EN 9101:2023
(Main)Aerospace series - Quality management systems - Requirements for conducting audits of aviation, space, and defence quality management Systems
Aerospace series - Quality management systems - Requirements for conducting audits of aviation, space, and defence quality management Systems
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).
Luft- und Raumfahrt - Qualitätsmanagementsysteme - Anforderungen für die Durchführung von Audits von Qualitätsmanagementsystemen in der Luft- und Raumfahrt und Verteidigung
1.1 Allgemeines
Dieses Dokument legt die Anforderungen an Vorbereitung und Ausführung des Auditprozesses fest. Außerdem legt es den Inhalt und die Form der Audit-Berichterstattung über die Konformität und Prozesseffektivität in Bezug auf die Normen der Normenfamilie EN 9100 sowie die Dokumentation des QMS der Organisation, die Anforderungen von Kunden und gesetzliche/behördliche Anforderungen fest.
Die Anforderungen in diesem Dokument sind Ergänzungen oder stellen Änderungen zu den Anforderungen und Richtlinien in den von ISO/IEC veröffentlichten Normen zur Konformitätsbewertung, zur Auditierung und Zertifizierung dar (z. B. ISO/IEC 17000:2020, ISO/IEC 17021 1). Bestehen Widersprüche zu diesen Normen, haben die Anforderungen dieses Dokuments Vorrang.
ANMERKUNG 1 In diesem Dokument umfasst der Begriff „Normen der Normenfamilie EN 9100“ die Normen EN 9100, EN 9110 und EN 9120, die von der IAQG entwickelt und von verschiedenen nationalen Normungsgremien veröffentlicht wurden.
ANMERKUNG 2 Zusätzlich zu diesem Dokument veröffentlicht die IAQG empfohlene Anwendungshinweise auf der IAQG-Website (siehe http://www.iaqg.org), die von Auditteams bei der Ausführung des Auditprozesses verwendet werden können.
1.2 Anwendung
Dieses Dokument ist dafür bestimmt, für Audits nach der Normenfamilie EN 9100 durch Zertifizierungsstellen (CB, en: Certification Body) zur Zertifizierung von Organisationen im Rahmen des Zertifizierungssystems der ASD-industrie (auch bekannt als Schema der durch die Industrie überwachten dritten Seite [en: Industry Controlled Other Party, ICOP]) angewendet zu werden. Die Anforderungen des ICOP-Schemas sind in den Normen der Normenreihe EN 9104 festgelegt (d. h. EN 9104 1, EN 9104 2, EN 9104 3).
ANMERKUNG Geeignete Abschnitte dieses Dokuments können von einer Organisation zur Unterstützung interner Audits (Audits von erster Seite) und externer Audits bei Zulieferern (Audits von zweiter Seite) angewendet werden.
Série aérospatiale - Systèmes de management de la qualité - Exigences pour la conduite d’audits des systèmes de management de la qualité dans l’aéronautique, l’espace et la défense
1.1 Généralités
Le présent document définit les exigences relatives à la préparation et à l’exécution du processus d'audit. De plus, il définit le contenu et la composition des rapports relatifs à la conformité et à l'efficacité du processus par rapport aux normes de la série EN 9100, à la documentation du SMQ de l’organisme et aux exigences client ainsi que légales/réglementaires.
Les exigences dans le présent document sont des ajouts ou traduisent des modifications apportées aux exigences et aux recommandations des normes d'évaluation de la conformité, d'audit et de certification publiées par l'ISO/CEI (à savoir l'ISO/CEI 17000:2020 et l'ISO/CEI 17021 1). En cas de contradiction avec ces normes, les exigences de la norme EN 9101 doivent prévaloir.
NOTE 1 Dans le présent document, le terme « normes de la série EN 9100 » englobe les normes EN 9100, EN 9110 et EN 9120 développées par l'IAQG et publiées par différents organismes de normalisation nationaux.
NOTE 2 En plus du présent document, l'IAQG publie des supports sur son site web (voir https://www.iaqg.org) qui peuvent être utilisés par les équipes d'audit lors de l’exécution du processus d'audit.
