FprEN 9101
(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).
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
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
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN 9101:2021
01-oktober-2021
Zahteve za presojo sistemov vodenja kakovosti organizacij zračnega prometa,
vesoljskih poletov in obrambe
Requirements for Conducting Audits of Aviation, Space, and Defence Quality
Management Systems
Qualitätsmanagementsysteme - Audit-Anforderungen für Organisationen der Luftfahrt,
Raumfahrt und Verteidigung
Ta slovenski standard je istoveten z: prEN 9101
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
oSIST prEN 9101:2021 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN 9101:2021
DRAFT
EUROPEAN STANDARD
prEN 9101
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2021
ICS 03.100.70; 49.020 Will supersede EN 9101:2018
English Version
Requirements for Conducting Audits of Aviation, Space,
and Defence Quality Management Systems
This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee ASD-
STAN.
If this draft becomes a European Standard, 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.
This draft European Standard was established by CEN 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, Turkey and
United Kingdom.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are
aware and to provide supporting documentation.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without
notice and shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 9101:2021 E
worldwide for CEN national Members.
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Contents Page
European foreword . 4
0 Introduction . 5
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
4.2 Audit Program . 10
4.3 Audit Reporting . 11
5 Common Audit Activities . 12
5.1 General. 12
5.2 Audit Planning . 12
5.3 Conducting Audits . 14
5.3.1 General. 14
5.3.2 Conducting the Opening Meeting . 14
5.3.3 Site Tour . 14
5.3.4 Audit Conduct . 15
5.3.5 Special Processes . 15
5.3.6 Identifying and Recording of Audit Findings . 15
5.3.7 Process Results . 16
5.3.8 Process Realization . 16
5.3.9 Process Effectiveness. 16
5.3.10 Preparing Audit Conclusions . 18
5.3.11 Conducting the Closing Meeting . 18
5.4 Audit Report . 18
5.5 Nonconformity Management . 18
6 Audit phase specific requirements . 20
6.1 General. 20
6.2 Pre-audit Activities (Initial Audit) . 20
6.2.1 General. 20
6.2.2 Application . 20
6.2.3 Application Review . 20
6.2.4 Requirements for the Certification Body . 21
6.2.5 Requirements for the Audit Team Leader . 21
6.3 Stage 1 Audit . 21
6.3.1 General. 21
6.3.2 Collection of Information . 21
6.3.3 Review of the Organization . 22
6.3.4 Stage 1 Conclusions . 23
6.4 Stage 2 Audit . 23
6.5 Surveillance Audit . 23
6.6 Recertification Audit. 24
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6.7 Special Audit . 24
Annex A (informative) Acronym log . 25
Annex B (informative) Forms . 26
B.1 9101 Form 1: Stage 1 Audit Report . 26
B.2 9101 Form 2: QMS Process Matrix Report . 27
B.3 9101 Form 3: Process Effectiveness Assessment Report . 28
B.4 9101 Form 4: Nonconformity Report (NCR) . 29
B.5 9101 Form 5: Audit Report . 30
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European foreword
This document (prEN 9101:2021) 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 is currently submitted to the CEN Enquiry.
This document will supersede EN 9101:2018.
This standard 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.
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0 Introduction
0.1 General
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 9100-series standards,
b) specific ASD additions in 9100-series standards,
c) use of common audit tools, and
d) 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;
• “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 standard 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.
0.2 Auditing Approach
This standard supports the engagement and evaluation of an organization’s QMS process approach, as
required by the 9100-series standards. When evaluating an organization's QMS, there are basic
questions that should be asked of every process, for example:
e) Is the process appropriately determined?
f) Are responsibilities assigned?
g) Are the processes adequately implemented and maintained?
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h) 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 standard 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.
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AUDIT REQUIREMENTS
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 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, ISO/IEC 17021-1). When there is conflict with these standards, the
requirements of 9101 standard take precedence.
NOTE 1 In this document, the term “9100-series standards” comprises the 9100, 9110, and 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.sae.org/iaqg/) 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 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 9104-series standards (i.e. EN 9104-001, EN 9104-002, EN 9104-003).
NOTE Relevant parts of this document can also be used by an organization in support of internal audits
st nd
(1 party) and external audits at suppliers (2 party).
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
EN 9100:2018, Quality Management Systems — Requirements for Aviation, Space, and Defence
1
Organizations
1
EN 9110:2018, Quality Management Systems — Requirements for Aviation Maintenance Organizations
1
EN 9120, Quality Management Systems — Requirements for Aviation, Space, and Defence Distributors
EN 9104-001:2013, Aerospace series — Quality management systems — Part 001: Requirements for
1
Aviation, Space, and Defence Quality Management System Certification Programs
EN 9104-002, Aerospace series — Quality management systems — Part 002: Requirements for Oversight
1
of Aerospace Quality Management System Registration/Certification Programs
1
As developed under the auspice of the IAQG and published by various standards bodies [e.g., AeroSpace and
Defence Industries Association of Europe – Standardization (ASD-STAN), SAE International, European Committee
for Standardization (CEN), Japanese Standards Association (JSA)/Society of Japanese Aerospace Companies
(SJAC), Brazilian Association for Technical Norms (ABNT)].
