EN 9104-001:2013
(Main)Aerospace series - Quality management systems - Part 001: Requirements for Aviation, Space, and Defence Quality Management System Certification Programs
Aerospace series - Quality management systems - Part 001: Requirements for Aviation, Space, and Defence Quality Management System Certification Programs
This European Standard defines the requirements and industry-accepted practices for managing the ICOP scheme, which provides confidence to aviation, space, and defence customers and organizations that their suppliers with certification of their quality management systems, issued by accredited CBs, meet the applicable AQMS standard requirements. The requirements established in this standard are applicable to the IAQG and its three sectors for managing AQMS certification and associated activities. The requirements are applicable to IAQG working groups [e.g. SMS, Other Party Management Team (OPMT)], IAQG member companies, ABs, CBs, Certification Body Management Committees (CBMCs), AABs, TPABs, Training Providers (TPs), and organizations seeking/obtaining AQMS standard certification.
The AQMS standard adopted by the organization should be EN 9100, EN 9110, and/or EN 9120, as appropriate to the organization’s activities; these standards are referred to throughout this writing as ‘AQMS standards’. IAQG member companies have committed to recognize the certification of a supplier’s quality management system to all equivalent AQMS standards (e.g. AS, EN, JISQ, NBR). IAQG sectors may expand the application of the requirements defined in this standard for other standards approved by the IAQG and its three sectors [i.e., Americas Aerospace Quality Group (AAQG), European Aerospace Quality Group (EAQG), Asia/Pacific Aerospace Quality Group (APAQG)].
Luft- und Raumfahrt - Qualitätsmanagmentsysteme - Teil 001: Anforderungen an Zertifizierungsverfahren für Qualitätsmanagementsysteme der Luftfahrt, Raumfahrt und Verteidigung
Diese Europäische Norm legt die Anforderungen und die von der Industrie anerkannten Vorgehensweisen für die Handhabung des ICOP Schemes fest, die für die Kunden und Organisationen der Luftfahrt, Raumfahrt und Verteidigung das Vertrauen schaffen, dass ihre Lieferanten mit durch akkreditierte Zertifizierungsstellen zertifizierten Qualitätsmanagementsystemen die Anforderungen der anzuwendenden AQMS Normen erfüllen. Die in dieser Norm aufgestellten Anforderungen sind anzuwenden für die IAQG und ihre drei Sektoren für die Handhabung der AQMS Zertifizierung und damit verbundener Tätigkeiten. Die Anforderungen gelten für IAQG-Arbeitsgruppen [z. B. SMS, Managementteam der dritten Seite (OPMT, en: Other Party Management Team)], IAQG Mitgliedsunternehmen, Akkreditierungsstellen, Zertifizierungsstellen, Steuergremien für Zertifi-zierungsstellen (CBMCs), AABs, TPABs, Schulungsanbieter (TPs) und Organisationen, die eine Zertifizierung nach AQMS Norm anstreben oder erhalten.
Die Organisation muss entsprechend ihrem Tätigkeitsfeld die Norm(en) EN 9100, EN 9110 und/oder EN 9120 anwenden. In diesem Dokument werden diese Normen durchgängig als „AQMS Normen“ bezeichnet. Die IAQG Mitgliedsunternehmen haben sich verpflichtet, die Zertifizierung des Qualitätsmanagementsystems eines Lieferanten nach allen gleichwertigen AQMS Normen anzuerkennen (z. B. AS, EN, JISQ, NBR). IAQG Sektoren dürfen die Anwendung der in dieser Norm festgelegten Anforderungen auf weitere durch die IAQG und ihre drei Sektoren [d. h. Americas Aerospace Quality Group (AAQG), European Aerospace Quality Group (EAQG), Asia/Pacific Aerospace Quality Group (APAQG)] zugelassene Normen ausweiten.
Série aérospatiale - Systèmes de management de la qualité - Partie 001: Exigences applicables aux processus de certification des systèmes de management de la qualité dans le domaine aéronautique, spatial et de défense
L’objet de la présente Norme européenne est de définir les exigences et les pratiques répandues dans
l'industrie pour la gestion du schéma ICOP qui donne l'assurance aux clients et aux organismes dans le
domaine aéronautique, spatial et de défense que leurs fournisseurs dont la certification de leurs systèmes de
management de la qualité a été délivrée par des OC accrédités, satisfont les exigences des normes de SMQA
applicables. Les exigences établies dans la présente norme sont applicables à l'IAQG et à ses trois secteurs
pour gérer la certification de SMQA et les activités associées. Les exigences sont applicables aux groupes de
travail de l'IAQG (par exemple : SMS, Équipe de management autre partie [OPMT]), sociétés membres de
l'IAQG, OA, OC, Comité d'harmonisation des organismes de certification CBMC), AAB, TPAB, prestataires de
formation, et organismes recherchant/obtenant la certification selon les normes de SMQA.
