SIST EN 9110:2008
(Main)Aerospace series - Quality systems - Model for quality assurance applicable to maintenance organizations
Aerospace series - Quality systems - Model for quality assurance applicable to maintenance organizations
This standard includes ISO 9001:2000 quality management system requirements and specifies additional requirements for a quality management system for aerospace maintenance organizations. The additional aerospace requirements are shown in bold, italic text.
It is emphasized that the quality management system requirements specified in this standard are complementary (not alternative) to contractual and applicable law and regulatory requirements.
This Standard specifies requirements for a quality management system where an organization
a) needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements, and
b) aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable regulatory requirements.
NOTE In this Standard, the term "product" applies only to the product intended for, or required by, a customer.
Luft- und Raumfahrt - Qualitätsmanagement - Qualitätssicherungsmodelle für wartungsfirmen
Diese Internationale Norm enthält die Anforderungen an das Qualitätsmanagementsystem nach ISO 9001:2000 ) und legt ergänzende Anforderungen an ein Qualitätsmanagementsystem für Instandhaltungsbetrieben der Luft- und Raumfahrt fest. Die ergänzenden Anforderungen für die Luft- und Raumfahrt sind in Fettdruck und Kursivschrift angegeben.
Es wird ausdrücklich darauf hingewiesen, dass die in dieser Norm angegebenen Anforderungen an das Qualitätsmanagementsystem eine Ergänzung (und keine Alternative) zu den vertraglichen und geltenden gesetzlichen und regelsetzenden Anforderungen sind.
Diese Internationale Norm legt die Anforderungen an ein Qualitätsmanagementsystem fest, wenn eine Organisation
a) ihre Fähigkeit zur ständigen Bereitstellung von Produkten darzulegen hat, die die Anforderungen der Kunden und die zutreffenden behördlichen Anforderungen erfüllen und
b) danach strebt, die Kundenzufriedenheit durch wirksame Anwendung des Systems zu erhöhen, einschließlich der Prozesse zur ständigen Verbesserung des Systems und der Zusicherung der Einhaltung der Anforderungen der Kunden und der zutreffenden behördlichen Anforderungen.
ANMERKUNG In dieser Norm bezieht sich die Benennung „Produkt“ nur auf Produkte, die für einen Kunden vorgesehen sind oder von diesem gefordert werden
Série aérospatiale - Systèmes qualité - Modèle pour l'assurance qualité applicable aux organismes d'entretien
La présente norme comporte les exigences en matière de système de management de la qualité développées dans l'ISO 9001:2000 ) et spécifie des exigences supplémentaires en matière de système de management de la qualité pour les organismes d’entretien aérospatiaux. Les exigences supplémentaires sont indiquées par du texte en gras et en italique.
Il faut signaler que les exigences en matière de système de management de la qualité spécifiées dans la présente norme sont complémentaires aux exigences contractuelles, légales et réglementaires applicables, mais ne les remplacent pas.
La présente norme internationale spécifie les exigences relatives au système de management de la qualité lorsqu'un organisme :
doit démontrer son aptitude à fournir régulièrement un produit conforme aux exigences des clients et aux exigences réglementaires applicables, et ;
vise à accroître la satisfaction de ses clients par l'application efficace du système, y compris les processus pour l'amélioration continue du système et l'assurance de la conformité aux exigences des clients et aux exigences réglementaires applicables.
NOTE Dans la présente norme internationale, le terme "produit" s'applique uniquement au produit destiné à, ou exigé par, un client.
