CELEX: 
Language: en
Date: 2021-02-16
Title: COMMISSION DELEGATED DIRECTIVE (EU) .../… amending Annex III to Directive 2014/90/EU of the European Parliament and of the Council on marine equipment as regards the applicable standard for laboratories used by conformity assessment bodies for marine equipment

EXPLANATORY MEMORANDUM
            
            
               1.CONTEXT OF THE DELEGATED ACT
            
            
               Directive 2014/90/EU of the European Parliament and of the Council of 23 July 2014 on marine equipment and repealing Council Directive 96/98/EC (hereafter called ‘the Directive’) provides that “The Commission shall be empowered to adopt delegated acts in accordance with Article 37 in order to update the references to standards, as referred to in Annex III, when new standards become available”.
            
            
               Annex III of the Directive requires conformity assessment bodies acting as notified bodies for marine equipment to ensure that testing laboratories used for conformity assessment purposes meet the requirements of standard EN ISO/IEC 17025.
            
            
               EN ISO/IEC 17025 enables laboratories to demonstrate that they operate competently and generate valid results, thereby promoting confidence in their work.
            
            
               The last version of EN ISO/IEC 17025 was published in 2005 and, since then, market conditions and technology have changed. Therefore a new version of the standard was published by the International Standardisation Organization (ISO) and the International Electrotechnical Commission (IEC) in 2017.
            
            
               According to ISO, the most substantive changes are as follows :
            
            
               ·The scope has been revised to cover all laboratory activities, including testing, calibration and the sampling associated with subsequent calibration and testing.
            
            
               ·A new structure has been adopted to align the standard with the other existing ISO/IEC conformity assessment standards such as the ISO/IEC 17000 series on conformity assessment.
            
            
               ·The process approach now matches that of newer standards such as ISO 9001 (quality management), ISO 15189 (quality of medical laboratories) and the ISO/IEC 17000 series (standards for conformity assessment activities), putting the emphasis on the results of a process instead of the detailed description of its tasks and steps.
            
            
               ·The standard has a stronger focus on information technologies. In recognition of the fact that hard-copy manuals, records and reports are slowly being phased out in favour of electronic versions, it incorporates the use of computer systems, electronic records and the production of electronic results and reports.
            
            
               ·A new section has been added introducing the concept of risk-based thinking and describes the commonalities with the new version of ISO 9001:2015, Quality management systems – Requirements.
            
            
               ·The terminology has been updated. Examples include changes to the International Vocabulary of Metrology (VIM) and alignment with ISO/IEC terminology, which has a set of common terms and definitions for all standards dedicated to conformity assessment.
            
            
               This third edition of the standard (EN ISO/IEC 17025:2017) cancels and replaces the second edition (EN ISO/IEC 17025:2005), and the reference to the standard in the Directive should therefore be updated accordingly.
            
            
               Taking into account the limited scope of the changes proposed, the Commission considers that a notification of the transposition measures by the Member States in accordance with the Joint Political Declaration of 28 September 2011 of Member States and the Commission on explanatory documents explaining the relationship between the components of the Directive and the corresponding parts of national transposition instruments will not be necessary.
            
            
               2.CONSULTATIONS PRIOR TO THE ADOPTION OF THE ACT
            
            
               Stakeholders were consulted in the framework of a meeting of the Marine Equipment Working Group (E02653), which comprises the Member State competent authorities and stakeholder representatives, on 3 November 2020.
            
            
               In addition, the general public will be consulted through the forthcoming standard 4-week public consultation on Delegated/Implementing Acts.
            
            
               3.LEGAL ELEMENTS OF THE DELEGATED ACT
            
         
         
            
               The Delegated Act replaces the reference to EN ISO/IEC 17025:2005 in Annex III of the Directive with a reference to the revised standard, EN ISO/IEC 17025:2017.
            
            
               COMMISSION DELEGATED DIRECTIVE (EU) .../…
            
            
               of XXX
            
            
               amending Annex III to Directive 2014/90/EU of the European Parliament and of the Council on marine equipment as regards the applicable standard for laboratories used by conformity assessment bodies for marine equipment 
               
            
               (Text with EEA relevance)
            
            
               THE EUROPEAN COMMISSION,
            
            
               Having regard to the Treaty on the Functioning of the European Union,
            
            
               Having regard to Directive 2014/90/EU of the European Parliament and of the Council of 23 July 2014 on marine equipment and repealing Council Directive 96/98/EC
                  1
               , and in particular Article 36 thereof,
            
            
               Whereas:
            
            
               (1)Directive 2014/90/EU requires that conformity assessment bodies are to comply with the requirements laid down in Annex III in order to become notified bodies.
            
            
               (2)Conformity assessment bodies are to ensure that testing laboratories used for conformity assessment purposes meet the requirements of standard EN ISO/IEC 17025.
            
            
               (3)Standard EN ISO/IEC 17025 specifies the general requirements for the competence, impartiality and consistent operation of laboratories.
            
            
               (4)In 2017, ISO published a revision to standard EN ISO/IEC 17025 and has withdrawn the previous version of the standard, which could still be used during a three-year long transition period ending in November 2020.
            
            
               (5)The reference made in Directive (EU) 2014/90 to standard EN ISO/IEC 17025 should therefore be amended accordingly,
            
            
               HAS ADOPTED THIS DIRECTIVE:
            
            
               Article 1
            
            
               In point 19 of Annex III to Directive 2014/90/EU, the reference to standard ‘EN ISO/IEC 17025:2005’ is replaced by a reference to ‘EN ISO/IEC 17025:2017’.
            
            
               Article 2
            
            
               1.Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by [the last day of the month in which the date calculated as the date of entry into force of this Directive falls + 5 months] at the latest. They shall forthwith communicate to the Commission the text of those provisions.
            
            
               When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
            
         
         
            
               2.Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
            
            
               Article 3
            
            
               This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
            
            
               Article 4
            
            
               This Directive is addressed to the Member States.
            
            
               Done at Brussels,
            
            
               
                     For the Commission
               
               
                     The President
                     
                     Ursula VON DER LEYEN