Unconfirmed-minutes-of-the-22nd-General-Assembly by asafwewe

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									                                                                       EA/GA(08)M22_draft Rev 00

                                                          nd
                        Unconfirmed minutes of the 22 General Assembly
                                  Estoril, 18-19 November 2008


1.      Opening of the meeting

The Chair welcomed the delegates, especially the delegates from GAC, the accreditation body of
Georgia who were invited to attend the meeting for the first time as observers.

He reminded the members that, according to the rules, nominations for the Chair of the Horizontal
Harmonization Committee (HHC) and for a member of the Financial Oversight Committee (FOC) could
be accepted, by the Secretariat, until the lunch break of the first day of the General Assembly.
The Chair also informed the delegates that reports from several stakeholder organisations would be
received, with pleasure, during the final part of the meeting.

The Chair then communicated to the GA that apologies had been received from EURAMET and IANZ
and he invited a roll call.

Finally, he indicated that, pursuant to the procedure proposed by the EX for the decision-making proc-
ess at GA meetings, a draft list of resolutions would be made available at lunch time for the members’
consideration. Voting on the resolutions, as formal endorsement of the decisions taken during the
meeting and reported in the present minutes, would take place at the very end of the meeting on the
second day.

The host, L. Cortez (LC), gave a welcome speech in the name of IPAC and of the Portuguese compe-
tent National Authorities. He also informed about the practical and social arrangements for the GA.

The Chair thanked LC and opened the meeting.


2.      Approval of the Agenda

The Chair invited comments on the proposed Agenda for the meeting.

He indicated that item 7.1.1 c) “Development of the EA Secretariat and related issues”, that was ini-
tially tabled for decision, would eventually be tabled for discussion only, but with a view to get the GA
approval on the proposed way forward.
He added that the EX suggested that item 10.3 “MoU with APLAC”, that was tabled for information,
would eventually be discussed with a view to make a decision on giving mandate to the EX to achieve
the signing process, provided the GA can agree on the proposed draft MoU.
In response to a suggestion by CEOC, it was agreed that the issue of the controversial paper called
“What is accreditation?”, developed within ILAC and IAF, would be addressed under item 10 “Interna-
tional issues”.

With these comments and changes, the agenda was approved.

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3.      Review and approval of the minutes of the 21 meeting of the EA General Assembly in
        Tallinn

The Chair reported that the Secretariat had received only one comment from EAK requesting to cor-
rect a spelling mistake in the name and title of the Vice Secretary of the Ministry for Economic Affairs
and Communication and Chair of EAK Accreditation Board who opened the meeting in Tallinn.
He added that an additional change would be introduced under item 13.3 “Report of EURACHEM”, to
clarify that a short oral report had been given to the GA.
The minutes were finally approved.
4.      Communications

4.1     Information to the members on the procedure proposed by the Executive Committee for
        decision making at GA meetings and others

As indicated at the opening of the meeting, the Chair reported that the Executive Committee was
submitting a procedure for the decision-making process at GA meetings for approval with immediate
implementation at this very meeting.

There was no objection and the procedure was approved.


5.      Report from the Chairman

The Chair made a review of the report which had been distributed with the papers for the meeting,
highlighting the main issues and pointing especially to those being raised and discussed during the
GA. He invited the participants to look at the activity report provided by the Secretariat in order to get
additional, more detailed, information on the developments within the Technical Committees.

Moreover, the Chair pointed out that the draft budget 2009 that had been distributed for the meeting,
was based on an increase in the costs charged by RvA of 2,5%. However, RvA has later informed the
Secretariat after publication of the document that the forecasted increase should be changed to 4%.
As a consequence, a revised version of the draft budget taking account of the revised rate will be dis-
tributed and presented to the GA during the meeting.

The Chair commented on the document put forward to the GA for information, that outlines an esti-
mate of the costs for EA becoming an employer in Paris. The estimate covers the costs for transfer, to
an external service provider, of the accomplishments related to the management of the staff (monthly
pay slips, quarterly payroll taxes, annual declarations, etc.), as well to the keeping and administration
of accounts (accounting software, periodic checks, preparation of financial statements, etc), such ser-
vices being presently partly provided by COFRAC. The Chair underlined that the above will contribute
to enhancing the independence and effectiveness of operation of EA, besides enabling saving the 20
% non deductible VAT on COFRAC labour costs (approx. 40.000 €).
The Chair clarified that the provided estimate only shows the above additional external costs (approx.
10.000 € per year) but doesn’t take into account the aspects of legal liability related to EA becoming
an employer and hiring the present staff of the Central Secretariat in Paris, including financial risks.
This is the reason why the Executive decided to investigate further the additional implications of such
a move, the objective being to complete the study for further consideration at its first meeting in Janu-
ary 2009.

The Chair added that the draft budget 2009 presented does not take into account any financial contri-
bution that might be received from the European Commission, that, as developed by Project Team 3
led by P. Stennett, would allow for the reimbursement of the costs incurred by the EA officers and
other liaison persons actively involved in the EA and international works, as well for partially covering
other costs related to the EA activities.

As a conclusion of his report, the Chair expressed his thanks to the full membership and stakeholder
partners, paying tribute also to the high dedication, involvement and enthusiasm showed by the Secre-
tariat teams, both in Paris and Utrecht.


6.      Operational issues

6.1     Document approval

6.1.1   Ratification of ballots completed since the last General Assembly meeting

The Chair reviewed briefly the summary of the results that had been distributed with the papers for the
meeting. This did not raise any comment and the results of the ballots were ratified.




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6.1.2   MoU with CEN/CENELEC

The draft of a MoU between EA and CEN/CENELEC had been distributed with the papers for the
meeting. The Chair informed the meeting that the MoU will be signed by EA on the one side and by
                                                                                                   st
CEN and CENELEC jointly on the other side, at an event that is planned to take place on January 21
2009 in Brussels. There was no objection and the MoU was approved..

6.1.3   MoU with EEPCA

The Chair reported that the draft MoU, which was distributed with the papers for the meeting, would be
signed in the evening, during the gala dinner organised by IPAC. He also indicated that the delegate
from EEPCA, Valberto Baggio, Chairman of EEPCA, would make a short presentation on the second
day of the GA. There was no objection and the MoU was approved.

6.2     Termination of the membership status of DATECH

The Chair reminded the meeting that some time ago, EA was informed that DATECH had merged into
TGA Gmbh, the activities of DATECH being incorporated into TGA. This merge shows a positive move
in the establishment of a unified AB in Germany and was received with appreciation by EA.
The change should now be reflected formally in the EA membership and related EA publications.
The GA approved.


7.      Strategic and policy issues

7.1     EA Development Plan for the years 2007-2013

7.1.1   Implementation of the Project Teams proposals endorsed at the previous meetings of
        the General Assembly: progress report

a)      Revision of the EA Articles of Association and Rules of Procedure

The Chair introduced the agenda item, stating that the submitted documents were the result of the
work of an internal TFG of the EX and they were not necessarily reflecting a common position in the
Committee.
He emphasized that the revision of the Articles and Rules of Procedure represent a key strategic
stake, as both documents have a major impact on the organisation and operation of EA.
Besides aligning with the new role of EA set forth by Regulation (EC) 756/2008, the proposed revision
should aim to improve the EA structure and EA working practices and turn the Association into a more
professional one, enhancing its visibility outside and demonstrating its capabilities to properly manage
its new role and fulfil the new obligations and responsibilities as set forth by the above Regulation and
the related Guidelines for cooperation between EA, the EC, EFTA and the competent National Au-
thorities.

The Chair then invited the delegates to feedback their comments to the Secretariat as soon as possi-
ble, as the plans are for the EX to review all the comments and revise the draft at its upcoming meet-
ing at the end of January 2009, for a final draft to be, possibly, submitted to the GA for approval in May
2009.

