Изабель Эллер - isabelle heller- 10.04.2008 the reform of technical regulating through...
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Изабель Эллер - Isabelle Heller- 10.04.2008The reform of technical regulating through the eyes of a European expert
International Standardization – The effective instrument for competitiveness
raising of the Russian Industry
Isabelle Heller - Изабель Эллер - 10.04.2008
The reform of technical regulatingthrough the eyes of a European expert
Изабель Эллер - Isabelle Heller- 10.04.2008The reform of technical regulating through the eyes of a European expert
2
The Law on Technical Regulating
RF
Стандартизация
Аккредитация
ЕU
Изабель Эллер - Isabelle Heller- 10.04.2008The reform of technical regulating through the eyes of a European expert
3
The Law on Technical Regulating
RF
Conformityattestation
State surveillance
Products and linked processes
Standardization
Accreditation
Mandatory field Voluntary field
Products and all processes linked to the products life cycle
Services Services
Other objectsOther objects
Technical regulations
Objects
Voluntary certification
Other processes of the life cycle of
products
ЕU
Изабель Эллер - Isabelle Heller- 10.04.2008The reform of technical regulating through the eyes of a European expert
Mandatory compliance with essential requirements and voluntary application of standards
4
Mandatory field
Compliance with standards / codes of practice Presumption of conformity to essential requirements
Level of participation in the attestation of conformity process of a third-party dependent of the risk degree Increasing role of declaration of conformity Importance of market surveillance
ЕU RF
Изабель Эллер - Isabelle Heller- 10.04.2008The reform of technical regulating through the eyes of a European expert
Mandatory attestation of conformitywithout third party
Declaration of conformity
Manufacturer or his representative
Technical documentation
Federal Body ofExecutive Power
Registration
ЕU RF
Validity period
5
Conformity assessment - Art. 7.3Surveillance
Изабель Эллер - Isabelle Heller- 10.04.2008The reform of technical regulating through the eyes of a European expert
Mandatory attestation of conformity schemesModules
ЕU
6
Design phase Production phase
А: Internal control
С:Internal production control
В: EC Type examinationNB D:Quality assurance of the production
processNB
E:Product quality assuranceNB
F:Product verificationNB
H: Full quality assurance +design controlNB
G:Unit verificationNB
+ АB or NB
Dec
lara
tion
of C
onfo
rmity
Изабель Эллер - Isabelle Heller- 10.04.2008The reform of technical regulating through the eyes of a European expert
АB Mandatory certification
ControlTestsАB
Mandatory attestation of conformity schemesModules
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Design phase Production phase
Dec
lara
tion
RF
Declaration based on own proofs
Declaration based on own proofs
Declaration based on own proofs
TestsАB
Quality system certificateАB
and/or
? Possible certification schemes ?
Cer
tific
ate
? Type certification ?
? Compliance with a standard?
Изабель Эллер - Isabelle Heller- 10.04.2008The reform of technical regulating through the eyes of a European expert
High voltage equipment Qualification -х х?
Low voltage equipment No qualification хх
-х
Objects of directives and technical regulationsRisk level evaluation
EU RF
8
Object danger Qualification of users
Directive
Tech Reg
Third party
Appliances burning gaseous fuels
No qualification хх
хх?
Equipment used in potentially explosive atmospheres
Qualification хх
хх?
Изабель Эллер - Isabelle Heller- 10.04.2008The reform of technical regulating through the eyes of a European expert
ISO /
IEC 2
Different kinds of activities and their results
mandatoryorvoluntary
On the basis of a consensus
LAW
on T. R.
Products,Processes, design, production, construction, …Sale and useWorks or services
voluntary Maximum account of interests of the stakeholders
9
Standardization
EU RF
Objects of standards Application Elaboration
WTO TBT
Products or related processes and production methods
voluntary Consensus not required
Electrical installation in habitationTreatment of friable asbestos
Electrical installation in habitationTreatment of friable asbestos
Изабель Эллер - Isabelle Heller- 10.04.2008The reform of technical regulating through the eyes of a European expert
? Specific mark / a unique scheme ?
National regulations Compliance with ISO/IEC documents
Participation of all interested parties in the definition of principles and certification rules Publication of certification rules and lists of certified objects
Mark of conformityNot liable to cause confusion with СЕ marking
10
Voluntary certification
ЕU RF
Few requirements Compliance with national standards
Изабель Эллер - Isabelle Heller- 10.04.2008The reform of technical regulating through the eyes of a European expert
?
Accreditation / notification
UE RF
State member
Notifying body
Accreditation criteria
Notified body for a directive / modules / product category
NotificationNotification
+CriteriaParticipation in standardization,in coordination of N.B.
?
Accredited certification body for a technical regulation / product category / ?
State
?? Notification Notification ??
Accreditation
Accreditedlaboratory
No
tifi
cati
on
No
tifi
cati
on
?
? N
otifica
tion
N
otifica
tion
??
? /mandatory attestation ?
for ?
Accreditation for a kind of product/ requirement/ conformity assessment
11
Art. 41-42
? Accreditation body ?
by an accreditation body
Изабель Эллер - Isabelle Heller- 10.04.2008The reform of technical regulating through the eyes of a European expert
Thank you for your attention
Изабель Эллер - Isabelle [email protected]
www.aebrus.ruwww.mam-consult.com