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

Status
Published
Publication Date
15-May-2018
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
16-May-2018
Completion Date
16-May-2018

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SLOVENSKI STANDARD
SIST EN 9101:2018
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
SIST EN 9101:2018 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 9101:2018
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SIST EN 9101:2018
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.
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SIST EN 9101:2018
EN 9101:2018 (E)
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

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SIST EN 9101:2018
EN 9101:2018 (E)
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.
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SIST EN 9101:2018
EN 9101:2018 (E)
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.

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SIST EN 9101:2018
EN 9101:2018 (E)
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 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, during the audit process. They are

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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SIST EN 9101:2018
EN 9101:2018 (E)
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 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

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 , Quality Management Systems — Requirements for Aviation, Space and Defence Organizations

EN 9102 , Aerospace First Article Inspection Requirement

EN 9104-001 , Aerospace series — Quality management systems — Part 001: Requirements for Aviation,

Space, and Defence Quality Management System Certification Programs

EN 9104-002 , Aerospace series — Quality management systems — Part 002: Requirements for Oversight

of Aerospace Quality Management System Registration/Certification Programs

EN 9104-003 , Aerospace series — Quality management systems — Part 003: Requirements for Aerospace

Quality Management System (AQMS) Auditor Training and Qualification

As developed under the auspice of the IAQG and published by various standards bodies [e. g., SAE

International, European Committee for Standardization (CEN), Japanese Standards Association/Society of

Japanese Aerospace Companies (JSA/SJAC), Brazilian Association for Technical Norms (ABNT)].

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SIST EN 9101:2018
EN 9101:2018 (E)

EN 9110 , Quality Management Systems — Requirements for Aviation Maintenance Organizations

EN 9115 , Quality Management Systems — Requirements for Aviation, Space and Defence

Organizations — Deliverable Software (Supplement to EN 9100:2016)

EN 9120 , Quality Management Systems — Requirements for Aviation, Space and Defence Distributors

EN 9131 , Aerospace series — Quality Management Systems — Nonconformance Data Definition and

Documentation
EN ISO 9000:2015, Quality management systems — Fundamentals and vocabulary

EN ISO/IEC 17000, Conformity assessment — Vocabulary and general principles (ISO/IEC 17000:2004)

EN ISO/IEC 17021-1, Conformity assessment — Requirements for bodies providing audit and certification

of management systems — Part 1: Requirements (ISO/IEC 17021-1:2015)
IAQG Procedure 105.6, IAQG Forms Management

IAF MD 3:2008, IAF Mandatory Document for Advanced Surveillance and Recertification Procedures

IAF MD 4:2008, IAF Mandatory Document for the Use of Computer Assisted Auditing Techniques (“CAAT”)

for Accredited Certification of Management Systems
3 Terms and definitions

For the purpose of this standard, the terms and definitions provided in EN ISO 9000, EN ISO/IEC 17000,

EN 9100-series standards, EN 9104-001 standard, and the following apply. Furthermore, an acronym

log for this standard is presented in Annex A.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
3.1
containment

action to control and mitigate the impact of a nonconformity and protect the customer's operation (stop

the problem from getting worse); includes correction, immediate corrective action, immediate

communication, and verification that the nonconforming situation does not further degrade

3.2
Key Performance Indicator
KPI

measures associated with goals or targets showing how well an organization is achieving its objectives

or critical success factors for a particular project. KPIs are used to objectively define a quantifiable and

measurable indication of the organization's progress towards achieving its goals

Note 1 to entry: KPIs relating to an organization’s financial performance are not in the scope of the EN 9101

standard; however, economic measures (e. g., sales quotas, scrap value reduction) can be considered acceptable

measures for process improvement.
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SIST EN 9101:2018
EN 9101:2018 (E)
3.3
major nonconformity
The requirements of EN ISO/IEC 17021-1 clause 3.12 apply.

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 of the product or

service;

• the absence of or total breakdown of a system to meet a EN 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;

and

• a condition that can result in the failure or reduce the usability of the product or service and its

intended purpose.
3.4
minor nonconformity
The requirements of EN ISO/IEC 17021-1 clause 3.13 apply.

In addition a minor nonconformity can be a single system failure or lapse in conformity to meet a

EN 9100-series standard requirement, customer QMS requirement, or documented information defined

by the organization.
3.5
Nonconformity Report
NCR

a document stating results and providing objective evidence of nonconformity against audit criteria,

including the following information: containment, correction, root cause, corrective action

implementation, and closure
3.6
Online Aerospace Supplier Information System
OASIS

web-based IAQG database containing information on participating IAQG member companies, National

Aerospace Industry Associations (NAIA), National Accreditation Bodies (NAB), accredited CBs,

authenticated Aerospace Experience Auditors (AEAs), Aerospace Auditors (AAs) certified suppliers,

certificates, and audit results
3.7
planned activities

the means, methods, and internal requirements by which the organization intends to achieve planned

results of a given process to meet customer requirements. Planned activities include conformity to

process requirements and maintained documented information
3.8
planned results

the intended performance of a process as determined and measured by the organization. Planned

results include product and service conformity and On-time Delivery (OTD) to meet customer

requirements, and may include other elements related to the process, as defined by the organization

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SIST EN 9101:2018
EN 9101:2018 (E)
3.9
Process Effectiveness Assessment Report
PEAR

a document stating process evaluation results; providing evidence of conformity to requirements and

process effectiveness
4 Auditing and reporting

The audit and reporting process established to assess conformity, including the determination of QMS

effectiveness to the EN 9100-series standards, shall meet the requirements of EN ISO/IEC 17021-1, as

stated in each relevant clause of this standard. Additional audit requirements for the aviation, space,

and defence industry are invoked by this standard.

