Implementation of Technical Regulations on Company Level

1
Implementation of Technical Regulations on
Company Level
Chamber of Commerce and Industry, Ljubljana

• Top Management Seminar

Expert Willem Wolf
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Frequently Asked Questions
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• What is a European Directive
• when is it applicable
• is my product subjected
• how do you comply
• which standards
• are imports subjected

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Frequently Asked Questions
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• Is certification obligatory
• what about national requirements
• who can assist
• what are the costs
• how long does it take

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EU Legislation
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• Member States and the legal structures to
  accomplish the Unified Europe

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Member States EU
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• Austria, Belgium, Denmark, Finland,
  France,Germany, Greece, Ireland, Italy,
  Luxembourg, The Netherlands, Portugal, Spain,
  Sweden, United Kingdom

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European Economic AreaApplicability of Directives
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• European Union
• Iceland, Norway and Liechtenstein
• (Switzerland implements voluntarily)

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TREATY OF ROME, 1957
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Art. 118A
Art. 100A
95
137
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EC Directives
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According Art. 100 Realisation of the internal
market Transposition in national law without
changes According Art. 118A Approximation of
laws and regulations Minimum requirements
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Article 100AWhy Product directives ?
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• Free movement of goods
• Safety, Health, Environmental
• Technical harmonization

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Article 100ABy whom ?
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• Brussels (European Commission)
• order to member states
• national implementation
• maximum requirements no differences

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Article 100AFor whom ?
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• Manufacturer
• Importer
• end user

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Article 118A
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Social
Safety
Working environment
Health
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Article 118A
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Why ?
absence through illness
Diminish
occupational disease
occupational accidents
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Article 118ABy Whom ?
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• Brussels (European Commission)
• order to member states
• national implementation
• minimum requirements, differences allowed

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Article 118AFor whom ?
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• Employees
• Employer

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NEW PRODUCT DIRECTIVES
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• Low voltage
• EMC
• Machinery
• Medical devices
• ATEX (94/9/EG)
• CE-marking
• etc.

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NEW OSH DIRECTIVES
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• Safety at the working place
• Working devices
• Working with Visual Display Units
• ATEX (Draft)
• etc.

OSH - Occupational Safety and Health
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TREATY OF ROME
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100A
118A

• Technical harmonization
• free movement of prod.
• safety for the user
• national implementation
• maximum requirements
• No differences
• manufacturer, Importer
• end user

• safety/health of worker
• national implementation
• minimum requirements
• employee/worker
• employer

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NEW APPROACH
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• No technical requirements
• Only essential requirements
• references to standards

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DIRECTIVES AIM AT
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• free movement
• harmonization of laws
• safety
• health
• environment

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NEW APPROACH
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• since 1985
• directive per group of products
• only essential requirements
• technical requirements by CEN/CENELEC
• permanent committee (judge standards)
• publication in the official journal

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New Approach
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Placing on the market initial action to sell or
to use a product in the European
community Putting a product into service First
use by the final user in the European
community Manufacturer Person responsible for
design and production Authorized
representative Person appointed by the
manufacturer to act on his behalf Importer One
importing goods into the European community
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STANDARDIZATION
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activity (process) of establishing provisions
(appointments/specifications) for common and
repeated use, aimed at the achievement of the
optimum degree of order in a given context. Made
(drawn up) with consensus by all relevant
parties concerned.
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STANDARD (voluntary) agreement between parties
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• with which compliance is not compulsory
• which is available for the public
• approved and issued by a recognized body

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STANDARDIZATION AIMS AT
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• fitness for purpose
• compatibility/interchangeability
• variety reduction and efficiency
• (self)regulation of the market
• elimination of (technical) barriers to trade
• safety and health
• protection of the environment

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STANDARDIZATION BENEFITS
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• reduction of enterprise risks
• serves the competitiveness
• means market opportunities
• market oriented application of Know-how

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THE STANDARDS WORLD
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Some important Directives
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• Low Voltage
• Medical Devices
• Telecom Terminal Equipment
• Machinery
• Explosive Atmosphere
• EMC

• Automotive
• Active Implantable
• Tractors and agricultural vehicles
• Pressure equipment
• ...
• over 47 directives (19 are New Approach)

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CE-marking
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• Compliance with all applicable directives
• internal quality control system
• procedure on how conformity is achieved
• applying the CE-mark
• retain documentation for 10 years

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CE- marking
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Sanctions
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• Sales embargo
• liable for all cost of taking products of the
  market
• liable for all cost of testing by government
• (In Holland) Offenses regarded as economic fraud.
  The (whole) company is defendant.

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STEPS TO CE
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no
CE
directive(s) applicable ?
yes
no
harmonized standards
yes
no
self testing
competent body
yes
test report
test report
declaration by manufacturer / apply CE-marking
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Conformity assessment
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A. Internal control of production B. Type
examination C. Conformity to type D. Production
quality assurance E. Product quality
assurance F. Product verification G. Unit
verification H. Full quality assurance
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Declaration of conformity
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• Name and address of manufacturer
• Product identification
• Conformity to directive(s)
• Notified body (if applicable)
• Reference to standard(s) (if applicable)
• Responsibility of manufacturer