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EN 9104-003, Aerospace series — Quality management systems — Part 003: Requirements for Aerospace
1
Quality Management System (AQMS) Auditor Training and Qualification
ISO 9000, Quality management systems — Fundamentals and vocabulary
ISO/IEC 17000, Conformity assessment — Vocabulary and general principles
ISO/IEC 17021-1:2015, Conformity assessment — Requirements for bodies providing audit and
certification of management systems — Part 1: Requirements
IAQG Procedure 105.6, IAQG Forms Management
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 9000, ISO/IEC 17000, 9100-
series, 9104-series, the IAQG International Dictionary (located on the IAQG website) and the following
apply. An acronym log for this document is presented in Annex A.
3.1
containment
action to control and mitigate the impact of a nonconformity to protect the customer, organization, or
product (i.e., stop the problem from getting worse)
Note 1 to entry: This includes immediate action, immediate communication, and verification to ensure that the
nonconforming situation does not further degrade
3.2
key performance indicator
KPI
measure associated with goals or targets showing how well an organization is achieving its objectives
or critical success factors, used to objectively define a quantifiable and measurable indication of
performance
3.3
major nonconformity
nonconformity that affects the capability of the management system to achieve the intended results
Note 1 to entry: Nonconformities could be classified as major in the following circumstances:
• if there is a significant doubt that effective process control is in place, or that products or services will
meet specified requirements;
• a number of minor nonconformities associated with the same requirement or issue could demonstrate
a systemic failure and thus constitute a major nonconformity.
Note 2 to entry: In addition, a major nonconformity can be one or more of the following situations:
• a nonconformity where the effect is judged to be detrimental to the integrity or safe use of the product
or service;
• the absence of or total breakdown of a system to meet a 9100-series standard requirement, a customer
QMS requirement, or documented information defined by the organization;
• any nonconformity that can result in the probable delivery of nonconforming product or service;
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• a condition that can result in the failure or reduce the usability of the product or service for its
intended purpose.
[SOURCE: ISO/IEC 17021-1:2015, 3.12, modified – Note 2 to entry has been added.]
3.4
minor nonconformity
nonconformity that does not affect the capability of the management system to achieve the intended
results
Note 1 to entry: In addition, a minor nonconformity can be a single system failure or lapse in conformity to meet a
9100-series standard requirement, customer QMS requirement, or documented information defined by the
organization.
[SOURCE: ISO/IEC 17021-1:2015, 3.13, modified – Note 1 to entry has been added.]
3.5
nonconformity report
NCR
document that provides details of the nonconformity, organization’s planned actions, and auditor
verification/closure
Note 1 to entry: See Form 4.
3.6
planned activity
criteria and methods by which the organization plans to achieve the intended results of, and conformity
to, a given process to meet requirements
3.7
planned result
intended performance of a process as determined and measured by the organization
Note 1 to entry: Performance measures include product/service conformity and On-time Delivery (OTD), and
may include other measures related to the process defined by the organization.
3.8
process effectiveness assessment report
PEAR
document that provides details of a given process, process results, process realization, and the level of
process effectiveness
Note 1 to entry: See Form 3.
3.9
repeat nonconformity
trend of identical nonconformities reported against the same requirement, indicating that previous
corrective action attempt(s) failed to prevent recurrence of the nonconforming situation
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4 Auditing and reporting
4.1 General
4.1.1 The audit and reporting process established to assess conformity, including the determination
of QMS effectiveness to the 9100-series standards, shall meet the requirements of ISO/IEC 17021-1, as
stated in each relevant clause of this standard.
4.1.2 For Integrated Management System (IMS) audits, the requirements of EN 9104-001:2013, 8.5.2
apply.
4.1.3 The audit program and associated activities (see 4.2) shall be followed when auditing and
certifying organizations to 9100-series standards in the ASD industry.
4.1.4 The audit process requirements consist of three main parts:
a) the phases of the audit process (see 4.2.1);
b) the common audit activities (see Clause 5) used to support each audit phase;
c) the specific requirements for each audit phase (see Clause 6).
4.2 Audit Program
4.2.1 The audit program consists of the following phases:
a) Pre-audit activities (see 6.2);
b) Stage 1 audit (see 6.3);
c) Stage 2 audit (see 6.4);
d) Surveillance audit (see 6.5);
e) Recertification audit (see 6.6).
