EN 9101:2011

SLOVENSKI STANDARD
01-september-2011
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SIST EN 9101:2008
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Quality Management Systems - Audit Requirements for Aviation, Space, and Defence
Organizations
Qualitätsmanagementsysteme - Audit-Anforderungen für Organisationen der Luftfahrt,
Raumfahrt und Verteidigung
Systèmes de management de la Qualité - Exigences d’audit pour les Organismes de
l’Aéronautique, l'Espace et la Défense
Ta slovenski standard je istoveten z: EN 9101:2011
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 9101
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2011
ICS 03.120.20; 49.020 Supersedes EN 9101:2008
English Version
Quality Management Systems - Audit Requirements for Aviation,
Space, and Defence Organizations
Systèmes de management de la Qualité - Exigences Qualitätsmanagementsysteme - Audit-Anforderungen für
d'audit pour les Organismes de l'Aéronautique, l'Espace et Organisationen der Luftfahrt, Raumfahrt und Verteidigung
la Défense
This European Standard was approved by CEN on 28 March 2011.

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, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.

EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2011 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 9101:2011: E
worldwide for CEN national Members.

Contents Page
Foreword . 3
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 . 8
4.1 General . 8
4.1.1 Audit Process . 9
4.1.2 Audit Methodology . 11
4.2 Common Audit Activities . 15
4.2.1 Audit Planning . 15
4.2.2 On-site Audits . 16
4.2.3 Audit Reporting . 19
4.2.4 Nonconformity Management . 19
4.2.5 Audit Records . 20
4.3 Audit Phase Specific Requirements . 20
4.3.1 Pre-audit Activities . 20
4.3.2 Stage 1 Audit . 21
4.3.3 Stage 2 Audit . 24
4.3.4 Surveillance . 25
4.3.5 Recertification . 25
4.3.6 Special Audits . 26
Annex A (normative) Objective Evidence Record (OER) . 28
Annex B (normative) Nonconformity Report (NCR) . 53
Annex C (normative) Process Effectiveness Assessment Report (PEAR) . 56
Annex D (normative) QMS Process Matrix Report . 58
Annex E (normative) Audit Report (Stage 2, Surveillance, Recertification/Approval and Special) . 62
Annex F (normative) Audit Report (Stage 1) . 69
Annex G (normative) Supplemental Audit Report . 76

Foreword
This document (EN 9101:2011) has been prepared by the Aerospace and Defence Industries Association of
Europe - Standardization (ASD-STAN).
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 January 2012, and conflicting national standards shall be withdrawn
at the latest by January 2012.
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 9101:2008.
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 standard was reviewed by the Domain Technical Coordinator of ASD-STAN’s Quality Domain.
To assure customer satisfaction, aviation, space, and defence organizations must produce and continually
improve, safe, reliable products 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 from suppliers throughout the world and at all levels of the supply chain. Suppliers have
the challenge of delivering products to multiple customers having varying quality requirements and
expectations.
Industry has established the International Aerospace Quality Group (IAQG), with representatives from
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 standard has been
prepared by the IAQG.
This document standardizes the requirements for conducting and reporting of quality management system
audits. It provides requirements for an audit and reporting process based on:
• the process and continual improvement approach defined in 9100-series standards;
• the specific aviation, space, and defence additions in 9100-series standards;
• the use of common audit tools; and
• the uniform, transparent, and standardized reporting of audit results.
It can be used by aviation, space, and defense organizations at all levels throughout the global supply chain.
In this European Standard, the word “shall” indicates a requirement and the word “should” a recommendation
to meet the intent of the standard. Words “typical”, “example”, or “e.g.” indicate suggestions given for
guidance. Information marked “NOTE” is for guidance in understanding or clarifying the associated
requirement.
This standard has been completely rewritten to incorporate the 2009 changes to IAQG 9100-series standard
quality management system requirements, the requirements for accredited Certification Bodies (CBs)
introduced by International Organization for Standardization (ISO) / International Electrotechnical Commission
(IEC) 17021, and inputs received from industry stakeholders associated to process based auditing methods
and the evaluation of process effectiveness. It replaces the existing versions of 9101, 9111, and 9121
(e.g., AS9101C, AS9111, AS9121, EN 9101:2006, EN 9111:2005, EN 9121:2005, SJAC 9101C).
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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia,
Spain, Sweden, Switzerland and the United Kingdom.
0 Introduction
0.1 General
Auditing is a basic tool to assess effective implementation of and conformity to quality management system
requirements. In addition to the determination of conformity, this standard focuses on the evaluation of
effectiveness of the quality management system and its associated processes.
An organization is not only required to be in conformity with quality management system requirements, but to
be effective in meeting customer expectations and delivering products that meet those expectations. In other
words, an organization must not only meet the requirements of the quality management system standard, but
at the same time deliver products that satisfy customer expectations.
Additionally, this standard takes into account the new requirements presented in the 2009 revisions of the
9100-series standards [e.g., critical items, special requirements, On-time Delivery (OTD) performance, risk
management, project management].
0.2 Auditing Approach
This standard supports the engagement and evaluation of an organization’s quality management system
process approach, as required by the 9100-series standards. When evaluating an organization’s quality
management system, there are basic questions that should be asked of every process, for example:
a) Is the process identified and appropriately defined?
b) Are responsibilities assigned?
c) Are the processes 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.
Additionally, product quality (as delivered), customer satisfaction, and quality management system
effectiveness can be considered as interrelated. This relationship should be reflected in the audit process
and associated results.
0.3 Audit Records and Reports
This standard defines the audit records and reports to be generated and maintained. They are critical in
providing objective evidence on the conformity and effectiveness of the quality management system
(including process effectiveness), and reporting the audit results. They can be used to inform the
organization and its customers in a standard format/structure.
Records and reports to be generated are identified within this standard as annexes and shall be used to fulfill
the reporting requirements.
NOTE Electronic templates of these documents will be made available by the IAQG.
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