From UE to the World

From UE to the WorldCarlo Casati

Milan, 1 April 2016

2 06.11.2013 NOTIFIED BODY TRAINING 01

• TIC Industry• Geography• Product category• Industry segment

Summary

TIC Industry

01.04.20163 WORKSHOP NUOVE DIRETTIVE LVD - EMC - RED - ATEX

4 01.04.2016 WORKSHOP NUOVE DIRETTIVE LVD - EMC - RED - ATEX

Testing, Inspection and Certification (TIC)

Commodities

LifeSciences

IndustrialServices

Environmental

Government

Systems & Services

Certification

Marine

Automotive

Food

ElectronicsPharmaceutical

Medical devices

Product conformity assessment

Pre-shipment inspection

Medical (PPE)

Environmental (ISO 14001)

IT (ISO 17799)

Telecom (TL

9000)

TIC Market Segments

Hardlines

Softlines

Emission testing

Health & Safety

Oil & Gas Agriculture

Minerals

Consumer products

Vehicle inspection

Engine & vehicle testing

Statutory inspection

Product & facility

certification Supply chain

Material testing

Industry standards

Vessel inspection

Offshore classificatio

n

Providers of TIC-services serve as advisors, testing laboratories, inspectors and certifiersTIC-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


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


Multiple levels

Geography Product category Industry segmentProducts 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.


Levels in 3DG

eogr

aphi

c st

anda

rds

Regional

International

National

Quality

Standard

s

Telec

om

IT, audio, video

Building inspectionFire & securityElectrical installation material

Defence industryLighting equipment

Maritime, oil & gasHealthcare equipment

Household appliancesTelecom

Industry specific standards

Machinery

Management systems

Product/ Service specific standards

Electro

nic dev

ices

The figure shows examples of organizations working on European and Norwegian levels

Geography



Certification process and possible markets

• Markets without regulations

• Free Markets (European Union)

• Semi-Free Markets (North America)

• Protectionist Markets (Far East)


IECEE CB Certification SchemeThe 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 Interna-tional #1;

18.0 %

TÜV Rhein-land #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 ApprovalNemko 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


CB Scheme


International ApprovalInternational Approval

Product Certification

Testing / Product Conformity to Standards

Product Category



Safety

EMC

Radio

Eco-design

Chemicals

Environment

Performance

CE related concerns


Service on the regional level

LVDEMC

RoHSEr

P

R&TTE

LVDCB

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


CE vs Product Certificate

Technical Standards

NLF DirectivesConformity to essential requirementsConformity AssessmentUE Declaration of conformityCE Marking

Certification Schemes

Conformity to technical standards

Surveillance Inspections

Certification Body Certificate

Quality Mark

CE Marking Product Certificate

Industry Segment



Multiple market segments

IT, Audio & Video Healthcare equipmentProducts: computers, televisions

Examples: intel, HP, Dell

Products: Active Medical Devices for diagnostic and treatment of humansExamples: GE Healthcare, Samsung Medison,Siemens

Telecom Maritime, Oil & GasProducts: all products with built-in transmitters/recieversExamples: 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 lightsExamples: Glamox, Luxo, Phillips

Defence industry Building inspectionProducts: All types of data and communication equipmentExamples: Kitron, Kongsberg Defence & Aerospace

Products: Inspection of technical installations in public buildingsExamples: Karstadt, Real SB Warenhaus

Electrical inst. material

MachineryProducts: Plug and socket outlets, Cord sets, Cables, SwitchesExamples: Elko, Nexans, Draka, Schneider Electric

Products: Power tools, lifting systems, conveyor beltsExamples: ABB, Husquarna

Fire & Security Management SystemsProducts: Alarm devices, power supplies, voice alarmsExamples: Consilium, Autronica, Hedengren, Honeywell

Products: quality systems, information security systems Examples:


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


IEC

CENELEC

CEI

National and International standards

ISO

CEN (EN)

UNI

From UE to the World

Engineering

Transcript of From UE to the World