EN 9110:2005

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Aerospace series - Quality systems - Model for quality assurance applicable to maintenance organizationsAeronavtika - Sistemi kakovosti - Model zagotavljanja kakovosti za vzdrževalne organizacijeSérie aérospatiale - Systèmes qualité - Modèle pour l'assurance qualité applicable aux organismes d'entretienLuft- und Raumfahrt - Qualitätsmanagement - Qualitätssicherungsmodelle für wartungsfirmen49.020Letala in vesoljska vozila na splošnoAircraft and space vehicles in general03.120.10Vodenje in zagotavljanje kakovostiQuality management and quality assuranceICS:SIST EN 9110:2008en,fr,deTa slovenski standard je istoveten z:EN 9110:200501-junij-2008SIST EN 9110:2008SLOVENSKI
STANDARD
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 9110December 2005ICS 03.120.10; 49.020 English VersionAerospace series - Quality systems - Model for qualityassurance applicable to maintenance organizationsSérie aérospatiale - Systèmes qualité - Modèle pourl'assurance qualité applicable aux organismes d'entretienLuft- und Raumfahrt - Qualitätsmanagement -Qualitätssicherungsmodelle für wartungsfirmenThis European Standard was approved by CEN on 28 October 2005.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the Central Secretariat or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2005 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 9110:2005: E

Value-adding activities
Information flow
supplier → organization → customer
The term “organization” replaces the term “supplier” used in ISO 9001:1994, and refers to the unit to which this International Standard applies.
Also, the term “supplier” now replaces the term “subcontractor”. Throughout the text of this International Standard, wherever the term “product” occurs, it can also mean “service”. 3.2 Additional terms and definitions 3.2.1 Authority The national aviation authority having jurisdiction over the manufacturer, aircraft owner and operator, maintenance organization; the Authority could be civil or military. 3.2.2 Key Characteristics The features of a material, process, or part whose variation has a significant influence on product fit, performance, service life, or manufacturability.
3.2.3 Maintenance The overhaul, repair, inspection, replacement, modification or defect rectification of an aircraft or an aircraft component that is performed after completion of manufacturing and initial airworthiness certification by the applicable Authority. 3.2.4 Technical data Data that is necessary to ensure that the aircraft or aircraft component can be maintained in a condition such that serviceability and airworthiness of the aircraft and related operational and emergency equipment, is assured.
This data includes maintenance programs, airworthiness directives, service bulletins, major repairs/modifications, operator maintenance manuals, drawings, engineering orders, component maintenance manuals, technical orders, etc.
3.2.5 Human factors Recognition that personnel performing tasks are affected by physical fitness, physiological characteristics, personality, stress, fatigue, distraction, communication and attitude. 3.2.6 Release certificate A document certifying that the activities performed, and the results achieved, conform to established organization, Authority, and contract requirements.

Control of such outsourced processes shall be identified within the quality management system. NOTE Processes needed for the quality management system referred to above should include processes for management activities, provision of resources, product realization and measurement. 4.2 Documentation requirements 4.2.1 General The quality management system documentation shall include a) documented statements of a quality policy and quality objectives, b) a quality manual, c) documented procedures required by this Standard, d) documents needed by the organization to ensure the effective planning, operation and control of its processes,
e) records required by this Standard (see 4.2.4), and f) quality system requirements imposed by the applicable Authorities, as well as the standards to which the organization intends to work. The organization shall ensure that personnel have access to quality management system documentation and are aware of relevant procedures. Customer and/or Authorities representatives shall have access to quality management system documentation.

The organization shall coordinate document changes with customers and/or Authorities in accordance with contract or regulatory requirements. 4.2.4 Control of records Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system. Records shall remain legible, readily identifiable and retrievable. A documented procedure shall be established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records. The documented procedure shall define the method for controlling records that are created by and/or retained by suppliers. Records shall be available for review by customers and Authorities in accordance with contract or regulatory requirements.

