IGQ - INTERNATIONAL CONFERENCE ON ACCREDITATION AND … Riva Accredia.pdf · 2015-04-08 ·...

Emanuele Riva – Accreditation Manager 27 March 2012

ACCREDIA The Italian Accreditation Body

INTERNATIONAL CONFERENCE ON

ACCREDITATION AND NOTIFICATION FOR THE

CONSTRUCTION PRODUCT REGULATION

Milano, 27 March 2012 Politecnico di Milano S01 room Piazza Leonardo da Vinci, 32

- 305/11/EC Construction Product Regulation -


The European system for the conformity assessment of products

New Legislative Framework Regulation 765 / 2008 / EC of the European Parliament and of the Council of July 9, 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and superseding Regulation (EEC)No339/93 Decision n. 768 / 2008 / EC of the European Parliament and of the Council of July 9, 2008 concerning a common framework for product marketing – EC Mark and notifications; Regulation 764 / 2008 / EC of the European Parliament and of the Council of July 9, 2008 establishing procedures for the application of technical national rules for products legally marketed in another member State.


ACCREDIA: the new sole Italian Accreditation Body

Our History

• “Regulations for the organisation and functioning of the sole national accreditation Body (in compliance with Reg. EC 765/2008)” of 16 11 2009.

• "Designation of ACCREDIA as Sole National Body authorised to undertake accreditation and surveillance activity of the market in conformity” of 22 12 2009

• Publication in the official journal of ministerial decrees

(January)

• EA MLA/IAF and ILAC MRA references (QMS, EMS, PRS, PRD, INSP, Testing, Calibration)


ACCREDIA is a non-profit-distributing association, covering the main institutional, scientific, technical, economic and social entities which have interests in acreditation and certification activity. 67 Members: 9 Ministries, National Public Administrations, Research Bodies, business organisations, Associations of accredited subjects, national standardization Bodies, Associations of consultancy services, consumers, public utility suppliers.


The association


ACCREDIA’s activities are performed by 4 departments: - Certification – of management, product and personnel systems – and Inspection - Testing laboratories - Testing laboratories for food safety - Calibration laboratories

ACCREDIA manages the entire range of activities covered by the international agreements of mutual recognition: EA MLA and IAF/ILAC MRA. The activity, directed by the Committee for accreditation activity, is divided into Sectorial Accreditation Committees: Inspection Bodies (ISO/IEC 17020) and Certification Bodies: product (EN 45011), system (ISO/IEC 17021), personnel (ISO/IEC 17024) CABs in the quality agri-food sectors (EN 45011) Medical and Testing Laboratories (ISO/IEC 17025 e ISO 15189) Food safety Testing Laboratories (ISO/IEC 17025) Calibration Laboratories (ISO/IEC 17025) Notified Bodies – A Notifies Bodies – B Environment

ACCREDIA: the accreditation activity

The departments


The assessors must be familiar with the accreditation standard and ACCREDIA accreditation procedures, the relevant conformity assessment standards; they must be capable to understand the business processes of the CABs, to assess such processes and to formulate judgements. They are required for specialist knowledge and experience and trained and monitored upon appropriate procedures and processes. • Assessors and Experts: lead assessors available to the AB: 195 assessors available to the AB: 235 experts available to the AB: 32 • Certification and Inspection Department activity 2011: 2.560 man-days (accreditation, recognition, cross frontier)

• Testing Laboratories Department activity 2011: 6.747 man-days (on-site and supplementary audits, examination days)

• Calibration Laboratories activity 2011: 541 man-days

ACCREDIA: the accreditation activity

The assessors’ team



The role

ACCREDIA performs a role of public authority in the general interest, operating under the supervision of the Ministry of Economic Development which is the national authority for accreditation activity and the point of contact with the European Commission.

•ACCREDIA performs accreditation of bodies conducting conformity assessment in voluntary fields. •Specific statutory Body for activities in regulated fields:

Coordination Committee with ACCREDIA Members Administrations


Constitute, for the Italian Government, for the interested parties and for all users, an authoritative interlocutor, such as to make the complementarity of systems and expertises in the regulated and voluntary fields, for accreditation and conformity assessment; Extend the relevance of accreditation activities, highlighting the importance in the Italian economic system, in order to enhance the choice of the quality; Provide with certificates of conformity issued under accreditation the maximum reliability for businesses and consumers; Share the experiences of existing institutions in order to make the system more efficient and less costly, and guaranteeing public control and managerial skills, as well as competence, independence and impartiality.


The objectives


In particular, the Body performs the following operational tasks: Operate in voluntary fields;

Operate in the regulatory area as entrusted and supervised by the government, based on specific formal assignments (by 2011);

Publish on its website and other mass media, its procedures for accreditation, the provisions relating to accreditation activities and the lists of accredited organizations;

Maintain relationships with accreditation institutions in other countries, supranational and international (IAF, ILAC, EA).


The tasks


In particular, care will be paid in order to:

Comply with the EC Regulation, to avoid conflicts or concurrence with the other European Bodies, EA, and with the peer evaluations;

Participate in the Mutual recognition agreements EA, ILAC, IAF;

Operate to spread the culture of conformity assessment in whatever area, as a positive element for quality, safety, environmental protection, etc.


