Standardisation and Certification

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Standardisation and Certification
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Content

• Introduction
• Standardisation
• Certification

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Introduction
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350 European standards and some 10.000 standard
parts take off
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Standards come along 24/7

• Fruit and vegetable juices, cereals and cereal
  products
• Food contact materials
• Cosmetics
• Protective clothing
• Construction products
• Machinery safety
• Furniture
• Toys
• Bycicles
• Equipment for vine cultivation and wine making
• etc.

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Standardisation
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Legal Basis

• Directive 98/34/EC laying down a procedure for
  the provision of information in the field of
  technical standards and regulations
• General guidelines for the co-operation between
  CEN, CENELEC and ETSI and the European Commission
  and the European Free Trade Association

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What are standards?

• Documented agreements establishing criteria for
  products, services and processes
• Voluntary
• Contractual obligations
• Presumption of conformity (e.g New Approach,
  GPSD)

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What are standards?

• Based on consenus of parties concerned
• Approved by a recognised body
• For common and repeated use

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Law
Regulations
Mandatory
Voluntary
Standards
Public
Professional good practice, corporate spec., etc.
Private
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Standards are developed at

• National level
• 
  
• International level
• International Standardization Organization
• International Electrotechnical Commission, etc.

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Standards are developed at

• European level
• Cenelec standards in the eletrotechnical field
• ETSI covers the telecommunications field and some
  aspects of broadcasting.
• CEN for all other sectors (e.g. chemistry,
  construction, consumers, food)
• European Standards (ENs) must be transposed into
  national standards and conflicting standards
  withdrawn

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Remember
1 European standard ... replaces 30 different
national standards in Europe ... creates access
to a market of 490 million
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Who takes part in the development of European
standards?

• Anyone having interest/will be affected can
  participate
• National business/standardisation organisation
• European business /standardisation organisation
• NORMAPME

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How are European standards developed?

• EC - mandate
• hEN

Industrial or Society needs
NSBs or other stakeholders EN
REQUEST TO STANDARDS BODY
DECISION
Set up new Technical Committee to draft standard
Use existing document (e.g. ISO)
Work with ISO (Vienna Agreement)
OR
OR
PUBLIC ENQUIRY
FORMAL VOTE
NATIONAL IMPLEMENTATION
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Where to get (draft) standards?

• National standards organisations
• Business organisations
• Standards are sold

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Benefits for SMEs

• Build a and ease access to Single European Market
• Self regulation by the market
• Ready to use appropriate technical solutions
• Reduction of transaction costs and liability
• Relationship supplier buyer
• Compatibility and interchangeability
• Export European knowhow

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Challenges for SMEs

• Getting involved and make voice heard
• Balance of intests
• Standardisation of services
• Open up markets instead of creating closed
  markets

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Certification
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• Certification procedure by which a third party
  gives written assurance that a product, process,
  system or person conforms to specified
  requirements
• Need for certification results from
• Market
• New Approach Directives requiring CE marking

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New Approach

• Applies to e.g. machinery, construction products,
  toys, low voltage equipment
• Legislation contains essential requirements
• Voluntary application of harmonised standards
  (presumption of conformity)
• Free movement clause
• Safeguard clause

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CE Marking the 8 Modules
Self-declaration
Type Examination
Total Quality Assurance
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Use relevant conformity assessment

• Machinery Directive
• Machinery not referred to in Annex IV internal
  production control
• Machinery referred to in Annex IV and
  manufactured in accordance with harmonised
  standards internal production control/EC
  type-examination plus internal production
  control/full quality assurance procedure
• Machinery referred to in Annex IV and not
  manufactured in accordance with harmonised
  standards EC type-examination plus internal
  production control/full quality assurance
  procedure

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Identify a Notified Body
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Conclusion

• SMEs have to cope with standardisation and
  certification
• SMEs often lack ressources to make their voice
  heard
• National and European business organissations can
  support SMEs

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Thank you!
Phare Business Support Programme III of the
European Union UEAPME - SME FIT II

• Markus Stock
• Austrian Federal Economic Chamber
• markus.stock_at_wko.at