4.2.2 Pre-audit activities and Stage 1/Stage 2 audits are applicable for initial certification. A Stage 1
audit can also be utilized for recertification audits and during CB transfer.
NOTE 1 Although ‘Special Audit’ is not listed as a part of the audit program, it can be applicable after initial
certification, when directed by special request. The requirements for special audits are defined in 6.7.
NOTE 2 The requirements for certification are defined by the 9104-001 standard.
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4.3 Audit Reporting
4.3.1 Audit reporting requirements are defined in Table 1.
Table 1 — Audit reporting requirements
Audit phase Stage 1 Stage 2 Surveillance Recertification Special
Audit report(s) (see 6.3) (see 6.4) (see 6.5) (see 6.6) (see 6.7)
Stage 1 Audit Report
Required
(see Form 1)
QMS Process Matrix Report
(see Form 2)
Required; per site or combined, as
See 4.3.2
Process Effectiveness
appropriate (see 4.3.3)
Assessment Report (PEAR)
(see Form 3)
Nonconformity Report (NCR)
Required (as applicable)
(see Form 4)
Audit Report (see Form 5) Required
4.3.2 A QMS Process Matrix Report (see Form 2) and PEAR (see Form 3) shall be issued dependent
upon the reason for the special audit, as defined in Table 2.
4.3.3 Recording of process information may be combined into a single PEAR and QMS Process Matrix
Report for multi-site organizations, provided that the process is common across the sites. Information
recorded shall reflect each site included in the PEAR and QMS Process Matrix Report. The process
effectiveness level shall reflect the lowest single value of the various sites assessed.
4.3.4 All audit reporting, defined within this standard, shall be managed electronically within the
Online Aerospace Supplier Information System (OASIS) database, including the audit reports defined in
Table 1.
NOTE In accordance with IAQG Procedure 105.6, representations of the 9101 forms are presented in Annex B
for reference only. These forms and supporting instructions are accessible via the IAQG website.
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Table 2 — Special audit reporting requirements
Process Effectiveness
QMS Process Matrix
Reason for Special Audit Assessment Report (PEAR)
Report (see Form 2)
(see Form 3)
Transferring certification from one CB
to another
Reducing an organization’s certification
scope, or number of sites and/or
locations Not required
Verification of evidence to support
application of Performance Based
Surveillance/Recertification Process
(PBS/RP)
Change to an organization’s certification
structure
Investigate a complaint or serious issue
Required, if special audit
activity is conducted against
Follow up from an organization’s
Required
9100-series standard
suspension
Clause 8
Expanding an organization’s
certification scope, or number of sites
and/or locations
5 Common Audit Activities
5.1 General
5.1.1 Common audit activities shall be undertaken for each phase of the audit program as defined in
Table 3.
5.1.2 Stage 1, Stage 2, surveillance, and recertification audit activities shall be described in the audit
program established during the ‘Pre-audit Activities’ phase (see 6.2).
5.2 Audit Planning
5.2.1 The requirements of ISO/IEC 17021-1:2015, 9.2 shall apply.
5.2.2 Audit teams shall plan audits in accordance with EN 9104-001:2013, 8.5.5.
5.2.3 Process names shall be consistent in the audit plan, QMS Process Matrix Report (see Form 2),
and PEAR (see Form 3) and shall correspond to the process names defined by the organization.
5.2.4 The audit team leader shall use the organization’s customer feedback requests, including those
received through the OASIS database (see EN 9104-001:2013, 8.5.12), to assist with audit planning for
surveillance and recertification audits, and special audits (when appropriate).
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Table 3 — Relationship between common activities and audit phases
Audit phase
Pre-audit
Stage 1 Stage 2 Surveillance Recertification
Special
Activities
(see 6.7)
(see 6.3) (see 6.4) (see 6.5) (see 6.6)
(see 6.2)
Common activity
Audit Planning
X X X X X X
(see 5.2)
Conducting Audits
X X X X X
(see 5.3)
Audit Reporting
X X X X X
(see 5.4)
Nonconformity
X X X X
Management (see 5.5)
5.2.5 Audit activities shall be prioritized based upon performance data for business risks that could
impact the customer and on processes that are not achieving planned results.
5.2.6 Audit planning shall take into account, as appropriate to the relevant audit phase:
a) Organization Certification Analysis Process (OCAP) data (see EN 9104-001:2013, 8.5.1);
b) risks identified in the risk analysis process (see EN 9104-001:2013, 8.5.1.5 and 8.5.5.6);
c) the sequence and interactions of the organization's processes;
d) the criticality of products, services, and processes, including special processes;
e) risks associated with QMS, product, service, and process maturity (e.g. new product or service
introduction, new process equipment or facilities);
f) product related safety issues (e.g. airworthiness issues, reporting to customer and/or authorities);
g) results of internal audits;
h) previous audit findings (e.g. CBs, cust
...
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