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Revision of the New Approach: The PED context

Revision of the New Approach: The PED context. Ing. Anthony Camilleri, B.Mech.Eng.(Hons.) Head – Consumer and Industrial Goods Directorate Malta Standards Authority. Workshop on Pressure Equipment, Nicosia, CYPRUS: 3, 4 and 5 October 2005. Revision of the New Approach: Background.

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Revision of the New Approach: The PED context

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  1. Revision of the New Approach:The PED context Ing. Anthony Camilleri, B.Mech.Eng.(Hons.) Head – Consumer and Industrial Goods Directorate Malta Standards Authority Workshop on Pressure Equipment, Nicosia, CYPRUS: 3, 4 and 5 October 2005

  2. Revision of the New Approach: Background • COMMUNICATION from the Commission to the Council and the European Parliament “Enhancing the Implementation of the New Approach Directives” – COM(2003) 240 of 07-05-2003; • COUNCIL RESOLUTION of 10 November 2003 on the Communication of the European Commission “Enhancing the Implementation of the New Approach Directives” – (2003/C 282/02) Workshop on Pressure Equipment, Nicosia, CYPRUS: 3, 4 and 5 October 2005

  3. Revision of the New Approach: Present situation (1) • The situation at present is that an overall Certif document (Certif 2004-1)over viewing the entire field of the revision has been discussed in two meetings of the Senior Officials Group on Standardization and Conformity Assessment (SOGS) - November 2004 and February 2005. • This document and the ensuing discussions have identified all the issues that have to be treated in order to revise, update and complete the New Approach. • These different issues are now being treated in individual Certif documents for discussion in SOGS and through general consultation of all stakeholders. Workshop on Pressure Equipment, Nicosia, CYPRUS: 3, 4 and 5 October 2005

  4. Revision of the New Approach: Present situation (2) • These Certif documents are being first discussed in SOGS and adapted taking into account comments received during the meetings as well as feedback received from the consultation process. • In other words the documents are intended to be seen as steps in the revision process and not as the end product. The revised documents can be discussed as and when required. • The declared strategy is to concentrate first on the issues requiring the most attention: the notified bodies and accreditation, the modules and market surveillance. Workshop on Pressure Equipment, Nicosia, CYPRUS: 3, 4 and 5 October 2005

  5. Revision of the New Approach: Working Progress during 2005 (1) • A first batch of Certifs was sent out in April 2005; • On this basis, four new Certif documents have been drawn up for the April meeting of SOGS: the quality issues of the modules, a draft common declaration of conformity for all directives, criteria for notified bodies and criteria for designating bodies of notified bodies. Workshop on Pressure Equipment, Nicosia, CYPRUS: 3, 4 and 5 October 2005

  6. Revision of the New Approach: Working Progress during 2005 (2) • A second batch of documents was sent in July 2005; • These covered: the role of accreditation in the designation of notified bodies, the European accreditation organisation, market surveillance, and a definitions paper (identification and responsibilities of actors in directives, placing on the market, amongst others). Workshop on Pressure Equipment, Nicosia, CYPRUS: 3, 4 and 5 October 2005

  7. Revision of the New Approach: Working Progress during 2005 (3) • A further batch is being sent during September 2005; • This batch of documents currently being circulated covers: cooperation between notified bodies, the development of NANDO, the safeguard clause and rapid information system, a comparative document on the status of marks and marking, and another on the relations between the CE marking and other marks. • These are planned to be discussed during the next SOGS meetingon 29 & 30 September 2005. Workshop on Pressure Equipment, Nicosia, CYPRUS: 3, 4 and 5 October 2005

  8. Revision of the New Approach: Main issues presented to date (1) • The document (draft Certif 2005-1) on adapting the quality assurance modules after the introduction of ISO 9001:2000 is proposing two optionsto incorporate the requirements of ISO 9001:2000 in the EC conformity assessment proceduresused in technical harmonisation directives. • OPTION 1(one standard, one quality system, one module) • OPTION 2(one standard, three quality systems, three modules); it also proposes an amendment in the structure of the modules for the design phase. Workshop on Pressure Equipment, Nicosia, CYPRUS: 3, 4 and 5 October 2005

