EN 9101:2015
(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 European Standard 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 European Standard 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, ISO/IEC 17021). When there is conflict with these standards, the requirements of the EN 9101 standard shall take precedence.
NOTE 1 In this European 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 European 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 European Standard shall be used for audits of EN 9100-series standards by CBs for certification of organisations, under the auspices of the aviation, space, and defence industry certification scheme [also known as Industry Controlled Other Party (ICOP) scheme]. The ICOP scheme requirements are defined in the EN 9104-series standards (i.e. EN 9104/1, EN 9104/2, EN 9104/3).
NOTE Relevant parts of this European Standard can 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
1.1 Allgemeines
Diese Europäische Norm legt die Anforderungen an die Vorbereitung und Ausführung des Auditprozesses fest. Außerdem legt sie den Inhalt und die Form der Audit-Berichterstattung über die Konformität und Prozesswirksamkeit 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 dieser Europäischen Norm sind Ergänzungen oder stellen Änderungen zu den Anforde¬rungen und Richtlinien in den von ISO/IEC veröffentlichten Normen zur Konformitätsbewertung, zur Auditie¬rung und Zerti¬fizierung dar (z. B. ISO/IEC 17000, ISO/IEC 17021). Bestehen Widersprüche zu diesen Nor¬men, haben die Anforderungen der EN 9101 Vorrang.
ANMERKUNG 1 In dieser Europäischen 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 Normungs¬instituten veröffentlicht wurden.
ANMERKUNG 2 Zusätzlich zu dieser Europäischen 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
Diese Europäische Norm ist für Audits nach den Normen der Normenreihe EN 9100 durch Zertifizierungs-stellen (CB) zur Zertifizierung von Organisationen im Rahmen des Zertifizierungssystems der Luft-, Raum-fahrt- und Verteidi¬gungsindustrie [auch bekannt als Schema der durch die Industrie überwachten dritten Seite (en: Industry Con¬trolled 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 Europäischen 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
1.1 Généralités
La présente Norme européenne définit les exigences relatives à la préparation et à l’exécution 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 Système de Management de la Qualité et aux exigences client, statutaires/réglementaires.
Les exigences de la présente norme 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.-à-d. : ISO/CEI 17000, ISO/CEI 17021). En cas de contradiction avec ces normes, les exigences de la norme EN 9101 prévalent.
NOTE 1 Dans la présente Norme européenne, le terme “normes de la série EN 9100” comprennent les normes de systèmes de la qualité 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
La présente Norme européenne doit être utilisée 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 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. à d. : EN 9104/1, EN 9104/2, EN 9104/3).
NOTE Les paragraphes appropriés de la présente Norme européenne peuvent être utilisés par un organisme en soutien 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 evropski 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 in zahtevami zakonodaje in predpisov.
Zahteve v tem evropskem standardu so dodatki ali predstavljajo spremembe zahtev in smernic v standardih za ugotavljanje skladnosti, presojo in certificiranje, kot je objavljeno v ISO/IEC (tj. ISO/IEC 17000, ISO/IEC 17021). V primeru nasprotij s temi standardi imajo prednost zahteve iz standarda EN 9101.
OPOMBA 1: V tem evropskem 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: Poleg tega evropskega standarda IAQG objavlja tudi pomožni material za razporeditev na spletnem mestu IAQG (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-oktober-2015
1DGRPHãþD
SIST EN 9101:2011
6LVWHPLYRGHQMDNDNRYRVWL=DKWHYH]DSUHVRMRRUJDQL]DFLM]UDþQHJDSURPHWD
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Quality Management Systems - Audit Requirements for Aviation, Space, and Defence
Organisations
Qualitätsmanagementsysteme - Audit-Anforderungen für Organisationen der Luftfahrt,
Raumfahrt und Verteidigung
Série aérospatiale - 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 9101:2015
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.
EN 9101
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2015
EUROPÄISCHE NORM
ICS 03.120.10; 49.020 Supersedes EN 9101:2011
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 20 March 2015.
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
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 9101:2015 E
worldwide for CEN national Members.
Contents Page
European foreword . 4
0 Introduction . 5
0.1 General . 5
0.2 Auditing approach . 6
0.3 Audit records and reports . 6
1 Scope . 7
1.1 General . 7
1.2 Application . 7
2 Normative references . 7
3 Terms and definitions . 8
4 Auditing and reporting . 10
4.1 General . 10
4.1.1 Audit process . 10
4.1.2 Audit approaches . 12
4.1.2.1 Customer focus . 12
4.1.2.2 Organisational leadership . 12
4.1.2.3 Quality management system performance and effectiveness . 12
4.1.2.4 Process management . 13
4.1.2.5 Special processes . 14
4.1.2.6 Continual improvement . 14
4.1.3 Reporting . 14
4.2 Common audit activities . 15
4.2.1 Audit planning . 16
4.2.2 Conducting on-site audits . 17
4.2.2.1 General . 17
4.2.2.2 Conducting the opening meeting . 17
4.2.2.3 Site tour . 17
4.2.2.4 Audit conduct . 18
4.2.2.5 Identifying and recording of audit findings . 18
4.2.2.5.1 Process results . 18
4.2.2.5.2 Process realization . 19
4.2.2.5.3 Process effectiveness . 19
4.2.2.6 Preparing audit conclusions . 19
4.2.2.7 Conducting the closing meeting . 20
4.2.3 Audit report . 20
4.2.4 Nonconformity management . 21
4.3 Audit phase specific requirements . 22
4.3.1 Pre-audit activities . 22
4.3.1.1 Application . 22
4.3.1.2 Application Review . 22
4.3.1.2.1 Requirements for the Certification Body . 22
4.3.1.2.2 Requirements for the audit team leader . 23
4.3.2 Stage 1 Audit . 23
4.3.2.1 General . 23
4.3.2.2 Collection of information . 23
4.3.2.3 Review of the organization . 24
4.3.2.4 Stage 1 conclusions . 26
4.3.3 Stage 2 audit. 26
4.3.4 Surveillance audit . 26
4.3.5 Recertification audit . 27
4.3.6 Special audit. 27
5 Notes . 27
Appendices
Appendix A (informative) ACRONYM LOG . 28
Appendix B (normative) FORMS . 29
Figures and Tables
Figure 1 — Overview of audit process flow . 11
Table 1 — CERTIFICATION STRUCTURE REPORTING MATRIX . 15
Table 2 — RELATIONSHIP BETWEEN COMMON ACTIVITIES AND AUDIT PHASES . 16
Table 3 — PROCESS EVALUATION MATRIX . 20
European foreword
This document (EN 9101:2015) 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 European
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 March 2016, and conflicting national standards shall
be withdrawn at the latest by March 2016.
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 9101:2011.
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.
RATIONALE
This European standard has been revised to incorporate the requirements for accredited Certification
Bodies (CBs) introduced by International Organization for Standardization (ISO) / International
Electrotechnical Commission (IEC) ISO/IEC 17021:2011, EN 9104/1:2012, and inputs received from
industry stakeholders associated to process-based auditing methods and the evaluation of process
effectiveness.
FOREWORD
To assure customer satisfaction, aviation, space, and defence organisations must produce and
continually improve safe reliable products that meet or exceed customer and applicable
statutory/regulatory requirements. The globalization of the industry and the resulting diversity of
regional and national requirements and expectations have complicated this objective. Organisations
...
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