TO START?
Please contact us with the following information:
• A description of your product, including data sheets, pictures, schemes, illustrations and any appropriate information.
• The name and address of the company responsible for the product, and a list of manufacturing locations.
After a few days, a written quotation will be sent to Client.
Sometimes a visit is necessary to view the machine (or plants).

 
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