For combined and integrated audits, the requirements of EN 9104-001 clause 8.2.3 apply.

4.1 General

The audit process and associated activities (see clause 4.1.1) shall be followed when auditing and

certifying organizations to AQMS standards in the aviation, space, and defence industry.

The audit process requirements consist of three main parts:
a) the phases of the audit process (see clause 4.1.1);

b) the common activities (see clause 4.2) that shall be used to support the audit phases; and

c) the specific requirements for each audit phase (see clause 4.3).
4.1.1 Audit process
The audit process consists of the following phases:
a) Pre-audit activities (see clause 4.3.1);
b) Stage 1 audit (see clause 4.3.2);
c) Stage 2 audit (see clause 4.3.3);
d) Surveillance audit (see clause 4.3.4); and
e) Recertification audit (see clause 4.3.5).

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 addressed in clause 4.3.6.

NOTE 2 The requirements for certification are defined by the EN 9104-001 standard.

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SIST EN 9101:2018
EN 9101:2018 (E)
4.1.2 Reporting

Reporting requirements associated with AQMS certification structures (see EN 9104-001 clause 3.11)

are included in Table 1.
Table 1 — Audit reporting matrix
Type of
Certification
Structure
Complex
Single Site Multiple Sites Campus Several Sites
Organization
Audit Phase
Stage 1 • Stage 1 Audit Report (Form 1)
• QMS Process Matrix Report (Form 2); per site or combined, as appropriate
Stage 2
• PEAR (Form 3); per site or combined, as appropriate
Surveillance
• Nonconformity Report (NCR) (Form 4); as applicable
Recertification
• Audit Report (Form 5)
Special
• Supplemental Audit Report (Form 6); optional

NOTE Use of the QMS Process Matrix Report and the PEAR, during a “Special” audit, is dependent upon the

reason for the audit.

Recording of process information may be combined into a single PEAR and QMS Process Matrix Report

for multiple site, several site, campus, or complex organizations, provided that the process is common

across sites/structures. Information recorded shall reflect each site included in the PEAR and QMS

Process Matrix Report. The process effectiveness level shall reflect the lowest value of the various sites

assessed.

In accordance with IAQG Procedure 105.6, representations of the EN 9101 forms are presented in

Annex B for reference only. Electronic versions of these forms, with supporting instructions, are

accessible via the IAQG website.
4.2 Common audit activities

Audit planning, on-site auditing, and audit reporting are common activities linked with Stage 1, Stage 2,

surveillance, recertification, and special audits. Nonconformity management is common for Stage 2,

surveillance, recertification, and special audits. The requirements for activities and common activities

that apply to each phase of the audit program are referenced in Table 2.

The Stage 1, Stage 2, surveillance, and recertification audit activities shall be described in the audit

program established during the “Pre-audit Activities” phase.
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Table 2 — Relationship between common activities and audit phases
Audit
Pre-audit
Phase Stage 1 Stage 2 Surveillance Recertification Special
Activities
Common (4.3.2) (4.3.3) (4.3.4) (4.3.5) (4.3.6)
(4.3.1)
Activity
Audit Planning
X X X X X X
(4.2.1)
On-site Auditing
X X X X X
(4.2.2)
Audit Reporting
X X X X X
(4.2.3)
Nonconformity
Management X X X X
(4.2.4)
4.2.1 Audit planning
The requirements of EN ISO/IEC 17021-1 clause 9.2 apply.

In addition, the audit plan shall be based on the processes defined by the organization and documented

in the QMS Process Matrix Report (see Form 2).

The audit team leader shall use the organization's customer feedback requests, including those received

through the OASIS database (see EN 9104-001 clause 14.2), to assist with audit planning for

surveillance and recertification audits. The audit activities shall be prioritized based upon performance

data for business risks that could impact the customer (i. e., customer concerns, customer special

statuses) and on processes that are not achieving planned results.

Audit planning shall take into account, as appropriate to the relevant audit phase:

a) the sequence and interactions of the organization's processes;

b) the criticality of products and services and processes, including special processes;

c) the risks associated with QMS, product, service, and process maturity (e. g., new product or service

introduction, new process equipment or facilities);

d) product related safety issues (e. g., airworthiness issues, reporting to customer and/or authorities);

e) results of internal audits;
f) previous audit findings (e. g., CBs, customers, regulatory authorities);

g) performance measures and trends for quality and OTD (e. g., KPIs, scorecards, dashboards);

h) previous management review results;
i) customer requirements;
j) statutory/regulatory requirements;
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EN 9101:2018 (E)
k) customer satisfaction/performance data;

l) certification structure [i. e., single site, multiple site, campus, several sites, complex organization

(see EN 9104-001)];
m) integrated and
...

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