Robin Croft organised in co-operation with TAIEX EUROPEAN LEGAL - - PowerPoint PPT Presentation

REGULATION (EC) No 765/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products

Robin Croft

• rganised in co-operation with

TAIEX

EUROPEAN LEGAL FRAME WORK TO DELIVER PRODUCT SAFETY

GENERAL PRODUCT SAFETY DIRECTIVE 2001/95/EC & EU REGULATION (EC) 765/2008 & EU DECISION (EC) 768/2008 & PRODUCT DIRECTIVES & REGULATIONS

GPSD & REGULATION 765/2008

 Two horizontal Community laws  Both contain requirements for Market

Surveillance regarding the safety of products

 GPSD applies to all consumer products  Regulation allies to all “harmonised products”  Areas of clear overlap  Areas where both provisions apply

3

4

General Product Safety New Approach Directives Other scenarios

PRODUCT CATEGORIES

5

General Product Safety Directive

 Requirement on manufacturers &

importers to place only safe products

• n the market

 Post-sale duty to monitor their

products

 Update warnings and instructions  Withdraw an unsafe product  Recall from consumers

5

6

New Approach Directives

 TECHNICAL REGULATIONS  Only products fulfilling the essential

requirements may be placed on the market

• r put into service.

 Harmonised standards are presumed to

conform to the corresponding essential requirement = Presumption of conformity

 CE mark = Mark of conformity  Technical files = Check on conformity  Declaration of Conformity = Included

6

LV/2006/IB/EC/01 7

CE MARK

7

8

Standard elements New Approach Directives

 Application of harmonised standards is

generally voluntary for consumer goods

 Manufacturers are mainly free to choose

any technical solution that provides compliance with the essential requirements

 Self-certification can be allowed – if so -

no need for any 3rd party certification

 Manufacturers may choose between the

different conformity assessment procedures set out in the directives

8

Quality Framework

 Conformity assessment and accreditation are important parts of the

EU’s quality infrastructure.

 By providing confidence in goods, services, management systems and

people, they make a significant contribution to the economy, health and safety, and environment of all member states.

 Accreditation is also conformity assessment but as it is used to

evaluate third party conformity assessors, it functions better as part of the framework for the conformity assessment market rather than within it. In this paper therefore accreditation is considered separately from other forms of conformity assessment.

9

What is conformity assessment

• Conformity assessment is the demonstration that what is

supplied actually meets the requirements specified or claimed.

• Conformity assessment can be applied to a product (including

a service), a process, a system, a body or persons and includes activities such as testing, inspection and certification.

• Conformity assessment can be by:-
• any party that is interested in the outcome of the assessment; or
• a third party conformity assessment by an independent body.

10

Conformity assessment in EU Acquis

 A manufacturer can only place a product on the EU market

when it meets all the applicable requirements.

 Therefore some conformity assessment procedure has to be

carried out before the product can be sold.

 The regulations and directives set out the options for

conformity assessment.

 The European Commission’s main objective is to help ensure

that unsafe or otherwise non-compliant products do not find their way to the EU market.

11

Objectives of the conformity assessment and accreditation procedures

• To demonstrate to the manufacturer or importer that a product

which they plan to place on the market complies with all legislative requirements.

• To provide manufactures with a high degree of confidence in the

results of the conformity assessment process

• The procedure should also ensure confidence of consumers, public

authorities regarding the conformity of products

• A single IT product may need to meet the essential requirements of

upto five separate directives – LVD/EMC/RoHS/R&TTE/WEEE

12

How does it work in practice?

• Product legislation describes the conformity assessment procedures for

each product.

• Manufacturers may choose between different conformity assessment

procedures, if applicable.

• The assessment is carried out by or for the manufacturer.
• If the applicable legislation requires it, a conformity assessment body is

involved in the conformity assessment process – EU Notified bodies.

• Conformity of a product is assessed before it is placed on the market.

13

What Conformity Assessment is NOT

• Conformity assessment is not part of market surveillance
• Market surveillance is concerned with conformity compliance
• Conformity assessment is complementary to market surveillance.
• Both procedures help ensure the smooth functioning of the internal

market

• Notified bodies are not allowed to engage in market surveillance

14

Declaration of Conformity

• As part of conformity assessment, the manufacturer or the authorised

representative must draw up an Declaration of conformity (DoC).

• The declaration should contain all information to identify:

 the product  the legislation according to which it is issued  the manufacturer or the authorised representative  the notified body if applicable  a reference to harmonised standards or other normative documents, where

appropriate.

15

EU REGULATION (EC) 765/2008

• Important that conformity assessment bodies (CABs) operate

to acceptable standards

• Legal framework for the provision of accreditation services

across Europe

• Requires each Member State to appoint a single National

Accreditation Body [NAB]

• Accreditation process determines the technical competence

and integrity of organisations such as those offering testing, calibration and certification services (conformity assessment)

Accreditation

• Operates across all market sectors
• Provides an impartial assessment against internationally

recognised standards.

