CE Conformity Marking, First Edition : and New Approach Directives
by: Ray Tricker
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Topics include: products concerned satisfy, new approach directives, internal production control, notified body, approved quality system, harmonised standards, satellite earth station equipment, conformity procedure, full quality assurance, conformity marking, technical construction file, final product inspection, telecommunications terminal equipment, simple pressure vessels, active implantable medical devices, authorised representative, unit verification, examination certificate, conformity assessment procedures, technical file, essential safety requirements, applicable directives, weighing instruments, product quality assurance, quality management system
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First Sentence:
Although harmonisation and European standardisation commenced in 1957 with the Treaty of Rome (and its aim of progressively establishing the internal market over a period expiring on 31 December 1992), it wasn't until 1985 that the European Economic Community (EEC) - now the European Union (EU) - initiated the 'New Approach of Harmonised Directives and Standards'.
CE Marking can be regarded as a product's trade passport for Europe. It is a mandatory European marking for certain product groups to indicate conformity with the essential health and safety requirements set out in the European Directive.
The prime aim of the CE Directive is to ensure that "all industrial products that are placed on the market do not compromise the safety and health of users when properly installed, maintained and used in accordance with their intended purpose. Users and third parties should be provided with a high level of protection and the devices should attain the performance levels claimed by the manufacturer."
This book explains the meaning of CE Marking, its history, how the Directive can affect all manufacturers of industrial products, its current status, its associated quality management requirements, and how manufacturers can easily and cost-effectively meet the requirements for CE Conformance.
Essential information for any manufacturer or distributor wishing to trade in the European Union.
Practical and easy to understand.
Book Info
CE Marking is a mandatory European marking for certain product groups to indicate conformity with essential health and safety requirements set out in the European Directive. This text explains the meaning of CE Marking, its history, its associated quality management requirements, and how manufacturers can easily and cost effectively meet the requirements for CE Conformance. Softcover.
About the Author
Ray Tricker served with the Royal Corps of Signals (for a total of 37 years) during which time he held various managerial posts culminating in being appointed as the Chief Engineer of NATO ACE COMSEC. Most of Ray's work since joining Herne European Consultancy Ltd has centred on the European Railways. He has held a number of posts with the Union International des Chemins de fer (UIC) (e.g. Quality Manager of the European Train Control System (ETCS), European Union (EU) T500 Review Team Leader, European Rail Traffic Management System (ERTMS) Users Group Project Co-ordinator, HEROE Project Co-ordinator) and currently (as well as writing books!) he is busy preparing a complete Quality Management System for the European Rail Research Institute (ERRI) in Holland, aimed at gaining them ISO 9000 accreditation in the near future. He is also consultant to the Association of American Railroads (AAR) advising them on ISO 9001:2000 compliance, and has recently been appointed Fellow of the Institution of Railway Signal Engineers (FIRSE).
Contents
1. BACKGROUND TO THE NEW APPROACH DIRECTIVES: European Directives
Transition Period and Overlapping of Directives
Application
Mutual Recognition Agreements/European Conformity Assessment Protocols
Types of Directives and Standards
Concurrent Application of Directives
Aim of Standardisation
International Standardisation
Harmonised European Standards
Revision of Harmonised Directives
Management of the List of Standards
Recognition of European Standards. 2. STRUCTURE OF NEW APPROACH DIRECTIVES: Articles
Adoption of New Approach Directives
Transposition of New Approach Directives
Advisory Committee
Review and Reporting
Transitional Provisions
Repeal
Entry into Force. 3. STRUCTURE OF THE CE CONFORMITY MARKING DIRECTIVE (93/465/EEC): Main Part
General Guidelines
Conformity Assessment Modules - Short Description
Choice of Module
CE Marking
Industrial Product Type conformity
Competent Authority
Notified Bodies
Essential Standards for Notified Bodies
Relevant Standards of the EN45000 Series for Each Module
Notified Bodies Tasks Under Each Module
Requirements of the Various Directives affected by CE Marking
Content of the Directives
Conformance
Principle Directives
Other Directives
Medical Devices - in vitro diagnostics (COM (95) 130) 180
Other Directives Associated with the CE Marking Directive.
4. GAINING OF CONFORMITY: Self Declaration
Voluntary Certification
Mandatory Certification
The 5 Steps to Conformity
Quality Management System
Conformity Assessment Procedures
Conformity requirements of each Module
Conformance Requirements of New Approach Directives
Manufacturers
Manufactuer's Tasks Under Each Module
Basic Requirements of manufacturers of Industrial Products
Registration of manufacturers
EC Verification
Design and Construction Requirements
Index
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