  9. Revision of the New Approach: Main issues presented to date (2) • The document (draft Certif 2005-2) on the EC Declaration of Conformity (DoC) is proposing that, on the occasion of the revision of Council Decision 93/465/EEC on the modules, there should be a harmonisation of the minimum amount of information included in the DoC across the various directives, in accordance with the following model: Workshop on Pressure Equipment, Nicosia, CYPRUS: 3, 4 and 5 October 2005

  10. Revision of the New Approach: Main issues presented to date (3) • The document (draft Certif 2005-3) on the Designation of notified bodies (Part 1) – common requirements for notified bodies, set out a proposal for a consolidated set of common requirements for the designation and operation of notified bodies. It also raised a number of issues for discussion in view of their appropriate treatment at horizontal level. Workshop on Pressure Equipment, Nicosia, CYPRUS: 3, 4 and 5 October 2005

  11. Revision of the New Approach: Main issues presented to date (4) • The document (draft Certif 2005-4) on the Designation of notified bodies (Part 2) – common requirements for authorities and bodies involved in the assessment, designation and monitoring of notified bodies supplemented draft CERTIF 2005-3 and set out a proposal for a consolidated set of common criteria for bodies involved in the assessment, designation and monitoring of notified bodies. • In the interests of a more transparent and homogeneous designation system in the EU, it also proposed a set of general criteria covering the competence of designating bodies and a general description of the procedures applied by them. Workshop on Pressure Equipment, Nicosia, CYPRUS: 3, 4 and 5 October 2005

  12. Revision of the New Approach: Main issues presented to date (5) • The document (draft Certif 2005-5) on the Development of the European Infrastructure for Accreditation outlines the need for repositioning and strengthening accreditation activities in the context of the revision of the New Approach and proposes establishing a clear legal framework for a European infrastructure for accreditation by: • Repositioning the European Accreditation (EA); • Structurally developing EA; • Re-defining the missions of EA. Workshop on Pressure Equipment, Nicosia, CYPRUS: 3, 4 and 5 October 2005

  13. Revision of the New Approach: Main issues presented to date (6) • The document (draft Certif 2005-6) on Accreditation in support of designation of notified bodies aims at defining the role of accreditation in support of designation of notified bodies and proposes steps and measures that are intended to generalize the recourse to accreditation in order to arrive at more consistent designation procedures. • At the same time, the measures suggested seek to ensure and promote further the acceptance by the national authorities of certificates and attestations issued by accredited NB and of accreditation certificates issued by nationally recognized accreditation bodies that are signatories to the multilateral agreement (MLA) operated by European co-operation for Accreditation (EA). Workshop on Pressure Equipment, Nicosia, CYPRUS: 3, 4 and 5 October 2005

  14. Revision of the New Approach: Main issues presented to date (7) • The document (draft Certif 2005-7) on a Community framework for Market Surveillance defines a Community framework for market surveillance as envisaged in Chapter 9 of document SOGS N 492 EN, to be organized on three levels, namely: the essential requirements of the system, Community control and administrative co-operation. • The Annex to this document includes the following: • a draft preliminary guide (Part I) which aims to clarify and detail the system foreseen (an interpretative description of the system); and • proposals for implementing measures of a Community framework (Part II). Workshop on Pressure Equipment, Nicosia, CYPRUS: 3, 4 and 5 October 2005

  15. Revision of the New Approach: Main issues presented to date (8a) • The document (draft Certif 2005-8) on Creating a network of Notified Bodies discusses how to transform the Groups of Notified Bodies operating under the New Approach Directives into an effective network, to support their activities and to ensure co-operation and information exchange between the Notified Bodies. • Legal effect to the RECOMMENDATIONS could be provided by a revision of Decision 93/465/EEC and/or amendment to the existing Directives. Workshop on Pressure Equipment, Nicosia, CYPRUS: 3, 4 and 5 October 2005

