Commission Regulation (EU) No 1169/2010Show full title

ANNEX I U.K. Procedure for assessing conformity with requirements for obtaining safety authorisations to be issued in accordance with Article 11(1)(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 authorisation shall be built upon the following framework principles. U.K.

(a) Setting up and reviewing the assessment process U.K.

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. 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 U.K.

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

(c) Scope of the assessment U.K.

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 infrastructure manager's overall ability to operate safely as described in its safety management system.

(d) Timing of the assessment U.K.

National safety authorities shall complete the assessment within the time 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 infrastructure managers of issues of major concern as early as practically possible during the assessment phase.

(e) Decision making during the assessment U.K.

A decision to accept or reject an application for a safety 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 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. U.K.

3. When granting a safety authorisation, compliance of the applicant's safety management system with the assessment criteria shall be documented in relation to each assessment criterion. U.K.

4. 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: U.K.

(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 authorisation.