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From UE to the World
Carlo Casati
Milan, 1 April 2016
06.11.2013 NOTIFIED BODY TRAINING 012
• TIC Industry
• Geography
• Product category
• Industry segment
Summary
TIC Industry
01.04.20163 WORKSHOP NUOVE DIRETTIVE LVD - EMC - RED - ATEX
01.04.2016 WORKSHOP NUOVE DIRETTIVE LVD - EMC - RED - ATEX4
Testing, Inspection and Certification (TIC)
Commodities
Life
Sciences
Industrial
Services
Environmental
Government
Systems&Services
Certification
Marine
Automotive
Food
Electronics
Pharmaceutical
Medical devices
Product conformity
assessment
Pre-shipment inspection
Medical (PPE)
Environmental (ISO
14001)
IT(ISO17799)
Telecom (TL
9000)
TIC MarketSegments
Hardlines
Softlines
Emission testing
Health &Safety
Oil &Gas AgricultureMinerals
Consumerproducts
Vehicle inspection
Engine &vehicle
testing
Statutory
inspection
Product& facility
certification Supply chain
Material testing
Industry standards
Vessel inspection
Offshore
classification
Providers of TIC-services serve as advisors, testing laboratories,
inspectors and certifiers
TIC-companies work as third-party service providers to ensure their clients that
their products and organizations comply with all applicable standards, regulations
and requirements.
1. To help clients design
their products according to
standards applicable in the
markets they wish to enter
2. To document testing and
inspection standards
ensuring compliance
3. To provide certifications
which can be used both as
a tool in the market entry-
process and for marketing-
purposes
4. To serve as advisors
and provide testing,
inspection and certification
services when clients
explore opportunities to
enter new markets
01.04.2016 WORKSHOP NUOVE DIRETTIVE LVD - EMC - RED - ATEX5
TIC Services
Assessment of the design of a
product to applicable standards.
Involvement already in the design-
phase to adapt the design to the
requirements of the markets where
entry is planned.
Accredited assessment of a
product according to a
standard. Testing is
performed in Nemko labs or
in partner or client labs.Certification according to various
schemes. Comes as a result of
product testing and makes up the
building blocks of international
approval.
Assessment of a product, and/
or manufacturer qualification,
according to country-specific
import regulations and sales
requirements.
1. Pre-
compliance
2. Product
Testing
3. Product
Certification
4.
International
Approvals
01.04.2016 WORKSHOP NUOVE DIRETTIVE LVD - EMC - RED - ATEX6
Multiple levels
Geography Product category Industry segment
Products must meet the
standards set in the
particular geographic
market in which they are
offered. International
organizations like the IEC
and ISO work to
establish and harmonise
global standards which
are universally
applicable. However,
there will usually be
additional regional and/or
national standards to
comply with.
A product will have to meet
standards specific to the
product category it belongs
to. As an example, a
computer has to meet
safety standards set for
electronic devices as well
as standards for
electromagnetic fields
which are generated by the
product. As it transmits and
receives digital signals, the
same computer will also be
subject to standards from
telecom regulation
authorities.
Each industry or
market segment has
standards and
requirements attached
to a large number of
specific equipment and
products.
01.04.2016 WORKSHOP NUOVE DIRETTIVE LVD - EMC - RED - ATEX7
Levels in 3DGeographicstandards
Regional
International
National
IT, audio, video
Building inspection
Fire & security
Electrical installation material
Defence industry
Lighting equipment
Maritime, oil & gas
Healthcare equipment
Household appliances
Telecom
Industry specific
standards
Machinery
Management systems
Product/ Service specific standards
The figure shows examples of organizations working on European and Norwegian
levels
Geography
01.04.20168 WORKSHOP NUOVE DIRETTIVE LVD - EMC - RED - ATEX
01.04.2016 WORKSHOP NUOVE DIRETTIVE LVD - EMC - RED - ATEX9
Certification process and possible markets
• Markets without
regulations
• Free Markets (European
Union)
• Semi-Free Markets
(North America)
• Protectionist Markets
(Far East)
01.04.2016 WORKSHOP NUOVE DIRETTIVE LVD - EMC - RED - ATEX10
IECEE CB Certification Scheme
The IEC CB (Certified Body) scheme is the largest international product certification scheme
The scheme is the world’s first truly international system for mutual acceptance of test reports and certificates dealing
with safety of electrical and electronic components, equipment and products.
