ANNEX IISupplementary provisions
ANNEX II REQUIREMENTS FOR ORGANISATIONS INVOLVED IN THE DESIGN OR PRODUCTION OF ATM/ANS EQUIPMENT (Part-DPO.OR) SUBPART A GENERAL REQUIREMENTS (DPO.OR.A) DPO.OR.A.001 Scope This Annex establishes the common requirements as regards the rights and obligations of an applicant for, and a holder of, an organisation approval for the design or production of ATM/ANS equipment. DPO.OR.A.005 Eligibility Any natural or legal person who has demonstrated, or is set to demonstrate, their capability to design or produce ATM/ANS equipment in accordance with point DPO.OR.A.010, may apply for a design or production organisation approval under the conditions laid down in this Annex. DPO.OR.A.010 Application for a design or production organisation approval and demonstration of capability (a) An application for a design or production organisation approval shall be made in a form and manner established by the Agency. (b) In order to obtain an approval, an organisation involved in the design or production of ATM/ANS equipment shall comply with the requirements set out in this Regulation where those requirements are applicable to the design or production of ATM/ANS systems and ATM/ANS constituents that the organisation performs or intends to perform. DPO.OR.A.015 Organisation exposition (a) An organisation involved in the design or production of ATM/ANS equipment shall establish and maintain an organisation exposition, which provides the following information: (1) a statement signed by the accountable manager confirming that the organisation exposition and any associated manuals, which define the organisation’s compliance with the requirements will be complied with at all times; (2) the title(s) and name(s) of the key manager(s) as referred to in point DPO.OR.B.020; (3) the duties and responsibilities of the manager(s), including matters for which they may deal directly with the Agency on behalf of the organisation; (4) an organisational chart showing lines of responsibility and accountability of the managers throughout the organisation, including a direct accountability of the accountable manager; (5) a general description of the organisation’s manpower resources; (6) a general description of the facilities located at each location specified in the organisation’s approval; (7) a general description of the organisation’s scope of work relevant to the terms of approval; (8) the procedure(s) for the verification and demonstration that the design of ATM/ANS equipment, or changes to it, complies with the applicable detailed specifications and requirements as established by Delegated Regulation (EU) 2023/1768 and has no unsafe or insecure features, as applicable; (9) the procedure for the preparation and maintenance of the technical data and records, for each model of each piece of ATM/ANS equipment for which a certificate or declaration of design compliance has been issued in accordance with Delegated Regulation (EU) 2023/1768, as applicable; (10) the procedure(s) for the notification of organisational changes to the Agency; (11) the amendment procedure for the organisation’s exposition; (12) a description, direct or by cross reference, of the organisation’s management system and procedure(s); (13) a description, direct or by cross reference, of the contractors’ management and procedure(s) of supervision referred to in point DPO.OR.B.015 of this Annex. (b) The organisation exposition shall be amended as necessary to remain an up-to-date description of the organisation, and a copy of it, including its amendments, shall be supplied to the Agency. (c) An application for a change approval referred to in point DPO.OR.B.005 of this Annex shall be based on the submission of the proposed changes to the organisation exposition. DPO.OR.A.025 Duration, continued validity and privileges of an organisation approval (a) An organisation’s approval shall remain valid for an unlimited period of time provided that: (1) the organisation remains compliant with Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on its basis; (2) the approval has not been surrendered by the organisation or suspended or revoked by the Agency. (b) Upon revocation or surrender of the approval, if issued in a paper format, it shall be returned to the Agency without delay. (c) The holder of an organisation approval shall be entitled, within the scope of its terms of approval and under the relevant procedures of the design management system: (1) to classify changes to an ATM/ANS equipment as ‘major’ or ‘minor’; (2) to approve minor changes to an ATM/ANS equipment certificate(s) and/or declaration(s) issued under Delegated Regulation (EU) 2023/1768; (3) to approve certain major changes to an ATM/ANS equipment certificate issued under Delegated Regulation (EU) 2023/1768; (4) to issue declarations of design compliance of ATM/ANS equipment pursuant to Article 5 of Delegated Regulation (EU) 2023/1768; and (5) to issue statements of compliance of ATM/ANS equipment pursuant to Article 6 of Delegated Regulation (EU) 2023/1768. DPO.OR.A.030 Facilitation and cooperation (a) An organisation involved in the design or production of ATM/ANS equipment shall facilitate the inspections and audits performed by the Agency or by a qualified entity that acts on its behalf, and it shall cooperate