SIST EN 2000:2001
(Main)Aerospace series - Quality assurance - EN aerospace products - Approval of the quality system of manufacturers
Aerospace series - Quality assurance - EN aerospace products - Approval of the quality system of manufacturers
This standard prescribes the requirements and the procedure for approving the quality system implemented by the manufacturer, for manufacturing EN aerospace products. It also provides instructions for verifying that this approved system is maintained. It is applicable whenever referenced.
Luft- und Raumfahrt - Qualitätssicherung - EN-Erzeugnisse der Luft- und Raumfahrt - Anerkennung des Qualitätssicherungssystems der Hersteller
Diese Norm legt die Anforderungen sowie das Verfahren zur Anerkennung des Qualita"tssicherungssystems eines Herstellers fu"r die Fertigung von Erzeugnissennach EN-Normen der Luft- und Raumfahrt fest. Sie entha"lt auch Angaben zur Feststellung der Aufrechterhaltung dieses anerkannten Systems. Sie ist anzuwenden, wenn auf sie Bezug genommen wird.
Série aérospatiale - Assurance qualité - Produits aérospatiaux EN - Agrément du systeme qualité des fabricants
La présente norme prescrit les exigences et la procédure pour agréer le système qualité mis en place par le fabricant en vue de la fabrication des produits aérospatiaux EN. Elle donne aussi des instructions pour vérifier le maintien du niveau du système agréé. Elle s'applique chaque fois qu'elle est référencée.
Aerospace series - Quality assurance - EN aerospace products - Approval of the quality system of manufacturers
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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Aerospace series - Quality assurance - EN aerospace products - Approval of the quality system of manufacturersLuft- und Raumfahrt - Qualitätssicherung - EN-Erzeugnisse der Luft- und Raumfahrt - Anerkennung des Qualitätssicherungssystems der HerstellerSérie aérospatiale - Assurance qualité - Produits aérospatiaux EN - Agrément du systeme qualité des fabricantsAerospace series - Quality assurance
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1 Scope
1.1 General
The aviation, space, and defence industries rely on the development and manufacture of complex products comprised of multiple systems, subsystems, and components each designed by individual designers (design activities) at various levels within the supply chain. Each design or manufacturing activity controls various aspects of the configuration and specifications related to the product. When a change to design or process is requested or required, the change is typically required to be evaluated against the impacts to the entire system.
Proposed changes to design data/information that the design activity identifies to be minor and have no effect on the product requirements or specifications, have the potential to be implemented and approved, where authorized to do so, but requires notification. Changes that affect customer mandated requirements or specifications shall be approved prior to implementation. In many cases, the design activity is not conducted by the DAH or design authority. The design activity may be several layers below the design approval. Irrespective of where the design activity is conducted in the supply chain, notification is required. The typical change notification flow is presented in Figure 1.
[Figure 1]
Submitting NOC data either electronically or conventionally on paper is subject to the terms and conditions of the customer’s contract. This also includes, where applicable, data access under the regulations of export control.
The process of exchanging, coordinating, and approving NOC data varies with the multiple relationships and agreements among all organizations concerned. An objective of this document is to provide the definition of a data set that can be integrated into any form of communication (e.g. electronic data interchange, submission of conventional paper forms). A sample form can be found in the Supply Chain Management Handbook (SCMH).
If all or part of this document is contractually invoked, design organizations and design holders (i.e. the organization responsible for the product end item design) that have responsibility for change management of products used on other higher-level designs shall use the information and processes defined in this document for submitting change notifications.
1.2 Application
This document defines the common NOC requirements for aviation, space, and defence organizations. The requirements that a design organization are to use when submitting a NOC to the customer for either change authorization or notification are included herein. A NOC informs the customer of physical or functional (e.g. design, material, software, maintenance) changes or any associated process changes to an established baseline configuration.
Retention of the NOC establishes a means of configuration control and captures the evolution of the part. This requirement is of utmost importance in commercial/civil aviation products where changes to type certificated products are mandated by regulations; however, these same concepts are also required in defence and space applications per contractual requirements.
Where there are changes to items which the organization does not have design input or is not permitted to make any changes to the design [e.g. build to print, Technical Standard Order (TSO) articles] then change requests are to be formally submitted to the customer and approved via the customer’s change request process.
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1.1 General
This document establishes the requirements for performing and documenting FAI. It is emphasized the requirements specified in this document are complementary (not alternative) to customer and applicable statutory and regulatory requirements.
1.2 Purpose
The primary purpose of FAI is to verify and validate product realization processes are capable of producing characteristics that meet engineering and design requirements. A well-planned and executed FAI by a multi-disciplinary team (e.g. members from responsible functions) provides objective evidence the manufacturer’s processes can produce compliant product; having effectively understood and incorporated the associated requirements.
