EN 9101:2018
(Main)Quality Management Systems - Audit Requirements for Aviation, Space, and Defence Organisations
Quality Management Systems - Audit Requirements for Aviation, Space, and Defence Organisations
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., EN ISO/IEC 17000, EN ISO/IEC 17021-1). When there is conflict with these standards, the requirements of the EN 9101 standard shall take precedence.
NOTE 1 In this standard, the term "EN 9100-series standards" comprises the following Aerospace Quality Management System (AQMS) standards: EN 9100, EN 9110, and EN 9120; developed by the IAQG and published by various national standards bodies.
NOTE 2 In addition to this standard, the IAQG publishes deployment support material on the IAQG website (see http://www.sae.org/iaqg/) that can be used by audit teams, when executing the audit process.
1.2 Application
This document shall be used for audits of EN 9100-series standards by CBs for certification of organizations, under the auspices of the aviation, space, and defence 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., EN 9104-001, EN 9104-002, EN 9104-003).
NOTE Relevant parts of this standard can also be used by an organization in support of internal audits (1st party) and external audits at suppliers (2nd party).
Qualitätsmanagementsysteme - Audit-Anforderungen für Organisationen der Luftfahrt, Raumfahrt und Verteidigung
1 Anwendungsbereich
1.1 Allgemeines
Dieses Dokument legt die Anforderungen an die 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 Normenreihe EN 9100 sowie die Dokumentation des QMS der Organisation und die Anforderungen von Kunden und behördliche/gesetzliche 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. EN ISO/IEC 17000, EN ISO/IEC 17021 1). Bestehen Widersprüche zu diesen Normen, haben die Anforderungen der EN 9101 Vorrang.
ANMERKUNG 1 In dieser Norm umfasst der Begriff „Normen der Normenreihe EN 9100“ die folgenden Normen zu Qualitätsmanagementsystemen der Luft- und Raumfahrt (AQMS, en: Aerospace Quality Management System): EN 9100, EN 9110 und EN 9120, die von der IAQG entwickelt und von verschiedenen nationalen Normungsinstituten veröffentlicht wurden.
ANMERKUNG 2 Zusätzlich zu dieser Norm veröffentlicht die IAQG empfohlene Anwendungshinweise auf der IAQG Website (siehe http://www.sae.org/iaqg/), die von Auditteams bei der Ausführung des Auditprozesses angewendet werden können.
1.2 Anwendung
Dieses Dokument ist für Audits nach den Normen der Normenreihe EN 9100 durch Zertifizierungsstellen (CB) zur Zertifizierung von Organisationen im Rahmen des Zertifizierungssystems der Luftfahrt-, Raumfahrt- und Verteidigungsindustrie (auch bekannt als Schema der durch die Industrie überwachten dritten Seite [en: Industry Controlled Other Party, ICOP]) anzuwenden. Die Anforderungen des ICOP Schemas sind in den Normen der Normenreihe EN 9104 festgelegt (d. h. EN 9104 001, EN 9104 002, EN 9104 003).
ANMERKUNG Geeignete Abschnitte dieser Norm können von einer Organisation zur Unterstützung interner Audits (Audits von erster Seite) und externer Audits bei Zulieferern (Audits von zweiter Seite) angewendet werden.
Systèmes de Management de la Qualité - Exigences d’Audits pour les Organisations de l'Aéronautique, l'Espace et la Défense
1 Domaine d'application
1.1 Généralités
Le présent document définit les exigences relatives à la préparation et à la réalisation du processus d’audit. De plus, elle définit le contenu et la composition des rapports relatifs à la conformité et à l’efficacité par rapport aux normes de la série EN 9100, à la documentation du SMQ 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 (c’est-à-dire : EN ISO/CEI 17000, EN ISO/CEI 17021-1). En cas de contradiction avec ces normes, les exigences de la norme 9101 prévalent.
NOTE 1 Dans la présente norme, le terme « normes de la série 9100 » englobe les normes Système de Management de la Qualité Aéronautique Spatial et Défense suivantes : EN 9100, EN 9110, et EN 9120 ; développées par l’IAQG et publiées par différents organismes de normalisation nationaux.
NOTE 2 En plus de la présente norme, l’IAQG publie des pratiques recommandées sur son site Internet (voir http://www.sae.org/iaqg/) qui peuvent être utilisées par les équipes d’audit lors de la réalisation du processus d’audit.
1.2 Application
Le présent document doit être utilisé pour les audits selon les normes de la série 9100 par les organismes de certification (OC) pour la certification des organismes, sous l’égide du schéma de certification de l’industrie aéronautique, spatiale et de défense [aussi connu en tant que schéma ICOP (Industry Controlled Other Party)]. Les exigences du dispositif ICOP sont définies dans les normes de la série EN 9104 (c’est-à-dire : EN 9104-001, EN 9104-002, EN 9104-003).
NOTE Les paragraphes appropriés de la présente norme peuvent également être utilisés par un organisme dans le cadre des audits internes (1ère partie) et des audits externes chez les fournisseurs (2ème partie).
Sistemi vodenja kakovosti - Zahteve za presojo organizacij zračnega prometa, vesoljskih poletov in obrambe
Ta dokument standard 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 EN 9100, dokumentacijo sistema vodenja kakovosti 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. EN ISO/IEC 17000, EN ISO/IEC 17021-1). V primeru nasprotij s temi standardi imajo prednost zahteve iz standarda EN 9101.
