EA provides a high level of service for the benefit of the European economy, the European Commission and EFTA, the European industry, governments and citizens. All interested parties and stakeholders are involved in the EA activities. They can and do contribute to the EA work through membership in the EA Advisory Board, committees and working groups.
In compliance with the Regulation 765/2008, EA members:
- Shall develop accreditation as a service of general interest with a public authority status as the last level of control of conformity assessment services in the voluntary and regulated fields;
- Shall operate at the national level upon suitable mandate of the governments, in full independence and impartiality, on a non-profit-distributing and non-competitive basis;
- Are fully accountable to accreditation stakeholders and their structure does not allow for predominant interests to take control.
EA has been appointed by the European Commission to manage the official European accreditation
infrastructure. This became effective on 1 April 2009 when the Guidelines for Cooperation between the European Commission (EC), EFTA, EA and the competent national authorities were signed. These Guidelines set out the principles and objectives for the cooperation between these bodies and the EA, and provide criteria for the effective and timely implementation of the reinforced role of EA.
The appointment of EA to manage the European accreditation infrastructure follows the adoption of Regulation (EC) no 765/2008 by the European Parliament and the European Council on 9 July 2008 which established a legal framework for accreditation in the EU member states. This regulation came into effect from 1st January 2010.
The formal relationship between EA and the European Commission is further elaborated in a Framework Partnership Agreement (FPA - Part 1 and Part 2) that was signed by EA and the European Commission on 24 June 2014 for a new 4-years period 2014-2017. The purpose of the FPA is to define the respective roles and responsibilities of the European Commission and EA in implementing their partnership. It further establishes the means for specific grant agreements that may be signed under the framework agreement that relate to grants for an action and operating grants.
A similar FPA was signed specifically with EFTA.
At the operational level, the development of relations between EA and the European authorities is based on:
- Communication processes and channels being established with the EC Directorates and other bodies (coordinating committees);
- Participation in the meetings of the EC Inter-Service Steering Group for Accreditation;
- EA's participation in the meetings of the Expert Group on the Internal Market for Products (former Senior Offcial Group for Standardisation and Conformity Assessment).
EA has been appointed by the European Commission to manage the official European accreditation infrastructure. This became effective on 1 April 2009 when the Guidelines for Cooperation between the European Commission (EC), EFTA, EA and the competent national authorities were signed. These Guidelines set out the principles and objectives for the cooperation between these bodies and the
EA, and provide criteria for the effective and timely implementation of the reinforced role of EA.
The appointment of EA to manage the European accreditation infrastructure follows the adoption of Regulation (EC) no 765/2008 by the European Parliament and the European Council on 9 July 2008
which established a legal framework for accreditation in the EU member states. This regulation came into effect from 1st January 2010.
The formal relationship between EA and the European Commission is further elaborated in a Framework Partnership Agreement3 (FPA - Part 1 and Part 2) that was signed by EA and the European Commission on 24 June 2014 for a new 4-years period 2014-2017. The purpose of the FPA is to define the respective roles and responsibilities of the European Commission and EA in implementing their partnership. It further establishes the means for specific grant agreements that may be signed under the framework agreement that relate to grants for an action and operating grants.
A similar FPA was signed specifically with EFTA.
At the operational level, the EA Chairman, Vice-Chairman and Executive Secretary are the official contact persons for the EC. Other contact persons can be appointed by the EA Executive Committee for specific cooperation projects with the EC.
The main communication channel is EC DG GROW, which has an observer within the EA
Advisory Board, Multilateral Agreement Council and Horizontal Harmonisation Committee. The EC is also invited to attend the EA General Assembly meetings.
EA maintains close relationships and active discussions with the EC through:
- Communication processes and channels being established with the EC Directorates
and other bodies (coordinating committees)
- Participation in the meetings of the EC Inter-Service Steering Group for Accreditation
- EA's participation in the meetings of the Expert Group on the Internal Market for
Products (former Senior Offcial Group for Standardisation and Conformity Assessment)
Regulation (EC) 765/2008 makes EA’s relations with the EC even closer. Specific cooperation projects are notably developed with DGs Climate Action (CLIMA), Transport, Justice, Health and Consumers (SANCO), Justice and Agriculture.
ECIBC (European Commission Initiative on Breast Cancer)
ECIBC (European Commission Initiative on Breast Cancer) is a patient-centred initiative aiming to improve and harmonize breast cancer care in Europe. ECIBC develops a European quality assurance scheme for breast cancer services supported by accreditation and referring to high-quality, evidence-based guidelines.
EA is actively contributing through an EA working group led by ACCREDIA, the Italian national accreditation body (NAB), whose members are:
- Franco Gattafoni (Accredia, the Italian NAB), Project Manager
- Isabel de la Villa (ENAC, the Spanish NAB),
- Henrik Jørgensen Lykkegaard (DANAK, the Danish NAB),
- Trpe Ristoski (IARM, the Macedonian NAB),
- Tuija Sinervo (FINAS, the Finnish NAB),
The EA activities are monitored by a Steering Group chaired by Jan van der Poel (RvA, the Dutch NAB).