NOTE A FAI is not a product acceptance document. While interrelated, FAI and product acceptance are separate activities. The focus of FAI is verification of production processes via assessment of product. FAI and supporting documentation do not provide assurance regarding conformance for product acceptance purposes; neither does the lack of a FAI necessarily imply product is nonconforming to engineering and design requirements.
FAI will:
- provide confidence, through objective evidence, the product realization processes are capable of producing conforming product;
- demonstrate the manufacturers and processors of the product have an understanding of the associated requirements;
- provide assurance of product conformance at the start of production and after changes, as outlined in this document.
A FAI is intended to:
- mitigate risks associated with production startup and process changes;
- reduce future escapes;
- help ensure product safety;
- improve quality, delivery, and customer satisfaction;
- reduce costs and production delays associated with product nonconformances;
- identify product realization processes not capable of producing conforming characteristics and initiate and/or validate associated corrective actions.
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1.3 Application
This document applies to organizations and their suppliers responsible for product realization processes that produce the design characteristics of the product. The organization shall flow down the requirements of this document to suppliers who produce design characteristics.
This document also applies to suppliers performing special process(es). A certificate of conformance (CoC) provided by processors attests to satisfying the requirements. External suppliers providing special process(es) can satisfy this document's requirements by either:
- documenting the design characteristics and associated results on a first article inspection report (FAIR); or
- documenting the design characteristics and associated results on a detailed CoC.
This document applies to assemblies, sub-assemblies, and detail parts including castings, forgings, and modifications to standard catalogue or commercial-off-the-shelf (COTS) items. Each of these items have a separate FAI.
Unless contractually required, this document does not apply to:
- development and prototype parts that are not considered as part of the first production run;
- procured standard catalogue item, COTS, or deliverable software. When these items are included in an assembly, they shall be documented in the index of part numbers in an assembly FAIR.
1.4 Informative
If there is a conflict between the requirements of this document, and customer or applicable statutory/regulatory requirements, the latter takes precedence.
In this document, the following verbal forms are used:
- "shall" indicates a requirement;
- "should" indicates a recommendation;
- "may" indicates a permission;
- "can" indicates a possibility or a capability.
Information marked as "NOTE" is for guidance in understanding or clarifying the associated requirement .
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This document defines the minimum requirements for auditors, CBs, auditor authentication bodies (AABs), training provider approval bodies (TPABs), and training providers (TPs) who participate in the IAQG industry controlled other party (ICOP) scheme. The requirements in this document supplement those defined within the EN 9104-001, EN 9104-002, EN ISO/IEC 17021-1, and EN ISO/IEC 17021-3 standards.
Data protection for the parties subject to this document and other relevant requirements of the ICOP scheme are managed via bi-lateral contracts between the joint controllers of the data.
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This document defines the industry-accepted requirements for the ICOP scheme, which provides confidence to ASD customers, that organizations with certification of their QMS, issued by accredited CBs, meet applicable AQMS standard requirements. The requirements in this document are applicable to all participants in the ICOP scheme. If there is a conflict between the requirements of this document, and customer or applicable statutory/regulatory requirements, the latter takes precedence.
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1.1 General
This document defines requirements for the preparation and execution of the audit process. In addition, it defines the content and composition for the audit reporting of conformity and process effectiveness to the EN 9100-series standards, the organization’s QMS documentation, and customer and statutory/regulatory requirements.
The requirements in this document are additions or represent changes to the requirements and guidelines in the standards for conformity assessment, auditing, and certification as published by ISO/IEC (i.e. ISO/IEC 17000:2020, ISO/IEC 17021 1). When there is conflict with these standards, the requirements of this document take precedence.
NOTE 1 In this document, the term “EN 9100-series standards” comprises the EN 9100, EN 9110, and EN 9120 standards; developed by the IAQG and published by various national standards bodies.
NOTE 2 In addition to this document, the IAQG publishes deployment support material on the IAQG website (see http://www.iaqg.org) that can be used by audit teams, when executing the audit process.
1.2 Application
This document is intended to be used for audits of EN 9100-series standards by Certification Bodies (CBs) for certification of organizations, under the auspices of the ASD industry certification scheme [also known as the Industry Controlled Other Party (ICOP) scheme]. The ICOP scheme requirements are defined in the EN 9104-series standards (i.e. FprEN 9104-1, prEN 9104-2, EN 9104 3).
NOTE Relevant parts of this document can also be used by an organization in support of internal audits (1st party) and external audits at suppliers (2nd party).
