oSIST prEN 9104-002:2022
(Main)Aerospace series - Quality management systems - Part 2: Requirements for the Oversight of Aviation, Space, and Defense Quality Management System Certification Programs
Aerospace series - Quality management systems - Part 2: Requirements for the Oversight of Aviation, Space, and Defense Quality Management System Certification Programs
2022-11-06: change of reference to prEN 9104-2 - ENQ circulated under reference prEN 9104-002
Luft- und Raumfahrt - Qualitätsmanagementsysteme - Teil 2: Ergänzendes Element
Série aérospatiale - Systèmes de management de la qualité - Partie 2 :Exigences relatives à la supervision des programmes de certification des systèmes de management de la qualité de l'aéronautique, l'espace et la défense
La présente norme définit le processus de supervision du schéma de certification ICOP, fondé sur les risques et partagé, applicable aux secteurs de l’IAQG et associés, permettant d’assurer la supervision des exigences établies de l’industrie ASD contenues dans les normes de la série EN 9104 (c’est-à-dire EN 9104 1, EN 9104-2 et EN 9104-3). Le processus de supervision fournit des preuves objectives de la conformité aux exigences des normes de la série EN 9104 et associées en matière d’accréditation et de certification SMQA. S'il existe un conflit entre les exigences de la présente norme et les exigences légales ou réglementaires applicables, ce sont ces dernières qui prévalent.
Aeronavtika - Sistemi vodenja kakovosti - 2. del: Zahteve za nadzor programov certificiranja sistemov vodenja kakovosti v letalstvu, pri vesoljskih dejavnostih in obrambi
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN 9104-002:2022
01-januar-2022
Aeronavtika - Sistemi vodenja kakovosti - 2. del: Zahteve za nadzor programov
certificiranja sistemov vodenja kakovosti v letalstvu, pri vesoljskih dejavnostih in
obrambi
Aerospace series - Quality management systems - Part 2: Requirements for the
Oversight of Aviation, Space, and Defense Quality Management System Certification
Programs
Luft- und Raumfahrt - Qualitätsmanagementsysteme - Teil 2: Ergänzendes Element
Série aérospatiale - Systèmes de management de la qualité - Partie 2 :Exigences
relatives à la supervision des programmes de certification des systèmes de management
de la qualité de l'aéronautique, l'espace et la défense
Ta slovenski standard je istoveten z: prEN 9104-002
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 9104-002:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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DRAFT
EUROPEAN STANDARD
prEN 9104-002
NORME EUROPÉENNE
EUROPÄISCHE NORM
November 2021
ICS Will supersede EN 9104-002:2016
English Version
Aerospace series - Quality management systems - Part 2:
Requirements for the Oversight of Aviation, Space, and
Defense Quality Management System Certification
Programs
Série aérospatiale - Systèmes de management de la Luft- und Raumfahrt - Qualitätsmanagementsysteme -
qualité - Partie 2 :Exigences relatives à la supervision Teil 2: Ergänzendes Element
des programmes de certification des systèmes de
management de la qualité de l'aéronautique, l'espace et
la défense
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 9104-002:2021 E
worldwide for CEN national Members.
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Contents Page
European foreword . 3
Introduction . 4
1 Scope . 5
2 Normative references . 5
3 Terms and definitions . 5
4 General. 7
5 Resource requirements . 7
5.1 General. 7
5.2 Other Party Assessor competence . 8
5.3 Confidentiality and conflicts of interest . 10
5.4 Oversight chair . 12
6 Requirements for a risk-based approach to oversight . 12
6.1 General. 12
6.2 Risk analysis . 12
6.3 Establishing Oversight Assessment Activity . 14
7 Perform oversight assessment activities . 15
7.1 Plan oversight assessment activities . 15
7.2 Conduct oversight assessment activities . 17
7.3 Report oversight assessment activities . 18
7.4 Complete the oversight assessment activity . 18
8 Requirements for international aerospace quality group member company
supplemental oversight . 19
8.1 General. 19
8.2 Supplemental oversight requirements . 19
9 Management system requirements . 19
9.1 General. 19
9.2 Oversight records . 20
Annex A (informative) Acronym log . 21
Annex B (informative) The EN 9104-2 oversight assessment process . 22
Bibliography . 23
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European foreword
This document (prEN 9104-002:2021) has been prepared by the Aerospace and Defence Industries
Association of Europe — Standardization (ASD-STAN).
This document will supersede EN 9104-002:2016.
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.