• This has benefits for:

 Government: supports the implementation of government

policies and regulations that impact on health, welfare, security and the environment.

 Industry: essential for decision-making and risk management  Consumers: enhances product safety and competition.

17

Regulation 756/2008 requirements

• The Regulation promotes a uniformly rigorous approach to accreditation

across Member States – so that one accreditation certificate will be enough to demonstrate the technical capacity of a CAB

• The main principles of accreditation are:
• One accreditation body per EU country
• Possibility to use another country’s national accreditation body
• Public authority/sector activity
• Clear distinction from other national authorities
• Not-for-profit operation
• Must not compete with other national accreditation bodies
• Cannot provide conformity assessment services provided by CABs

Requirements for NAB

• Independent of conformity assessment bodies that it assesses
• Free from commercial pressures and conflicts of interest
• Decisions of attestation of competence taken by competent

persons separate from the assessors

• Adequate arrangements to safeguard confidentiality of

information

• Efficient management procedures and internal controls
• Publish annual accounts prepared in accordance with

accepted accounting principles

19

Duties of NAB

• Evaluation of competency to ensure that CABs have the

technical capacity to perform their duties adequately

• Issue of accreditation certificates
• Monitor the CABs that the have certified
• Deal with complaints against CABs
• Revoke certificates if CAB no longer can demonstrate

competence

• Accreditation aims to increase trust in conformity and

mutual recognition

Requirements for NAB

• Subject themselves to peer evaluation to determine if they

meet the requirement of the Regulation

• Conformity to relevant harmonised standard demonstrated

through peer evaluation gives presumption of conformity to Regulation requirements

• Publish the outcome of its peer evaluation
• Inform other NABs of the areas of conformity assessment of

which it operates accreditation

• Allow participation of stakeholders in parts of the process

21

Notification

• Member State “notifies” the EU of the bodies that it has

designated to carry out conformity assessment of a directive.

• Notification of Notified Bodies and their withdrawal are the

responsibility of the notifying Member State.

• EEA members and other countries with which the EC has

concluded Mutual Recognition Agreements (MRAs) and Protocols to the Europe Agreements on Conformity Assessment and Acceptance of Industrial Products (PECAs) have designated Notified Bodies, established per directive.

22

Notified Bodies & Accreditation

23

23 23 23

Directive / Regulation Specific requirements for products and to Conformity Assessment procedures Specific competence of the CAB with regard to (parts) of the Directive / Regulation Technical competence of the Conformity Assessment Body

ACCREDITATION DESIGNATION NOTIFICATION

Accreditation & Notification

Why accreditation and not “authorisation”?

• Impartial and independent recognition of competence
• Responds to a need of the industry
• Same criteria for all certification bodies
• Same criteria for all testing laboratories

Why notification and not “authorisation”?

• Delegation of state power
• Recognition of competences and capabilities above

technical competence

24

24

European Accreditation [EA]

• EA exists to coordinate and lead the European

accreditation infrastructure to allow the results of conformity assessment services in one country to be accepted by Regulators and the market place in another country without further examination, for the benefit of the European community and the global economy."

• The EA is a not-for-profit association set up in November

1997 and registered in the Netherlands in June 2000.

25

EA – European cooperation for accreditation

• EA has been recognised by the European Commission

according to Article 14 of Regulation (EC) No 765/2008 to

• perate the peer evaluation system
• Accreditation Bodies are evaluated against the international

standard ISO/IEC 17011, and other relevant standards and related criteria {CERTIF documents}

• The Multilateral Agreement [MLA] process is overseen by the

European Commission, the EA Advisory Board and the national authorities.

26

EA’s mission

• Consistency by ensuring common interpretation and

application of the standards used by its members;

• Ensuring transparency of the assessments and results

provided by its members;

• Maintaining a multilateral agreement on mutual recognition

and reciprocal acceptance results;

• Managing a peer evaluation system;
• Technical resource on matters related to accreditation.

27

EA-2/17 INF: 2014

EA Document on Accreditation For Notification Purposes

• Policy agreed by EA Members for accreditation of Conformity

Assessment Bodies for notification purposes

• March 2014_rev02 – Re published May 2015
• Document is a “Members’ procedural document” with an

informative status

• Identifies the requirements that should be used by National

Accreditation Bodies when accrediting Conformity Assessment Bodies seeking notification

28

THE BLUE GUIDE

• EA-2/17- EA Guidance on the horizontal

requirements for the accreditation of conformity assessment bodies for notification purposes

• The 'Blue Guide' on the implementation of EU

product rules - 2016 contains guidance on the application of all aspects of the implementation of EU product rules, including conformity assessments.

• http://ec.europa.eu/DocsRoom/documents/16210