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1.1 General
This document is primarily intended to apply to new parts and products intended to be produced in an on-going production phase but can also be applied to parts currently in production (e.g., manufacturing, maintenance). This document is applicable to all production processes that influence the variation of KCs, as well as maintenance and service processes in which KCs are identified. It applies to organizations for assemblies and all levels of parts within an assembly, down to the basic materials including castings and forgings, and to organizations that are responsible for producing the design characteristics of the product.
The variation control process begins with product definition, typically stated in the design documentation (e.g., digital model, engineering drawing, specification) which identifies KCs, and leads to a variation management process for those KCs. This process may also be used for producer-identified KCs (e.g., process KCs, additional/substitute product KCs).
Producers and their subcontractors are responsible for flow down of the standard requirements to those external providers, who produce design characteristics and provide production and service provisions, to ensure that KCs conform to the customer’s requirements.
1.2 Purpose
This document is designed to drive the improvement of manufacturing and maintenance processes through adequate planning and effective management of KC variation. This focus is intended to improve uniformity (less variation or minimum variation of product KCs) and acceptance probability of the end-product.
NOTE Control of a product or process KC per this document does not constitute, nor imply acceptance of the resulting product. If variation management, under this document, is to be part of an acceptance decision, the requirements need to be specified in the applicable product acceptance plan or contract.
1.3 Convention
The following conventions are used in this document:
- "shall" indicates a requirement;
- "should" indicates a recommendation;
- "may" indicates a permission; and
- "can" indicates a possibility or a capability.
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1.1 General
This document is limited to the aerospace industry, where an approved manufacturer requests a supplier to ship an article against the approved manufacturer’s quality system directly to a customer. The direct ship process is not required or applicable to standard parts or military parts. In this process, the approved manufacturer is responsible for assurance that the article conforms to type design information.
1.2 Purpose
This document provides guidance to approved manufacturers, their suppliers, and customers when an approved manufacturer requests a supplier to ship an article against the approved manufacturer’s purchase document directly to a customer, commonly known as “Direct Ship”.
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1.1 Application
This standard defines the common nonconformity data definition and documentation that shall be exchanged between an internal/external supplier or sub-tier supplier, and the customer when informing about a nonconformity requiring formal decision. The requirements are applicable, partly or totally, when reporting a product nonconformity to the owner or operator, as user of the end item (e.g., engine, aircraft, spacecraft, helicopter), if specified by contract.
Reporting of nonconformity data, either electronically or conventionally on paper, is subject to the terms and conditions of the contract. This also includes, where applicable, data access under export control regulations.
1.2 Purpose
The process of exchanging, coordinating, and approving nonconformity data via concession or product quality escape varies with the multiple relationships and agreements among all parties concerned. The information provided by this standard forms architecture for submitting and managing data that allows for concise and accurate communication using various documented methods. The main objective of this standard is to provide the definition of a data set that can be integrated into any form of communication (e.g., electronic data interchange, submission of conventional paper forms).
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1.1 General
This document provides requirements and guidance for the retention, storage, retrieval and disposal of records for the international aviation, space and defense industry.
1.2 Applicability
1.2.1 This document is applicable to all documents and data records, on current and earlier products, produced using current and previous business agreements and applicable statutory and regulatory requirements.
1.2.2 Documents should be interpreted in the broadest possible sense to include all records, data and information, in paper or in electronic form or on film, including external providers working on own behalf.
1.2.3 Some documents may be retained electronically. The form in which documents are to be retained varies from one jurisdiction to another and varies depending on the document involved. Some countries prescribe that certain documents be retained in their original form as a hardcopy (e.g. board minutes, documents under seal, trust documents and original documents that are subject to specific legal requirements…).
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1.1 Purpose
This European standard establishes requirements when implementing statistical product acceptance methods to meet defined risk requirements. This standard also establishes the minimum content required to be covered in an organization’s documented procedures that govern their application of statistical product acceptance methods.
These general requirements and documented procedures apply the requirements of the EN 9100/EN 9110/EN 9120 quality management system standards, in addition to establishing requirements for retrievability, safety/critical characteristics, and quality parameters that protect the customer.
1.2 Application
This standard is applicable when invoked in a purchasing contract or specification, contractual document, customer agreement, or adopted by the organization. The purchase contract/agreement may or may not identify the appropriate EN 9138 clause(s) to be applied by the organization. All statistical methods of product acceptance require the use of Clause 4 and Clause 5.
To accept product produced:
- by individual lots, see Clause 6;
- under switching rules, see Clause 7;
- under process controls, see Clause 8; and
- by continuous sampling or special case methods, see Clause 9.
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