Moreover the Chair informed that the EX had been considering the possibility to hold an Extraordinary
GA that would be concentrated in full on discussing the new drafts of the AoA and RoP, suggested
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dates being April 20 or 21 2009, possibly in Brussels.

The EFTA representative, T.N. Thomassen, kindly indicated that EFTA would be pleased to host the
extraordinary GA meeting, provided the facilities are available in EFTA at that time, which he promised
to check and confirm as soon as possible.
The Chair thanked Mr. Thomassen and promised to come back to him as soon as the extraordinary
meeting would have been confirmed.




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Concluding his introduction, besides renewing the invitation for written contributions, the Chair invited
general, immediate, comments from the delegates (if any), with special reference to both the main
principles underlying the proposed revision and the proposed revision process.

There were several comments.

N. Van Laethem (NvL) suggested that the EX should organise a round of comments by email and
supported that holding an EGA would be likely to create difficulties and extra burden on most of the
members in terms of availability and budget.

L. Tikkanen (LTik) suggested to start the discussions immediately at the present meeting, without de-
lay or additional intermediary comments, with a view to avoid an extra meeting of the GA and not to
retard the approval process.

T. Hauge (TH) welcomed a preliminary discussion at the meeting, he invited the EX to come up with a
final position on the AoA and RoP before the GA can discuss usefully and did not support the organi-
sation of an EGA.

M. Stadler (MS) insisted that stakeholders have a basic interest in the way EA is to be organised and
operated. He added that time for consultation within every constituency within the EA Advisory Board
shall be allocated for a fruitful input to be given and would appreciate that the GA allows the EAAB to
have a detailed discussion on the proposals, before a final decision is made.

The EA Chair confirmed that, as is the rule normally, all stakeholders and observers would be very
welcome to put forward their comments during the development process as well.

B. Rivera (BR) thanked the Executive for the work they had achieved. ENAC received the drafts with
appreciation even if it is clear that in their current status, the drafts have not been considered in detail
yet by the Executive Committee. She questioned the proposed process and supported to avoid the
EGA, based on the assumption that the EX will be fully capable to manage all the comments raised.

H. Holmqvist pointed out that, as identified by Project Team 1, the change in the Articles and Rules of
Procedure is also stirred by the fact that a number of EA documents have been updated in the mean-
time or are being updated. He added that overall there is nothing in the proposed changes which
should be seen as really critical.

V. Andersen, member of the TFG of the EX in charge of the revision, thanked the members intervened
so far for their positive comments to the proposals put forward. He advocated that the ultimate objec-
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tive should be to adopt final drafts at the 23 meeting of the GA in May 2009.

J. McMillan (J.McM) commented that the proposals, as they stand, would create huge difficulties for
the EC when it would come to negotiating with EA, as it would be much harder to discuss with a full
Committee rather than with one or two individuals duly mandated.

He recommended that EA should seek to achieve the appropriate balance between the powers of the
EX and those of the Chair. Putting all the responsibilities, including for the day-to-day operations, on a
Committee may not be the best solution to improve efficiency and effectiveness in the end.

D. Pierre (DP) supported J.McM’s statement and added that the proposal would also create difficulties
for the operation of the Secretariat itself. Having the whole Executive responsible for managing the
Secretariat would not work efficiently in practice.

J. McMillan added that the point is not to challenge the overall organisation but the new distribution of
roles. The proposed Articles and RoP create new relationships between the Chair and the EX in op-
erational terms that are questionable. That the Chair appears to be there only to chair the GA meet-
ings does not make much sense and there is no point in having the Chair acting as if he/she were
outside EA.




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BR objected that EA ABs do experience such an organisation as most of them are managed by Com-
mittees. She recognized that responsibilities might need to be better distributed but the competence of
the EX as a whole needs certainly to be enhanced. She supported VA position to go for a formal 60
day comment period as soon as possible, leaving the EX the authority to decide on how to deal with
the comments. An EGA would have to be set up only in case the comments cannot be properly ac-
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commodated within the EX. In that case, another approach could be to plan a 3 day in the GA meet-
ing in May.

Finally the Chair concluded that, apparently and save further confirmation, there is no need to organ-
ize an EGA, since this hypothesis didn’t find the support of the members, and reiterated his request for
preliminary inputs and comments from the GA in writing by the end of the year for consideration at the
EX at its meeting in January 2009. New drafts will then be put out for a formal 60-day comment period
immediately after the meeting. In addition to the welcome contribution from stakeholders who will be
consulted during the comment period, the EAAB as such will have the opportunity to provide further
input until during its meeting in April 2009.

b)      Setting up of the Horizontal Harmonisation Committee: approval of Terms of Reference

The Chair reported that, after consideration of the proposed draft, the EX had come up with a revised
version which was projected. A brief discussion followed.

In response to H. Schaub (HS), the Chair clarified that drafting horizontal guidance would be a task for
the new HHC as it is proposed.

For NvL, liaison between the HHC and the Technical Committees should be emphasized in the pro-
posed ToR.

For HP Ischi (HPI) the proposed ToR may create some risk of overlapping between the HCC and the
Technical Committees. The issue of interface would need to be addressed.

Regarding the relations with the MAC Council, the Chair commented that the MAC is expected to con-
centrate on the peer evaluation process, procedures and related issues.

M. Nitsche (MN) questioned the process for endorsement of the ToR and supported that more time
should be given for comments including from stakeholders. He supported that the proposal should go
out for the regular comment period.
In response, the Chair noted that accepting this proposal would lead to postpone the establishment of
the Committee contrarily to what foreboded by the majority of the members.

NvL supported to endorse the preliminary ToR to enable the Committee to start to operate and, in
particular, to start with the review of its ToR. This will give time for introducing possible amendments
and the possibility to all members and stakeholders to contribute.

For T. Facklam, the HHC and the MAC will have, respectively, to establish the requirements the first
and to ensure their observance the second. For the Chair, the HHC is not expected to elaborate the
rules, which are already given by ISO/IEC 17011 and pertinent ILAC, IAF and EA application docu-
ments. Rather the HHC should develop a common understanding in order to foster harmonisation. On
its part, MAC is expected mainly to verify and ascertain that harmonisation really happens.

HS welcomed the setting of the HHC as the appropriate forum where feedback from stakeholders and
findings from peer evaluations will be able to be discussed and valued.

Finally, the Chair recommended to the GA to approve the ToR submitted by the EX, which would have
to be reinforced in terms of interaction with the other Committees. As first task, the HHC will have to
review and refine its ToR as soon as it is established.

With this clarification, the ToR were approved.
Action HHC




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c)      Development of the EA Secretariat

The Chair introduced the agenda item by reminding the issues for consideration. Work has been un-
dertaken to analyze the possibility and opportunities for EA to register as an employer in France (at
the Prefecture of Paris), hiring the present staff of the central Secretariat (3 persons, Martine Blum,
Bénédicte Ziemann and Frédérique Laudinet) by simply transferring the working contracts from
COFRAC to EA, and acquiring from external service providers the services for the management of the
personnel and keeping and administration of accounts. In addition, implications related to liability is-
sues will be considered.
The Chair indicated that the EX is seeking the GA agreement on the proposed way forward, namely
completing the study addressing all aspects related to EA becoming an employer, not only in eco-
nomical and organizational terms, but also in legal terms, this being based on the assumption that the
contract with RvA will not change in the near future.
This was confirmed by J. Van der Poel (JvdP) who indicated that the situation with M. Zaffe – the MAC
Secretary – is different from the situation with the Secretariat team in Paris and does not justify to
change anything to the current arrangements.

The Chair added that, according to the terms of the contract with COFRAC, a decision shall be made
at the next GA meeting in May 2009. Hence the need to get all the background and relevant informa-
tion in advance for the GA to be able to make a decision.
The Chair pointed out that an option could be that the GA decides to seek a renewal of the contract for
another 2-year time, under the same conditions, to have more time to assume sound and well in-
formed decisions.