NOTE Guidance on configuration management is given in ISO 10007.
5 Management responsibility 5.1 Management commitment Top management shall provide evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness by a) communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements, b) establishing the quality policy, c) ensuring that quality objectives are established, d) conducting management reviews, and e) ensuring the availability of resources. 5.2 Customer focus Top management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction (see 7.2.1 and 8.2.1). 5.3 Quality policy Top management shall ensure that the quality policy a) is appropriate to the purpose of the organization, b) includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system, c) provides a framework for establishing and reviewing quality objectives, d) is communicated and understood within the organization, and e) is reviewed for continuing suitability. 5.4 Planning 5.4.1 Quality objectives Top management shall ensure that quality objectives, including those needed to meet requirements for product [see 7.1 a)], are established at relevant functions and levels within the organization. The quality objectives shall be measurable and consistent with the quality policy. 5.4.2 Quality management system planning Top management shall ensure that a) the planning of the quality management system is carried out in order to meet the requirements given in 4.1, as well as the quality objectives, and

Top management shall appoint a manager with corporate authority to ensure that all ordered maintenance can be financed, the necessary resources obtained, and all ordered maintenance completed in accordance with all organization, customer, and Authority requirements.
5.5.1.2 Maintenance manager Top management shall appoint a manager responsible for assuring that all maintenance required is carried out in accordance with all organization, customer, and Authority requirements. 5.5.2 Management representative Top management shall appoint a member of management who, irrespective of other responsibilities, shall have responsibility and authority that includes a) ensuring that processes needed for the quality management system are established, implemented and maintained, b) reporting to top management on the performance of the quality management system and any need for improvement, c) ensuring the promotion of awareness of customer requirements throughout the organization, and d) the organizational freedom to resolve matters pertaining to quality. NOTE The responsibility of a management representative can include liaison with external parties on matters relating to the quality management system. 5.5.3 Internal communication Top management shall ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the quality management system. 5.6 Management review 5.6.1 General Top management shall review the organization's quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. This review shall include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives. Records from management reviews shall be maintained (see 4.2.4). 5.6.2 Review input The input to management review shall include information on

b) provide training or take other actions to satisfy these needs, c) evaluate the effectiveness of the actions taken, d) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives, e) maintain appropriate records of education, training, skills and experience (see 4.2.4),

h) ensure that continuation training is provided that covers changes in relevant regulatory requirements, the organization’s procedures, and the maintenance standards of the products being maintained.
6.3 Infrastructure The organization shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable
a) buildings, workspace and associated utilities, b) process equipment (both hardware and software), and c) supporting services (such as transport or communication). 6.4 Work environment The organization shall determine and manage the work environment needed to achieve conformity to product requirements. NOTE Factors that may affect the conformity of the product include temperature, humidity, lighting, cleanliness, protection from electrostatic discharge, etc.
7 Product realization 7.1 Planning of product realization The organization shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirements of the other processes of the quality management system (see 4.1). In planning product realization, the organization shall determine the following, as appropriate: a) quality objectives and requirements for the product; b) the need to establish processes, documents, and provide resources specific to the product; c) required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance; d) records needed to provide evidence that the realization processes and resulting product meet requirements (see 4.2.4);
e) the identification of resources to support operation and maintenance of the product.
The output of this planning shall be in a form suitable for the organization's method of operations. NOTE 1 A document specifying the processes of the quality management system (including the product realization processes) and the resources to be applied to a specific product, project or contract, can be referred to as a quality plan. NOTE 2 The organization may also apply the requirements given in 7.3 to the development of product realization processes.

Instead the review can cover relevant product information such as catalogues or advertising material. Contract amendment processes shall include provisions for disposition of out-of-scope defects discovered during maintenance. 7.2.3 Customer communication The organization shall determine and implement effective arrangements for communicating with customers in relation to a) product information, b) enquiries, contracts or order handling, including amendments, and c) customer feedback, including customer complaints. 7.3 Design and development This clause applies only to organizations responsible for the design of modifications.