Il convient que les normes de SMQA adoptées par l'organisme soient les EN 9100, EN 9110 et/ou l’EN 9120,
appropriées aux activités de l'organisme ; ces normes sont appelées "normes de SMQA" tout au long de ce
texte. Les sociétés membres de l'IAQG se sont engagées à reconnaître la certification du système de
management de la qualité des fournisseurs selon toutes les normes de SMQA équivalentes (par exemple : AS,
EN, JISQ, NBR). Certains secteurs de l’IAQG peuvent étendre l'application des exigences définies dans la
présente norme à d'autres normes approuvées par l'IAQG et ses trois secteurs [c.-à-d., Americas Aerospace
Quality Group (AAQG), European Aerospace Quality Group (EAQG), Asia/Pacific Aerospace Quality Group
(APAQG)].
Aeronavtika - Sistemi vodenja kakovosti - 001. del: Zahteve za programe certificiranja sistemov vodenja kakovosti v letalstvu, vesoljskih dejavnostih in obrambi
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
01-februar-2014
1DGRPHãþD
SIST EN 9104:2009
Aeronavtika - Sistemi vodenja kakovosti - 001. del: Zahteve za programe
certificiranja sistemov vodenja kakovosti v letalstvu, vesoljskih dejavnostih in
obrambi
Aerospace series - Quality management systems - Part 001: Requirements for Aviation,
Space, and Defence Quality Management System Certification Programs
Luft- und Raumfahrt - Qualitätsmanagementsysteme - Teil 001: Anforderungen an
Zertifizierungsprogramme für Qualitätsmanagementsysteme in der Luftfahrt, Raumfahrt
und Verteidigung
Série aérospatiale - Systèmes de management de la qualité - Partie 001: Exigences
applicables aux processus de certification des systèmes de management de la qualité
dans le domaine aéronautique, spatial et de défense
Ta slovenski standard je istoveten z: EN 9104-001:2013
ICS:
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.
EUROPEAN STANDARD
EN 9104-001
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2013
ICS 03.120.10; 49.020 Supersedes EN 9104:2006
English Version
Aerospace series - Quality management systems - Part 001:
Requirements for Aviation, Space, and Defence Quality
Management System Certification Programs
Série aérospatiale - Systèmes de management de la Luft- und Raumfahrt - Qualitätsmanagementsysteme - Teil
qualité - Partie 001: Exigences applicables aux processus 001: Anforderungen an Zertifizierungsprogramme für
de certification des systèmes de management de la qualité Qualitätsmanagementsysteme in der Luftfahrt, Raumfahrt
dans le domaine aéronautique, spatial et de défense und Verteidigung
This European Standard was approved by CEN on 10 November 2012.
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, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2013 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 9104-001:2013: E
worldwide for CEN national Members.
Contents Page
Foreword . 4
Introduction . 5
Rationale . 6
1 Scope . 8
2 Normative references . 8
3 Terms and definitions . 9
4 Requirements of the sector management structure . 12
5 Requirements for accreditation bodies . 14
6 Requirements for certification bodies . 20
7 For aerospace requirements quality management system auditors . 23
8 Requirements for audits and reporting . 23
9 Requirements for oversight process. 36
10 Requirements for auditor authentication bodies . 36
11 Requirements for training provider approval bodies . 38
12 Online aerospace supplier information system database . 40
13 Requirements of the other party management team . 41
14 Online aerospace supplier information system database feedback process . 42
15 Sector management structure . 43
16 Cross frontier policy for EN 9104/2 oversight activity . 45
17 Records . 45
18 Requirements for certified organizations . 46
19 Confidentiality and conflicts of interest . 46
20 Fees and financials . 47
21 NOTES . 47
Appendix A ACRONYM LOG . 48
Appendix B Industry controlled other party scheme certification structures matrix for
9100/9110/9120:2009 certification audits . 49
Appendix C Information to be uploaded into the online aerospace supplier information system
database . 51
Figures and Tables Page
Table 1 — Accreditation body assessment requirements of certification bodies . 17
Table 2 — Audit duration requirements . 25
Table 3 — Multiple site organization audit frequency . 27
Table 4 — Permissible reductions for reduced SCOPE / complexity for several site organizations . 28
Table 5 — Online aerospace supplier information system database data responsibility . 40
Figure 1 — Illustration of the customer – Supplier – Certification body feedback loops within
the online aerospace supplier information system database . 43
Figure 2 — Sector management structure diagram . 44
Foreword
This document (EN 9104-001:2013) 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 September 2013, and conflicting national standards shall be withdrawn at the
latest by September 2013.