1.2 Application
Le présent document est destiné à être utilisé pour les audits selon les normes de la série EN 9100 par les organismes de certification (OC) pour la certification des organismes, sous l'égide du schéma de certification de l'industrie ASD [aussi connu en tant que schéma ICOP (Industry Controlled Other Party)]. Les exigences du schéma ICOP sont définies dans les normes de la série EN 9104 (c’est-à-dire : EN 9104 1, EN 9104 2, EN 9104 3).
NOTE Les paragraphes appropriés du présent document peuvent également être utilisés par un organisme en support des audits internes (1re partie) et des audits externes chez les fournisseurs (2e partie).
Aeronavtika - Sistemi vodenja kakovosti - Zahteve za presojo sistemov vodenja kakovosti organizacij zračnega prometa, vesoljskih poletov in obrambe
Ta dokument določa zahteve za pripravo in izvedbo postopka presoje. Poleg tega določa vsebino in sestavo za poročanje o presoji glede skladnosti ter učinkovitosti postopka v skladu s skupino standardov 9100, dokumentacijo sistema vodenja kakovosti (QMS) organizacije, zahtevami za stranke ter zahtevami zakonodaje in predpisov.
Zahteve v tem dokumentu so dodatki ali predstavljajo spremembe zahtev in smernic v standardih za ugotavljanje skladnosti, presojo in certificiranje, kot je objavljeno v standardih ISO/IEC (tj. ISO/IEC 17000, ISO/IEC 17021-1). V primeru nasprotij s temi standardi imajo prednost zahteve iz standarda 9101.
OPOMBA 1: Izraz »skupina standardov 9100« v tem dokumentu vključuje standarde 9100, 9110 in 9120, ki jih je zasnovala organizacija IAQG, objavili pa različni nacionalni organi za standarde.
OPOMBA 2: Organizacija IAQG poleg tega dokumenta na spletnem mestu IAQG objavlja tudi pomožno gradivo za pripravo (glej http://www.sae.org/iaqg/), ki ga lahko uporabljajo skupine za presojo med izvajanjem presoje.
1.2 Uporaba
Ta dokument je namenjen za uporabo pri presojah skupine standardov 9100, ki jih izvajajo certifikacijski organi (CB) za certificiranje organizacij, v okviru industrijske certifikacijske sheme ASD (z drugim imenom shema ICOP – Industry Controlled Other Party). Zahteve sheme ICOP so opredeljene v skupini standardov 9104 (tj. EN 9104-001, EN 9104-002, EN 9104-003).
OPOMBA: Organizacija lahko ustrezne dele tega dokumenta uporablja tudi za podporo notranjih presoj (presoja prve stranke) in zunanjih presoj pri dobaviteljih (presoja druge stranke).
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-januar-2024
Aeronavtika - Sistemi vodenja kakovosti - Zahteve za presojo sistemov vodenja
kakovosti organizacij zračnega prometa, vesoljskih poletov in obrambe
Aerospace series - Quality management systems - Requirements for conducting audits
of aviation, space, and defence quality management Systems
Qualitätsmanagementsysteme - Luft- und Raumfahrt - Anforderungen an die
Durchführung von Audits von Qualitätsmanagementsystemen in Luftfahrt, Raumfahrt
und Verteidigung
Série aérospatiale - Systèmes de management de la qualité - Exigences pour la
conduite d’audits des systèmes de management de la qualité dans l’aéronautique,
l’espace et la défense
Ta slovenski standard je istoveten z: EN 9101:2023
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 9101
EUROPEAN STANDARD
NORME EUROPÉENNE
November 2023
EUROPÄISCHE NORM
ICS 03.100.70; 03.120.10; 03.120.20; 49.020 Supersedes EN 9101:2018
English Version
Aerospace series - Quality management systems -
Requirements for conducting audits of aviation, space, and
defence quality management Systems
Série aérospatiale - Systèmes de management de la Qualitätsmanagementsysteme - Luft- und Raumfahrt -
qualité - Exigences pour la conduite d'audits des Anforderungen an die Durchführung von Audits von
systèmes de management de la qualité dans Qualitätsmanagementsystemen in Luftfahrt, Raumfahrt
l'aéronautique, l'espace et la défense und Verteidigung
This European Standard was approved by CEN on 7 August 2023.
