European Federation of Clinical Chemistry and Laboratory Medicine has been accepted as an Observer member of the General Assembly




EA Liaison Report – January 2008 
 

    • The new role for EA in the European Infrastructure for Conformity Assessment

The European Commission draft legislation is still being examined in detail by the WG of the European Council and in the Parliament.  Recent information received tend to confirm that the text could be approved in the Parliament before summer. 
 

    • The EA Development Plan

The draft EA Development Plan was presented to the General Assembly at the meeting held in May 2007 in Sofia. The General Assembly welcomed the Plan and decided to establish 3 project groups to further elaborate on 3 topics, identified as key topics for the future of EA, in line with the proposed development plan:

  • project group 1: Review of the general structure of EA. Convenor Hanseric Holmqvist (SWEDAC)
  • project group 2: Strengthening the EA Secretariat and related issues. Convenor Vagn Andersen (DANAK)
  • project group 3: Needs and ways of financing EA. Convenor Paul Stennett (UKAS).

At the last meeting in November, the 3 Project Teams submitted their first proposals to the General Assembly. Comments were invited from the Members and it was agreed to set up a meeting of the conveners and co-conveners of the project teams to come up with a single, comprehensive proposal for consideration at an extraordinary meeting of the General Assembly planned to take place in April 2008. The meeting of the Project Teams will he held in Paris on February 15 2008.

In parallel the five sub-project groups of the EA Development Project which were set up to prepare EA for its future role as foreseen by the European Commission draft legislation, continue to progress their work according to the agreed timeline. It is worth noting in particular that a Best Practice Guide on Communications with the National Regulators has been published for use by the EA ABs in developing or maintaining closer relations with their national authorities. Besides, the first draft of a horizontal guidance for assessment of notified bodies has been circulated for comments until March 7th.  
 

  • EA membership

IARM, the accreditation institute of the Former Yugoslav Republic of Macedonia was accepted as a full member by the General Assembly at the meeting held in November 2007 in Nicosia (Cyprus).

EA now has 35 full AB members and 17 contracts of cooperation with accreditation bodies from non EU/EFTA countries which are distributed as follows:

  • 6 ABs from economies of Europe, Russia and Ukraine
  • 3 ABs from economies of the Mediterranean region
  • 8 ABs from economies in the Americas, Africa and Asia.

 
 

    • Elections

Vagn Andersen from DANAK (Denmark) was elected Chairman of the Communications and Publications Committee at the General Assembly in Nicosia. Vagn is also convener of the Project Group on information and knowledge database of the EA development project. 
 

    • Relations with stakeholders and liaison activities

EA has been approached by a number of stakeholder organisations over the last weeks: ECN in the field of breast cancer, GFSI in the field of food stuff products, the Friend of the Sea in the field of sustainable fishereies and aquaculture, EURALARM in the field of security of buildings and persons, EURADOS in the field of ionising radiation, but also UNECE, the UN Economic Committee for Europe… EFCC, the European Federation of Clinical Chemistry and Laboratory Medicine has been accepted as an Observer member of the General Assembly. A project of a cooperation agreement with CEN is in progress. In the meantime, EA is developing an information brochure on accreditation for the National Authorities of the Mediterranean economies, through a contract with CEN for the Commission.

Serving stakeholder and society expectations remains one of the main objectives of EA, this is why and given the increasing number of organisations that have contacted EA recently, the Executive decided to set out a policy to support such a development.

The Chair and Vice Chair of EA continue to develop close relations with ILAC, IAF and the regional cooperation bodies by attending their General Assembly meetings on a regular basis. It is worth noting that such initiatives are always very well received; the EA members also express appreciation of the move and involvement from the EA officers in support of the EA strategic agenda.

The Chair and Vice Chair of EA, with support of T.Hauge (NA, Norway), convener of the Project Group in charge of the relations with the European Commission, are also much involved in strengthening relations with the services of the Commission. EA was formally invited to attend the last SOGS meeting in October 2007 and the Inter Service meeting of the Commission in December 2007. In both cases, presentations were made to the participants which were very well received, EA being committed to demonstrate its willingness to serve European Regulators and meet the society expectations for a reliable and fair trade in Europe and with the economies in the neighbourhood. 
 

A procedure for liaison activities will be soon distributed for voting. It will apply to liaison persons appointed by the Committees for a given mandate when representing EA in meetings of partner organisations. 
 

    • New work items

At its last meeting in November, the General Assembly agreed on a new work item for the Certification Committee to draft a guidance on the use of ISO TS 22003 in combination with ISO/IEC 17021 for accreditation in the field of food safety management certification, focusing on scoping issues. 
 