The European QA scheme is a collection of requirements and indicators. Its implementation guarantees that compliant breast cancer services can offer to users (women, patients and carers) top quality and most updated procedures for breast cancer screening and care. The requirements focus on the person’s needs and are based on the most updated evidence-based guidelines.The European QA scheme Scope describes in detail the interventions and services covered, the quality dimensions and future implementation according to the European legislation for accreditation. After its piloting, the European QA scheme will be available to all interested breast cancer services (hospitals, clinics, diagnostic centres, etc.) worldwide.
The breast cancer services, underpinned by accreditation, will be published as soon as they will implement the European QA scheme.
The ECIBC Concept Document has been updated and is now published. The document describes ECIBC's background, general goal, specific objectives and expected benefits and includes information on on-going activities.
For further information: http://ecibc.jrc.ec.europa.eu/home
EA has been developing relationships with a number of stakeholder organisations over the years. The objective is firstly to establish confidence in accordance with the EA policy for relations with stakeholders, and and secondly to allow parties interested in accreditation to put their views forward to EA.
It is important to highlight the considerable contribution that representatives from the various stakeholder groups make to the work of EA. They participate in all the EA technical committees.
According to Regulation (EC) 765/2008, EA is required to consult and interact with its stakeholders in a more efficient and transparent way. The EA Advisory Board shall be “the appropriate structure to ensure the effective and balanced involvement of all interested parties”, particularly to manage the increasing number of bodies wising to become EA stakeholders.
As a result, EA has adopted a policy for relations with stakeholders (EA-1/15: EA Policy for Relations with Stakeholders) which defines the conditions and procedures for constructive and transparent co-operation between EA and its stakeholders. According to this policy, a distinct ‘Recognised Stakeholder’ status with associated rights and obligations is granted to organisations that wish to become more directly involved in EA’s associative life and have a particular institutional interest in contributing to EA’s technical activities.
Recognised Stakeholders must be organisations or bodies, either private or public, having a distinct European or international role (in this latter case, having predominantly a proactive contribution to European social and economic matters) and bearing a clear interest in accreditation activities. Associations, in particular, must have a significant membership from the EU and EFTA Member States.
Applications for the recognized stakeholder status shall be sent to the EA Secretariat in order to be reviewed by the EA Executive Committee. The decisions made by the latter are then submitted to the EA Advisory Board for support, before their final endorsement by the EA General Assembly.
Private and public entities represented in the EAAB are treated as Recognised Stakeholders of right. If desired by the concerned entity, such treatment is maintained even after completion of the tenure in the Board. They include:
- EA, EURACHEM, EUROLAB, EURAMET and CEOC (MoU signed in January 2005)
- EURAMET (MoU signed in June 2005)
- WELMEC - European Cooperation in Legal Metrology (MoU signed in May 2009)
The organisations listed below are now formally part of the EA Recognised Stakeholders. Since a new agreement has been signed, any MoU previously signed between the organisation and EA is now terminated.
- E3S - European Sensory Science Society
- EDQM - European Directorate for the Quality of Medicines
- EFAC – European Federation of Associations of Certification Bodies
- EFLM – European Federation of Clinical Chemistry and Laboratory Medicine
- EFNDT - European Federation for Non-Destructive Testing
- EGOLF – European Group of Organisations for Fire Testing, Inspection and Certification
- ENFSI - European Network of Forensic Science Institutes
- EOCC – European Organic Certifiers Council
- EOQ – European Organization for Quality (The Recognised Stakeholder agreement supersedes the MoU 17 March 2009)
- EPPO – European and Mediterranean Plant Protection Organization
- ERA – European Railway Agency
- ETICS - European Testing Inspection and Certification System
- EWF – European Federation for Welding, Joining and Cutting
- FAMI-QS - the Quality and Safety System for Specialty Feed Ingredients and their Mixtures
- GLOBALG.A.P. - the worldwide standard that assures Good Agricultural Practice
- IFIA - International Federation of Inspection Agencies
- IIOC - Independent International Organisation for Certification
- IQNet - International Certification Network
- PEFC - Programme for the Endorsement of Forest Certification Schemes
Sector schemes are requirements developped by e.g. an industry or retail sector for products or services produced or traded. The requirements may be based on international standards or other
normative documents developed by the sector.
In the field of conformity assessment, a sector scheme is most often a scheme developed by an industrial sector such as food, aeronautics, automotive, telecommunications or sustainable development. It is often a vertical scheme that covers all the chain from production or manufacturing to “accreditation”, through certification. In most cases, a sector scheme is based on an international generic standard used for certification that is adapted to the specific technical requirements for the industrial sector. In the field of food, there would be specific requirements related to hygiene or safety; in the field of health, there would be specific requirements related to health care; etc.