A CB-certificate is documentation of product compliance with the relevant standard
A certificate gives access to, and simplifies national certification, in more than 60 member nations and is also widely
recognized in other countries
UL International
#1, 18.0 %
TÜV
Rheinland
#2, 16.5 %
Nemko
#3, 9.9 %Intertek
Semko,
9.1 %
TÜV Süd,
8.8 %
Dekra
Cert., 7.1 %
CQC,
5.9 %
SGS,
4.1 %
Others,
20.7 %
CB CERTIFICATES – NEMKO
RANKING #3 IN 2014
The scheme serves as the basis for International Approval
Nemko is a “National Certification Body” (NCB), a title gained as a
result of meeting strict requirements with regard to the NCBs’ internal
quality system and proven technical competence
When seeking access to a new market, the CB certificate can serve
as a basis for meeting the local certification requirements
Through mutual recognition, NCBs can accept testing reports from
other NCBs as documentation of their certifications
Nemko ranks #3 in the global CB-market
NCBs normally take regional and local considerations
Nemko includes European standards where possible, to make the CB
certification valid documentation for LVD and CE-marking
Nemko can also include testing for national requirements to
strengthen the certificate’s recognition in selected countries
01.04.2016 WORKSHOP NUOVE DIRETTIVE LVD - EMC - RED - ATEX11
CB Scheme
01.04.2016 WORKSHOP NUOVE DIRETTIVE LVD - EMC - RED - ATEX12
International Approval
International
Approval
Product
Certification
Testing / Product
Conformity to Standards
Product Category
01.04.201613 WORKSHOP NUOVE DIRETTIVE LVD - EMC - RED - ATEX
01.04.2016 WORKSHOP NUOVE DIRETTIVE LVD - EMC - RED - ATEX14
Safety
EMC
Radio
Eco-design
Chemicals
Environment
Performance
CE related concerns
01.04.2016 WORKSHOP NUOVE DIRETTIVE LVD - EMC - RED - ATEX15
Service on the regional level
LVD
R&TTE
The largest certification service of its kind to support mandatory CE-marking of electronics
• Nemko Europe provides a one-stop-shop for CE-marking – the client only has to sign the Declaration of Conformity
(DoC)
• Nemko evaluates and performs applicable testing and certification requirements and reviews existing
documentation in order to establish a complete technical file
• A Nemko Europe certificate is issued and a DoC is created and submitted after signing
• The Nemko CB certificate can be used as a valid base for showing compliance with one of the five directives for
CE-marking
01.04.2016 WORKSHOP NUOVE DIRETTIVE LVD - EMC - RED - ATEX16
CE vs Product Certificate
Technical
Standards
NLF Directives
Conformity to
essential
requirements
Conformity
Assessment
UE Declaration of
conformity
CE Marking
Certification
Schemes
Conformity to
technical standards
Surveillance
Inspections
Certification Body
Certificate
Quality Mark
CE Marking Product Certificate
Industry Segment
01.04.201617 WORKSHOP NUOVE DIRETTIVE LVD - EMC - RED - ATEX
01.04.2016 WORKSHOP NUOVE DIRETTIVE LVD - EMC - RED - ATEX18
Multiple market segments
IT, Audio & Video Healthcare equipmentProducts: computers, televisions
Examples: intel, HP, Dell
Products: Active Medical Devices for
diagnostic and treatment of humans
Examples: GE Healthcare, Samsung
Medison,Siemens
Telecom Maritime, Oil & GasProducts: all products with built-in
transmitters/recievers
Examples: Samsung, HP, Lego,
Sennheiser, Jotron
Products: maritime, offshore, subsea
Examples: Kongsberg Maritime,
Benestad, Miros, Roxar
Household appliances Lighting equipmentProducts: refrigerators, blenders
Examples: Wilfa, Bosch, Samsung
Products: LED, Fluorescent, Light
sources & controls, emergency lights
Examples: Glamox, Luxo, Phillips
Defence industry Building inspectionProducts: All types of data and
communication equipment
Examples: Kitron, Kongsberg Defence
& Aerospace
Products: Inspection of technical
installations in public buildings
Examples: Karstadt, Real SB
Warenhaus
Electrical inst. material MachineryProducts: Plug and socket outlets,
Cord sets, Cables, Switches
Examples: Elko, Nexans, Draka,
Schneider Electric
Products: Power tools, lifting
systems, conveyor belts
Examples: ABB, Husquarna
Fire & Security Management SystemsProducts: Alarm devices, power
supplies, voice alarms
Examples: Consilium, Autronica,
Hedengren, Honeywell
Products: quality systems,
information security systems
Examples:
01.04.2016 WORKSHOP NUOVE DIRETTIVE LVD - EMC - RED - ATEX19
CB classification
E3
EMC
EX
HOUS
HSTS
INST
MEAS
MED
OFF
PV
TOOL
TRON
Chemicals
60335
Eco-design
A/V 60065
ITE 60950
60601
61010
60745
Component
01.04.2016 WORKSHOP NUOVE DIRETTIVE LVD - EMC - RED - ATEX20
IEC
CENELEC
CEI
National and International standards
ISO
CEN (EN)
UNI

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From UE to the World

