Title: Standardisation
1Standardisation Certificationin the EU
Phare Business Support Programme III of the
European Union UEAPME - SME FIT II
Zagreb 13th October 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.
2Table 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
3NORMAPME 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
4NORMAPME 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
5NORMAPME 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
6NORMAPME 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
7NORMAPME how we do it (communication)
All publications and the website are translated
in six languages ENG, FR, DE, SP, IT and PL
8(No Transcript)
9Table of contents
- 2. Standardisation
- Principles of Standardisation
10What 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.
11Standards, regulations and private specifications
Law
Regulations
Mandatory
Voluntary
Standards
Public
Professional good practice, corporate spec., etc.
Private
12What 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.
13Standard 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
14European 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
15Main elements of the ESOs Internal Regulations
- Standstill
- Weighted voting
- Implementation
- Withdrawal of conflicting standards
16Facts 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
17How 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
18Table of contents
- 2- Standardisation
- - Standards - benefit or burden?
19Benefits 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)
20A fact to remember. . .
- 1 European standard
- ... replaces 30 different national standards in
Europe - ... creates access to a market of 490 million
21Benefits 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
22Standards 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!
23 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.
24SMEs, 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)
25Involvement of SMEs in Export
26The 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.
27The 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
28Main 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
29Development (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
30Development (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
31Implementation
- 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
32What 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
33Table of contents
- 2. Standardisation
- - Influencing Standardisation
34How 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.
35At National level
- Participation in mirror committees,
- Active participation in SME associations,
- Contacts with governmental authorities,
- Contacts with Members of the Parliament and
European Parliament
36At 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
37SMEs 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
38Table of contents
- 3- Certification
- - Principles of Certification
39Key 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
40Guiding 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)
41What 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)
42The 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
43Steps 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.Â
- 6. Constitute a technical file.
44CE Marking the 8 Modules
Self-declaration
Type Examination
Total Quality Assurance
45The 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.
46CE 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.
47A 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
48A 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
49How 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
50Table of contents
- 3- Certification
- - Impact of Certification on SMEs
51Impact 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
52Table of contents
- 3 Certification
- - New Legal Framework
53NORMAPME the  New ApproachÂ
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.
54Key elements of NORMAPME position
1. Definition of  making available on the
marketÂ
- 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 markingÂ
- 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
55Key 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)
56Key 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
57Achievements of NORMAPME
1. Definition of  making available on the
marketÂ
2. CE markingÂ
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
58QUESTIONS ?
59Thank 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 32 2 282 05 36