The General Assembly also welcomed the draft of a top level document on accreditation of flexible scopes, prepared by the “Box”1 of the Executive Committee. The proposed principles aim to enhance visibility on the market and enable comparison of scopes of various accredited bodies. CABs would have an additional responsibility in managing the related information within agreed boundaries. The draft is now out for comments and the General Assembly agreed that the technical Committees could start initial work to look at any sector specific supplement to be attached to the main document 
 

    • Committees reports

 
 

The Inspection Committee (IC)

The IC set up a task force group to elaborate on requirements and criteria for evaluating independence of “Type A” inspection bodies. A first draft was discussed at the IC meeting in September 2007 and should be finalised for a wider consultation in EA at the next meeting of the Committee in February 2008. The Committee is also involved in the drafting of a guidance for accreditation of inspection and laboratory activities on the scene-of-crime, jointly with ENFSI, the European Network of Forensic Institutes. A joint ILAC/IAF initiative has started also in the field and EA is willing to share the results already achieved at the European level. 
 

The Certification Committee (CC)

The drafting of a guidance on combined audits in the field of management systems is progressing. A first draft was circulated within the CC and will be discussed at the next meeting in February 2008.

A final document should then be ready for distribution for comments in EA. A new revision of EA-6/03 EA Guidance for Accreditation of Verifiers under EU/ETS directive is also being carried out to align with publication of the directive new requirements in Europe. 
 

The Laboratory Committee (LC)

Publication of documents prepared by the Laboratory Committee that do not necessarily fall under the existing classification, clarification of expectations of stakeholder organizations represented in the Committee and review of the work program for the next years will be on the agenda for the next meeting in March 2008.

The draft guidance on scopes of medical laboratories prepared by the Committee is now ready for distribution for comments in EA. 
 

The Multilateral Agreement Committee (MAC)

The MAC started a pilot project to evaluate a risk-based approach to enhance the peer evaluation process. Three EA AB’s of different sizes and range of activities will be evaluated in 2008 according to the proposed principles, the objective being also to dimension the changes to be made in the process.

The Committee continues to work on the EA MLA coverage along the agreed lines. The General Assembly indeed, resolved in May 2007 to have a single MLA based on compliance with ISO/IEC 17011, with a technical scope structured in tiers.

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    European Federation of Clinical Chemistry and Laboratory Medicine has been accepted as an Observer member of the General Assembly

    EA Liaison Report – January 2008 
     

      • The new role for EA in the European Infrastructure for Conformity Assessment

    The European Commission draft legislation is still being examined in detail by the WG of the European Council and in the Parliament.  Recent information received tend to confirm that the text could be approved in the Parliament before summer. 
     

      • The EA Development Plan

    The draft EA Development Plan was presented to the General Assembly at the meeting held in May 2007 in Sofia. The General Assembly welcomed the Plan and decided to establish 3 project groups to further elaborate on 3 topics, identified as key topics for the future of EA, in line with the proposed development plan:

    • project group 1: Review of the general structure of EA. Convenor Hanseric Holmqvist (SWEDAC)
    • project group 2: Strengthening the EA Secretariat and related issues. Convenor Vagn Andersen (DANAK)
    • project group 3: Needs and ways of financing EA. Convenor Paul Stennett (UKAS).

    At the last meeting in November, the 3 Project Teams submitted their first proposals to the General Assembly. Comments were invited from the Members and it was agreed to set up a meeting of the conveners and co-conveners of the project teams to come up with a single, comprehensive proposal for consideration at an extraordinary meeting of the General Assembly planned to take place in April 2008. The meeting of the Project Teams will he held in Paris on February 15 2008.

    In parallel the five sub-project groups of the EA Development Project which were set up to prepare EA for its future role as foreseen by the European Commission draft legislation, continue to progress their work according to the agreed timeline. It is worth noting in particular that a Best Practice Guide on Communications with the National Regulators has been published for use by the EA ABs in developing or maintaining closer relations with their national authorities. Besides, the first draft of a horizontal guidance for assessment of notified bodies has been circulated for comments until March 7th.  
     

    • EA membership

    IARM, the accreditation institute of the Former Yugoslav Republic of Macedonia was accepted as a full member by the General Assembly at the meeting held in November 2007 in Nicosia (Cyprus).

    EA now has 35 full AB members and 17 contracts of cooperation with accreditation bodies from non EU/EFTA countries which are distributed as follows:

    • 6 ABs from economies of Europe, Russia and Ukraine
    • 3 ABs from economies of the Mediterranean region
    • 8 ABs from economies in the Americas, Africa and Asia.