DP commented. He reminded the meeting that, initially, the GA decided to go for a 4-year contract,
                              st
which started on January 1 2006. He supported that the GA would not collect any additional informa-
tion from an extension of the contract. Negotiating for another 2-year time would create additional
burden for COFRAC in particular with regard to the uncertainty related to the situation where the staff
would have to be taken back in the AB. DP confirmed that COFRAC remains ready to host the secre-
tariat until the end of 2009.

Finally, the GA accepted the proposal from the Chair. The EX will complete the study concerning the
option of EA employer for a decision to be made at the meeting in May 2009.
Action EX

7.1.2   EA policy for relations with stakeholders

The Chair commented on the present draft of the policy document.

He reminded that the objective of the policy is to facilitate and optimise participation of stakeholders in
EA activities, pursuant to the obligations stemming from the Regulation (EC) 765/2008 and the Coop-
eration Guidelines.

In response to HS’s comment, the Chair confirmed that the previous draft had been circulated to all
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EA stakeholder organisations in the formal comment round which closed on August 8 2008.

MS indicated that the current draft was being commented within the EAAB and he requested the
EAAB Vice Chairs to make sure that all comments raised by their constituencies be sent to the Secre-
tariat in due time.
G. Jacques confirmed that in the CAB college, all the comments received at the time of the previous
comment period had been consolidated and transferred to EA. He also pointed out that the policy will
have an impact on other EA and EAAB documents, which would have to be reviewed accordingly.

A. Safarik-Pstrosz added that, as mentioned at the EAAB meeting, rights and obligations associated
with Stakeholder member status would have to be defined and made known as soon as possible, for
the discussions on the draft policy to be complete and consistent.

M. Golze emphasized that stakeholder participation in the EA Technical Committees and WGs shall
be secured and possibly reinforced as it has proved to be a real strength for EA in its operations over
the past years.



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DP recommended to harmonize the texts between the policy and other draft documents currently un-
der development, such as the AoA and RoP. In response, the Chair assured that this will be done as
son as the policy will be approved.

As a last comment, NvL requested that in future draft papers having been changed be circulated both
in a clean and track change versions, which is normally the case with other draft documents issued by
EA Committees. The request was noted.

7.1.3   Strengthening the role of the EAAB: revision to the terms of reference

The Chair reported that the terms of reference of the EAAB were under revision, as a result, in particu-
lar, of Regulation 765/2008 and the role it gives to the Board.

For HS the draft should be circulated to all stakeholder organisations for comments, and not just to the
EAAB members. The Chair responded that terms of reference are an internal document which, as
such, will only be considered at the EAAB and EA levels. MS indicated that he would still welcome any
comments but to the EAAB relevant college, to enable the EAAB colleges to make sure to accommo-
date all the comments received.
The objective is that a final version of ToR be submitted for approval at the next EAAB meeting in April
2009 and for endorsement by the GA in May 2009.

The Chair commented that both the policy for relations with stakeholders and the EAAB ToR support
the strengthening of the relations between EA and the EAAB and the reinforcement of EA in its role as
foreseen by the new Regulation.

J. McM insisted that the Regulation does not require that EA consult every single stakeholder organi-
sation. The EAAB was designed to be the organ representing stakeholders interested in the EA activi-
ties. How representation is working in practice should be addressed within the EAAB because each
college is responsible for ensuring a balanced participation of their constituency, and organising their
own internal consultation mechanism.

The Chair reiterated that the objective is to involve as many stakeholders as possible in the EA activi-
ties, with the appropriate rules and processes.

In response to a question, MS indicated that the rules and procedure for appointment of the college
members are in the RoP of the EAAB, which specify that it is a clear and full responsibility of the col-
leges themselves to manage appointment and balanced representation of interests. By revising the
ToR, the EAAB aims to reinforce and make the process more efficient and transparent. Colleges have
a responsibility towards their constituencies, which has to be reinforced since the EAAB is to operate
as “the appropriate structure to ensure the effective and balanced involvement of all interested parties”
as referred to in Article 4, par. 11 of Regulation (EC) 765/2008.

7.2     EA Development Project: progress of the activities

The Chair invited the EA Vice Chair G. Talbot (GT) to coordinate the presentations and reporting by
the sub-project groups conveners.

GT made a general introduction saying first that it was worth underlying that real results were coming
out. The reports to be presented would focus on feedback on developments with sub-projects 1, 2 and
5 in particular. GT informed the meeting that SP4’s role had been successfully transferred back to the
EX, where contacts between the EX and the DGs of the EC are developing and organising. SP4 is not
proceeding any further at the moment.

7.2.1 Sub-project 1 “Harmonisation of assessment practices”

M. Malqvist (MM) reported.

The sub-project group is nearing completion of a fruitful learning process.




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As for the Horizontal Guidance for assessment of CABs in view of notification, the related document
has been completed and a final draft has been sent out for a final round of comments which will be
considered at the next meeting of SP1 on December 16-17, 2008.

Regarding the issue of technical competence criteria for assessors, a survey will start after consulta-
tion of SP5 to establish a list of experts on Directives.

Finally, concerning the scope of assessment/accreditation, the document is still under development.

A few issues remain open and they will be considered shortly within the sub-project group at a next
stage.

MM pointed out that the SP members are very grateful to BELAC to have hosted most of the meetings
including the next one that is planned for December. She thanked also the EA members for their sup-
port and confidence and SP members for their valuable input and positive exchange during the meet-
ings.

MM’s report raised comments.

J. McM recommended that the last draft should also be submitted to the national authorities who are
responsible for notification.
MM indicated that the intention is to go through all comments during the December meeting where it
will also be decided how to treat them. The EC will be invited to input after that stage, although it was
assumed in the SP group that the EC had taken advantage of the previous comment rounds to input,
including through the EAAB appointed contact persons.
J. McM replied that the approach for the EC has been to refrain from commenting until a mature
enough draft is available. The point was to identify when the right stage was to input in the appropriate
way. He added that SOGS should also have the opportunity to input the process.
A. Safarik supported the point made adding that EA should indeed present a final draft to the SOGS
but only when there is a consolidated, agreed version available.

GT suggested that, after consolidation of the comments by SP1, a final draft would be provided to the
EC and the EAAB National Authorities college for discussion in the SOGS, the objective being that the
last comments from SOGS would be considered before a very final draft goes out for voting.

J. McM pointed out that his objective is to make sure that all Regulators get duly involved in the com-
ment period and process at the appropriate stage.

GJ added that, as soon as the draft is recognized as mature enough, it should also be sent to the Co-
ordination Groups of Notified Bodies.

MM welcomed the suggestions. She recommended that a clear definition of what the document con-
tains and addresses is needed to avoid any confusing statement to be raised by the various DGs, and
to avoid to go into irrelevant technical details.
Further to MM’s point, J. McM insisted that accreditation has still to be promoted to the Regulators. He
does not expect problems within the EC but in some Member States’ sectoral departments. This is
why there is a need to explain what the framework is and to convince these departments. The widest
consensus on the overall framework is needed.

In response to a question raised by HH, J. McM replied that the point is not to write a document for the
national authorities, the proposed guidance is for the ABs and that is needed. The point is that NA
should see the document because they will use it and it is necessary to ensure they have ownership of
the guidance in the end.

GT noted the point and ensured that an appropriate preface to the guidance would make that very
clear for the Regulators.
Action SP1




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The Chair added that the main issue is to convince the Regulators that EA is competent to perform the
task of duly assessing CABs in view of notification, task that has been and is still carried out by the
Regulators themselves in some Member States.

Finally GT confirmed the process agreed: SP1 will consolidate the comments received by 12 Decem-
ber 2008, revise the draft to be considered in view of the way forward from an EA perspective, forward
the final draft to the EC and EAAB for their comments in 2009, for a final draft to be sent out for voting.
Action SP1

7.2.2   Sub-project 2 “Information and knowledge database”

VA presented a short review of his report which was distributed with the papers for the meeting.

