Standardisation and Certification at European level

1
Standardisation and Certificationat European
level
Phare Business Support Programme III of the
European Union UEAPME - SME FIT II

Bucarest 24 and 25/09/2008
This project is funded by the European Union
under the Phare Business Support Programme and
implemented by UEAPME and its partners. The
content of this document does not necessarily
reflect the opinion of the European Commission.
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Table of contents

• 1. NORMAPME
• 2. Standardisation
• - Principles of Standardisation
• - Standardisation and SMEs
• - Influencing Standardisation
• 3. Certification
• - Principles of Certification
• - Impact of Certification to SMEs
• - New Legal Framework

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NORMAPME who we are
European Office of Crafts, Trades SMEs for
Standardisation

• International and non-profit association
• Sister organisation of UEAPME
• UEAPME/NORMAPME represent 11 M enterprises in EU
  and EFTA countries

SMEs
99 of enterprises
65 M jobs
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NORMAPME what we do
MISSION
Defend the interests of all European SMEs in the
Standardisation process
Actions

• Information
• Formulation on proposals on standards and New
  Approach Directives
• Promotion of the interests of European SMEs on
  standardisation issues

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NORMAPME how we do it (relations)
EC
EP
Nat. repres.at EU
National Government
NORMAPME Secretariat
SMEs associations
Members
ESOs
ISOs
NSOs
BTs GAs
BTs GAs
Experts
TCs
ESOs European Standardisation Organisations ISOs
International Standardisation Organisations NSOs
National Standardisation Organisations
BTs Technical Board GAs General Assemblies TCs
Technical Committees
EC European Commission EP European Parliament
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NORMAPME how we do it (activities)
Technical Committees
NORMAPME aims at representing SMEs interests in
standardisation. Therefore, we recruit experts
for different subjects to follow and report the
work in European and International TCs
SMEs Consultations
NORMAPME aims at representing all European SMEs.
In order to voice their concerns, we undertake
consultations on topics regarding general
standardisation policy or sectoral issues
Political Interventions
NORMAPME influences International and European
standardisation via its membership in ISO, CEN,
CENELEC ETSI and thanks to the recognition of
our SME representation by the European Commission
Projects
NORMAPME aims at providing tools for SMEs and
creating European networks
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NORMAPME how we do it (communication)
All publications and the website are translated
in six languages ENG, FR, DE, SP, IT and PL
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(No Transcript)
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Table of contents

• 2. Standardisation
• Principles of Standardisation

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What is a standard?

• A document, that is
• established by consensus, on a voluntary basis,
  by the main stakeholders
• approved by a recognised body
• providing - for common and repeated use - rules,
  guidelines or characteristics for activities or
  their results
• aimed to achieve the optimum degree of order in a
  given context,
• based on the consolidated results of science,
  technology and experience
• aimed to achieve optimum community benefits
• publicly available in all stages of
  standardisation process until ratification
• Specifications of private companies and
  organisations are not standards and do not comply
  with this definition.

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Standards, regulations and private specifications
Law
Regulations
Mandatory
Voluntary
Standards
Public
Professional good practice, corporate spec., etc.
Private
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What is standardisation?

• Voluntary process based on consensus amongst all
  stakeholders (Industry, SMEs, consumers, workers,
  public authorities, NGO, etc.),
• Made by independent, officially recognised bodies
  on National, European and World level,
• Increasingly used by EU authorities as a tool in
  their legislation,
• EC use today technical harmonisation, ICT,
  public procurement.
• Future basis environment, competitiveness,
  safety health, consumer protection.
• EC sees a strong Standardisation infrastructure
  in Europe as an effective tool to harmonise
  legislation and to represent European interests
  world-wide.

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Standard process
Industrial or Society needs
NSBs or other stakeholders EN
EC - mandate hEN
REQUEST
DECISION Technical Board
Set up new Technical Committee
Use existing document (e.g. ISO)
Work with ISO (Vienna Agreement)
OR
OR
PUBLIC ENQUIRY
FORMAL VOTE
NATIONAL IMPLEMENTATION
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European Directive 83/189

• Centralisation of the development and
  harmonisation of European standards.
• The execution lies with the European
  Standardisation Organisations
• - CEN for all standards except
• - CENELEC electrical sector
• - ETSI telecommunications/ information systems.
• These ESOs cooperate with national organisations
  as for example BSI, AFNOR, DIN, NEN, who are also
  their (voting) members. NORMAPME is an associate
  member.
• Members are admitted to standards committees and
  vote on standards adoption.
• NORMAPME does not vote directly, but influences

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Main elements of the ESOs Internal Regulations

• Standstill
• Weighted voting
• Implementation
• Withdrawal of conflicting standards