as necessary for the efficient and effective exercise of the powers of the Agency. (b) An organisation involved in the design or production of ATM/ANS equipment shall cooperate with and support the ATM/ANS providers using its ATM/ANS equipment in their compliance demonstration process to the competent authorities concerned. DPO.OR.A.035 Findings and corrective actions Following the receipt of the notification of findings from the Agency, the organisation involved in the design or production of ATM/ANS equipment shall: (a) identify the root cause of the non-compliance; (b) define a corrective action plan; (c) demonstrate the implementation of the corrective action to the satisfaction of the Agency within the time period proposed and approved by the Agency, as defined in point (e)(2) of point DPO.AR.C.015. DPO.OR.A.040 Immediate reaction to a safety, security and interoperability problem An organisation involved in the design or production of ATM/ANS equipment shall implement any safety and security measures, including ATM/ANS equipment directives, taken by the Agency in accordance with points DPO.AR.A.010 and DPO.AR.A.015. DPO.OR.A.045 Failures, malfunctions, and defects (a) The holder of an approval issued in accordance with this Regulation shall: (1) establish and maintain a system for collecting, investigating and analysing reports of and information on failures, malfunctions, defects or other occurrences which have caused or might cause adverse effects on the continuing compliance of the ATM/ANS equipment with the applicable requirements; (2) inform all known users of the ATM/ANS equipment concerned and, on request, any person mandated under other associated regulations, about the system established in accordance with point (1) and about how to provide such reports of and information on failures, malfunctions, defects or other occurrences. (b) For organisations that have their principal place of business in a Member State, the system established in accordance with point (a)(1) shall include provisions for occurrence reporting and follow-up that meet the requirements of Regulations (EU) No 376/2014 and (EU) No 2018/1139 and the delegated and implementing acts adopted on their basis. (c) The approval holder shall report to the Agency any failure, malfunction, defect or other occurrence of which it is aware, and which has resulted or may result in an unsafe, insecure, or under-performing condition. (d) For approval holders that do not have their principal place of business in a Member State, reports shall be made in a form and manner established by the Agency, as soon as practicable and in any case submitted not later than 72 hours after the person or organisation has become aware of the particular occurrence, unless exceptional circumstances prevent this. (e) The approval holder shall investigate an occurrence that has been reported under point (c), including the deficiencies that have led to that occurrence, and report to the Agency the results of its investigation and any action it intends to take or proposes to take to correct these deficiencies. DPO.OR.A.050 Approval transferability An organisation approval is not transferable, except as a result of a change in the ownership of the organisation. SUBPART B MANAGEMENT (DPO.OR.B) DPO.OR.B.001 Management system (a) An organisation involved in the design or production of ATM/ANS equipment shall implement and maintain a management system that includes the following: (1) clearly defined lines of responsibility and accountability throughout its organisation, including direct accountability of the accountable manager; (2) a description of the overall philosophy and principles of the organisation, collectively constituting a policy, signed by the accountable manager; (3) the means to verify the performance of the organisation in the light of the performance indicators and performance targets of the management system; (4) a process to identify changes within the organisation and the context in which it operates, which may affect established processes, procedures and products and, where necessary, change the management system to accommodate those changes; (5) a process to identify the scope of changes to the ATM/ANS equipment and the associated risk; (6) a process to review the management system, identify the causes of substandard performance of the management system, determine the implications of such substandard performance, and eliminate or mitigate such causes; (7) a process to ensure that the personnel of the organisation are trained and competent to perform their duties in a safe, efficient, continuous and sustainable manner; in this context, the organisation shall establish policies for the recruitment and training of its personnel; (8) a formal means for communication which ensures that all personnel of the organisation are fully aware of the management system that allows critical information to be communicated and that makes it possible to explain why particular actions are taken and why procedures are introduced or changed; (9) as regards design activities, procedures for: (i) the design of ATM/ANS equipment, and for changes to its design; (ii) the assurance that the design of ATM/ANS equipment, or the changes to its design, comply with the applicable specifications, including independent