As a preliminary comment, J. McM invited EA to consider in future that Regulation (EC) 765/2008
does not just apply to New Approach Directives but also to other pieces of European sectoral legisla-
tion where reference is made to accreditation and accredited conformity assessment services.

MN commented on recommendation N. 2 about appointment of convenors. He reported that Germany
offered convenors for several areas who are real experts, having accumulated experience with notifi-
cation for more than 20 years. As the German system is changing, it is expected that such experts will
be integrated into the future national accreditation body, thus qualifying for the criteria for convenor-
ship.

GT stated that EA very much welcomes all the experts who may provide useful inputs. However, the
point is that the RoP currently in force provide that convenors of EA WGs shall come from EA member
ABs. GT recognised that there is uncertainty regarding how the RoP will change and what the German
system will look like in future, and concluded that, as discussed also in the EX, it is proposed to con-
tinue with the present rules for convenors.

I. Mikelioniene (IM) asked for flexibility in the requirement to take into account the specific situation of
small ABs who still have limited experience. She suggested not to make it mandatory for such ABs to
take responsibility even for one Directive only. Instead she recommended to encourage ABs willing to
take responsibility for several Directives, to do so.

VA highlighted that the workload may vary a lot from one Directive to another and ensured that the
point would be considered by the EX when making the appointment decision.

K. Tsimillis supported IM’s point and added that for small ABs time will be needed before being able to
take up the role of a convenor.

NvL pointed out that the specific sectoral expertise does not necessarily have to be within the ABs, but
it is the responsibility of the ABs to ensure they have appropriate access to the relevant expertise, as
far as necessary. Furthermore, she clarified that a convenor for a network should not be expected to
be the high level expert but the focal point for the ABs to rely upon and interact with the network. Ex-
perts, contact persons and convenors will have separate roles and should have different profiles.

Finally the GA approved the establishment of an EA network meant to share knowledge and informa-
tion on EU Directives as foreseen in the proposal submitted.

7.2.3   Sub-project 3 “Communications with the National Regulators”

GT reminded the delegates that SP3 produced a Best Practice Guide for Communications between
EA ABs and their National Authorities that was published in summer. As agreed when the document
was endorsed, a benchmarking exercise was started to evaluate the situation in the EA ABs with re-
gard to communications with regulators at national level and use of the Guide. The survey has just
been circulated and responses will be consolidated in the next weeks.

GT invited those members who had not done so to please respond in order to get a picture as com-
plete and informative as possible.




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7.2.4   Sub-project 4 “Relations with the European Commission”

The activities are being dealt directly by the Executive as specified in the introduction to the agenda
item.

7.2.5   Sub-project 5 “Enhancing the peer evaluation process”

Gro Rodland (GR) presented shortly her report which was distributed with the papers for the meeting.

She stated that the SP was grateful for the feedback received which will be considered and taken into
account in the future developments.

For MG, the proposals as they develop will not put extra burden on ABs, which is a very positive ele-
ment for EUROLAB.

MS took the floor to report on the presentation made by SP5 at the last EAAB meeting. He first
thanked GR and Thomas Facklam (TF) for the very good report they presented at the meeting. The
Board very much appreciated the proposals made for the development of the process and is fully con-
fident that the process will serve the purpose and meet the expectations.
He confirmed that, for the NA college, the outcome of the project team constitutes an important step
forward in addressing sectoral requirements and needs.
He further specified that the reporting and decision-making process, as well as KPIs will have to be
further developed.
He concluded stating that the EAAB supported the suggestion to make better use of the expertise
available at Notified Bodies and National Authorities levels, recommending such suggestion to be put
to the SOGS.

Concerning the suggestion to extend the evaluation team composition in order to cover Directives, it
was recognized that it may be difficult to appoint one extra evaluator per Directive, and GR indicated
that sampling would be used, based on appropriate rules and criteria.

J. McM added that, as agreed in the EAAB, the proposals will be submitted to the Accreditation Steer-
ing Committee at a special meeting of the EC services which would be fully dedicated to the presenta-
tion of the peer evaluation process.

GR concluded by saying that in the next stage, SP5 proposals will be put out to the MAC and then to
EA members for comments.

It was agreed that SP5 would have to produce a separate summary of all proposals to be circulated to
the Steering Committee and SOGS, to give a full, understandable presentation of the system for users
who are not familiar with it.
Action SP5

At the end of the above presentations and discussions, the Vice Chair thanked all the conveners for
their report and concluded insisting that a lot of work is still developing, with SPs working very hard.
Coordination issues have been clearly identified and will be covered at the next stage of the project
development.
He confirmed that the GA will be kept informed of progress, indicating that the objective remains that
most of the work should be completed by May 2009. By that time, GT pointed out, a lot of work will
have to continue also within the ABs.

7.3     Regulation (EC) 765/2008 and Decision 768/2008 (EC)

7.3.1   Action plan for issues requiring actions from EA

The list of actions worked out by VA and the EX had been distributed with the papers for the meeting.
As agreed at the GA in May, comments were called and none were received. The Chair reiterated the
invitation to forward comments to the EA Secretariat.




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VA commented that, in the EX, it is assumed that most EA ABs are preparing themselves to imple-
ment provisions of the Regulation. However the EX is interested in receiving feedback on issues which
would be considered as critical by the members or raising difficulties for their implementation at na-
tional level.

7.4     EA’s relations with the European Commission

7.4.1   Draft guidelines for the cooperation between EA, EC, EFTA and competent national
        authorities

The Chair reported informing that a revised version of the Guidelines had been made available (SOGS
N 578 EN REV 2) and distributed to the full members only, in advance of the meeting.
The Chair indicated that, provided the GA can accept the contents of the revised draft Guidelines, the
EX recommended to give a mandate to the EX to approve and to the Chair to sign the Guidelines with
the EC, EFTA and the competent national authorities as soon as possible. He added that the revised
                                                                                     th
document would be submitted to the SOGS at their upcoming meeting on December 4 2008.

J. McM added that all comments received were accommodated. All DG services have been asked to
confirm their agreement, especially the legal service which have already given their green light. How
to manage the signature process is the next issue for discussion and the intention is to invite together
EC, EFTA, EA and the SOGS representatives that will be involved in the signature and to hold the
signing ceremony on the occasion of a next SOGS meeting.
J. McM insisted that the objective in getting agreement on the Guidelines is to lay down the conditions
to be able to work out the Framework Partnership Agreement and set the whole picture for the coop-
eration between EA and the EC. He informed the meeting that he was waiting for the agreement of the
legal service of DG Budget to transfer the funds to EA, as the budget is already there. For that to hap-
pen, the legal basis is needed, that will be given by the partnership agreement, which cannot be de-
veloped until the Guidelines have been signed.

Finally the GA agreed to mandate the EX to approve and the Chair to sign the Guidelines.

7.4.2   EA input to the revision of EMAS

The Chair reported specifying that the draft text of EMAS III had been circulated to the members.
Comments were being collected as a position paper was planned to be prepared by the EX to input
the development in EC DG Environment.
The Chair informed the GA that the EX intends to push EC DG ENV to use the EA MLA in order to
avoid that a parallel peer evaluation system be set up for that particular sector.
Concerning the management of the EMAS peer evaluation process, he indicated that a call for tender
was at a standstill at the moment, as no AB has volunteered so far.

Finally, the GA agreed to progress as proposed by the EX, namely that the EX would consolidate an
EA position and approach DG ENV towards using EA MLA accreditations and relying upon the EA
peer evaluation system. J.McM supported the move.
Action EX

7.4.3   Other relations with the EC Directorates

a)      DG Environment: EA’s involvement in the development of EU/ETS scheme

The Chair indicated that the issue is coordinated at the Executive level by the Vice Chair of EA who is
acting as the liaison between the EX and DG ENV.