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Facts and figures

• CEN Technical activity
• 1 800 committees and groups
• 400 European professional organizations
• gt 60 000 national experts
• CEN Affiliates can participate as observers
• ISO observers under the Vienna Agreement
• Timeframe to develop an European standard
• Average under 36 months
• Not more than 54 months
• But it is possible in 16 months

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How to find

• A draft standard
• http//www.cenorm.be/cenorm/standards_drafts/findi
  ngdraftstandards/index.asp
• http//www.normapme.com/English/standard20project
  s-en.htm
• http//www.iso.ch/iso/en/CatalogueListPage.Catalog
  ueList?COMMID0scopelistPROGRAMME
• A new standard and new CEN work items
• http//www.cenorm.be/newapproach/dirlist.asp
• http//www.normapme.com/English/standard20project
  s-en.htm
• A standard European standards are sold in NSO
  only and International standards can be sold in
  ISO
• http//europa.eu.int/comm/enterprise/newapproach/s
  tandardization/harmstds/reflist.html
• http//www.cenorm.be/catweb/cwsen.htm
• http//www.iso.ch/iso/en/CatalogueListPage.Catalog
  ueList

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Table of contents

• 2- Standardisation
• - Standards - benefit or burden?

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Benefits of standards to the economy

• Production of public goods through network
  externalities
• Standards contribute 1 to the annual growth of
  the German economy (DIN study, 2000)
• Standards have contributed 13 towards the growth
  in the productivity of British workers since 1945
  (BSI/DTI study)

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A fact to remember. . .

• 1 European standard
• ... replaces 30 different national standards in
  Europe
• ... creates access to a market of 490 million

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Benefits of standardisation for the various
stakeholders

• simplification of the growing variety of products
  and procedures in human life
• variety control and efficient use of materials,
  energy and human resources
• compatibility and inter-changeability
• safety, health, protection of life and the
  environment
• reduction of the degree of market uncertainty
• protection of consumers and community interests
• fitness for purpose
• elimination of trade barriers

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Standards Benefit or Burden?(1)

• Good use of standards reduces cost of operation
• Less product/process variation,
• Reduced risk in exports, in supply to large
  customers
• Legal protection
• Less rejects
• Increased efficiency
• What you right you dont do twice!

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Standards Benefit or Burden?(2)

• Standards should be adapted to the SME structure
  to be used effectively
• Standards can be very costly for Small
  Enterprises if
• designed for the large enterprise only,
• too complicated (costly) to use effectively in
  SME,
• not understood but used as a basis for contracts
  or exports,
• ignored by the SME, in case that a faulty product
  leads to a legal dispute.

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SMEs, which use standards

• Are more profitable
• Gain closer contact with large-scale enterprises
• Export more
• Can more easily be convinced to use quality
  management systems
• Are ready for the next phase (environment,
  aspects of adhesion, development of the
  e-Business)

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Involvement of SMEs in Export
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The Advantage of Participating in Standardisation
(1)(According to DIN study of 2000)

• 52 of Participating Companies believe they have
  an Advantage over Non-Participating ones
• 60 Believe that Early Access to Information
  gives them a Competitive Edge
• 48 consider it gives them a cost saving.
• In case of Exports this is even more relevant.

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The Advantage of Participating in Standardisation
(2)(According to DIN study of 2000)

• Standards can be a burden if you are not informed
  and protected
• Micro-Enterprises tend to ignore standards unless
  competition, clients or authorities force the
  issue
• NORMAPME tries to ensure that the Craft Small
  enterprises
• are well protected

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Main Issues

• SMEs recognise the importance of standards as
  well as their lack of fitness
• During the development of standards
• Lack of consideration for SME concerns
• Lack of consideration for practical issues
• Simplification of standards
• During the implementation of standards
• Costs
• Human resources
• Awareness

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Development (1)

• Lack of consideration for SME concerns
• Limited participation of SMEs in standardisation
• - Due to lack of human resources
• - Due to lack of financial resources
• National and European Standardisation policies
  are not always very effective to help SMEs
  participation
• Overwhelming participation of some types of
  stakeholders
• Standardisation experts have no knowledge of the
  reality of SME activities
• Non series product provisions

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Development (1)

• Lack of consideration for practical issues
• Standards are developed by Standard professionals
  not properly translating the requirements in the
  activity
• Dramatic decrease of experts in TCs
• Rigidity of the standards
• Simplification of standards
• Standard structure
• - Presentation and organisation
• - Cross reference
• Usage of standardisation language

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Implementation

• Human resources
• MANAGER Understanding of the standard
  Administrative implementation
• STAFF Production installation implementation
• Awareness
• Scope of the standards
• Lack of information on new standards and
  regulation

• Costs
• STANDARDS
• TRAINING
• MATERIAL
• TESTS
• TIME
• For example conformity with EN 13241-1, means
  450 per gate on a basis of 40 gates

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What should be done

• Improve SME access to standardisation
• Write standards thinking small first
• Have a balanced representation in Technical
  Committees
• Create an SME helpdesk
• Write explicit scopes
• Develop training materials for SMEs and standard
  developers
• Write simplified instruction for SMEs, e.g.
  checklists
• Provide solutions for non and small series
  production
• Organise wide proactive information campaigns on
  new standards

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Table of contents

• 2. Standardisation
• - Influencing Standardisation

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How to influence standards and directives at
European level?

