Auswertung

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TÜV Rheinland Group Global Regulations An
Overview Mr. Enrico Ruhle Managing
Director TÜV Rheinland (India) Private
Limited 28.08.2009
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Content

• Introduction TÜV Rheinland Group
• Introduction Export Market
• Agencies India / Europe
• Regulations scenario India Vs Europe
• Examples Due To Non Compliance
• Other important certifications
• Where is compliance going in the future?

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Introduction TÜV Rheinland Group
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Experience Comes with Time
For more than 136 years TÜV Rheinland has
assisted people and companies in all aspects of
quality assurance. Our integrated portfolio
offers much more than safety. We base
partnerships on trust and endeavor to develop,
strengthen and secure the competitive advantages
of our clients.
People
Environment
Technology
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Introduction - TÜV Rheinland Group

• Global Headquarters Cologne, Germany
• Asia Headquarters Yokohama, Japan
• India Headquarters Bangalore, India
• Main Regional Offices in India

New Delhi, Mohali, Kolkata, Vadodara, Mumbai,
Pune, Kolhapur, Hyderabad, Chennai, Coimbatore,
Cochin
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Offices World Wide
Offices Worldwide Over 110 associated
companies in 490 locations throughout 61
countries around the world with 13.500
Employees. Wherever your target market is we are
already there.
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Offices Worldwide - Asia
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Offices Worldwide - Europe
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Offices Worldwide - Americas
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Industrial Service

• TÜV Rheinland industrial services ensure maximum
  safety, optimal
• functioning and the smooth operation of plants,
  equipment, constructions
• and systems. We offer all necessary
  accreditations.

Mobility
Mobility on the road, on the railways, and in the
air. TÜV specialists are e.g. accompanying the
start of the transrapid magnetic monorail in
China, consult in the toll collection system in
Germany and make sure that future vehicle models
meet all legal specifications.
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Products
TÜV Rheinland evaluates, tests and certifies the
safety and quality of products in virtually all
categories, from toys to state-of-the-art
computer equipment and heavy industrial machinery
- national and international.
Life Care
TÜV Rheinland Group offers a wide range of
services in the field of health care from quality
checks for high-tech equipment at clinics to
psychology consulting services in companies to
food testing services.
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Education Consulting
TÜV Rheinland Group offers a broad range of
vocational advanced training courses,
organizational system capacity building,
temporary employment, transfer agency services,
project management assistance.
Systems
TÜV Rheinland Group assesses management systems,
IT processes entire companies in accordance
with internationally recognized standards or
individual performance criteria.
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TÜV Rheinland STAR
TÜV Rheinland STAR is a service which provides a
company rating over 91 Dimensions, offering such
benefits as
Supplier Assessment Purchasers can evaluate and
rate their existing or potential
suppliers. Competitive Advantage Suppliers can
prove their capabilities towards their potential
buyers. Investment Decisions Investors have
access to detailed reports allowing for smart and
safe investments. Internal Improvement
Organizations can internally evaluate their
risks. Proof of Societal Commitment
Organizations can verify their dedication to
Corporate Social Responsibility (CSR).  
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Opportunities For Exporters
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Opportunities For Exporters
Indias overall export during the year 2007
2008 Indias overall export during the year
2007-08 is estimated to be Rs. 1068331 crore
(US 265.00 billion) registering a growth of
12.10 percent (20.26 percent in US
terms). Electronics IT - Production Indias
Electronics and Computer Software / Services
industry is estimated to be Rs. 303100 crores
(US 75.29 billion) during the year 2007-08. 
Electronics Hardware - Production In
percentage share terms, production of Electronics
Hardware accounts for a share of 26.66 percent
Source Electronics Computer Software Export
Promotion Council
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Opportunities For Exporters

• Electronics Software Export 2007 - 2008

• Indias Electronics and Computer Software /
  Services export registered a growth of
• 18.74 percent (27.56 percent in US terms)
  during 2007-08 over the year 2006-07.
• Export of Electronics / Services sector has
  been maintaining an outstanding annual
• average growth rate of 29.28 percent (34.13
  percent in US terms) during the period
• 2002-03 to 2007-08.