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Introduction
Industry established the IAQG, with representatives from ASD companies in the Americas, Asia-Pacific,
and European sectors, 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 to define an oversight process that monitors and reviews
the ICOP certification scheme deployment and ensures conformance to established ASD industry 9104-
series requirements for accreditation and AQMS certification. This standard also provides a means of
initial and ongoing evaluation of participating other parties e.g. Certification Bodies (CBs), for IAQG
members and other approved organizations that utilize ASD authorities’ recognition of the ICOP scheme
as part of the requirements for supplier, vendor, and/or subcontractor control.
This document provides requirements for an oversight process based on:
— the establishment of harmonized risk-based oversight processes at the international level and
within all three global sectors (i.e. Americas, Asia-Pacific, and Europe);
— the shared review and assessment of ICOP certification scheme participants including Sector
Management Structures (SMSs), Regional Management Structures (RMSs), Accreditation Bodies
(ABs), CBs, Auditor Authentication Bodies (AABs), and Training Provider Approval Bodies (TPABs);
— the use of qualified and approved Other Party (OP) Assessors;
— the use of common assessment tools; and
— the reporting and review of oversight results.
In this standard, the following terms are used:
— “shall” indicates a requirement;
— “may” indicates a permission;
— “can” indicates a possibility or capability;
— “annual” or “annually” indicates a 12-month period beginning January 1st and ending December
31st; and
— “days” are calendar days, unless otherwise specified.
The term “e.g.” indicate suggestions given for guidance, and information marked “NOTE” is for guidance
in understanding or clarifying the associated requirement.
Rationale
In early 2000, the International Aerospace Quality Group (IAQG) developed the Industry Controlled
Other Party (ICOP) scheme to support the certification of Aviation, Space, and Defence (ASD)
organization’s Aerospace Quality Management System (AQMS). The ICOP certification scheme was built
upon the existing International Organization for Standardization (ISO)/International Electrotechnical
Commission (IEC) and International Accreditation Forum (IAF) requirements for the accredited
certification of an organization’s Quality Management System (QMS).
This standard has been revised to align with the latest revisions of the IAQG 9104-1 and 9104-3
standards; the EN ISO/IEC 17000, 17011, and 17021-1 standards; and to incorporate lessons learned
from past oversight activities, including feedback from interested parties.
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1 Scope
This document defines the ICOP certification scheme risk-based, shared, oversight process applicable to
the IAQG and associated sectors for managing oversight of the ASD industry established requirements
contained in 9104-series standards (i.e. 9104-1, 9104-2, 9104-3). The oversight process provides
objective evidence of conformance to the 9104-series standards and the associated requirements for
accreditation and AQMS certification. If there is a conflict between the requirements of this document
and applicable statutory or regulatory requirements, the latter takes precedence.
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 9104-1, Aerospace series — Quality management systems — Part 1: Requirements for Aviation,
Space, and Defence Quality Management System Certification Programs 1)
EN 9104-3, Aerospace series — Quality management systems — Part 3: Requirements for Aviation,
1)
Space, and Defence Auditor Training, Development, Competence, and Authentication
3 Terms and definitions
For the purposes of this document, the terms and definitions in EN 9104-1, EN 9101, the IAQG
International Dictionary (located on the IAQG website), and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
• ISO Online browsing platform: available at https://www.iso.org/obp
• IEC Electropedia: available at https://www.electropedia.org/
NOTE 1 An acronym log for this standard is presented in Annex A.
NOTE 2 see also the terms and definitions listed in EN ISO 9000, EN ISO/IEC 17000 and EN ISO/IEC 17021-1
3.1
activity review
oversight assessment activity, applicable to entities participating in the ICOP scheme determined to be
of low or medium risk that is focused on harmonization and improvement. This includes a review of an
internal or self-assessment against applicable requirements, and successes, opportunities, failures, and
threats
3.2
file review
review of the documented information pertaining to a given accreditation, certification, authentication,
or approval file, against applicable standards, requirements, and entity procedures to evaluate the
conformance and effectiveness of their deployed processes
3.3
joint team assessment
office or witness assessment of a CB conducted in accordance with the requirements of this standard by
a team comprised of AB and OP Assessors
Note 1 to entry: observers may attend joint team assessments.
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3.4
observation
statement, comment, or remark raised to an assessed entity based on something that was observed,
heard, or noticed during an oversight assessment
3.5
office assessment
oversight assessment of the management office of an entity participating in the ICOP scheme to
applicable requirements using the evaluation tools and methods defined in the 9104-series standards
3.6
Opportunity for Improvement
OFI
identified harmonization, improvement, or clarification opportunity agreed between an OP Assessor
and the assessed entity that needs to be addressed within a defined timeframe
3.7
Other Party (OP) Assessor
full-time employee (not a contractor or retired staff member) from either an IAQG member company or
National Aerospace Industry Association (NAIA) member company actively participating in the ICOP
scheme oversight process
Note 1 to entry: an OP Assessor may be categorized as an OP Assessor or an Experienced OP Assessor based on
their level of experience and training.