The tasks


For New Approach EC Directives and other EC Regulations several agreements have been signed in 2011:

ACCREDIA – Ministry of the Economic Development Safety of toys(2009/48/EC) Measuring Instruments Directive (2004/22/EC) Hot-water boilers (92/42/EEC) Pressure equipment (97/23/EC) Equipment and protective systems intended for use in potentially explosive

atmospheres (94/9/EC) Electromagnetic compatibility (2004/108/EC) ACCREDIA – Ministry of Infrastructure and Transport European Electronic Toll Service (EETS) Transportable pressure equipment (2010/35/EU)


The mandatory sectors


ACCREDIA - Ministry of the Economic Development – Ministry of Work and Social Policies Machinery (2006/42/EC) Lifts (95/16/EC) Low voltage directive (2006/95/EC) Personal protective equipment (1989/686/EEC) ACCREDIA – Ministry of the Environment Noise emission in the environment by equipment for use outdoors

(2000/14/EC) Greenhouse gas emission (2003/87/EC) Fuel quality directive(2009/30/EC) Energy from renewable sources (2009/28/EC) Fluorinated greenhouse gases (Reg. 842/2006) Emas (Reg. 1221/2009) ACCREDIA - Ministry of the Economic Development Radio and telecommunications terminal equipment (1999/5/EC)


The mandatory sectors


Accredited body in regulated sector

Regulated sectors Accreditations granted

97/23/CE PED 5

95/16/CE ASCENSORI 2

2006/42/CE Macchine 3

1994/9/CE ATEX 1

2010/35/UE T-PED 1

89/686/EEC DPI 2

2009/48/CE Giocattoli 2

2004/108/CE EMC 0

2006/95/CE Bassa Tensione 0

2000/14/CE Rumore 0

2004/22/CE MID 0

1999/5/CE Apparecchi Radio 0

Decisione 2009/750/CE 0

tot 16


Accreditation Process

1) Document review

2) Office assessment

Decision for accreditation (Accreditation committee)

After 6 monthes


2) 2 witness audit

Annual Surveillance


2) 1 witness audit for each Directive (from 2013)


Why Accreditation?

• Article 43

Requirements for notified bodies

1. For the purposes of notification, a notified body shall meet the requirements

set out in paragraphs 2 to 11.

• Article 44

Presumption of conformity

A notified body to be authorised to carry out third party tasks in the process of

assessment and verification of constancy of performance which demonstrates

its conformity with the criteria laid down in the relevant harmonised standards

or parts thereof, the references of which have been published in the Official

Journal of the European Union, shall be presumed to comply with the

requirements set out in Article 43 in so far as the applicable harmonised

standards cover those requirements.


Why Accreditation?

• Article 47

• Application for notification

• 1. A body to be authorised to carry out third party tasks in the process of

assessment and verification of constancy of performance shall submit an

application for notification to the notifying authority of the Member State

in which it is established.

• 2. The application shall be accompanied by a description of the activities to

be performed, the assessment and/or verification procedures for which the

body claims to be competent, an accreditation certificate, where one exists,

issued by the national accreditation body within the meaning of Regulation

(EC) No 765/2008, attesting that the body meets the requirements laid

down in Article 43.


Why Accreditation?

• Article 47

• 3. Where the body concerned cannot provide an accreditation certificate, it

shall provide the notifying authority with all documentary evidence

necessary for the verification, recognition and regular monitoring of its

compliance with the requirements laid down in Article 43.

• Article 48

• Notification procedure

• 1. Notifying authorities may notify only bodies which have satisfied the

requirements laid down in Article 43.


OPEN ITEMS 1

Management System are much more regulated in comparison with Product certification

How to close this gap?

• E.g.: – transfer of accredited certificates

– What happens to the certificates if the accreditation is revoked?

– Man-day calculation

– Number of Witness audits to be performed by the NAB for granting and extending the accreditation

– Report (ISO 17022)

– …


OPEN ITEMS 2

• The accreditation granted is valid for all the construction products, or Annex IV can be applicable? (35 Product areas and requirements for TABS)

• Can a Notify body or a CAB act also as a TAB (Technical assessment body)? According Annex IV, table 2, the TAB shall be independent from the stakeholders and from any particular interest

• How to increase the effectiveness of the NAB role? Is it possible for the NAB to pick up directly from the market some CE product, and to verify directly the declaration of performance already evaluated by a Notify body?


Accreditation Price List - 1

• Commissione di Sorveglianza – Supervisory Committee (DM 27-07-2010) approves the price list proposed by ACCREDIA, following the principles written in the same Decrete (Art. 7) – To take into consideration what is applied in the others NAB

– Strict evaluation of the operational costs of Accredia

– Proportionality between differt CABs

– Periodical review of the price list

Working group to reissue the Accredia Price List, with the involvement of all the interested parties (Subcommittee of the Comitato di indirizzo e Garanzia / Steering committee)



• Only for the Bodies operating in the regulated field, utilizing the accreditation for the purposes of public authorization, under standards having the force of law, the annual fee for maintenance is fixed at € 2.000,00.

• For each additional accreditation granted in the regulated schemes an additional € 1.500,00 shall be added.

• The accredited Bodies in both voluntary and regulated field, must indicate separately the revenue realized under accreditation for the voluntary fields (schemes) and those regulated (Directives, Regulations or nation-al laws).



- Presentation of Accreditation Application € 1.550,00 + VAT

This fee includes acceptance of application and initial document examination. For subsequent examinations, if requested, the activities of personnel – specified in a quotation of expenses – are calculated at a fee of € 900.00 + VAT per man-day.

- Presentation of Application for Extension

For the presentation of the Application for Extension no fee is involved. The fee for examination of documents is set at € 900.00 + VAT for each man-day needed for the analysis and evaluation of the documentation, as indicated in the expense quotation, with a minimum of one half man-day.


Thanks for your kind attention www.accredia.it [email protected] Certification and Inspection Department Testing Laboratories Department Testing Laboratories for food safety Department Calibration Laboratories Department

ACCREDIA - The Italian Accreditation Body

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