OPOMBA 1: v tem standardu izraz »skupina standardov EN 9100« zajema naslednje standarde sistema vodenja kakovosti v aeronavtiki (AQMS): EN 9100, EN 9110 in EN 9120; pripravil IAQG, objavili pa različni nacionalni organi za standarde.
OPOMBA 2: IAQG poleg tega standarda na spletnem mestu IAQG objavlja tudi pomožni material za pripravo (glej http://www.sae.org/iaqg/), ki ga lahko uporabljajo skupine za presojo med izvajanjem presoje.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2018
1DGRPHãþD
SIST EN 9101:2015
6LVWHPLYRGHQMDNDNRYRVWL=DKWHYH]DSUHVRMRRUJDQL]DFLM]UDþQHJDSURPHWD
YHVROMVNLKSROHWRYLQREUDPEH
Quality Management Systems - Audit Requirements for Aviation, Space, and Defence
Organisations
Qualitätsmanagementsysteme - Audit-Anforderungen für Organisationen der Luftfahrt,
Raumfahrt und Verteidigung
Systèmes de Management de la Qualité - Exigences d’Audits pour les Organisations de
l'Aéronautique, l'Espace et la Défense
Ta slovenski standard je istoveten z: EN 9101:2018
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 9101
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2018
EUROPÄISCHE NORM
ICS 03.100.70; 03.120.10; 03.120.20; 49.020 Supersedes EN 9101:2015
English Version
Quality Management Systems - Audit Requirements for
Aviation, Space, and Defence Organisations
Systèmes de Management de la Qualité - Exigences Qualitätsmanagementsysteme - Audit-Anforderungen
d'Audits pour les Organisations de l'Aéronautique, für Organisationen der Luftfahrt, Raumfahrt und
l'Espace et la Défense Verteidigung
This European Standard was approved by CEN on 10 March 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 9101:2018 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
Rationale . 4
Foreword . 4
0 Introduction . 5
0.1 General . 5
0.2 Auditing approach . 5
0.3 Audit records and reports . 5
1 Scope . 6
1.1 General . 6
1.2 Application . 6
2 Normative references . 6
3 Terms and definitions . 7
4 Auditing and reporting. 9
4.1 General . 9
4.1.1 Audit process . 9
4.1.2 Reporting . 10
4.2 Common audit activities . 10
4.2.1 Audit planning . 11
4.2.2 Conducting on-site audits. 12
4.2.3 Audit report . 16
4.2.4 Nonconformity management . 17
4.3 Audit phase specific requirements . 18
4.3.1 Pre-audit activities . 18
4.3.2 Stage 1 audit . 19
4.3.3 Stage 2 audit . 21
4.3.4 Surveillance audit . 22
4.3.5 Recertification audit . 22
4.3.6 Special audit . 23
Annex A (informative) Acronym log . 24
Annex B (informative) Forms . 25
B.1 EN 9101 Form 1: Stage 1 Audit Report . 25
B.2 EN 9101 Form 2: QMS Process Matrix Report . 27
B.3 EN 9101 Form 3: Process Effectiveness Assessment Report . 28
B.4 EN 9101 Form 4: Nonconformity Report (NCR) . 28
B.5 EN 9101 Form 5: Audit Report . 29
B.6 EN 9101 Form 6: Supplemental Audit Report . 30
Tables
Table 1 — Audit reporting matrix . 10
Table 2 — Relationship between common activities and audit phases . 11
Table 3 — Process evaluation matrix . 16
European foreword
This document (EN 9101:2018) 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 November 2018, and conflicting national standards
shall be withdrawn at the latest by November 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 9101:2015.
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 standard has been revised to incorporate the requirements for accredited Certification Bodies
(CBs) introduced by International Organization for Standardization (ISO) / International
Electrotechnical Commission EN ISO/IEC 17021-1:2015, the 2016 changes to International Aerospace
Quality Group EN 9100-series standards Quality Management System (QMS) requirements, and inputs
received from interested parties relating to process-based auditing methods and the evaluation of
process effectiveness.
Foreword
To assure customer satisfaction, aviation, space, and defence organizations must provide and
continually improve safe and reliable products and services that meet or exceed customer and
applicable statutory and regulatory requirements. The globalization of the industry and the resulting
diversity of regional and national requirements and expectations have complicated this objective.
Organizations have the challenge of purchasing products and services from suppliers, throughout the
world, at all levels of the supply chain. Suppliers have the challenge of delivering products and services
to multiple customers having varying quality requirements and expectations.
Industry established the IAQG, with representatives from aviation, space, and defence 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 and
reporting of QMS audits. It can be used at all levels of the supply chain by organizations around the
world.
It provides requirements for an audit and reporting process, based on the:
• process and continual improvement approach defined in EN 9100-series standards;
• specific aviation, space, and defence additions in EN 9100-series standards;
• use of common audit tools; and
• uniform, transparent, and standardized reporting of audit results.
In this standard, the following terms are used:
• “shall” indicates a requirement;
• “should” indicates a recommendation;
• “may” indicates a permission; and
• “can” indicates a possibility or capability.
Words “typical”, “example”, or “e. g.” indicate suggestions given for guidance. Information marked
“NOTE” is for guidance in understanding or clarifying the associated requirement.
0 Introduction
0.1 General
Auditing is a basic tool to assess effective implementation of and conformity to QMS requirements. In
addition to assessing conformity, this standard focuses on the evaluation of effectiveness
(see EN ISO 9000 clause 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.
Additionally, this standard takes into account the requirements presented in the 2016 revisions of the
EN 9100-series standards.
0.2 Auditing approach
This standard 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 relationshi
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