  • 1. From UE to the World Carlo Casati Milan, 1 April 2016
  • 2. 06.11.2013 NOTIFIED BODY TRAINING 012 • TIC Industry • Geography • Product category • Industry segment Summary
  • 3. TIC Industry 01.04.20163 WORKSHOP NUOVE DIRETTIVE LVD - EMC - RED - ATEX
  • 4. 01.04.2016 WORKSHOP NUOVE DIRETTIVE LVD - EMC - RED - ATEX4 Testing, Inspection and Certification (TIC) Commodities Life Sciences Industrial Services Environmental Government Systems&Services Certification Marine Automotive Food Electronics Pharmaceutical Medical devices Product conformity assessment Pre-shipment inspection Medical (PPE) Environmental (ISO 14001) IT(ISO17799) Telecom (TL 9000) TIC MarketSegments Hardlines Softlines Emission testing Health &Safety Oil &Gas AgricultureMinerals Consumerproducts Vehicle inspection Engine &vehicle testing Statutory inspection Product& facility certification Supply chain Material testing Industry standards Vessel inspection Offshore classification Providers of TIC-services serve as advisors, testing laboratories, inspectors and certifiers TIC-companies work as third-party service providers to ensure their clients that their products and organizations comply with all applicable standards, regulations and requirements. 1. To help clients design their products according to standards applicable in the markets they wish to enter 2. To document testing and inspection standards ensuring compliance 3. To provide certifications which can be used both as a tool in the market entry- process and for marketing- purposes 4. To serve as advisors and provide testing, inspection and certification services when clients explore opportunities to enter new markets
  • 5. 01.04.2016 WORKSHOP NUOVE DIRETTIVE LVD - EMC - RED - ATEX5 TIC Services Assessment of the design of a product to applicable standards. Involvement already in the design- phase to adapt the design to the requirements of the markets where entry is planned. Accredited assessment of a product according to a standard. Testing is performed in Nemko labs or in partner or client labs.Certification according to various schemes. Comes as a result of product testing and makes up the building blocks of international approval. Assessment of a product, and/ or manufacturer qualification, according to country-specific import regulations and sales requirements. 1. Pre- compliance 2. Product Testing 3. Product Certification 4. International Approvals
  • 6. 01.04.2016 WORKSHOP NUOVE DIRETTIVE LVD - EMC - RED - ATEX6 Multiple levels Geography Product category Industry segment Products must meet the standards set in the particular geographic market in which they are offered. International organizations like the IEC and ISO work to establish and harmonise global standards which are universally applicable. However, there will usually be additional regional and/or national standards to comply with. A product will have to meet standards specific to the product category it belongs to. As an example, a computer has to meet safety standards set for electronic devices as well as standards for electromagnetic fields which are generated by the product. As it transmits and receives digital signals, the same computer will also be subject to standards from telecom regulation authorities. Each industry or market segment has standards and requirements attached to a large number of specific equipment and products.
  • 7. 01.04.2016 WORKSHOP NUOVE DIRETTIVE LVD - EMC - RED - ATEX7 Levels in 3DGeographicstandards Regional International National IT, audio, video Building inspection Fire & security Electrical installation material Defence industry Lighting equipment Maritime, oil & gas Healthcare equipment Household appliances Telecom Industry specific standards Machinery Management systems Product/ Service specific standards The figure shows examples of organizations working on European and Norwegian levels
  • 8. Geography 01.04.20168 WORKSHOP NUOVE DIRETTIVE LVD - EMC - RED - ATEX
  • 9. 01.04.2016 WORKSHOP NUOVE DIRETTIVE LVD - EMC - RED - ATEX9 Certification process and possible markets • Markets without regulations • Free Markets (European Union) • Semi-Free Markets (North America) • Protectionist Markets (Far East)
