EN 9133:2018
(Main)Aerospace series - Quality Management Systems - Qualification Procedure for Aerospace Standard Products
Aerospace series - Quality Management Systems - Qualification Procedure for Aerospace Standard Products
1.1 General
This document defines a system for the qualification of standard products for aviation, space, and defenc applications. It defines the principles that shall be adhered to when carrying out product qualification; applied in conjunction with the rules and procedures of the CA. The system enables the CA to confirm compliance is achieved and maintained, in accordance with the requirements of its product definition and associated controlling technical specifications by an Original Component Manufacturer (OCM) of standard products.
This document requires an OCM that has been granted product qualification approval to ensure applicable approvals are maintained and renewed in accordance with the CA’s quality system for that qualified product.
OCMs and OCM designated Value Added Distributors (VADs) requesting product qualification to this standard, shall as a prerequisite, maintain EN 9100 standard quality management system certification approval. This certification shall be visible in the Online Aerospace Supplier Information System (OASIS) database.
1.2 Application
The application of this document will be mandated either in the product standard or its controlling technical specifications. When invoked, the OCM wanting to produce aerospace standard products will need to gain qualification approval from an aerospace CA. The processes defined herein will be performed impartially for the benefit of the aerospace industry, by the CA, to ensure continued compliance of standard products to the requirements defined in their controlling technical specifications.
OCMs will need to ensure they allow sufficient lead-time to complete this process to gain product approval from the CA to support/satisfy their customer delivery requirements. Qualified products using this process shall not be supplied or used without qualification approval and a valid Product Qualification Certificate (PQC) being granted.
Luft- und Raumfahrt - Qualitätsmanagementsystem - Qualifikationsverfahren für genormte Teile der Luft- und Raumfahrt
1.1 Allgemeines
Dieses Dokument legt ein System für die Qualifikation von genormten Produkten für Anwendungen in der Luftfahrt, Raumfahrt und Verteidigung, fest. Sie legt die Grundsätze fest, die bei der Durchführung der Produktqualifikation eingehalten werden müssen und in Verbindung mit den Regeln und Verfahren der Zertifizierungsstelle angewendet werden. Das System ermöglicht der Zertifizierungsstelle, einem Original¬teilhersteller (OCM, en: Original Component Manufacturer) von genormten Produkten das Erreichen und Aufrechterhalten der Übereinstimmung entsprechend den Anforderungen der Produktfestlegung und den zugehörigen maßgebenden technischen Lieferbedingungen zu bestätigen.
Dieses Dokument fordert von einem Originalteilhersteller, dem eine Bauartzulassung für das Produkt erteilt wurde, sicherzustellen, dass die entsprechenden Zulassungen in Übereinstimmung mit dem Qualitäts¬sicherungssystem der Zertifizierungsstelle für das qualifizierte Produkt aufrechterhalten und erneuert werden.
OCM und vom OCM benannte Value-Added-Distributoren (VAD), die eine Produktqualifikation nach dieser Norm beantragen, müssen als Vorbedingung die Zertifizierung und Zulassung nach dem Qualitätsmanage¬mentsystem nach EN 9100 aufrechterhalten. Diese Zertifizierung muss in der Datenbank des Online Aerospace Supplier Information System (OASIS) sichtbar sein.
1.2 Anwendung
Die Anwendung dieses Dokuments wird entweder in der Produktnorm oder den maßgebenden technischen Lieferbedingungen vorgeschrieben. Der Originalteilhersteller, der genormte Produkte der Luft- und Raum¬fahrt herzustellen beabsichtigt, muss eine Bauartzulassung durch eine Zertifizierungsstelle für die Luft- und Raumfahrt anstreben, wenn dies geltend gemacht wird. Die dabei festgelegten Prozesse werden unparteiisch im Interesse der Luft- und Raumfahrtindustrie durch eine Zertifizierungsstelle durchgeführt, um eine fortlaufende Übereinstimmung der genormten Produkte mit den Anforderungen, die in ihren maßgebenden technischen Lieferbedingungen festgelegt sind, sicherzustellen.
Originalteilhersteller werden sicherstellen müssen, dass sie ausreichend Vorlaufzeit für den Abschluss die¬ses Prozesses einräumen, um von der Zertifizierungsstelle eine Produktzulassung für die Unter¬stützung/Er¬füllung der Lieferanforderungen ihrer Kunden zu erhalten. Qualifizierte Produkte, für die dieser Prozess angewendet wird, dürfen ohne Bauartzulassung und ohne ein gültiges Produktqualifikations¬zertifikat (PQC, en: Product Qualification Certificate) nicht geliefert oder verwendet werden.
Série aérospatiale - Systèmes de management de la qualité - Procédure de qualification pour pièces aérospatiales normalisées
1.1 Généralités
Le présent document définit un système de qualification des produits normalisés pour les applications aéronautiques, spatiales et de défense. Il définit les principes qui doivent être respectés lors de la qualification du produit ; elle s’applique conjointement avec les règles et procédures de l’AC. Le système permet à l'AC de confirmer que la conformité est atteinte et maintenue, conformément aux exigences de sa définition de produit et des spécifications techniques de contrôle associées, par un Fabricant de pièces d'origine (OCM) de produits normalisés.