GT reported at the meeting. Progress is being made with the scheme. EA is aware that DG ENV is
preparing a Regulation to be put in force by 2013 which represents phase III of the overall program for
ETS. An agreement between all interested parties is needed in advance of that final date.
In the course of the discussions with the EC, EA has been highlighting use of ISO 14065, insisting that
EA is in the best position to help DG ENV, and offered to provide both top level input and technical
input into the drafting of the Regulation.




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GT informed about the proposal from the EX to form a WG made of EA ABs only, and to appoint a
convener who would act as technical focus for the input of EA into the DG ENV work.
He reminded that there is already a WG of the CC that has been dealing with the revision of EA-6/03
EA “Guidance for the Recognition of Verifiers under EU/ETS Directive”, but noted that such WG is
much wider than just the EA ABs, as it involves many stakeholders. The proposed limited member-
ship aims to ensure the EA ABs’ input, stakeholders’ input being ensured through other mechanisms
already active in EA.
To complete the picture, GT added that the aviation sector should be involved within a very short time-
frame.
The plans are that all the documentation should be in place between February and June 2009 such
that the process can start and operate for two years as a free trading period. It implies that EA-6/03
would have to go for further revision in the coming 6 months under the aegis of the Certification Com-
mittee.

The Chair confirmed the EA commitment to input the development of the ETS Regulation in the best
way and concluded by indicating that the point of constitution of the WG and approval of related ToR
would be addressed under item 12.6.1, CC report.

b)      DG Agriculture: use of accreditation in Regulations on Organic Food, Geographical Indications
        and Traditional Specialities Guaranteed

The Chair had attended a meeting with DG AGRI on September 26 2008 and prepared a report which
was distributed with the papers for the meeting. The report did not raise any comment.

c)      DG Health and Consumer protection / DG Enterprise: accreditation/certification scheme for
        breast cancer services in Europe

The Chair reported, confirming that discussions are underway about launching a joint EA/ECN project
for the establishment of a sectoral accreditation / certification scheme for breast cancer screening,
diagnosis and treatment in Europe.
The project is supported by EC DG SANCO and EC DG ENTER and strongly backed by the European
Parliament, so as there are very positive prospects for the development of the activity that could attain
a remarkable size from both technical and economical point of view.
The Chair informed that UKAS and FINAS have indicated to be willing to participate in the work on the
EA side.

As a conclusion, the Chair pointed out that overall relations with the various services of the EC are
developing in a very positive way, thanks to the support of DG ENTER that facilitates contacts and
interactions and, within such DG, thanks to the help of J. McMillan and A. Brewka, in particular.

7.4.4   EA/EC event in June 2009

The Chair reminded the meeting that the ambition is to set up, jointly with the EC, a high profile event
to celebrate the new role of EA.

At present, the EC has to check technical feasibility, including whether there is a possibility for the
event to be hosted within the EC facilities in Brussels.

The Chair indicated that it had been considered to organize the event in connection with the Interna-
                                th
tional Accreditation Day (June 9 ). J.McM commented that the proposal raises two issues that remain
open: 1) concerning the possibility to raise money to support the event and 2) concerning the pro-
posed date, June 2009 not being an appropriate time for such a high profile event, as it will be an elec-
tion time in the European Parliament.

The Chair reported that the EX has discussed the point and would be prepared to consider to move
the date to November 2009 or even to 2010, after the entering into application of the new Regulation,
if more appropriate.

The issue will continue to be discussed with the EC and the GA will be kept informed.




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7.5     Review of co-operations with other stakeholder organisations

The Chair reported that the list that had been distributed for information with the papers for the meet-
ing is the list of all organisations being more or less involved with EA at the moment, with different
roles and to different extents.
He pointed out that the draft EA policy for relations with stakeholders aims also to clarify and formalize
such relations, including membership status and conditions for contributing as a member and taking
part in all technical works.


8.      Elections

8.1     Election of the Chair of the Horizontal Harmonisation Committee

The Chair informed the meeting that the Secretariat had received only one nomination from SWEDAC
nominating M. Malmqvist (MM) to the post. He added that MM had informed the EX that she intends to
step down from the chairmanship of the IC at the end of her current mandate and invited the GA to
proceed with the election.

MM was elected Chair of the HHC unanimously.

She thanked the members for their support and promised that members would be given time to nomi-
nate delegates to the new Committee. She confirmed that the proposed ToR would be reviewed to
accommodate the comments raised by the GA meeting, as a first task of the Committee at its inaugu-
ral meeting.

8.2     Election of one member of the Financial Oversight Committee

The Chair informed the meeting that the Secretariat had received only one nomination from NA for
Torleif Hauge (TH) to replace I. Matsas from ESYD, who resigned from the FOC since no longer with
ESYD.

The GA elected TH unanimously as member of the Financial Oversight Committee with Jan van der
Poe as, Chair and Jiri Ruzicka as other member. TH thanked the GA for the election and committed to
do his best to profitably contribute to the work of the Committee.


9.      Financial issues

9.1     Accounts 2007

9.1.1   Financial audit report

The Chair introduced the point, reminding that the financial audit report had been distributed with the
papers for the meeting. No objections were raised and the report was adopted.

9.1.2   Report by the Financial Oversight Committee

The Chair introduced the point, apologizing for the late distribution of the report that was made avail-
able just before the meeting. The report raises a number of comments and put forward a number of
recommendations that were considered by the Executive at its meeting held the day before.

The Chair reviewed briefly the main points of the report and the responses proposed by the EX.

-       Provision from the reserves to finance development of a Data Base for accredited services;
        the FOC pointed to its recommendation made in its report for the accounts 2006 to re-
        integrate the provision in the reserve, the EA Database for accredited services having been
        completed, and requested that the recommendation be implemented immediately in the ac-
        counts 2007.




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        The EX reconsidered the point and it appeared that the GA made a subsequent decision to al-
        low for use of the provision to further finance development of the facility and of a database for
                                                                      th
        cross frontier activities as reported in the minutes of the 20 meeting in Nicosia (item 7.2.1)
        and reflected in document EA/EX(08)50 submitted at the previous GA meeting in Tallinn. The
        EX accepted however the recommendation and committed to implement it in the accounts for
        2008.

-       Process for closure of accounts and preparation of financial statements and reports; the EX
        recognised that submitting financial reports and audit documents to the GA at its first annual
        meeting would become possible only if EA becomes independent in the management of its
        accounts, this being, by the way, part of the project for the future of the EA Secretariat.

-       Book-keeping in the Secretariat; the EX agreed with the FOC that having the task carried di-
        rectly by the Secretariat would contribute to improve the process but noted that this would
        anyhow require resorting to external consultant services.

-       Procedure for authorization and control of expenditures and preparation of budgets; the Chair
        confirmed that the EX is preparing such procedure, as reported by the FOC. The proposed
        draft will be sent out for comments before the end of 2008 and comments considered at the
        EX meeting in January 2009 for a final draft to be voted as soon as possible. It is also pro-
        posed that rules for travel expenses, as set out by Project Team 3 led by P. Stennett, would
        be adopted jointly.
        In order to be able to improve the process with regard to expenses immediately, not waiting for
        the complete procedure to be published, the Chair prepared a resolution outlining rules to be
        used on an interim basis. The Chair presented the proposed resolution pointing out that the
        present Articles of Association and Rules of Procedure put responsibilities on the EX, Chair
        and Secretary that may overlap or create inconsistency in practice.
        As a very first stem, the intention with the resolution is to clarify the situation and create the
        conditions to improve the process, ensure better transparency but also to meet the insurance
        requirements for the establishment of a dual control on expenses and payments.
        The Chair confirmed that he was not asking for an immediate decision and that the resolution
        would have been submitted to the GA for approval at the end of the meeting.

Then the Chair invited J. van der Poel, Chair of the FOC, to present his report.