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Key Statistics Top Ten Trading Partners for
India
Source CMIE (Centre for Monitoring Indian
Economy) April - 2008
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Agencies India / Europe
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Agencies involved
Europe European Union Competanant Authority

• India
• BIS Bureau of Indian Standards
• STQC Standardization Testing
• Quality Certification
• WPC Wireless Planning
• Coordination Wing
• TEC Telecommunication
• Engineering Centre
• IBR Indian Boiler Regulation
• CDSCO Central Drug Standard
• Control Organization (IMRDA)

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Regulations scenario India vs Europe
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Recent Limelight incidents in India
Regulations scenario India vs Europe

• Six-day-old infant burnt alive in Delhi hospital
  
• March 12th, 2008 - 957 pm ICT by admin
• Five infants killed in Punjab hospital fire
  (Lead)
• January 31st, 2009 - 144 pm ICT by IANS
• Four-month-old dies in incubator in Allahabad
  hospital Lucknow
• May 3

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Regulations scenario India vs Europe
Democratic Toy Quality Norms

• NEW DELHI India is working on new regulations
  for toy imports which would make it mandatory for
  all countries wanting to sell toys to India to
  meet prescribed quality norms. The move follows
  Chinas complaint that the quality restrictions
  imposed by India on Chinese toys violated the
  World Trade Organization (WTO) rule of treating
  all member countries alike. Source
  www.indiatimes.com

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Regulations in India vs Europe
India
Europe
Notified body CE marking is mandatory for medical
devices in European union according to medical
device directive. CE marking covers almost
all products. CE marking requirements are
updated to latest requirements time to time based
on international standards.

• The Government of India is proposing to set-up
  the Indian Medical Devices Regulatory Authority
  (IMDRA). The IMDRA is expected to formulate
  appropriate guidelines to be a national
  certifying and regulatory agency in India for
  medical equipment and devices.
• Bureau of Indian Standard (BIS) has a Limited
  Scope.
• BIS standards refers to very old regulations like
  IS 65671972.

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HOW DIFFICULT IS CE MARKING?
The CE marking is a mandatory European marking
for certain product groups to indicate conformity
with the essential health and safety requirements
set out in European Directives. The CE Marking,
standing for Conformité Européenne ("European
Conformity") is a European Mark of conformity
indicating that a product or system to which it
is applied, complies with the applicable European
laws (Directives) regulating a necessary level of
protection with respect to safety, health,
environment and consumer protection.  
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HOW DIFFICULT IS CE MARKING?

• It is not !! In fact easier than ISI mark !!
• The requirements of CE marking on based on
  international standards which are made
  considering all member countries inputs including
  India (IEC standards).
• Requirements laid down are bare minimum
  requirements.
• Majorly concentrating on EHSR ( Environmental
  Health and Safety Requirements).
• Manufacturer can show compliance and self
  Declare.

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HOW DIFFICULT IS CE MARKING?
ISI Mark

• ISI mark not only confirms to product safety but
  also considers performance requirements.
• Certification can be done only by BIS.
• Annual follow-ups are mandatory.
• Note Supply voltage system in Europe and India
  is same!! Also the environmental conditions in
  India are more stringent than Europe.

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Product Off Market Due To Non - Compliance
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Recent Recall Cases

• Mattel
• Millions of products recalled in North America-
  manufactured in China, Mexico
• 25 of public company value wiped out overnight
• Estimated recall costs of U25,000,000
• Chinese Governments remove export licenses for
  toy manufacturers
• Menu Foods Inc. (Pet food)
• 60,000,000 cans
• Estimated recall costs of U42,000,000
• Foreign Tire Sales
• 500,000 tires products recalled due to
  non-authorized production
• Estimated recall and damage costs of U80,000,000

• Other recall examples
• Cars, batteries, kerosene fan heaters, electric
  fans, etc.

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Product Off Market Due To Non - Compliance
Compliance Accreditation
 
Sourcehttp//ec.europa.eu
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Compliance Accreditation
Examples of Certification For Seamless Exports
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Selection of World Wide Access
Switzerland
Hong Kong
Singapore
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Other important certifications for Exporters

• Quality, e.g. ISO 9000
• Environment, e.g. ISO14000, REACH, WEEE, RoHS
• Occupational Health Safety, e.g. OHSAS
• Social Accountability, e.g. SA8000, BSCI, BRC,
  CoC

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Changes in Compliance Requirements
Tomorrow ? Multi-dimensional
Complexity
Societys Expectations
Information Security
Today ? Technical/material
Certifications
?
REACH
ELV
Product Safety
RoHS
WEEE
Time
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A Possible Scenario for Future Compliance
Requirements
Current Compliance Requirements
New Compliance Requirements
Expectationsof Society
Stakeholder
Environmental impact
Producer
BannedSubstances
?
Political, social, etc.conditions
ofproducingcountry
Processing
?
Certifications
Transport
RecyclingTargets
?
Retailer
TransportRegulations
?
Monitoring
Consumer
Local Testing Requirements
?
Other
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Thank you
Mr.Enrico Ruhle Managing Director TÜV Rheinland
(India) Pvt. Ltd. Alpha Tower, Sigma Tech Park
7, Whitefield Main Road, Varthur Kodi Bangalore
560 066 Ph 080-39899888 / 30554319 Fax
080-30554342 Info_at_ind.tuv.com


http//www.ind.tuv.com