Chwilio Deddfwriaeth

Commission Implementing Regulation (EU) 2018/2067Dangos y teitl llawn

Commission Implementing Regulation (EU) 2018/2067 of 19 December 2018 on the verification of data and on the accreditation of verifiers pursuant to Directive 2003/87/EC of the European Parliament and of the Council (Text with EEA relevance)

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CHAPTER IV ACCREDITATION

Article 44Accreditation

A verifier issuing a verification report to an operator or an aircraft operator shall be accredited for the scope of activities referred to in Annex I for which the verifier is carrying out the verification of an operator's or aircraft operator's report.

For the purpose of verifying baseline data reports or new entrant data reports, a verifier issuing a verification report to an operator shall in addition be accredited for activity group No 98 referred to in Annex I.

Article 45Objectives of accreditation

During the accreditation process and the monitoring of accredited verifiers, each national accreditation body shall assess whether the verifier and its personnel undertaking verification activities:

(a)

have the competence to carry out the verification of operator's or aircraft operator's reports in accordance with this Regulation;

(b)

are performing the verification of operator's or aircraft operator's reports in accordance with this Regulation;

(c)

meet the requirements referred to in Chapter III.

Article 46Request for accreditation

1.Any legal person or other legal entity may request accreditation pursuant to Article 5(1) of Regulation (EC) No 765/2008 and the provisions of this Chapter.

The request shall contain the information required on the basis of the harmonised standard referred to in Annex III.

2.In addition to the information referred to in paragraph 1 of this Article, an applicant shall also, prior to the commencement of the assessment pursuant to Article 45, make available to the national accreditation body the following:

(a)all information requested by the national accreditation body;

(b)procedures and information concerning processes referred to in Article 41(1) and the information on the quality management system referred to in Article 41(2);

(c)the competence criteria referred to in Article 36(2)(a) and (b), the results of the competence process referred to in Article 36 as well as other relevant documentation on the competence of all personnel involved in verification activities;

(d)information on the process for ensuring continuous impartiality and independence referred to in Article 43(6), including relevant records on the impartiality and independence of the applicant and its personnel;

(e)information on the technical experts and key personnel involved in the verification of operator's or aircraft operator's reports;

(f)the system and process for ensuring appropriate internal verification documentation;

(g)other relevant records referred to in Article 42(1).

Article 47Preparation for assessment

1.When preparing the assessment referred to in Article 45, each national accreditation body shall take into account the complexity of the scope for which the applicant requests accreditation as well as the complexity of the quality management system referred to in Article 41(2), the procedures and information on processes referred to in Article 41(1) and the geographical areas in which the applicant is carrying out or planning to carry out verification.

2.For the purposes of this Regulation, the national accreditation body shall meet the minimum requirements set out in the harmonised standard referred to in Annex III.

Article 48Assessment

1.The assessment team referred to in Article 58 shall carry out at least the following activities for the purposes of making the assessment referred to in Article 45:

(a)a review of all relevant documents and records referred to in Article 46;

(b)a visit of the premises of the applicant to review a representative sample of the internal verification documentation and to assess the implementation of the applicant's quality management system and the procedures or processes referred to in Article 41;

(c)witnessing of a representative part of the requested scope for accreditation and the performance and competence of a representative number of the applicant's staff involved in the verification of the operator's or aircraft operator's report to ensure that the staff are operating in accordance with this Regulation.

In carrying out those activities, the assessment team shall meet the requirements set out in the harmonised standard referred to in Annex III.

2.The assessment team shall report the findings and non-conformities to the applicant in accordance with the requirements set out in the harmonised standard referred to in Annex III and shall request the applicant to respond to the reported findings and non-conformities in accordance with those provisions.

3.An applicant shall take corrective action to address any non-conformities reported pursuant to paragraph 2 and indicate in applicant's response to the reported findings and non-conformities of the assessment team what actions are taken or are planned to be taken within a time set by the national accreditation body to resolve any identified non-conformities.

4.The national accreditation body shall review the responses of the applicant to the findings and non-conformities submitted pursuant to paragraph 3.

Where the national accreditation body finds the response of the applicant to be insufficient or ineffective, it shall request further information or action from the applicant. The national accreditation body may also request evidence of the effective implementation of actions taken or carry out a follow-up assessment to assess the effective implementation of the corrective actions.