3.8
oversight assessment
systematic process to assess the conformance to applicable requirements of an entity participating in
the ICOP scheme, based on applicable requirements. The following are types of oversight assessment
activities:
— activity review;
— office assessment;
— witness assessment;
— post-audit assessment;
— file review;
— market surveillance (reference IAF ID 4)
3.9
post-audit assessment
technical review of a published audit report that includes an interview with the audit team leader and
the audit team. The objective being to assess the conformance and effectiveness of the deployed audit
processes and associated procedures to the applicable requirements
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3.10
shared oversight
IAQG Other Party Management Team (OPMT) managed process that assures conformance and global
harmonization of the ICOP scheme across all IAQG sectors. Shared oversight includes assessments of
approved, accredited, and authenticated stakeholders and prevents duplication of effort and allows
IAQG member companies to share results
3.11
supplemental oversight
additional oversight activity conducted by IAQG member companies in accordance with this standard,
using qualified OP Assessors that does not duplicate SMS or RMS shared oversight activities
Note 1 to entry: supplemental oversight may be used to address supply chain risk or increase IAQG member
company confidence in the ICOP scheme effectiveness.
3.12
witness assessment
oversight assessment that includes observation of an AB or CB conducting an assessment or AQMS
certification audit
4 General
4.1 Requirements for the oversight of the IAQG ICOP certification scheme are contained within this
standard.
4.2 Documented information (e.g. guidance documents) to support the conduct and reporting of
oversight assessments shall be provided by the IAQG through the IAQG website and Online Aerospace
Supplier Information System (OASIS) database.
4.3 The IAQG OPMT, SMS, or RMS may revise oversight assessment activities in response to identified
risks, opportunities, and significant changes, including items such as an extraordinary event or
circumstance (reference IAF ID 3).
4.4 Any IAQG member company wishing to recognize AQMS certification shall participate in shared
oversight assessment activities and provide resources to support the ICOP scheme.
5 Resource requirements
5.1 General
5.1.1 OP Assessors shall ensure they have the training, experience, and competence required by this
standard.
5.1.2 OP Assessors shall complete the appropriate IAQG declaration to document fulfilment of the
OP Assessor competence requirements.
5.1.3 OP Assessors shall be approved by their respective employers in accordance with the
requirements of this standard. Approval includes:
a. the authorization and allocation of appropriate resources (e.g. training, budget, time);
b. the necessary tools (e.g. published standards, computer equipment, access to applicable IAQG data)
to allow effective participation;
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c. documentation within the appropriate IAQG declaration.
5.1.4 When OP Assessors are employed by an NAIA member company, the respective SMS or RMS
Oversight Chair shall review, and when approved, document the approval within the appropriate IAQG
declaration.
5.1.5 An approved OP Assessor shall be eligible to conduct office assessments, activity reviews, and
file reviews. An approved Experienced OP Assessor shall be eligible to conduct all type of oversight
assessments including AQMS witness, post audit reviews, and AQMS market surveillance assessments.
5.1.6 OP Assessors and their employing organization shall retain documented information to support
the qualification and approval of OP Assessors, in accordance with the requirements of this standard.
Retained documented information supporting qualification and approval shall be made available to the
respective SMS, RMS, and the IAQG OPMT, upon request or for the purposes of oversight.
5.2 Other Party Assessor competence
5.2.1 OP Assessors shall be categorized as follows:
a. OP Assessors;
b. experienced OP Assessors.
5.2.2 OP Assessors and experienced assessors shall have knowledge of the ICOP scheme
(i.e. EN 9104-series standards requirements, relevant AQMS and ISO standards, applicable
IAF documents, IAQG OPMT resolutions) sufficient to be able to effectively assess conformity.
NOTE Table 1 provides a summary of the qualification requirements for becoming an OP Assessor.