  • 10. 01.04.2016 WORKSHOP NUOVE DIRETTIVE LVD - EMC - RED - ATEX10 IECEE CB Certification Scheme The IEC CB (Certified Body) scheme is the largest international product certification scheme The scheme is the world’s first truly international system for mutual acceptance of test reports and certificates dealing with safety of electrical and electronic components, equipment and products. A CB-certificate is documentation of product compliance with the relevant standard A certificate gives access to, and simplifies national certification, in more than 60 member nations and is also widely recognized in other countries UL International #1, 18.0 % TÜV Rheinland #2, 16.5 % Nemko #3, 9.9 %Intertek Semko, 9.1 % TÜV Süd, 8.8 % Dekra Cert., 7.1 % CQC, 5.9 % SGS, 4.1 % Others, 20.7 % CB CERTIFICATES – NEMKO RANKING #3 IN 2014 The scheme serves as the basis for International Approval Nemko is a “National Certification Body” (NCB), a title gained as a result of meeting strict requirements with regard to the NCBs’ internal quality system and proven technical competence When seeking access to a new market, the CB certificate can serve as a basis for meeting the local certification requirements Through mutual recognition, NCBs can accept testing reports from other NCBs as documentation of their certifications Nemko ranks #3 in the global CB-market NCBs normally take regional and local considerations Nemko includes European standards where possible, to make the CB certification valid documentation for LVD and CE-marking Nemko can also include testing for national requirements to strengthen the certificate’s recognition in selected countries
  • 11. 01.04.2016 WORKSHOP NUOVE DIRETTIVE LVD - EMC - RED - ATEX11 CB Scheme
  • 12. 01.04.2016 WORKSHOP NUOVE DIRETTIVE LVD - EMC - RED - ATEX12 International Approval International Approval Product Certification Testing / Product Conformity to Standards
  • 13. Product Category 01.04.201613 WORKSHOP NUOVE DIRETTIVE LVD - EMC - RED - ATEX
  • 14. 01.04.2016 WORKSHOP NUOVE DIRETTIVE LVD - EMC - RED - ATEX14 Safety EMC Radio Eco-design Chemicals Environment Performance CE related concerns
  • 15. 01.04.2016 WORKSHOP NUOVE DIRETTIVE LVD - EMC - RED - ATEX15 Service on the regional level LVD R&TTE The largest certification service of its kind to support mandatory CE-marking of electronics • Nemko Europe provides a one-stop-shop for CE-marking – the client only has to sign the Declaration of Conformity (DoC) • Nemko evaluates and performs applicable testing and certification requirements and reviews existing documentation in order to establish a complete technical file • A Nemko Europe certificate is issued and a DoC is created and submitted after signing • The Nemko CB certificate can be used as a valid base for showing compliance with one of the five directives for CE-marking
  • 16. 01.04.2016 WORKSHOP NUOVE DIRETTIVE LVD - EMC - RED - ATEX16 CE vs Product Certificate Technical Standards NLF Directives Conformity to essential requirements Conformity Assessment UE Declaration of conformity CE Marking Certification Schemes Conformity to technical standards Surveillance Inspections Certification Body Certificate Quality Mark CE Marking Product Certificate
  • 17. Industry Segment 01.04.201617 WORKSHOP NUOVE DIRETTIVE LVD - EMC - RED - ATEX
  • 18. 01.04.2016 WORKSHOP NUOVE DIRETTIVE LVD - EMC - RED - ATEX18 Multiple market segments IT, Audio & Video Healthcare equipmentProducts: computers, televisions Examples: intel, HP, Dell Products: Active Medical Devices for diagnostic and treatment of humans Examples: GE Healthcare, Samsung Medison,Siemens Telecom Maritime, Oil & GasProducts: all products with built-in transmitters/recievers Examples: Samsung, HP, Lego, Sennheiser, Jotron Products: maritime, offshore, subsea Examples: Kongsberg Maritime, Benestad, Miros, Roxar Household appliances Lighting equipmentProducts: refrigerators, blenders Examples: Wilfa, Bosch, Samsung Products: LED, Fluorescent, Light sources & controls, emergency lights Examples: Glamox, Luxo, Phillips Defence industry Building inspectionProducts: All types of data and communication equipment Examples: Kitron, Kongsberg Defence & Aerospace Products: Inspection of technical installations in public buildings Examples: Karstadt, Real SB Warenhaus Electrical inst. material MachineryProducts: Plug and socket outlets, Cord sets, Cables, Switches Examples: Elko, Nexans, Draka, Schneider Electric Products: Power tools, lifting systems, conveyor belts Examples: ABB, Husquarna Fire & Security Management SystemsProducts: Alarm devices, power supplies, voice alarms Examples: Consilium, Autronica, Hedengren, Honeywell Products: quality systems, information security systems Examples:
  • 19. 01.04.2016 WORKSHOP NUOVE DIRETTIVE LVD - EMC - RED - ATEX19 CB classification E3 EMC EX HOUS HSTS INST MEAS MED OFF PV TOOL TRON Chemicals 60335 Eco-design A/V 60065 ITE 60950 60601 61010 60745 Component
  • 20. 01.04.2016 WORKSHOP NUOVE DIRETTIVE LVD - EMC - RED - ATEX20 IEC CENELEC CEI National and International standards ISO CEN (EN) UNI