JvdP introduced his report by saying that, in its review of the EA accounts, the FOC considered as a
key concern, that EA should aim to bring its finances up to the level expected to be able to take up its
new role.
He stated that the FOC recognised that the book-keeping is made in an appropriate way.
He also underlined that a few recommendations that were reported in previous reports remained un-
answered, which first caused disappointment. However the Committee was pleased to acknowledge
that the EX took it seriously and reacted promptly with positive proposals, as shown in the paper pre-
pared by the EX the day before and distributed to the delegates during the meeting.
On behalf of the FOC, JvdP reiterated that any move to speed up the process for the FOC to be able
to see the documents beforehand would be received with much appreciation and encouraged the EX
to consider to change the chartered accountant from the Netherlands to France.
A response from the EX about this and all of the other open recommendations is requested in a next
stage together with the evaluation of the feasibility to transfer the management of accounts to the Se-
cretariat, eventually through an outsourced supplier.
Action Executive

Regarding the procedure for control of expenditures and preparation of budgets, the FOC recom-
mended that the procedure be implemented as soon as possible.
As for the recommendation N. 5 of the FOC report concerning the accounts 2007 which requests that
the budget for one activity be changed to another only with prior approval by the GA, it was recognised
that the EX should be entitled to take decision of limited impact on the budget. It was also reconfirmed
that any decision implying a significant, critical change would request that the EX consult and inform
the GA in advance.
The Chair pointed out though that, given the present structure of costs, it is unlikely that such a situa-
tion occurs, as the main costs are governed by the contracts with RvA and COFRAC.



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The Chair also added that there is no objection for EA to transfer the administration of accounts to an
external service provider as of 2009, noting that the related costs have been evaluated as a part of the
project for EA becoming more independent but recommended to wait for the decision of the GA on
such issues.

Finally the GA endorsed the report of the FOC together with the responses submitted by the EX and
based on the additional comments raised at the meeting, as reflected in these minutes.

9.1.3   Adoption of the accounts

The FOC noted an uncertainty with the costs to be charged by the financial auditor for his services
concerning the accounts 2007 and recommended to increase the reserves so as to reach an appro-
priate amount not far from half of the annual budget.
The Chair confirmed that the GA would be invited to endorse the proposal to transfer the 2008 ex-
pected result (36.000 € approximately) to the reserves thus approaching the recommended amount:
reserves at 31.12.2007 = 120. 497 + 36.000 (result 2008) + 38.000 (provisions) = 195.000 €.

Finally, and taking all comments made into account, the GA was approved the 2007 accounts.

9.2     Accounts 2008

9.2.1   Forecast at 31.12.2008

The Chair commented briefly the statement of accounts.
Travel costs for the Secretariat have been overestimated as some related activities were not carried
out. It is expected to close with a significant surplus, which, as discussed with the EX, would leave the
possibility to use money for legal advice on the various points raised in the previous discussions (e.g.
EA employer and related issues).

The GA noted the forecast.

9.3     Draft budget for 2009 and fees schedule

A revised version of the budget was distributed at the meeting. The Chair indicated that the draft
budget was revised just before the meeting to reflect the request by RvA to charge costs for the MAC
secretariat based on a 4% increase instead of the 2,5% that was applied in the previous version of the
budget which had been distributed with the papers for the meeting.

The revised budget did not raise any objection and the budget and related fees schedule were ap-
proved.

T. Facklam pointed out that the work program of the MAC may require to use external resources, in
addition to those that members can and are ready to offer and the GA should anticipate the conse-
quences in terms of membership fees for 2010.

The Chair commented that, in the present proposal for 2009, expenses for training activities that have
been allocated will only cover reimbursement of travel and subsistence expenses.

He added that, following the signature of the Cooperation Guidelines, there are good prospects that
EA could receive a substantial financial support from the EC that may also cover compensation of
external resources.
He warned, however, that the final decision for providing financial contribution to EA for 2009, before
the entering into application of the new Regulation and the signature of the Framework Partnership
Agreement, is subject to the approval of EC DG Finances and, in spite of the good willing of DG EN-
TER, surprises cannot be excluded .

9.4     Management of accounts and related administrative issues

Covered by the discussion under item 9.1.2.




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10.     International issues

10.1    EA statement of recognition of equal reliability of attestations of conformity issued un-
        der IAF/ILAC MLA/MRA accreditation

The Vice Chair reported on the proposed statement that had been distributed with the papers for the
meeting.

The proposal results from a number of conversations over the last months making clear that the publi-
cation of the new Regulation created uncertainty about how EA would fit with the ILAC and IAF
MLA/MRA. Moreover, there was a feeling that should EA decide that it would only consider equal reli-
ability from CABs accredited by ABs meeting exactly the same requirements as in EA, it would create
serious problems concerning the position of EA and EA members with respect to ILAC and IAF.
This was discussed with the Executive and the EC and it was confirmed that the EC does not want to
put itself into opposition with ILAC and IAF, putting the existing arrangements into jeopardy. This is the
reason why the Executive drafted the proposed document with the aim to set out a statement of the
EA position with regard to the ILAC/IAF MLA, within the framework of Regulation 765/2008.

The Vice Chair reviewed the draft briefly, highlighting the changes introduced after discussion in the
Executive at the meeting held the day before. He pointed out that the proposal allows a practical tran-
sitional period but, from the principle point of view, the statement provides recognition of equal reliabil-
ity immediately.
The proposed transition applies only to BLAs and CoCs currently in force. Any new applicant for a
CoC or bilateral with EA will have, as from 2010, to comply with the same requirements as an EA sig-
natory would do.

The Chair insisted that it is EA objective to remain committed to fulfil its obligations towards ILAC and
IAF, having however to meet in parallel the expectations from the European interested parties.

R. Robinson (RR) commented on the consequences for the US. The United Sates are in a different
situation compared with Europe, because of the difference in the rules governing competition.
She emphasized that A2LA had made the decision to remain signatory to a bilateral with EA because
it is very important for accredited CABs to work in support of trade to Europe. The possibility to over-
come trade barriers has been enhanced because A2LA has been maintaining such a position for
years. RR expressed distress that none of the ABs in the US would be able to meet the criteria set
forth in Regulation 765/2008 and she asked EA to consider seriously the difficulties accredited bodies
will now face in trading with Europe.

The Chair responded expressing sympathy with the position as stated by RR. He confirmed he shares
the concern and that EA was committed to maintain the good, positive relations with the USA.

G. Rødland (GR) challenged the proposal to introduce a different transition period for non EA mem-
bers that does not apply to the EA members.

T. Dempsey (TD) and BR welcomed the document and supported the reservations raised by GR
about timing.

The Chair clarified that the policy is to try and keep the BLAs in the EA community, and hence to give
them some more time to adjust to the criteria. Even EA members will have difficulties to be in line by
the deadline but this poses a different question as compliance is now a legal requirement.

BR pointed out that the EA Policy for relations with ABs of “third countries” is not aiming to maintain
BLAs except for particular cases only. In response, GT supported that the statement and such policy
should be considered separately.
The statement is there to respond to Regulation 765 whereas the policy, that was prepared in a paral-
lel but disconnected way, is there to define EA relations with ABs of countries not member of EU and
EFTA. He added that the policy started from the position that EA wanted to reinforce the IAF and ILAC
MLA/MRA and reliance on those. The policy is still at an early stage, out for comments until December
9, 2008. The timeframe for developing the two documents is different and for GT, it is important to
keep the two aspects separate.



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The present draft statement addresses the case of existing BLAs as they are now and how they
should be treated. The policy is for consideration of future development with BLAs.
Furthermore, account should be taken of the fact that BLA signatories have been asking for clarifica-
tion for some time. It is the first attempt to give a clear answer to what the EA position is. The transi-
tion can be seen as a move from EA to be fair as it has not been able to give a clear steer earlier,
having in mind that some BLA signatories already comply.

KT asked whether EA really has authority in making such an interpretative statement of a Regulation.
J. McM clarified that the statement shall not be taken as an interpretation because the Regulation
does not address the rules of EA in its relations with outside Europe. The objective is certainly not to
create any problem to CABs in their business but to protect accreditation in Europe so that it remains
the last level of control in the field of conformity assessment. J.McM insisted that the conditions set out
by the Regulation do not apply outside Europe, and application of the new rules does not mean that
Member States would systematically refuse an attestation of conformity from outside Europe.
The Regulation does not in itself create ground for refusing. It can be a reason for doing, but not by
definition.