     
     

      • Elections

    Vagn Andersen from DANAK (Denmark) was elected Chairman of the Communications and Publications Committee at the General Assembly in Nicosia. Vagn is also convener of the Project Group on information and knowledge database of the EA development project. 
     

      • Relations with stakeholders and liaison activities

    EA has been approached by a number of stakeholder organisations over the last weeks: ECN in the field of breast cancer, GFSI in the field of food stuff products, the Friend of the Sea in the field of sustainable fishereies and aquaculture, EURALARM in the field of security of buildings and persons, EURADOS in the field of ionising radiation, but also UNECE, the UN Economic Committee for Europe… EFCC, the European Federation of Clinical Chemistry and Laboratory Medicine has been accepted as an Observer member of the General Assembly. A project of a cooperation agreement with CEN is in progress. In the meantime, EA is developing an information brochure on accreditation for the National Authorities of the Mediterranean economies, through a contract with CEN for the Commission.

    Serving stakeholder and society expectations remains one of the main objectives of EA, this is why and given the increasing number of organisations that have contacted EA recently, the Executive decided to set out a policy to support such a development.

    The Chair and Vice Chair of EA continue to develop close relations with ILAC, IAF and the regional cooperation bodies by attending their General Assembly meetings on a regular basis. It is worth noting that such initiatives are always very well received; the EA members also express appreciation of the move and involvement from the EA officers in support of the EA strategic agenda.

    The Chair and Vice Chair of EA, with support of T.Hauge (NA, Norway), convener of the Project Group in charge of the relations with the European Commission, are also much involved in strengthening relations with the services of the Commission. EA was formally invited to attend the last SOGS meeting in October 2007 and the Inter Service meeting of the Commission in December 2007. In both cases, presentations were made to the participants which were very well received, EA being committed to demonstrate its willingness to serve European Regulators and meet the society expectations for a reliable and fair trade in Europe and with the economies in the neighbourhood. 
     

    A procedure for liaison activities will be soon distributed for voting. It will apply to liaison persons appointed by the Committees for a given mandate when representing EA in meetings of partner organisations. 
     

      • New work items

    At its last meeting in November, the General Assembly agreed on a new work item for the Certification Committee to draft a guidance on the use of ISO TS 22003 in combination with ISO/IEC 17021 for accreditation in the field of food safety management certification, focusing on scoping issues. 
     

    The General Assembly also welcomed the draft of a top level document on accreditation of flexible scopes, prepared by the “Box”1 of the Executive Committee. The proposed principles aim to enhance visibility on the market and enable comparison of scopes of various accredited bodies. CABs would have an additional responsibility in managing the related information within agreed boundaries. The draft is now out for comments and the General Assembly agreed that the technical Committees could start initial work to look at any sector specific supplement to be attached to the main document 
     

      • Committees reports

     
     

    The Inspection Committee (IC)

    The IC set up a task force group to elaborate on requirements and criteria for evaluating independence of “Type A” inspection bodies. A first draft was discussed at the IC meeting in September 2007 and should be finalised for a wider consultation in EA at the next meeting of the Committee in February 2008. The Committee is also involved in the drafting of a guidance for accreditation of inspection and laboratory activities on the scene-of-crime, jointly with ENFSI, the European Network of Forensic Institutes. A joint ILAC/IAF initiative has started also in the field and EA is willing to share the results already achieved at the European level. 
     

    The Certification Committee (CC)

    The drafting of a guidance on combined audits in the field of management systems is progressing. A first draft was circulated within the CC and will be discussed at the next meeting in February 2008.

    A final document should then be ready for distribution for comments in EA. A new revision of EA-6/03 EA Guidance for Accreditation of Verifiers under EU/ETS directive is also being carried out to align with publication of the directive new requirements in Europe. 
     

    The Laboratory Committee (LC)

    Publication of documents prepared by the Laboratory Committee that do not necessarily fall under the existing classification, clarification of expectations of stakeholder organizations represented in the Committee and review of the work program for the next years will be on the agenda for the next meeting in March 2008.

    The draft guidance on scopes of medical laboratories prepared by the Committee is now ready for distribution for comments in EA. 
     

    The Multilateral Agreement Committee (MAC)

    The MAC started a pilot project to evaluate a risk-based approach to enhance the peer evaluation process. Three EA AB’s of different sizes and range of activities will be evaluated in 2008 according to the proposed principles, the objective being also to dimension the changes to be made in the process.

    The Committee continues to work on the EA MLA coverage along the agreed lines. The General Assembly indeed, resolved in May 2007 to have a single MLA based on compliance with ISO/IEC 17011, with a technical scope structured in tiers.