If you wish to contribute or participate in the discussions about articles you are invited to join SKYbrary as a registered user
Regulation 1034/2011 - Safety Oversight in ATM and Air Navigation Services
From SKYbrary Wiki
|Category:||Single European Sky|
Commission Implementing Regulation (EU) No 1034/2011 of 17 October 2011 on safety oversight in air traffic management and air navigation services and amending Regulation (EU) No 691/2010 - text published in the Official Journal of the European Union
Subject Matter and Scope
This Regulation establishes requirements to be applied to the exercise of the safety oversight function by competent authorities concerning air navigation services (ANS), air traffic flow management (ATFM), airspace management (ASM) for general air traffic and other network functions. The Regulation does not cover military operations and training.
This Regulation shall apply to the activities of competent authorities and qualified entities acting on their behalf regarding the safety oversight of ANS, ATFM, ASM and other network functions.
Competent Authorities for Oversight
The competent authorities for the oversight of ATM and ANS provider organissations are:
- for organisations established in a EU State and providing services in the territory of that State - the National Supervisory Authorities (NSA) established or nominated by that State;
- for organisations for which under the agreements concluded among Member States in accordance with Article 2 of Regulation (EC) No 550/2004, the responsibilities for safety oversight have been allocated differently from above the competent authorities nominated or established under those agreements;
- for organisations providing pan-European ATM/ANS and other network functions, and for ATM/ANS providers established outside of EU and providing services within its territory – the European Aviation Safety Agency (EASA).
Member States and the European Commission shall ensure that competent authorities have the necessary capability to ensure the safety oversight of all organisations operating under their supervision, including sufficient resources to carry out the actions identified in this Regulation.
Competent authorities shall ensure that all persons involved in safety oversight activities are competent to perform the required function.
Safety Oversight and Compliance Monitoring
Competent authorities shall exercise safety oversight as part of their supervision of requirements applicable to ANS, ATFM, ASM and other network functions, in order to monitor the safe provision of these activities and to verify that the applicable safety regulatory requirements and their implementing arrangements are met.
When concluding an agreement on the supervision of organisations active in functional airspace blocks which extend across the airspace falling under the responsibility of more than one Member State or in cases of cross-border provision, Member States concerned shall identify and allocate the responsibilities for safety oversight in a manner which ensures that the requirements of this Regulation are met and relevant information is exchanged between the overseeing authorities and the certifying authority.
Competent authorities shall provide regular monitoring and assessment of the levels of safety achieved in order to determine whether they comply with the safety regulatory requirements applicable in the airspace blocks under their responsibility.
Competent authorities shall implement a documented process, based on safety regulatory audits and reviews, for the verification of compliance with the applicable safety regulatory requirements. The process shall ensure the initial (prior to the issue or renewal of the certificate) and the ongoing compliance of the service provider organisations with any safety related obligations. Competent authorities shall keep and maintain access to the appropriate records related to their safety oversight processes.
Safety Regulatory Audits
Competent authorities, or qualified entities as delegated by them shall conduct safety regulatory audits. The safety regulatory audits shall be independent of the internal auditing arrangements of the service providers and shall be conducted by qualified auditors.
Competent authorities shall establish and update at least annually a programme of safety regulatory audits in order to:
- cover all the areas of potential safety concern, with a focus on those areas where problems have been identified;
- cover all the organisations, services and network functions operating under the supervision of the competent authority;
- ensure that audits are conducted in a manner commensurate to the level of risk posed by the organisations’ activities;
- ensure that sufficient audits are conducted over a period of 2 years to check the compliance of all these organisations with applicable safety regulatory requirements in all the relevant areas of the functional system;
- ensure follow up of the implementation of corrective actions.
Audit observations and identified non-conformities shall be documented in an audit report. Competent authorities shall communicate the audit findings to the audited organisation and shall request corrective actions to address the identified non-conformities. The corrective actions shall be identified by the audited organisation and implemented following their acceptance by competent authority. Competent authorities shall ensure that implementation of corrective actions is followed up.
A competent authority my decide to delegate to a qualified entity the conduct of safety regulatory audits or reviews. In such case the competent authority shall ensure that the qualified entity has prior experience in assessing safety in aviation entities and employs adequately trained and qualified personnel.
The qualified entity shall accept the possibility of being audited by the competent authority or any body acting on its behalf.
Safety oversight of Changes to the Functional System
Service provider organisations shall use only procedures accepted by the relevant competent authority when deciding whether to introduce a safety-related change to their functional systems.
Organisations shall notify the relevant competent authority of all planned safety-related changes. Minor changes shall be implemented following the procedures accepted by the competent authority. The introduction into service of a major change requires NSA acceptance.
Competent authorities shall review the safety arguments associated with new functional systems or changes to existing functional systems proposed by an organisation when:
- the severity assessment conducted in accordance with Annex II, point 3.2.4 of Regulation (EU) No 1035/2011 determines a severity class 1 or a severity class 2 for the potential effects of the hazards identified; or
- the implementation of the changes requires the introduction of new aviation standards.
Reviews shall be conducted in a manner commensurate with the level of risk posed by the new functional systems or by the proposed changes to existing functional systems. Article 5 of the Regulation establishes detailed requirements on the scope and conduct of the reviews.
Competent authorities shall issue a safety directive when they have determined the existence of an unsafe condition in a functional system requiring immediate action.
The safety directives shall be forwarded to the organisation concerned and a copy of the safety directive to the EASA and any other competent authorities concerned, in particular those involved in the safety oversight of the functional system, and to the European Commission.
Competent authorities shall verify the compliance with applicable safety directives.
Safety Oversight Reporting
Competent authorities shall report annually on safety oversight actions pursuant to this Regulation. Member States shall use the reports produced by their competent authorities when submitting their annual reports to the European Commission.
The annual safety oversight reports shall be made available to the Member States concerned in the case of FABs, to the EASA and to the programmes or activities conducted under agreed international arrangements to monitor or audit the implementation of the safety oversight of ANS, ATFM, ASM and other network functions.
Competent authorities shall make arrangements for close cooperation and exchange any appropriate information to ensure the safety oversight of all organisations providing cross-border services or functions.
Entry into Force
This Regulation entered into force in November 2011. It repeals Regulation (EC) No 1315/2007.
Regulation (EU) No 1034/2011 on safety oversight in ATM and ANS (OJ, 18.10.2011)