Le présent document exige un OCM qui a obtenu l'approbation de la qualification du produit pour garantir que les approbations applicables sont maintenues et renouvelées conformément au système qualité de l'AC pour ce produit qualifié.
Les OCM et les Distributeurs à valeur ajoutée (DVA) désignés par l'OCM qui demandent la qualification du produit selon la présente norme doivent, comme condition préalable, maintenir l'agrément de certification des systèmes de management de la qualité de la norme EN 9100. Cette certification doit être visible dans la base de données du Système d'information en ligne des fournisseurs de l'aérospatiale (OASIS).
1.2 Application
L'application du présent document est rendue obligatoire soit dans la norme de produit, soit dans ses spécifications techniques de contrôle. Lorsqu’appelé, l'OCM qui veut produire des produits normalisés dans le domaine aérospatial doit obtenir l'approbation de qualification d'une AC aérospatiale. Les processus définis dans le présent document doivent être exécutés de manière impartiale au profit de l'industrie aérospatiale, par l’AC, afin d'assurer la conformité continue des produits normalisés aux exigences définies dans leurs spécifications techniques de contrôle.
Les OCM doivent s'assurer qu'ils accordent un délai de mise en œuvre suffisant pour mener à bien ce processus afin d'obtenir l'approbation de l’AC pour appuyer/satisfaire les exigences de livraison de leurs clients. Les produits qualifiés par ce processus ne doivent pas être fournis ou utilisés sans l'approbation de la qualification et l'obtention d'un Certificat de qualification de produit (CQP) valide.
Aeronavtika - Sistemi vodenja kakovosti - Postopek za razvrščanje standardiziranih proizvodov v aeronavtiki
Ta dokument opredeljuje sistem za razvrščanje standardiziranih proizvodov za uporabo na področju zračnega prometa, vesoljskih poletov in obrambe. Opredeljuje načela, ki jih je treba upoštevanju pri razvrščanju proizvodov; uporablja se skupaj s pravili in postopki CA. Sistem omogoča CA, da potrdi doseganje in ohranjanje skladnosti v skladu z zahtevami opredelitve izdelka in povezanih nadzornih tehničnih specifikacij, ki jih zagotovi proizvajalec originalne komponente (OCM) za standardizirane proizvode.
Ta dokument zahteva, da OCM, ki je prejel odobritev kvalifikacije proizvoda, poskrbi za ohranjanje in obnavljanje ustreznih odobritev v skladu s sistemom kakovosti pri CA za zadevni razvrščeni proizvod.
OCM-ji in distributerji z dodano vrednostjo (VAD), ki jih določijo OCM-ji, ki zahtevajo kvalifikacijo proizvoda po tem standardu, morajo kot predpogoj imeti odobritev certifikata za sistem vodenja kakovosti po standardu EN 9100. Ta certifikat mora biti viden v podatkovni bazi sistema Online Aerospace Supplier Information System (OASIS).
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2018
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SIST EN 9133:2005
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VWDQGDUGL]LUDQLKSURL]YRGRYYDHURQDYWLNL
Aerospace series - Quality Management Systems - Qualification Procedure for
Aerospace Standard Products
Luft- und Raumfahrt - Qualitätsmanagementsystem - Qualifikationsverfahren für
genormte Teile der Luft- und Raumfahrt
Série aérospatiale - Systèmes de management de la qualité - Procédure de qualification
pour pièces aérospatiales normalisées
Ta slovenski standard je istoveten z: EN 9133:2018
ICS:
03.100.70 Sistemi vodenja Management systems
03.120.10 Vodenje in zagotavljanje Quality management and
kakovosti quality assurance
49.020 Letala in vesoljska vozila na Aircraft and space vehicles in
splošno general
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN 9133
EUROPEAN STANDARD
NORME EUROPÉENNE
June 2018
EUROPÄISCHE NORM
ICS 03.100.70; 03.120.10; 49.020 Supersedes EN 9133:2004
English Version
Aerospace series - Quality Management Systems -
Qualification Procedure for Aerospace Standard Products
Série aérospatiale - Systèmes de management de la Luft- und Raumfahrt - Qualitätsmanagementsystem -
qualité - Procédure de qualification pour pièces Qualifikationsverfahren für genormte Teile der Luft-
aérospatiales normalisées und Raumfahrt
This European Standard was approved by CEN on 18 September 2017.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 9133:2018 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
Rationale . 4
Foreword . 4
1 Scope . 5
1.1 General . 5
1.2 Application . 5
2 Normative references . 5
3 Terms and definitions . 6
4 Qualification process . 10
5 Mandated body representative registration . 12
6 Qualification procedure . 12
7 Qualification activity report . 14
8 Qualification requested by analogy . 15
9 Qualification requested by grandfather product status . 16
10 Certification procedure . 16
11 Qualified products list . 17
12 Qualified product certification maintenance and renewal . 17
13 Manufacturing change request for a manufacturing sealed route . 18
14 Value added distributors . 18
15 Quality failures, noncompliance, and customer complaints . 19
(informative) Acronym log . 20
(informative) Mandated Body — Product Qualification Activity Report (QAR)
Template example . 21
European foreword
This document (EN 9133:2018) has been prepared by the Aerospace and Defence Industries
Association of Europe - Standardization (ASD-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
ASD, 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 December 2018, and conflicting national standards
shall be withdrawn at the latest by December 2018.
