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

7

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 Hellerisabelle.heller@mam-consult.com

www.aebrus.ruwww.mam-consult.com