  16. Revision of the New Approach: Main issues presented to date (8b) • RECOMMENDATIONS: • To set up a horizontal co-ordination group of the Presidents of the sectoral groups, under the chairmanship of the Commission to ensure coherence and transparency and to reinforce the networking of the Notified Bodies; • To set up an effective reporting mechanism to SOGS to highlight the functioning of the network and participation of Notified Bodies in the groups; • To strengthen the requirement for exchange of information between Notified Bodies through registration and participation in the sectoral groups – through the systematic use of CIRCA; • To strengthen the requirement for Notified Bodies to keep themselves up-to-date with and abide by common positions elaborated by their sectoral group; • Use the network to establish procedures for the exchange of information on the withdrawal and refusal of certificates, subject to limitations in relation to professional integrity and appropriate protection and/or restriction of confidential information; • Review of the groups to ensure all directives are covered. Workshop on Pressure Equipment, Nicosia, CYPRUS: 3, 4 and 5 October 2005

  17. Revision of the New Approach: Main issues presented to date (9) • The document (draft Certif 2005-9) on Common understanding of basic notions in technical harmonisation reviews some common terms with the aim to bring more coherence into definitions in order to facilitate the implementation of our legislation and thereby contribute to the objectives of “Better Regulation”. • The terms dealt with include “placing on the market”, “putting into service”, “manufacturer”, “authorized representative”, “importer” and “distributor”. Workshop on Pressure Equipment, Nicosia, CYPRUS: 3, 4 and 5 October 2005

  18. Revision of the New Approach: Main issues presented to date (10a) • The document (draft Certif 2005-11) on The Role and Significance of the CE Marking examines the options relating to CE marking and, if it is to be maintained, on what conditions. • Lack of understanding in the meaning of the CE marking by the consumers, and poor policing of its rules undermines the confidence in the New Approach. The option of abolishing it should be an object of public debate. • Changing its content (e.g. by introducing systematic certification) also merits a discussion. It would raise the level of understanding by consumers, but at the same time has significant drawbacks. Workshop on Pressure Equipment, Nicosia, CYPRUS: 3, 4 and 5 October 2005

  19. Revision of the New Approach: Main issues presented to date (10b) • Preserving the CE marking underlines the need to reinforce a number of obligations the authorities of the Member States already have for the proper implementation of market surveillance anyway. • Its meaning needs to be clarified in the legal texts, notably by stating that it is also addressed to consumers and that it is symbol of an entire economic system guaranteeing safety of products, not just a manufacturer’s declaration. In this respect, a series of information campaigns for the general public should be conducted at European and national level. The Commission would conduct its own campaign and suggest publicity measures to the Member States. It would also review the situation on an annual basis. • Community legal texts are clear about the responsibilities for the protection of the CE marking. Implementation of the relevant provisions requires a body of legislative and administrative measures at national level, which will cover all cases of improper use. Enforcement authorities should also possess the adequate means in this respect. Workshop on Pressure Equipment, Nicosia, CYPRUS: 3, 4 and 5 October 2005

  20. Revision of the New Approach: Main issues presented to date (11) • The document (draft Certif 2005-12) on Community Accreditation Policy: responsibilities and obligations within the European Accreditation System puts together the various elements and conclusions drawn from comments made on previous documents addressing the subject of accreditation policy and provides an overview of the political responsibilities and obligations within the European accreditation system. • It is also intended to clarify further some specific issues relating to the definition of accreditation that were raised at the last meeting of SOGS on 8 July 2005. Workshop on Pressure Equipment, Nicosia, CYPRUS: 3, 4 and 5 October 2005