Recognising that the market sometimes requires accreditation of conformity assessment bodies to conform to the special requirements set out in sector schemes, EA-1/22: EA Policy for Conformity Assessment Schemes by EA accreditation bodu Members is aimed at underpinning cooperation and mutual confidence with scheme owners.
This policy provides for the conditions and process under which scheme owners can have their schemes evaluated by EA and, if successfully evaluated, used for accreditation by EA NABs. In short, schemes can be used for accreditation by EA NABs when scheme owners:
- Do not establish requirements other than those established in ISO/IEC 17011 for the accreditation bodies and the relevant standards used by EA to establish its MLA scopes for conformity assessment bodies;
- Do not have any role in the assessment and recognition of conformity assessment bodies.
In accordance with EA-1/22, any scheme owner applying for having its scheme evaluated by EA in view of its accreditation by EA national accreditation bodies (NABs) shall contact the NAB in the country where the scheme is most used. This so-called “home AB” (hAB) will perform analysis of the scheme and report the outcome of it to the EA Secretariat. A 30-day call for comments will be launched among EA Members in order to confirm the scheme’s evaluation by the hAB. In case of divergent opinions, a consensus shall be found between the disagreeing NABs, the hAB and the scheme owner. When a consensus is reached, the scheme can be used for accreditation by EA NABs which will be kept informed by the EA Secretariat.
EA is a recognised regional cooperation body of ILAC and IAF. It means that the EA MLA is recognized by both organisations and covered by their respective arrangements. In application of EA policy, IAF and ILAC are considered as Observers and may send delegates to the EA General Assembly meetings. As a basic rule for its operations, EA does not duplicate any work that is undertaken at the international level provided it does not conflict with EA rules or policies.
EA is willing to develop and maintain close and active relationships with its sister organisations in the other regions of the world. MoUs have been signed with APLAC, the Asian Pacific Laboratory Accreditation Cooperation, PAC, the Pacific Accreditation Cooperation, and IAAC, the InterAmerican Accreditation Cooperation aiming to facilitate cross participation in training activities or Proficiency Testing programmes in particular. Similar contacts are developing with SADCA, the Southern African Development Community in Accreditation, ARAC, the Arab Accreditation and AFRAC, the African Accreditation Cooperation. EA regularly attends GA meetings of these organisations. In turn, representatives of the other regional cooperations are invited to the meetings of the EA General Assembly and technical committees.
Conformity assessment market
National accreditation bodies (NABs) are the competent bodies to handle complaints from conformity assessment bodies (CABs), from customers to CABs or from third parties.
A CAB can be accredited by the NAB after due assessment and demonstration of full compliance with applicable standards, including the requirements for handling complaints.
CABs should raise technical issues directly to their NAB which has full competencies to give them the most appropriate solutions according to the requirements in the relevant standard. Besides, as an EA member, the NAB is quite able to provide harmonized positions which are relevant at the European level.
EA handling complaints from accredited CABs and third parties?
The main task for EA regarding complaints concerning NABs and accredited CABs is to monitor that EA-member accreditation bodies / EA MLA signatories are handling complaints in accordance with the policies and procedures established by the NABs. These procedures shall be based on the requirements in international standards, which the NAB has to comply with.
EA may receive complaints from Accreditation Bodies, accredited CABs or third parties, which have been dealt with by the NAB and the complainant is requesting EA to investigate the issue.
When EA receives a complaint, it will be dealt with according to the procedure described in Supplement 3 to EA1-17 EA Procedure for the investigation and resolution of Complaints and Appeals, part 2.3.
The main objective for EA is to examine if the NAB has handled the complaint according to its procedure. If the complaint has not been presented to NAB, then EA will respond to the complainant that the complaint should be presented to the relevant NAB.
If EA decides to handle the complaint according to the procedure in Supplement 3 to EA-1/17 then:
- The complainant will be informed that EA has requested the NAB to provide a report on its handling of the complaint and that the complainant will be informed on the result of investigation initiated by EA.
- The relevant NAB will be requested to provide a report on how the subject of the complaint has been dealt with and the outcome of the complaint handling process.
When the report from the NAB is received, EA will decide if the complaint has been handled by the NAB in accordance with the applicable requirements in the standards and EA documents.
In case the NAB has handled the complaint correctly, the complainant will be informed that the NAB has followed its procedure and that the complaint handling process is in line with the criteria the NAB shall meet and that EA has no means to interfere further in the issue.
If the complaint handling process of the NAB does not meet the requirements in the standards and EA documents, the decision of the EA Executive Committee will be to recommend the NAB to re-consider the complaint and to invite the complainant to request the NAB to re-open the complaint. The EA Executive Committee may further request the EA MAC Council to impose specific peer evaluation activities for the NAB or to focus specifically on the complaint handling process during the regular peer evaluation of the NAB.
In cases where members do not meet the requirements in the standard, the issue for EA is to ensure that the NAB within a set time line provides documentation for complying with the membership criteria and if not, inform the member of the consequences of continued violation of the membership criteria.