Aeronavtika - Sistemi kakovosti - Model zagotavljanja kakovosti za vzdrževalne organizacije
General Information
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Standards Content (Sample)
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
EN 9110:2005 (E) 2 Contents Page Foreword.3 Introduction.4 0.1 General.4 0.2 Process approach.4 1 Scope.6 1.1 General.6 1.2 Application.6 2 Normative references.6 3 Terms and definitions.7 4 Quality management system.8 4.1 General requirements.8 4.2 Documentation requirements.8 5 Management responsibility.10 5.1 Management commitment.10 5.2 Customer focus.10 5.3 Quality policy.10 5.4 Planning.10 5.5 Responsibility, authority and communication.11 5.6 Management review.11 6 Resource management.12 6.1 Provision of resources.12 6.2 Human resources.12 6.3 Infrastructure.13 6.4 Work environment.13 7 Product realization.13 7.1 Planning of product realization.13 7.2 Customer-related processes.14 7.3 Design and development.14 7.4 Purchasing.17 7.5 Production and service provision.19 7.6 Control of monitoring and measuring devices.22 8 Measurement, analysis and improvement.23 8.1 General.23 8.2 Monitoring and measurement.23 8.3 Control of nonconforming product.25 8.4 Analysis of data.26 8.5 Improvement.27 Bibliography.28
EN 9110:2005 (E) 3 Foreword This European Standard (EN 9110:2005) has been prepared by the European Association of Aerospace Manufacturers - Standardization (AECMA-STAN). After enquiries and votes carried out in accordance with the rules of this Association, this Standard has received the approval of the National Associations and the Official Services of the member countries of AECMA, prior to its presentation to CEN. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by June 2006, and conflicting national standards shall be withdrawn at the latest by June 2006. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights. In December 1998, the Aerospace Industry established the International Aerospace Quality Group (IAQG) with the purpose of achieving significant improvements in quality and reductions in cost throughout the value stream. This organization, with representation from Aerospace companies in Americas, Asia and Europe and sponsored by SAE, SJAC and AECMA has agreed to take responsibility for the technical contents of this standard. This standard was reviewed by the Domain Technical Coordinator of AECMA-STAN's Quality Domain. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: 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 the United Kingdom.
EN 9110:2005 (E) 4 Introduction 0.1 General The adoption of a quality management system should be a strategic decision of an organization. The design and implementation of an organization's quality management system is influenced by varying needs, particular objectives, the products provided, the processes employed and the size and structure of the organization. It is not the intent of this Standard to imply uniformity in the structure of quality management systems or uniformity of documentation. The quality management system requirements specified in this Standard are complementary to requirements for products. Information marked “NOTE” is for guidance in understanding or clarifying the associated requirement. This Standard can be used by internal and external parties, including certification bodies, to assess the organization's ability to meet customer, regulatory and the organization's own requirements. The quality management principles stated in ISO 9000 and ISO 9004 have been taken into consideration during the development of this Standard. 0.2 Process approach This Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer requirements. For an organization to function effectively, it has to identify and manage numerous linked activities. An activity using resources, and managed in order to enable the transformation of inputs into outputs, can be considered as a process. Often the output from one process directly forms the input to the next. The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management, can be referred to as the “process approach”. An advantage of the process approach is the ongoing control that it provides over the linkage between the individual processes within the system of processes, as well as over their combination and interaction. When used within a quality management system, such an approach emphasizes the importance of a) understanding and meeting requirements, b) the need to consider processes in terms of added value, c) obtaining results of process performance and effectiveness, and d) continual improvement of processes based on objective measurement. The model of a process-based quality management system shown in Figure 1 illustrates the process linkages presented in clauses 4 to 8. This illustration shows that customers play a significant role in defining requirements as inputs. Monitoring of customer satisfaction requires the evaluation of information relating to customer perception as to whether the organization has met the customer requirements. The model shown in Figure 1 covers all the requirements of this Standard, but does not show processes at a detailed level. NOTE In addition, the methodology known as “Plan-Do-Check-Act” (PDCA) can be applied to all processes. PDCA can be briefly described as follows.
EN 9110:2005 (E) 5 Plan: establish the objectives and processes necessary to deliver results in accordance with customer requirements and the organization's policies. Do: implement the processes. Check: monitor and measure processes and product against policies, objectives and requirements for the product and report the results. Act: take actions to continually improve process performance. Figure 1 — Model of a process-based quality management system Customers CustomersContinual improvement of the quality management system Satisfaction Resource managementManagement responsibilityMeasurement, analysis and improvementRequirements Input Product Output Product realizationKey
Value-adding activities
Information flow
EN 9110:2005 (E) 6 1 Scope 1.1 General This standard includes ISO 9001:2000 1) quality management system requirements and specifies additional requirements for a quality management system for aerospace maintenance organizations. The additional aerospace requirements are shown in bold, italic text. It is emphasized that the quality management system requirements specified in this standard are complementary (not alternative) to contractual and applicable law and regulatory requirements. This Standard specifies requirements for a quality management system where an organization a) needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements, and b) aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable regulatory requirements. NOTE In this Standard, the term “product” applies only to the product intended for, or required by, a customer. 1.2 Application All requirements of this Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided. Where any requirement(s) of this Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion. Where exclusions are made, claims of conformity to this Standard are not acceptable unless these exclusions are limited to requirements within Clause 7, and such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable regulatory requirements. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 9000:2000, Quality management systems — Fundamentals and vocabulary. 1) With the permission of the International Organization for Standardization (ISO). The complete standard may be obtained from any ISO member or from the ISO Central Secretariat, Case Postale 56, 1211 Geneva 20, SWITZERLAND. Copyright remains with ISO.