This document supersedes EN 9104:2006.
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.
According to the CEN-CENELEC Internal Regulations, the national standards organizations 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, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Introduction
In December 1998, the aviation, space, and defence industry established the IAQG with the goal of achieving
significant improvements in quality and reductions in cost throughout the value stream.
The IAQG developed specific requirements for aviation, space, and defence (interchangeably referred to as
'aerospace') quality management systems that are to be implemented and maintained throughout the supply chain
for the design, manufacture, and maintenance of products used in aviation, space, and defence applications.
These requirements are published simultaneously as the EN 9100-series standards (i.e., EN 9100, EN 9110,
EN 9120) by SAE International in the Americas, AeroSpace and Defence Industries Association of Europe -
Standardization (ASD-STAN) in Europe, and Japanese Standards Association (JSA) and Society of Japanese
Aerospace Companies (SJAC) in Asia/Pacific.
Another initiative of the IAQG was the development of a global scheme for the acceptance and recognition of
audits performed by Certification Bodies (CBs), using the EN 9100-series standards, and taking into account the
schemes already in use or under development in the various IAQG sectors. All these schemes have two major
elements in common:
rd
• the use of a 3 party audit certification scheme with specific aviation, space, and defence elements and
requirements, under the guidance and oversight of the aviation, space, and defence industry; and
• the use of a harmonized approach with the CBs for the purpose of improving the quality and process control
throughout the entire supply chain.
Rationale
After the initial publication of International Aerospace Quality Group (IAQG) EN 9104 standard in 2004, it became
evident that a single standard containing all aspects of the Industry Controlled Other Party (ICOP) Aerospace
Quality Management System (AQMS) was too complex. It was decided that the standard be broken into three
sections:
• EN 9104-001 – Requirements for Aviation, Space, and Defence Quality Management System Certification
Programs;
• EN 9104-002 – Requirements for Oversight of Aerospace Quality Management System Registration/
Certification Programs; and
• EN 9104-003 – Requirements for Aerospace Auditor Competency and Training Courses.
The requirements for oversight and AQMS auditor qualification information (EN 9104-002 and EN 9104-003
respectively) were removed from the original EN 9104 text. This effort necessitated the total rewrite of the initial
standard, now re-designated as EN 9104-001, which is the keystone document of the EN 9104-series trilogy.
This standard defines the basic requirements for managing the AQMS certification scheme (commonly referred to
as the 'ICOP scheme'). Two other standards in this series (i.e., EN 9104-002, EN 9104-003) provide specific
requirements for defining the oversight process, and the AQMS auditor qualification and training requirements,
respectively. These three standards together are commonly referred to as the ICOP certification management
system 'Trilogy'.
This standard establishes provisions for the individual IAQG sector schemes controlled use of audit results
provided by CBs, based on three primary criteria:
• the use of accredited CBs;
• the CB’s use of qualified and authenticated AQMS auditors; and
• the use of international aviation, space, and defence standards for quality management systems.
This standard addresses the following elements necessary for the ICOP scheme:
a) the approval of Accreditation Bodies (ABs), Auditor Authentication Bodies (AABs), and Training
Provider Approval Bodies (TPABs);
b) the qualification, accreditation, and recognition of CBs;
c) the audits of quality management systems by accredited CBs;
d) the criteria for determining the certification structure, content, and duration of audits;
e) the recording and disposition of nonconformities generated by the audits;
f) the posting of audit results, findings, and certification;
g) the entry of data into the Online Aerospace Supplier Information System (OASIS) database; and
h) the use of International Accreditation Forum (IAF) guidance and mandatory documents for established
processes (e.g. audit duration calculations, multiple site certifications).
Additionally, this standard references the other standards in the EN 9104-series (i.e., EN 9104-002, EN 9104-003)
that specify:
i) the minimum standards of qualification and experience for AQM
...
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