checking function of the demonstration of compliance on the basis of which the organisation submits compliance statements and associated documentation to the Agency; (iii) the verification of the acceptability of the elements of the ATM/ANS equipment designed, or the tasks performed, by the contracted organisations referred to in point DPO.OR.B.015; (iv) the assurance that staff involved in the design of ATM/ANS equipment are of sufficient numbers and are trained and competent, and have been authorised to discharge their allocated responsibilities; (v) close and efficient coordination between departments and within departments; (10) as regards production activities, procedures for: (i) the issue and approval of documents, or changes to them; (ii) assessment audits and the control of contracted organisations referred to in point DPO.OR.B.015; (iii) verifying that incoming materials and equipment, including the supply of new items or items used by ATM/ANS equipment buyers, are as specified in the applicable design data; (iv) verifying that ATM/ANS equipment conforms to the applicable design data; (v) identification and traceability; (vi) organisation processes; (vii) inspection and testing; (viii) calibration of tools and test equipment; (ix) the control of non-conforming items; (x) the coordination with the applicant for, or holder of, the design approval; (xi) the completion and retention of records of work carried out; (xii) the issue of release documents; (xiii) the handling, storage and packing of ATM/ANS equipment. (b) An organisation involved in the design or production of ATM/ANS equipment shall document all key management system processes, including a process for making personnel aware of their responsibilities, and the procedure for amending those processes. (c) An organisation involved in the design or production of ATM/ANS equipment shall establish a function within its management system to monitor its compliance with the applicable requirements and the adequacy of the established procedures. Compliance monitoring shall include a feedback system of findings to the accountable manager to ensure the effective implementation of corrective actions, as necessary. (d) The management system shall be proportionate to the size of the organisation involved in the design or production of ATM/ANS equipment and the complexity of its activities, taking into account the hazards and associated risks inherent in those activities. (e) In addition to the management system referred to in point (a), the organisation involved in the design or production of ATM/ANS equipment shall establish, implement and maintain an information security management system in accordance with Implementing Regulation (EU) 2023/203 in order to ensure the proper management of information security risks which may have an impact on aviation safety. DPO.OR.B.005 Change management (a) Following the issue of an organisation’s approval, any change to the management system that is significant shall be approved by the Agency before being implemented unless such a change is notified and managed in accordance with a procedure approved by the Agency. The organisation shall submit to the Agency an application for approval demonstrating continuous compliance with the applicable requirements. (b) Each change to ATM/ANS equipment shall be notified to and approved by the Agency before being implemented unless such a change is managed in accordance with a change management procedure approved by the Agency. This change management procedure shall define the classification of the changes to the ATM/ANS equipment and describe how such changes will be notified and managed. DPO.OR.B.010 Facility requirements An organisation involved in the design or production of ATM/ANS equipment shall ensure that its facilities and equipment, including testing facilities and equipment, are adequate and suitable to perform and manage all its tasks and activities in accordance with the applicable requirements. DPO.OR.B.015 Contracted activities (a) Contracted activities include all those activities that are within the scope of the organisation’s activities, in accordance with the terms of the certificate, which are performed by other organisations either themselves certified to carry out such activities or, if not certified, working under such an organisation’s supervision. An organisation involved in the design or production of ATM/ANS equipment shall ensure that when it contracts any part of its activities to, or when it purchases any part of its activities from, external organisations, the contracted or purchased activity, as applicable, conforms with the applicable requirements. (b) When an organisation involved in the design or production of ATM/ANS equipment contracts any part of its activities to an organisation that is not itself certified in accordance with this Regulation to carry out such activities, it shall ensure that the contracted organisation works under its supervision. An organisation involved in the design or production of ATM/ANS equipment shall ensure that the Agency is given access to the contracted organisation to determine its continued compliance with the applicable requirements of this Regulation. DPO.OR.B.020 Personnel requirements (a) An organisation involved in the design or