• National committees
• Large enterprises.
• Government.
• Research institutes/Universities.
• Consumers (National organisations),
• SME (National/Sector organisations).
• European committees
• Country representation
• Sector representation
• Sometimes expert consultants.

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At National level

• Participation in mirror committees,
• Active participation in SME associations,
• Contacts with governmental authorities,
• Contacts with Members of the Parliament and
  European Parliament

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At European/International level

• Participation in Normapme Working groups,
• Reaction on Normapme consultation,
• Participation in CEN-CLC-ETSI-ISO Technical
  Committees,
• Informing Normapme on encountered problems via
  SME associations.
• Participation in European campaigns at National
  level

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SMEs Can they influence the Standards
Directives on European level?

• Yes
• By being present at national level in the NSO,
• By your presence in parallel via the NORMAPME
  experts network
• Influence European level (world wide)
• Fast information targeted on the needs of the
  SME,
• SME alert system towards Brussels.
• In practice
• Work Groups via Email consisting of experts from
  each European country and lead by the NORMAPME
  expert.
• Result
• Standardisation better adapted, closer to the
  needs, better known
• Better result for the enterprise

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Table of contents

• 3- Certification
• - Principles of Certification

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Key words

• Certification procedure by which a third party
  gives written assurance that a product, process
  or service conforms to specified requirements
• Certificate of conformity document certifying
  that a product, process or service complies with
  a standard and/or a New Approach Directive
• Conformity assessment process to obtain a
  certificate of conformity
• Third party certification is done a Notified
  Body which tests a product, process or service
• Declaration of conformity CE marking
  compliance with the EU Directive

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Guiding Principles of the New Approach

• Choices offered to manufacturers as to the
  conformity assessment procedures to evaluate the
  compliance with directives
• Only those products complying with directives can
  be placed on the EC market and bear the CE
  marking
• Member States have the duty to control that only
  complying products are placed on the market
  (market surveillance)

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What CE-marking means

• It is mandatory on all products covered by the
  New Approach and indicates that the product is
  authorised to be placed freely on the EU market,
• Is affixed on the product or its packaging by the
  manufacturer or his authorised agent,
• Certifies that the product conforms to the
  provisions of the Directive(s) concerned,
• Does not specify the Modules applied,
• Is accompanied by a code identifying the Notified
  Body involved in the production control phase,
• Does not exclude the affixing of other marks
  indicating conformity to National or European
  standards (Keymark, TNO, TUV, NF, BSI)

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The benefits of CE marking

• A passport to free circulation in Member States
• products are fit for their intended use
• facilitate the free circulation of goods
• competitiveness of the sector

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Steps for CE marking

• What steps to follow to affix the CE marking to
  your product?
• 1. Identify the applicable Directive.
• 2. Respect the rules of the Directive. In
  particular for the essential requirements acc. to
  Annex 1 that cites the relevant European or
  national standards for your product.
• 3. Evaluate the conformity to these demands.
  There are 8 evaluation processes, depending on
  the type of product.
• 4. Affix the CE marking. It must be visible,
  readable and non-removable.
• 5. Make a CE conformity declaration. 
• 6. Constitute a technical file.

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CE Marking the 8 Modules
Self-declaration
Type Examination
Total Quality Assurance
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The 8 Modules

• Module A The CE-conformity declaration. The
  producer or distributor declares under his
  responsibility that his product is conform.
• Module B The Type test. A notified body issues a
  " declaration of test " after verification of a
  production sample.
• Module C Declaration of type conformity.  The
  producer assures by a procedure that his
  production remains conform (FPC). This
  declaration follows module B.
• Module D Production quality assurance. The
  producer has an approved and certified quality
  system in his production.  Must be completed by
  the CE type test certificate ". EN ISO 9002.
• Module E Product quality assurance. The producer
  has an approved and certified quality system for
  his product. Must be completed by the CE type
  test certificate ". EN ISO 9003.
• Module F Verification on products or CE
  verification. A notified body verifies the
  products individually or by lot. Must be
  completed by the CE type test certificate ".
• Module G Individual product verification.  A
  notified body verifies individual products. Must
  be completed by the CE type test certificate ".
• Module H complete quality assurance The
  producer puts in place un a complete quality
  system from conception, production till final
  product control that is certified a notified
  body. EN ISO 9001.

