Highlights of the 46th EA General Assembly – 25-26 November 2020 – Part II

Due to the COVID-19 pandemic, the 46^th European co-operation for Accreditation (EA) General Assembly (GA) on 25-26^th November 2020 took place entirely online.

The General Assembly gathered over 80 participants from 50 National Accreditation Bodies (NABs), the EU Commission, EFTA, Recognized Stakeholders, and the EA Advisory Board through participation of its Chairperson.

 

EU legislations and the applicable standard for accreditation

Many European legislations, using accreditation as the means to demonstrate the competence of Conformity Assessment Bodies (CABs), do not define the standard applicable for the accreditation of the CABs, even if EA is involved in the development of several legislations regarding accreditation and conformity assessment issues and effectively proposes to name the applicable harmonized standard for accreditation.

In order to enhance harmonisation at European level the General Assembly resolved the following:

When the European regulator publishes a new legislation which provides accreditation of CABs without defining the applicable standard for accreditation, the EA Horizontal Harmonization Committee (HHC) shall define the standard to be used for accreditation, in consultation with the Technical Committees ,if needed. National Accreditation Bodies (NABs) should not accredit CABs regarding such a new European legislation until the HHC has defined the applicable harmonized standard.

 

ERA ECM accreditation and certification schemes

EA has been supporting ERA since many years regarding the implementation of several EU legislations in the railway sector. It concerns for instance the implementation of Regulation (EU) No 402/2013 on the common safety method for risk evaluation and assessment, in the drafting on the Technical Document on Requirements for Conformity Assessment Bodies (CABs) seeking notification according to Directive (EU) 2016/797 on the interoperability of the rail system and finally, in the implementation of Regulation (EU) 445/2011 on a system of certification of entities in charge of maintenance for freight wagons, with a specific focus on Article 10 and related provisions for providing information on accredited bodies.

Recently, a Task Force Group, established by the EA Executive Committee, has been working with ERA which developed accreditation and certifications chemes regarding Implementing Regulation (EU) 2019/779 on a system of certification of entities in charge of maintenance of vehicles.

To foster harmonisation in the implementation of Regulation (EU) 2019/779, the General Assembly endorsed the mandatory application of the following documents published by the EU Agency for Railways (ERA):

• ECM Sectorial scheme for accreditation 1172-002 V3-1
• ECM Certification Scheme 1172-003 V1.1.

A workshop will be organized by EA on 8 December 2020 for its members; it will bring together experts from EA and ERA, the EU Agency for Railways. Technical issues, including points related to managing transition to the new versions of the ECM schemes, will be discussed with a view to ensure harmonization while meeting the Regulator’s needs.

Transition to ISO/IEC 17025:2017

The ILAC General Assembly decided that the end of the transition period, which was initially adopted as part of the ILAC Resolution GA 20.15 in November 2016, shall be extended from 30 November 2020 to 1 June 2021 to ensure that all laboratories are able to transition to the new standard despite or taking account of the restrictions imposed as a result of the global COVID-19 pandemic.

The General Assembly endorsed the ILAC resolution in order to be applicable in EA.

 

Application of IAF/ILAC documents

The EA General Assembly adopted:

– IAF MD 8:2020 Application of ISO/IEC 17011:2017 in the Field of Medical Device Quality Management Systems (ISO 13485);

– ILAC P10:07/2020 ILAC Policy on Metrological Traceability of Measurement Results;

– ILAC P14:09/2020 ILAC Policy for Measurement Uncertainty in Calibration;

– ILAC P15:05/2020 Application of ISO/IEC 17020:2012 for the Accreditation of Inspection Bodies;

as mandatory documents for all EA Members.

 

It was confirmed that the next 2021 General Assembly will be held remotely on 20-21 May 2021.

All the resolutions adopted at the 46th EA General Assembly are available here.