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.
This document supersedes EN 9133:2004.
According to the CEN-CENELEC Internal Regulations, the national standards organisations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Rationale
This document has undergone full technical revision to reflect improvements introduced to the product
qualification process and incorporate identified best practices since its initial release.
This document defines the process by which a manufacturer wishing to manufacture aviation, space,
and defence standard products may obtain qualification approval from the controlling Certification
Authority (CA). It defines the procedures to be followed by a manufacturer to request, carry out, obtain,
and maintain certification approval by confirming the manufactured products meet the minimum
technical and performance requirements defined by the product standard and controlling technical
specifications.
Foreword
To assure customer satisfaction, the aviation, space, and defence industry organizations must produce
and continually improve safe, reliable products that meet or exceed customer and regulatory authority
requirements. The globalization of the industry and the complexity of resulting organizations’ supply
chains have complicated this objective. End-product organizations face the challenge of assuring the
quality of, and integrating, product purchased from suppliers throughout the world and at all levels
within the supply chain. Furthermore, the aviation, space, and defence suppliers and processors, within
the industry, face the challenge of delivering product to multiple customers having varying quality
expectations and requirements.
The aviation, space, and defence industry established the International Aerospace Quality Group (IAQG)
for the purpose of achieving significant improvements in quality and safety, and reductions in cost,
throughout the value stream. This organization includes representation from aviation, space, and
defence companies in the Americas, Asia/Pacific, and Europe. This document defines the qualification of
standard products and should result in improved quality and safety, and decreased cost, due to the
standardization of this process.
1 Scope
1.1 General
This document defines a system for the qualification of standard products for aviation, space, and
defenc applications. It defines the principles that shall be adhered to when carrying out product
qualification; applied in conjunction with the rules and procedures of the CA. The system enables the CA
to confirm compliance is achieved and maintained, in accordance with the requirements of its product
definition and associated controlling technical specifications by an Original Component Manufacturer
(OCM) of standard products.
This document requires an OCM that has been granted product qualification approval to ensure
applicable approvals are maintained and renewed in accordance with the CA’s quality system for that
qualified product.
OCMs and OCM designated Value Added Distributors (VADs) requesting product qualification to this
standard, shall as a prerequisite, maintain EN 9100 standard quality management system certification
approval. This certification shall be visible in the Online Aerospace Supplier Information System
(OASIS) database.
1.2 Application
The application of this document will be mandated either in the product standard or its controlling
technical specifications. When invoked, the OCM wanting to produce aerospace standard products will
need to gain qualification approval from an aerospace CA. The processes defined herein will be
performed impartially for the benefit of the aerospace industry, by the CA, to ensure continued
compliance of standard products to the requirements defined in their controlling technical
specifications.
OCMs will need to ensure they allow sufficient lead-time to complete this process to gain product
approval from the CA to support/satisfy their customer delivery requirements. Qualified products using
this process shall not be supplied or used without qualification approval and a valid Product
Qualification Certificate (PQC) being granted.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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.
EN 9100, Quality Management Systems — Requirements for Aviation, Space and Defence Organizations
EN 9102, Aerospace series — Quality systems — First article inspection requirements
EN 9103, Aerospace series — Quality management systems — Variation management of key
characteristics
NOTE Equivalent versions (e.g. AS, EN, JISQ, SJAC, NBR) of the IAQG standards listed above are published
internationally in each IAQG sector.
EN ISO 9000, Quality management systems — Fundamentals and vocabulary
EN ISO 9001, Quality management systems — Requirements
ISO 10012, Measurement management systems — Requirements for measurement processes and
measuring equipment
ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories
ASD-CERT Quality Manual (see www.asd-cert.org)
AC7101/1 , Nadcap Audit Criteria for Materials Testing Laboratories — General Requirements for all
Laboratories
AC7102 , Nadcap Audit Criteria for Heat Treating
AC7108 , Nadcap Audit Criteria for Chemical Processing
AC7114 , Nadcap Audit Criteria for Nondestructive Testing (NDT) Suppliers — Accreditation Program
PD2000 , Governance and Administration of an Industry Managed Product Qualification Program
PD2001 , Manufacturer Request for Product Approval and Qualification Process
3 Terms and definitions
For the purpose of this document, the terms and definitions provided in EN ISO 9000 and the following
apply. Furthermore, an acronym log for this standard is presented in Annex A.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
3.1
analogy
act of granting product qualification certification approval based on testing that has been carried out on
similar qualified product; where the new standard product’s manufacturing method is substantially the
same as the manufacturing method of the existing qualified product
3.2
Certification Authority
CA
authority that administers a certification system for qua
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