Further to a comment raised by the delegates from TURKAK, an additional change was introduced in
the draft to address the case where EA can be faced with a request to recognise equal reliability of
ABs in Europe not being EA members but accepted in ILAC and IAF.

Finally the GA endorsed the statement as revised without any other objection, unanimously.

The Chair reiterated that EA would take full account of the situation of the accredited CABs in the US
in the discussions about implementation of the new Regulation and of the policy for relations with ABs
of “third countries”.

10.2    Feedback from Stockholm meetings

The Vice Chair reported, the objective being to keep the GA informed of the discussions that took
place at the open forum in Stockholm, about the future of ILAC and IAF.

Over the year, EA prepared a position paper on the EA view of the way how ILAC and IAF might be
structured and organised in order to enhance the international accreditation infrastructure in a way
complementary to and synergic with the role of regional co-operations. An EA position paper went to
the JCCC and was considered during summer. As a result of that phase the JCCC formed a TFG to
look at all input received and formulate a proposal on how to discuss further the issue within the ILAC
and IAF communities.

As a result of the discussions at the open forum, it appeared that there is still work to be carried out to
reach a consensus on a way forward. Another TFG has been formed within the JCCC to look at this
further in 2009 in order to present to the joint GA in Vancouver proposals for the way ahead.
The TFG formed comprises the Chairs of ILAC and IAF, the Chairs or representatives of each of the
regions, 3 representatives from the stakeholder community, unaffiliated bodies of ILAC and IAF and
the ILAC and IAF Secretaries. The TFG started to look at what activities need to be undertaken at
international level, what activities can or should be done at regional level and compare with the pre-
sent situation. The TFG will meet in early January in Paris. The EA EX was provided with the ques-
tions of the TFG in order to help EA representatives in the TFG to formulate EA’s views during the
process. GT indicated that the EA membership will be involved in the next steps.

The Chair thanked GT for his update and recognised with appreciation that the way discussions are
progressing eventually reflects the EA position and vision as it has been put forward so far.

In response to a question from H. Schaub about the situation, at the ILAC/IAF level, concerning the
issue of “What is accreditable?” the Chair confirmed that a joint communiqué was being published only
regarding the matter of what is covered by the ILAC/ IAF MLA MRA, that basically gives a list of “rec-
ognised” standards, this not being controversial.
The second controversial document on “What is accreditable” will be eventually withdrawn as a joint
communiqué and will be re-published as an internal information document.
He concluded by stating that this compromise solution, although not ideal, may be acceptable.



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10.3    MoU with APLAC

The Chair reminded that both organisations are expected to endorse the proposal before going for the
formal signing. There were a few comments.

In response, it was clarified that the proposed MoU was designed to supplement and complement, not
to undermine the existing regional or international co-operations. It was also indicated that similar
moves were being made towards the other regions, PAC and IAAC.

A. Steinhorst (AS) pointed out that the implementation of such an agreement (with APLAC) will require
additional resources to carry out the work.

HPI supported to have such a MoU provided that the related administration remains at an acceptable
level. But he supported also that EA should speak “louder” at the international level.

The Chair welcomed the comments raised and asked permission from the GA to proceed with the
signing unless critical changes are introduced on the APLAC side.

The GA approved.


11      Status of complaints and appeals

The Chair reviewed briefly the report which was distributed with the papers for the meeting.

Concerning the complaints against DAP, he specified that the Executive had decided first that all
complaints received would be processed simultaneously as they raise the same basic issues and that
a TFG would be appointed to that end. The Chair took the opportunity to invite the participants to ap-
point members to the TFG. Further to a recommendation by the EX, he invited BELAC and IPAC es-
pecially to propose members and thanked NvL and LC in advance for their cooperation.


12      Reports from the Committees

12.1 Report from the EAAB Chair

M. Stadler reported briefly as most of the issues under discussion in the EAAB had been already cov-
ered during the meeting.
He pointed out that the EA policy for relations with stakeholders had been addressed thoroughly at the
last meeting as the key topic, together with the need for and means to reinforcing administrative sup-
port to the Board.
As agreed at the previous meeting in April, a draft list of conclusions is now issued immediately after
the Board meetings. The draft list for the last meeting had been distributed with the papers for the GA.

The Board Chair concluded by saying that the complete report from the EAAB would be made avail-
able to the participants after the GA meeting.

12.2    Report from the MLA Council Chair

GR presented her report highlighting a few points.

12.2.1 Revision of the ToR of the MAC

The revision of the ToR of the MAC should be undertaken as a new work item that was in fact stirred
up by the setting up of the HHC. As requested and advised by the Executive, the MAC will consider an
initial proposal put forward by the EX.

The GA endorsed the new work item.




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12.2.2 Contracts of cooperation with ABs of Egypt, Kazakhstan and Montenegro

The recommendations put forward by the MAC did not raise any objection.

As a result, ATCG (Montenegro) entered into a contract of cooperation with EA that was signed at the
gala dinner during the GA meeting in Estoril on November 18, 2008.

The contract with the AB of Egypt would be signed as soon as the two existing ABs have merged.

Secretary note: The contract with NCA (Kazakhstan) was signed by exchange of mails in December 2008.

12.3    Report from the CPC Chair

VA gave a brief presentation of the CPC report distributed with the papers for the meeting.

As a general remark, JvdP expressed his satisfaction with the new “Welcome kit” developed by the
CPC and welcomed the document as a very nice tool and successful achievement on how to make
accreditation more “attractive”.

12.3.1 Approval of the revised ToR of the CPC

The revised ToR were approved without specific discussions.

12.3.2 Endorsement of ILAC/IAF documents and revision of EA-2/12

The Chair introduced the discussion. There were few comments.

For DP, there is no need for a TFG to look at how EA shall endorse IAF/ILAF documents as EA-2/12
already provides for the process to deal with special situations where there are conflicts.

For TD, clarification is needed to know the process in EA for when ILAC, IAF documents are to be
revised. Furthermore, it is unclear whether the intention is that each IAF, ILAF publications should be
submitted to the GA for voting in future.

The Chair pointed out that the proposed TFG will be responsible for the revision of EA- 2/12 and vot-
ing is only part of the revision mandate. Process for endorsement of ILAC / IAF documents remains
open and will be further developed by the TFG.

It was reminded that revision of EA-2/12 was also considered to address the case of the EA members
who are not members of ILAC or IAF and do no have a chance to vote on ILAC and IAF documents.
Besides, there is feedback from the other regions that, unlike EA, some of them decide not to endorse
ILAC/IAF documents automatically. These discrepancies between EA’s process and the other regions’
processes created a need for reviewing EA-2/12.

TD insisted that 2/12 provides that EA reserves the right to reject a document that would conflict with
the EA or European rules, therefore voting is already there when a conflict has been detected.

For HPI, it is important to have a mechanism to secure EA’s input in the drafting processes of ILAC
and IAF.

Finally the Chair concluded by saying that the point of voting would have to be further investigated by
the TFG. More important is that TC chairs are alerted and, in case they detect a problem, they should
feedback to the EX, as already stipulated in EA-2/12.

It was agreed that the revision will start as a new working item in care of a TFG, based on the revised
version of its mandate.




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12.4    Report from the LC Chair

In the absence of C. Waddington, the Chair of the LC, Martina Bednarova (MaB) gave a short presen-
tation of the activities of the Committee. Her presentation is available with the papers for the meeting.

A question was raised about use of ISO/IEC 15195 which is not a harmonised standard for accredita-
tion. MaB clarified that the WG Health Care recommended to process accreditation in the field of point
of care testing against ISO 15189 in combination with ISO 15195. But the recommendation is still un-
der discussion in the LC.