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CE Marking Logo
It is for the manufacturer or his authorized
representative established within the Community
to take responsibility for affixing the CE
marking on the product itself, on a label
attached to it, on its packaging, or on the
accompanying commercial documents.
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A Declaration of conformity can be

• Certificate of conformity of the product by a
  Notified body (third party certification)
• List of Notified bodies
• NANDO IS for all New Approach sectors except
  construction
• NANDO CPD for construction products
• see also EC Official Journal part C.
• Declaration of conformity of the product by the
  manufacturer
• To obtain CE marking you need a declaration of
  conformity

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A Notified Body

• is an impartial, professionally competent body
  notified by a Member State to the European
  Commission,
• is authorised for carrying out conformity
  assessments and certification procedures under
  the New Approach Directives for
• testing
• inspection
• Certification
• Is under regular surveillance to ensure these
  core competences are properly maintained

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How to find

• A notified body
• http//europa.eu.int/comm/enterprise/newapproach/l
  egislation/nb/notified_bodies.htm
• Other information related to standardisation and
  certification
• http//europa.eu.int/comm/enterprise/newapproach/s
  tandardization/harmstds/whatsnew.htmltextdir
• http//europa.eu.int/comm/enterprise/standards_pol
  icy/index_en.htm
• http//europa.eu.int/comm/enterprise/standards_pol
  icy/mandates/index.htm
• http//www.newapproach.org/
• http//www.cenorm.be/boss/index.htm
• http//www.cenorm.be/cenorm/index.htm
• http//www.normapme.com
• http//www.iso.ch/iso/en/ISOOnline.frontpage

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Table of contents

• 3- Certification
• - Impact of Certification on SMEs

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Impact of Certification on SMEs

• Cost administrative burden
• Proliferation of marks
• Overlapping meaning
• Lack of recognition
• Barrier to trade
• Most of the time, customers are not asking for
  certification
• Certification has limited added value for SMEs

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Table of contents

• 3 Certification
• - New Legal Framework

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NORMAPME the  New Approach 
The Goods Package includes

• the Regulation setting out the requirements for
  Accreditation and Market
• surveillance relating to the Marketing of
  products
• the Decision on a common framework for the
  Marketing of products

NORMAPME activities consisted in

• consult NORMAPME members
• consolidate a position paper
• organise with the support of our network
  (National Sectoral SME associations)
• a lobbying campaign towards the European
  Institutions and
• Member States authorities.

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Key elements of NORMAPME position
1. Definition of  making available on the
market 

• Exclude from the definition the assembly of
  products for ones own use and/or the
• manufacture of products to be integrated in a
  final work.
• Justification
• Avoid excessive administrative and financial
  burden for Craftsmen and SMEs
• In line with similar provision of the Guidance
  Paper M Construction Product Directive

2. CE marking 

• When non-series and small series production are
  submitted to CE marking a declaration of
• conformity should be sufficient. CE marking might
  be compulsory only when mentioned in
• the sectoral directive and/or when the product
  impacts on health and safety
• Justification
• Avoid the high costs of conformity assessment

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Key elements of NORMAPME position
3. Accreditation of laboratories and conformity
assessment structures

• Laboratories and conformity assessment structures
  belonging to business intermediary
• organisations and/or sectoral organisations
  should be entitled to be accredited.
• Justification
• better answer SMEs needs regarding certification
• ensure that conformity assessment procedures are
  carried out in a proportionate manner
• (taking into account the size, the structure, the
  involved technology, the sector and the
  serialcharacter of the production)

4. Scalability of conformity assessment procedures

• Ensure that conformity assessment procedures are
  carried out taking into account the size
• and the relative complexity of the technology
  used but also the sector, the structure of
• companies and the serial character of the
  production
• Justification
• avoid unnecessary costs
• take into account SMEs needs in regards to type
  of production (non-series and small series)

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Key elements of NORMAPME position
5. Shared ITT and cascading

• Include the definitions for
• Shared ITT results
• Initial Type Testing (ITT)
• Cascading ITT
• As shared ITT and cascading shall be accepted by
  third party certification bodies
• Justification
• avoid/reduce costs of conformity assessment
  generated by tests

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Achievements of NORMAPME
1. Definition of  making available on the
market 
2. CE marking 
3. Accreditation of laboratories and conformity
assessment structures
4. Scalability of conformity assessment procedures
5. Shared ITT and cascading
Key Elements 2, 3, 4 have been included Key
element 1 and 5 will be included in sectorial
directives
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QUESTIONS ?
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Thank you for your attention!
Phare Business Support Programme III of the
European Union UEAPME - SME FIT II

• Vanessa Pereira
• NORMAPME
• v.pereira_at_normapme.com
• Tel [phone]