production of ATM/ANS equipment shall appoint an accountable manager who has the authority to ensure that all activities may be financed and carried out in accordance with the applicable requirements of this Regulation. The accountable manager shall be responsible for establishing and maintaining an effective management system. (b) The authority, duties, and responsibilities of the nominated post-holders, in particular management personnel in charge of safety, quality, security, finance and human-resources, shall also be defined. DPO.OR.B.025 Record-keeping (a) An organisation involved in the design or production of ATM/ANS equipment shall establish a record-keeping system that allows for the adequate storage of records and the reliable traceability of all its activities, covering in particular all the elements indicated in point DPO.OR.B.001. (b) The format and the retention period of the records referred to in point (a) shall be specified in the organisation’s management system procedures. (c) Records shall be stored in a manner that ensures their protection against damage, alteration, and theft. (d) An organisation involved in the design or production of ATM/ANS equipment shall maintain a register of the ATM/ANS equipment deployed. SUBPART C TECHNICAL REQUIREMENTS (DPO.OR.C) DPO.OR.C.001 Organisations involved in the design or production of ATM/ANS equipment (a) An applicant for, and a holder of, a design or production organisation approval for ATM/ANS equipment shall be entitled, as applicable, to any of the following: (1) hold or apply to be issued a certificate for the design of ATM/ANS equipment; (2) issue a declaration of design compliance for ATM/ANS equipment; (3) issue a statement of compliance for ATM/ANS equipment, upon request of an ATM/ANS provider. (b) As regards design activities, an organisation involved in the design or production of ATM/ANS equipment shall: (1) issue a declaration of design compliance for the ATM/ANS equipment, as applicable; (2) issue data and information, including instructions, under its responsibility within the scope of its terms of approval as established by the Agency; (3) prepare and maintain, for each model of each piece for which an ATM/ANS equipment declaration has been issued, an up-to-date file of complete technical data and records. (c) As regards production activities, an organisation involved in the design or production of ATM/ANS equipment shall: (1) manufacture each article ensuring that the completed ATM/ANS equipment conforms to its design data and is safe for installation; (2) prepare and maintain, for each model of each piece for which an ATM/ANS equipment declaration has been issued, an up-to-date file of complete technical data and records; (3) prepare, maintain and update the master copies of all manuals required by the applicable declaration specifications for the particular equipment; (4) make available to the users of the ATM/ANS equipment, and to the Agency on request, those instructions for continued suitability necessary for the use and maintenance of the ATM/ANS equipment, and changes to those instructions; (5) mark each article; (6) continue to comply with the applicable requirements laid down in this Regulation. (d) In addition to point (c), an organisation involved in the production of ATM/ANS equipment shall be entitled, within the scope of its terms of approval, to determine that each completed ATM/ANS equipment conforms with the applicable design data and is in a condition for safe operation before issuing an EASA release form stating that the ATM/ANS equipment has been produced in accordance with the applicable requirements of this Regulation and with the applicable design data. (e) The EASA release form referred to in point (d) for each ATM/ANS equipment manufactured shall contain at least the following information: (1) a description of the ATM/ANS equipment; (2) the part number of the ATM/ANS equipment; (3) the serial number of the ATM/ANS equipment; (4) a statement that the ATM/ANS equipment has been manufactured in conformity with the applicable design data and is in a condition for safe operation; (5) a reference to the certificate or declaration of design compliance. DPO.OR.C.005 Coordination An organisation involved in the design or production of ATM/ANS equipment shall ensure: (a) the satisfactory coordination, with the appropriate arrangements, between design and production activities, as appropriate; (b) the satisfactory coordination with and proper support to the relevant ATM/ANS providers and aviation undertaking(s) as regards the continued suitability of the ATM/ANS equipment, as applicable. DPO.OR.C.010 ATM/ANS equipment directives When the Agency issues an ATM/ANS equipment directive, pursuant to point ATM/ANS.EQMT.CERT.065 of Annex II to Delegated Regulation (EU) 2023/1768, the organisation involved in the design or production of ATM/ANS equipment shall: (a) propose an appropriate corrective action and submit it together with details to the Agency for approval; (b) following the approval by the Agency of the proposal referred to in point (a), make available to all known users or owners of ATM/ANS equipment appropriate descriptive data and accomplishment instructions and, on request, to any person required to comply with the ATM/ANS equipment directive.