Requirements shall be complete, unambiguous and not in conflict with each other. 7.3.3 Design and development outputs The outputs of design and development shall be provided in a form that enables verification against the design and development input and shall be approved prior to release. Design and development outputs shall a) meet the input requirements for design and development, b) provide appropriate information for purchasing, production and for service provision, c) contain or reference product acceptance criteria,
d) specify the characteristics of the product that are essential for its safe and proper use, and

Records of the results of the reviews and any necessary actions shall be maintained (see 4.2.4). 7.3.5 Design and development verification Verification shall be performed in accordance with planned arrangements (see 7.3.1) to ensure that the design and development outputs have met the design and development input requirements.
Records of the results of the verification and any necessary actions shall be maintained (see 4.2.4). NOTE Design and/or development verification may include activities such as: − performing alternative calculations, − comparing the new design with a similar proven design, if available, − undertaking tests and demonstrations, and − reviewing the design stage documents before release. 7.3.6 Design and development validation Design and development validation shall be performed in accordance with planned arrangements (see 7.3.1) to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use, where known. Wherever practicable, validation shall be completed prior to the delivery or implementation of the product. Records of the results of validation and any necessary actions shall be maintained (see 4.2.4). NOTES − Design and/or development validation follows successful design and/or development verification. − Validation is normally performed under defined operating conditions. − Validation is normally performed on the final product, but may be necessary in earlier stages prior to product completion. − Multiple validations may be performed if there are different intended uses. 7.3.6.1 Documentation of design and/or development verification and validation At the completion of design and/or development, the organization shall ensure that reports, calculations, test results, etc., demonstrate that the product definition meets the specification requirements for all identified operational conditions.

Where tests are necessary for verification and validation, these tests shall be planned, controlled, reviewed, and documented to ensure and prove the following: a) test plans or specifications identify the product being tested and the resources being used, define test objectives and conditions, parameters to be recorded, and relevant acceptance criteria; b) test procedures describe the method of operation, the performance of the test, and the recording of the results; c) the correct configuration standard of the product is submitted for the test; d) the requirements of the test plan and the test procedures are observed; e) the acceptance criteria are met. 7.3.7 Control of design and development changes Design and development changes shall be identified and records maintained.
The changes shall be reviewed, verified and validated, as appropriate, and approved before implementation.
The review of design and development changes shall include evaluation of the effect of the changes on constituent parts and product already delivered. The organization’s change control process shall provide for customer and/or Authority approval of changes, when required by contract or regulatory requirement. Records of the results of the review of changes and any necessary actions shall be maintained (see 4.2.4). 7.4 Purchasing 7.4.1 Purchasing process The organization shall ensure that purchased product conforms to specified purchase requirements.
The type and extent of control applied to the supplier and the purchased product shall be dependent upon the effect of the purchased product on subsequent product realization or the final product. The organization shall be responsible for the quality of all products purchased from suppliers, including customer-designated sources. The organization’s purchasing process shall satisfy Authority requirements related to the use of non-certificated suppliers. The organization shall evaluate and select suppliers based on their ability to supply product in accordance with the organization's requirements. Criteria for selection, evaluation and re-evaluation shall be established.
Records of the results of evaluations and any necessary actions arising from the evaluation shall be maintained (see 4.2.4). The organization shall: a) maintain a register of approved suppliers that includes the scope of the approval; b) periodically review supplier performance; records of these reviews shall be maintained and used as a basis for establishing the level of controls to be implemented; c) define the necessary actions to take when dealing with suppliers that do not meet requirements; d) ensure where required that both the organization and all suppliers use customer-approved special process sources;

f) requirements for test specimens (e.g., production method, number, storage conditions) for design approval, inspection, investigation or auditing, g) requirements relative to − supplier notification to organization of nonconforming product and − arrangements for organization approval of supplier nonconforming material, h) requirements for the supplier to notify the organization of changes in product and/or process definition and, where required, obtain organization approval,
i) right of access by the organization, their customer, and Authorities to all facilities involved in the order and to all applicable records,
j) requirements for the supplier to flow down to sub-tier suppliers the applicable requirements in the purchasing documents, including key characteristics where required,
k) specific Authority approval requirements, l) format and content of the organization’s release documentation package, and
m) conditions under which defects and unairworthy conditions have to be reported. The organization shall ensure the adequacy of specified purchase requirements pr
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