  21. Revision of the New Approach: Main issues presented to date (12a) • The document (draft Certif 2005-13) on Safeguard Clauses and information procedure puts forward proposals which aim to improve the operational efficiency of the procedure relating to the safeguard clauses. • The proposals in this document are limited to the procedure to follow when a product is assumed not to be in conformity with community requirements or when a compliant product, nevertheless, presents a risk to health and safety. Workshop on Pressure Equipment, Nicosia, CYPRUS: 3, 4 and 5 October 2005

  22. Revision of the New Approach: Main issues presented to date (12b) • Therefore, this document does not cover the procedure concerning incorrect application and/or shortcomings in the harmonized standards. • Attached to this document are: • draft of the procedures to apply (Annex 1), and • draft of a flowchart of the procedure in Annex 1, part I (Annex 2). Workshop on Pressure Equipment, Nicosia, CYPRUS: 3, 4 and 5 October 2005

  23. Revision of the New Approach: Where are we heading? • Almost all CERTIF documents prepared and presented to SOGS. • A consolidated document will then be drawn up integrating all the results of this work, for the November 2005 meeting of SOGS. • Commission shall prescribe way forward: New Horizontal Directive (?), amending all existing New/Global Approach Directives (?), Directive on Accreditation (?)……... • For now, whilst keeping an extremely “vigilant eye”, we’ll have to liaise with each national SOGS representative, discuss within our Expert Group and…………….. wait and see! Workshop on Pressure Equipment, Nicosia, CYPRUS: 3, 4 and 5 October 2005

  24. Revision of the New Approach: PED related “NA revision” proposals (1) • (draft Certif 2005-1) on adapting the quality assurance modules after the introduction of ISO 9001:2000 – Article 10 and ANNEXES II & III; • (draft Certif 2005-2) on the EC Declaration of Conformity (DoC) – ANNEX VII; • (draft Certif 2005-3) on the Designation of notified bodies (Part 1) – common requirements for notified bodies – Article 12 & ANNEX IV; • (draft Certif 2005-4) on the Designation of notified bodies (Part 2) – common requirements for authorities and bodies involved in the assessment, designation and monitoring of notified bodies – Legal/Administrative; • (draft Certif 2005-5) on the Development of the European Infrastructure for Accreditation - Legal/Administrative; • (draft Certif 2005-6) on Accreditation in support of designation of notified bodies - Legal/Administrative; Workshop on Pressure Equipment, Nicosia, CYPRUS: 3, 4 and 5 October 2005

  25. Revision of the New Approach: PED related “NA revision” proposals (2) • (draft Certif 2005-7) on a Community framework for Market Surveillance – Articles 2, 8, 16 & 18; • (draft Certif 2005-8) on Creating a network of Notified Bodies - Administrative; • (draft Certif 2005-9) on Common understanding of basic notions in technical harmonisation – Article 1; • (draft Certif 2005-11) on The Role and Significance of the CE Marking – Articles 5, 15 & 16; • (draft Certif 2005-12) on Community Accreditation Policy: responsibilities and obligations within the European Accreditation System - Legal/Administrative; • (draft Certif 2005-13) on Safeguard Clauses and information procedure – Articles 8, 16, 17 and 18. Workshop on Pressure Equipment, Nicosia, CYPRUS: 3, 4 and 5 October 2005

  26. Thank You For further information, please contact: Ing. Anthony Camilleri Head – Consumer and Industrial Goods Directorate Malta Standards Authority 2nd. Floor, Evans Building, Merchants Street, Valletta. Tel: (00356) 2125 5545; Fax: (00356) 2124 2406; e-mail:anthony.camilleri@msa.org.mt Useful Web-site: http://www.msa.org.mt “We can forgive a child who is afraid of the dark; the real tragedy of life is when adults are afraid of the light.” PLATO (ca. 400 B.C.) Workshop on Pressure Equipment, Nicosia, CYPRUS: 3, 4 and 5 October 2005

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