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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye 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
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 9101:2023 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
0. Introduction . 4
1 Scope . 6
1.1 General. 6
1.2 Application . 6
2 Normative references . 6
3 Terms and definitions . 7
4 Auditing and reporting . 8
4.1 General. 8
4.2 Audit program . 9
4.3 Audit reporting . 9
5 Common audit activities . 11
5.1 General. 11
5.2 Audit planning. 11
5.3 Conducting audits . 13
5.4 Audit report . 17
5.5 Nonconformity management . 17
6 Audit phase specific requirements . 19
6.1 General. 19
6.2 Pre-audit activities (initial audit) . 19
6.3 Stage 1 audit . 20
6.4 Stage 2 audit . 22
6.5 Surveillance audit . 22
6.6 Recertification audit . 23
6.7 Special audit . 23
Annex A (informative) Acronym log . 24
Annex B (informative) Forms . 25
Bibliography . 30
Tables
Table 1 — Audit reporting requirements . 10
Table 2 — Special audit reporting requirements . 11
Table 3 — Relationship between common activities and audit phases . 12
Table 4 — Process evaluation matrix . 16
Table 5 — Nonconformity report management time frames . 18
European foreword
This document (EN 9101:2023) 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
document has received the approval of the National Associations and the Official Services of the
member countries of ASD-STAN, prior to its presentation to CEN.
This document shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by May 2024, and conflicting national standards shall be
withdrawn at the latest by May 2024.
Attention is drawn to the possibility that some of the elements of this document may be the subject
of patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN 9101:2018.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this document: Austria, Belgium, Bulgaria, Croatia,
Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Türkiye and the United Kingdom.
0 Introduction
0.1 General
This document has been revised to align with the latest revision of the International Aerospace Quality
Group (IAQG) 9104-1 standard, incorporating inputs received from interested parties, standard
clarifications, and Other Party Management Team (OPMT) resolutions.
Industry established the IAQG, with representatives from Aviation, Space, and Defence (ASD)
companies in the Americas, Asia/Pacific, and Europe, to implement initiatives that make significant
improvements in quality and reductions in cost throughout the value stream.
This document has been prepared by the IAQG and standardizes the requirements for conducting audits
of ASD Quality Management Systems (QMS). It can be used at all levels of the supply chain by
organizations around the world.
This document supplements the existing International Organization for Standardization
(ISO)/International Electrotechnical Commission (IEC) 17021-1 conformity assessment standard and
provides requirements for an audit and reporting process, based on the:
a) process and continual improvement approach defined in EN 9100-series standards;
b) specific ASD additions in EN 9100-series standards;
c) use of common audit tools; and
d) uniform, transparent, and standardized reporting of audit results.
In this document, the following terms are used:
— “shall” indicates a requirement;
— “should” indicates a recommendation;
— “may” indicates a permission;
— “can” indicates a possibility or capability; and
— “days” are calendar days.
Words “example” or “e.g.” indicate suggestions given for guidance, and information marked “NOTE” is
for guidance in understanding or clarifying the associated requirement .
Auditing is a basic tool to assess effective implementation of and conformity to QMS requirements.
In addition to assessing conformity, this document focuses on the evaluation of effectiveness
(see ISO 9000:2015, 3.7.11) of the QMS and its associated processes.
An organization is not only required to be in conformity with QMS requirements, but to be effective in
meeting customer expectations and delivering products and services that meet those expectations.
Notes to entry used in definitions, however, are considered normative and will provide additional information
that supplements the terminological data such as statements, instructions, recommendations or requirements
relating to the use of a term.
0.2 Auditing approach
This document supports the engagement and evaluation of an organization's QMS process approach, as
required by the EN 9100-series standards. When evaluating an organization's QMS, there are basic
questions that should be asked of every process, for example:
a) Is the process appropriately determined?
b) Are responsibilities assigned?
c) Are the processes adequately implemented and maintained?
d) Is the process effective in achieving the desired results?
The collective answers to these and other associated questions will contribute to the evaluation results.
In addition, product and service quality (as delivered), customer satisfaction, and QMS effectiveness can
be considered as interrelated. This relationship should be reflected in the audit process and associated
results.
0.3 Audit documented information
This document defines the documented information to be generated, during the audit process.
The documented information is critical in providing the organization and its customers with objective
evidence on the conformity and effectiveness of the QMS (including process effectiveness) and
reporting the audit results in a standard format/structure.
1 Scope
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
...
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