Article 49Decision on accreditation and accreditation certificate

1.The national accreditation body shall take into account the requirements laid down in the harmonised standard referred to in Annex III when preparing and taking the decision on whether to grant, extend or renew the accreditation of an applicant.

2.Where the national accreditation body has decided to grant, extend or renew the accreditation of an applicant, it shall issue an accreditation certificate to that effect.

The accreditation certificate shall at least contain the information required on the basis of the harmonised standard referred to in Annex III.

The accreditation certificate shall be valid for a period not exceeding five years after the date on which the national accreditation body has issued that certificate.

Article 50Surveillance

1.The national accreditation body shall carry out an annual surveillance of each verifier to which it has issued an accreditation certificate.

The surveillance shall at least comprise the following:

(a)a visit to the premises of the verifier with a view to carrying out the activities referred to Article 48(1)(b);

(b)witnessing the performance and competence of a representative number of the verifier's staff in accordance with Article 48(1)(c).

2.The national accreditation body shall carry out the first surveillance of a verifier in accordance with paragraph 1 no later than 12 months after the date on which the accreditation certificate has been issued to that verifier.

3.The national accreditation body shall prepare its plan for the surveillance of each verifier in a manner that allows for representative samples of the scope of accreditation to be assessed, in accordance with the requirements laid down in the harmonised standard referred to in Annex III.

4.Based on the results of the surveillance referred to in paragraph 1, the national accreditation body shall decide whether to confirm the continuation of accreditation.

5.Where a verifier carries out a verification in another Member State, the national accreditation body that has accredited the verifier may request the national accreditation body of the Member State where the verification is performed to carry out surveillance activities on its behalf and under its responsibility.

Article 51Reassessment

1.Before the expiry of the accreditation certificate, the national accreditation body shall carry out a reassessment of the verifier to which the national accreditation body has issued an accreditation certificate to determine whether the validity of that accreditation certificate may be extended.

2.The national accreditation body shall prepare its plan for the reassessment of each verifier in a manner that allows representative samples of the scope of accreditation to be assessed. In planning and carrying out the reassessment, the national accreditation body shall meet the requirements laid down in the harmonised standard referred to in Annex III.

Article 52Extraordinary assessment

1.The national accreditation body may conduct an extraordinary assessment of the verifier at any time to ensure that the verifier meets the requirements of this Regulation.

2.For the purposes of enabling the national accreditation body to assess the need for an extraordinary assessment, the verifier shall inform the national accreditation body forthwith of any significant changes relevant to its accreditation concerning any aspect of its status or operation. Significant changes shall include those changes mentioned in the harmonised standard referred to in Annex III.

Article 53Extension of scope

The national accreditation body shall, in response to an application by a verifier for an extension of the scope of a granted accreditation, undertake the necessary activities to determine whether the verifier meets the requirements of Article 45 for the requested extension of the scope of its accreditation.

Article 54Administrative measures

1.The national accreditation body may suspend, withdraw or reduce an accreditation of a verifier if the verifier does not meet the requirements of this Regulation.

The national accreditation body shall suspend, withdraw or reduce an accreditation of a verifier if the verifier so requests.

The national accreditation body shall establish, document, implement and maintain a procedure for the suspension of the accreditation, the withdrawal of the accreditation and the reduction of the scope of accreditation.

2.The national accreditation body shall suspend an accreditation, or restrict the scope of an accreditation in any of the following cases:

(a)the verifier has committed a serious breach of the requirements of this Regulation;

(b)the verifier has persistently and repeatedly failed to meet the requirements of this Regulation;

(c)the verifier has breached other specific terms and conditions of the national accreditation body.

3.The national accreditation body shall withdraw the accreditation in the following cases:

(a)the verifier has failed to remedy the grounds for a decision to suspend the accreditation certificate;

(b)a member of the top management of the verifier or a verifier's staff involved in verification activities under this Regulation has been found guilty of fraud;

(c)the verifier has intentionally provided false information or concealed information.

4.The decision of a national accreditation body to suspend, withdraw or reduce the scope of the accreditation in accordance with paragraphs 2 and 3 shall be subject to appeal.

Member States shall establish procedures for the resolution of those appeals.

5.The decision of a national accreditation body to suspend, withdraw or reduce the scope of the accreditation shall take effect upon its notification to the verifier.

The national accreditation body shall terminate the suspension of an accreditation certificate where it has received satisfactory information and is confident that the verifier meets the requirements of this Regulation.

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