EN 9110:2005 (E) 7 3 Terms and definitions 3.1 General For the purposes of this Standard, the terms and definitions given in ISO 9000 apply. The following terms, used in this edition of ISO 9001 to describe the supply chain, have been changed to reflect the vocabulary currently used:
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.
EN 9110:2005 (E) 8 4 Quality management system 4.1 General requirements The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this Standard. Maintenance organizations shall obtain and maintain any required quality management system approvals and any other approvals, certificates, ratings, licenses, and permits required by the responsible Authority. The organization shall a) identify the processes needed for the quality management system and their application throughout the organization (see 1.2), b) determine the sequence and interaction of these processes, c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective, d) ensure the availability of resources and information necessary to support the operation and monitoring of these processes, e) monitor, measure and analyse these processes, and f) implement actions necessary to achieve planned results and continual improvement of these processes. These processes shall be managed by the organization in accordance with the requirements of this Standard. Where an organization chooses to outsource any process that affects product conformity with requirements, the organization shall ensure control over such processes.
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.
EN 9110:2005 (E) 9 NOTE 1 Where the term “documented procedure” appears within this Standard, this means that the procedure is established, documented, implemented and maintained. NOTE 2 The extent of the quality management system documentation can differ from one organization to another due to a) the size of organization and type of activities, b) the complexity of processes and their interactions, and c) the competence of personnel. NOTE 3 The documentation can be in any form or type of medium. 4.2.2 Quality manual The organization shall establish and maintain a quality manual that includes a) the scope of the quality management system, including details of and justification for any exclusions (see 1.2), b) the documented procedures established for the quality management system, or reference to them, and − when referencing the documented procedures, the relationship between the requirements of this International Standard and the documented procedures shall be clearly shown. c) a description of the interaction between the processes of the quality management system. NOTE Guidance on quality manuals is given in ISO/TR 10013. 4.2.3 Control of documents Documents required by the quality management system shall be controlled. Records are a special type of document and shall be controlled according to the requirements given in 4.2.4. A documented procedure shall be established to define the controls needed a) to approve documents for adequacy prior to issue, b) to review and update as necessary and re-approve documents, c) to ensure that changes and the current revision status of documents are identified, d) to ensure that relevant versions of applicable documents are available at points of use, e) to ensure that documents remain legible and readily identifiable, f) to ensure that documents of external origin are identified and their distribution controlled, and g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.
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.
EN 9110:2005 (E) 10 4.3 Configuration management The organization shall establish, document and maintain a configuration management process appropriate to the product.
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
EN 9110:2005 (E) 11 b) the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented. 5.5 Responsibility, authority and communication 5.5.1 Responsibility and authority Top management shall ensure that the responsibilities and authorities are defined and communicated within the organization. 5.5.1.1 Accountable executive manager
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
EN 9110:2005 (E) 12 a) results of audits, b) customer feedback, c) process performance and product conformity, d) status of preventive and corrective actions, e) follow-up actions from previous management reviews, f) changes that could affect the quality management system, g) recommendations for improvement, and h) results of audits and requests for corrective action from Authorities. 5.6.3 Review output The output from the management review shall include any decisions and actions related to a) improvement of the effectiveness of the quality management system and its processes, b) improvement of product related to customer requirements, and c) resource needs. 6 Resource management 6.1 Provision of resources The organization shall determine and provide the resources needed. a) to implement and maintain the quality management system and continually improve its effectiveness, and b) to enhance customer satisfaction by meeting customer requirements. 6.2 Human resources 6.2.1 General Personnel performing work affecting product quality shall be competent on the basis of appropriate education, training, skills and experience. Non-certificated personnel shall be assessed on their ability to satisfactorily carry out maintenance operations prior to performing the work. 6.2.2 Competence, awareness and training The organization shall a) determine the necessary competence for personnel performing work affecting product quality,
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),
EN 9110:2005 (E) 13 f) ensure that personnel performing maintenance release of aircraft and aircraft components are qualified and certified in accordance with Authority requirements, g) establish a continuation training program to ensure that personnel performing specific tasks remain current in terms of procedures, human factors and technical knowledge, and
h) ensure that continuation training is pro
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