21.A.239 Design management system

• Regulation (EU) 2022/1358 found in: Initial Airworthiness and Environmental Protection (No 748/2012) Part-21 Part-21L (Jul 2024)

21.A.239 Design management system Regulation (EU) 2022/1358 (a)     The design organisation shall establish, implement and maintain a design management system that includes a safety management element and a design assurance element with clearly defined accountability and lines of responsibility throughout the organisation. (b)     The design management system shall: 1.       correspond to the size of the organisation and to the nature and complexity of its activities, taking into account the hazards and associated risks inherent in those activities; 2.       be established, implemented and maintained under the accountability of a single manager appointed pursuant to point [21.A.245](#_DxCrossRefBm1649096919)(a). (c)      As part of the safety management element of the design management system, the design organisation shall: 1.       establish, implement and maintain a safety policy and the corresponding related safety objectives; 2.       appoint key safety personnel in accordance with point [21.A.245](#_DxCrossRefBm1649096919)(b); 3.       establish, implement and maintain a safety risk management process that includes the identification of aviation safety hazards entailed by its activities, their evaluation and the management of the associated risks, including taking actions to mitigate the risks and verify their effectiveness; 4.       establish, implement and maintain a safety assurance process that includes: (i)      the measurement and monitoring of the organisation’s safety performance; (ii)     the management of changes in accordance with points [21.A.243](#_DxCrossRefBm1649097316)(c) and [21.A.247](#_DxCrossRefBm1649096950); (iii)     the principles for the continuous improvement of the safety management element; 5.       promote safety in the organisation through: (i)      training and education; (ii)     communication; 6.       establish an occurrence reporting system in accordance with point [21.A.3A](#_DxCrossRefBm1649096889) in order to contribute to continuous improvement of safety. (d)     as part of the design assurance element of the design management system, the design organisation shall: 1.       establish, implement and maintain a system for the control and supervision of the design, and of design changes and repairs, of products, parts and appliances covered by the terms of approval; this system shall: (i)      include an airworthiness function responsible for managing that the design of products, parts and appliances, or the design changes and repairs, comply with the applicable type-certification basis, technical specifications concerning the making of declarations, the applicable operational suitability data certification basis and the environmental protection requirements; (ii)     ensure that it properly discharges its responsibilities in accordance with this Annex and with the terms of approval issued under point [21.A.251](#_DxCrossRefBm1649097315); 2.       establish, implement and maintain an independent verification function of the demonstration of compliance on the basis of which the organisation declares compliance with the applicable airworthiness, operational suitability data and environmental protection requirements; and 3.       specify the manner in which the design assurance system accounts for the acceptability of the parts or appliances that are designed or the tasks that are performed by its partners or subcontractors according to the methods which are the subjects of written procedures. (e)     The design organisation shall establish, as part of the design management system, an independent monitoring function to verify compliance of the organisation with the relevant requirements of this Annex as well as the compliance with and adequacy of the design management system. Monitoring shall include feedback to the person or the group of persons referred to in point [21.A.245](#_DxCrossRefBm1649096919)(b) and to the manager referred to in point [21.A.245](#_DxCrossRefBm1649096919)(a) to ensure, where necessary, the implementation of corrective action. (f)      If the design organisation holds one or more additional organisation certificates within the scope of [Regulation (EU) 2018/1139](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32018R1139), the design management system may be integrated with that required under the additional certificate(s).