A. Steinhorst (convener of LC WG Health Care) pointed out that there is an ILAC resolution that pro-
vides for use ISO 15195 in combination with ISO/IEC 17025 for accreditation of reference laboratories.
He indicated that the recommendation’s only objective was to align the EA practice with ILAC’s and
noted that use of non harmonised standards is also recommended in other fields.

J.McM confirmed that CEN is in the process of harmonising a number of standards to be used for
accreditation. The Chair added that EA sent a list to the EC to make sure the mandate given to CEN
for harmonisation be complete and reflect the current practices in accreditation.

For AS, in the field concerned, reference to the general accreditation standard is sufficient. State-of-
the-art standards develop and are applicable at sectoral level and need not to be harmonised, the
number of standards concerned being very large and increasing constantly.

HPI suggested that the LC should set up a workshop on how to assess flexible scope, which was re-
ceived with appreciation.

The Chair thanked M. Bednarova for her presentation.

12.5    Report from the IC Chair

MM presented the IC report that was distributed with the papers for the meeting.

She informed the delegates that she intended to consult the IC members to decide whether the next
meeting should be maintained as the proposed agenda is not very substantial and may not justify to
gather all members and generate related use of resources.
The GA supported MM’s proposal to seek advice from the IC in that matter.

MM had informed the meeting that she intended to step down as Chair of the IC as a result of her
election as Chair of the HHC, earlier in the meeting. She concluded her report by saying that she
really appreciated the great time she spent with the IC and thanked the members for their support.

AS thanked MM for the input provided to the drafting of the guidance on use of conformity assessment
standards for bodies performing crime scene Investigation. He indicated that the reason why Germany
eventually voted against the draft was not because of the quality of the guidance itself, but because of
the clause stating that decisions on the independence type should be made on a case-by-case basis,
which raises a question as to how this can work in practice.

MM commented that the type describes the level of independence but says nothing about competence
or impartiality. She pointed out that depending on the various national legal frameworks, there will be
different situations and the final provision reflects the best consensus that could be reached. She also
invited AS (Germany) to be more flexible with regard to the type as revision of ISO/IEC 17020 may
introduce changes in this matter.

J. Beaumont welcomed and supported the proposed approach in the guidance as a very good solution
because of the different situations in force in the Member States, giving flexibility and the possibility to
accredit those who wish to be accredited for the standard they choose.




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As MM had just indicated she intended to terminate her mandate as Chair of the IC, TD suggested
that the EX should elaborate on the future of the IC without delay. In TD’s view, it might be appropriate
to revisit the need for maintaining the IC itself. MM supported that the IC should be maintain at least in
the short term for EA to follow on and input the revision process of ISO/IEC 17020.

Finally the Chair commented that the point raised by AS concerning the guidance needed clarification.
As for the future of the IC, he supported to ensure continuity. It is the Committee’s responsibility to
look at its future and revisit its mandate if necessary.

The GA recognised the high quality of the results achieved by the IC under MM’s chairmanship and
congratulated her for her successful mandate.

12.6    Report from the CC Chair

L. Cortez, Vice Chair of the CC presented the CC report on behalf of N. Müller, the Chair who could
not attend the GA. The presentation did not raise any comment or request for clarification.

The GA received the report with appreciation.


13      Cooperation with international organisations

13.1    Report from ILAC
13.2    Report from IAF

The ILAC and IAF Chairs, Daniel Pierre (DP) and Thomas Facklam (TF), presented together a joint
report of ILAC and IAF activities.

Concerning the discussions about the future of ILAC and IAF, VA indicated that it was agreed in
Stockholm that the draft ToR would be submitted for comments. DP responded that the main objective
is that every ILAC and IAF member be aware of the proposed work program. He confirmed that the
ToR of the Joint TFG would be made available for information, expressing the wish that additional
comments be avoided in order to avoid the whole process be compromised.

For IAF, TF informed the GA that elections would take place in 2009. He indicated that his term as
Chair of IAF would terminate and invited EA to consider putting forward nominations.

VA supported that EA should input and use the work about to the IAF MLA scope and related issues
such as the IAF MLA framework agreement or the possibility given to the CBs to use the MLA mark for
IAF endorsed schemes. These principles should be formally incorporated in the IAF rules which will
create a challenge for the regions, reason why EA should ensure an input.
The comment was noted.

The Chair thanked the Chairs of ILAC and IAF for their report which was received by the GA with
much appreciation.


14      Cooperation with regional accreditation organisations

14.1    Reports from regional organisations

14.1.1 APLAC and IAAC

R. Robinson (RR) gave a short presentation on behalf of APLAC and IAAC. The reports are published
on the intranet sub-directory for the meeting.
In response to a question, RR clarified that accreditation of medical laboratories against ISO 15189 is
included in the IAAC MLA for testing, whereas APLAC developed a separate MLA for that field.
The Chair thanked R. Robinson for her presentation. On behalf of the EA GA, he welcomed and sup-
ported the steps taken by IAAC to take over the role and responsibility of a region within the interna-
tional framework.



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15      Cooperation with CAB organisations and stakeholders

15.1    Reports

The GA received with appreciation the reports given by the representatives of CEOC, EFCC, EEPCA,
EUROLAB, WELMEC, EFTA, EURACHEM which are published on the intranet sub-directory for the
meeting. The following are to be noted, in particular.

The Chair of WELMEC reported that work is developing on the Measurement Instrument Directive and
guides for assessment in view of notification.
She pointed out that WELMEC identified a special link with EA as the main reason for entering into a
MoU with EA whose draft is being discussed, with a view to be signed at the EA GA in May 2009.

The Chair of EEPCA, Valberto Baggio (VB), highlighted a few headlines about EEPCA mission and
activities and concluded by saying that the signing of the MoU with EA represents a very positive
move forward and thanked the GA for their support.


16      Any other business

No other business was tabled for discussion.


17      Summary and confirmation of resolutions

The list of resolutions was reviewed and submitted to the meeting for final formal endorsement.

All resolutions were approved unanimously, except for the following:

-       Resolution 06 (setting up of a network for directives): approved with one abstention from Ger-
        many.
-       Resolution 11 (financial accounts for 2007): approved with one abstention from Germany.
-       Resolution 13 (administration of EA accounts): withdrawn.
-       Resolution 24 (signature of the MoU with APLAC): approved with two abstentions from France
        and Portugal.

The final version of the list of resolutions is attached to these minutes as integral part of them.


18      Next meetings of the General Assembly

Dates and places of the next meetings were confirmed as follows:

-       27-28 May 2009 in Luxembourg;
-       25-26 November 2009 in Belgium (later on fixed in the city of Bruges);

The following invitations already announced were also confirmed:

-       May 2010 in Bern (Switzerland);
-       May 2011 in Berlin (Germany).

Finally, the GA received with appreciation the invitation from ATCG to host the GA meeting on No-
vember 2010 in Montenegro;


Closure

The traditional ceremony took place marking the transfer of the “EA spirit” to the EA delegate repre-
senting the AB hosting the next GA meeting, in this case ILNAS the accreditation body of Luxem-
bourg.



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Jean-Marie Reiff, as representative of ILNAS, received the symbol of the spirit from Leopoldo Cortez
Director of IPAC and made a short presentation of anticipated welcome.

The Chair expressed once more the EA’s gratitude to IPAC and L. Cortez for the excellent organiza-
tion of the meeting and related social events and extended his thanks to all the IPAC staff.

He then thanked the staff of the EA Secretariat and the members of the EA Executive Committee and
of all the EA’s Committees, Working Groups and Task Forces for their dedication to EA and its activi-
ties and all the participants to the Assembly for their positive and valuable contribution to the discus-
sion.

He concluded trusting that everybody would recognize the outstanding progresses made by EA in
consolidating its technical and political role and expressed his satisfaction for the fact, thanks to the
collaboration of the GA, he managed to close on time, despite a busy agenda.




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