EN 9101:2018

SLOVENSKI STANDARD
01-julij-2018
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SIST EN 9101:2015
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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
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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