Commission Regulation (EU) No 1158/2010 (repealed)Dangos y teitl llawn

ANNEX I Procedure for assessing conformity with requirements for obtaining safety certificates to be issued in accordance with Article 10(2)(a) and (b) of Directive 2004/49/EC

1. The procedures that a national safety authority puts in place to receive and assess applications and to award safety certificates shall be built upon the following framework principles.

(a) Setting up and reviewing the assessment process

National safety authorities shall develop structured and auditable processes to be undertaken by suitably competent persons. They shall scrutinise applications against the assessment criteria for safety management systems set out in Annex II and III. They shall record and give reasons for all decisions. The national safety authority’s overall assessment process shall be periodically internally reviewed and continuously improved to secure its continued effectiveness and efficiency.

(b) Quality of the assessment process

National safety authorities shall monitor the quality of their own performance at key stages in the processing of applications for safety certificates.

(c) Scope of the assessment

The assessment shall be at management-system level and process-driven. Where scrutiny reveals shortcomings, the national safety authority may exercise discretion and, depending on the nature and seriousness of the non-conformity, shall outline the points which need to be enhanced. Ultimately, the national safety authority shall exercise its power to reject an application.

The assessment shall be:

• appropriate to the risks, character and extent of operations of the applicant;

• based on judgments of the railway undertaking’s overall ability to operate safely as described in its safety management system.

(d) Timing of the assessment

National safety authorities shall complete the assessment within the time period required by Article 12 of Directive 2004/49/EC whilst ensuring that the evidence provided by the applicant is sufficiently examined. The national safety authority shall inform railway undertakings of issues of major concern as early as practically possible during the assessment phase.

(e) Decision making during the assessment

A decision to accept or reject an application for a safety certificate or authorisation shall be based on the evidence provided by the applicant and on whether compliance with the relevant requirements has been shown or not.

2. The national safety authority shall assess whether the application for a safety certificate complies with Commission Regulation (EC) No 653/2007(1).

3. In particular, the national safety authority shall assess whether the attached summary of the safety management system manual allows an initial judgment on the quality and appropriateness of the safety management system and shall decide in which areas further information is necessary. The national safety authority may, as part of this request for more information, seek as much detailed information as it deems reasonably necessary to help its assessment of the application.

4. When granting a safety certificate, compliance of the applicant’s safety management system with the assessment criteria shall be documented in relation to each assessment criterion.

5. When identifying a point of query or possible non-compliance, the national safety authority shall be specific and help the applicant to understand the level of detail expected in the response. To do this it shall:

(a)

refer accurately to the relevant criteria and ensure that the applicant has understood clearly the identified areas of non-compliance;

(b)

identify the relevant part of related regulations, rules, and standards;

(c)

state why the assessment criterion is not met;

(d)

agree on further commitments, information and any supporting evidence to be provided, as required by the level of detail of the criterion, and specify both the action required by the applicant to rectify the deficiency and the timeframe for compliance;

(e)

specify areas which could be subject to further scrutiny through supervision after the award of the certificate.

6. If a railway undertaking applies for both Part A and Part B safety certificates at the same time, the national safety authority shall ensure that the Part A certificate is granted first or that both certificates are granted together as provided for in Regulation (EC) No 653/2007. Nevertheless, national safety authorities shall define a procedure for how to use the application form (in particular, the front page for the Annexes) if a new application is made for both certificates at the same time.

7. The general framework procedures in place for assessing applications for safety certificates shall also apply to applications for safety certificates as referred to in Article 10(2)(b) of Directive 2004/49/EC.

8. A national safety authority’s assessment of an application for a safety certificate as referred to in Article 10(2)(b) Directive 2004/49/EC shall only apply to a railway undertaking’s ability to comply with the requirements needed to operate on the specific network for which it is seeking a certificate by using the procedures it has established to obtain a Part A certificate.

9. These assessment criteria are based on showing that the results of applying the procedures or processes to manage operation on a specific network have been documented and the commitment to implement them has been made. Hence in order to check whether the criteria have been met, the national safety authority may request that the railway undertaking submit a sample of the documentation it plans to use.

10. National safety authorities shall cooperate to address issues of non-compliance with the Part B assessment criteria or to deal with queries on the Part B application. A national safety authority assessing a Part B application shall liaise with the national safety authority that issued Part A to discuss and agree what action, if any, each one will take to ensure compliance with the Part B assessment criteria.

(1)

OJ L 153, 14.6.2007, p. 9.