Table 1 — Other Party Assessor competence summary
Element OP Assessor Experienced OP Assessor
Baseline
Knowledge of the ICOP scheme
Knowledge
Evidence of four years ASD knowledge
and work experience that includes an
Work Evidence of two years ASD knowledge
understanding of the processes and
Experience and work experience
controls needed for conformance to
the applicable AQMS standard
Conducted at least three QMS audits Conducted at least three AQMS audits
(1st, 2nd, or 3rd party) or OP (1st, 2nd, or 3rd party) or OP
Audit
assessments for a minimum of nine assessments for a minimum of nine
Experience
assessment days within the last three assessment days within the last three
years years
IAQG OPMT
Evidence of successful completion (including examination, as applicable) of any
Mandated
IAQG OPMT mandated OP Assessor training
Training
Evidence of training for each AQMS
Other Training None required standard being assessed, and the
EN 9101
Continual
Evidence of 15 h within the last three Evidence of 24 h within the last three
Professional
years related to changes in the ASD years related to changes in the ASD
Development
industry and ICOP scheme industry and ICOP scheme
(CPD)
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5.2.3 OP Assessors shall initially and in each three-year period fulfil ASD knowledge and work
experience, auditing, and training requirements as follows:
a. work Experience: Two years aviation, space, or defence industry work experience.
Work experience shall be full time work experience in the aviation, space, or defence industry for
an IAQG or NAIA member company; directly involved in engineering, design, manufacturing,
quality, or process control for any of the following types of organizations:
• a major equipment manufacturer or integrator organization that designs, produces, and
delivers complete vehicles or systems for ASD applications (e.g. aircraft, ships, submarines,
major weapon systems, launchers, spacecraft),
• a direct supplier to a major equipment manufacturer or integrator,
• a prime organization that designs and/or produces a major assembly, major subassembly, or
major component of an ASD end item (e.g. cabins, wings, fuselages, propulsion systems, control
systems, health monitoring systems, ordnance management systems, radar systems,
emergency or backup systems),
• ASD regulatory agency (i.e. a civil, military, or space organization that is a public authority or
government agency responsible for exercising autonomous authority over ASD activities in a
regulatory or supervisory capacity);
b. audit experience: have conducted at least three QMS audits (1st, 2nd, or 3rd party) or OP
assessments for a minimum of nine assessment days;
c. training: successful completion of IAQG OPMT mandated OP Assessor training courses;
NOTE 1 Completion of IAQG OPMT mandated training courses is only required once for each identified
training course.
d. Continual Professional Development (CPD): a minimum of 15 hours related to changes in the ASD
industry and ICOP scheme.
NOTE 2 Mandated OP Assessor training courses may be used in support of CPD requirements.
5.2.4 Experienced OP Assessors shall initially, and in each three-year period, fulfil ASD knowledge
and work experience, auditing, and training requirements as follows:
a. work experience: a minimum of four years ASD industry work experience (see paragraph 5.2.3.a)
that includes an understanding of the processes and controls needed for conformance to the
applicable AQMS standard;
b. auditing experience: have conducted at least three AQMS audits (1st, 2nd, or 3rd party) or OP
assessments for a minimum of nine assessment days;
c. training: successful completion of IAQG OPMT mandated OP Assessor training courses. Evidence of
attending training for each AQMS standard being assessed and the EN 9101 standard;
d. Continual Professional Development (CPD): evidence of a total of 24 hours related to changes in the
ASD industry and ICOP scheme.
NOTE Each hour of structured learning activity is equivalent to one CPD hour.
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5.3 Confidentiality and conflicts of interest
5.3.1 OP Assessors shall complete the IAQG declaration for confidentiality and conflicts of interest,
prior to approval as an OP Assessor.
5.3.2 OP Assessors shall declare any perceived potential or actual conflicts of interest, prior to
acceptance of an oversight assignment. Declared conflicts shall be reviewed and resolved between all
affected parties, prior to any oversight activity taking place.
5.3.3 The resolution of any perceived or actual conflicts of interest shall be documented in the
applicable oversight assessment report.
5.3.4 OP Assessors shall be independent of the activity they oversight.
5.3.5 OP Assessors shall accept an oversight assignment only when the activity is permissible in
accordance with Table 2.
5.3.6 Information and data handled during oversight activities shall be treated as confidential, as
defined in EN 9104-1.
5.3.7 OP Assessors shall not disclose the assessed organization’s performance or oversight
results/data with the assessed organization’s clients without written permission (e.g. AB performance
to CB, CB performance to certified organization).
5.3.8 Declarations of confidentiality and conflicts of interest shall be provided to any assessed
organization, upon request.
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Table 2 — Identification of oversight activity that represents an unacceptable conflict of interest
OP Assessor Oversight Activity that is Not Permitted (Marked
by ‘X’)
Potential Conflict of
Interest SMS/RMS AB CB AAB TPAB
AR OA AR OA WA AR OA WA AR OA AR OA
Employment or
engagement by a CB in X X X X X X X X X X X X
any role
Employment or
engagement by an AB in X X X
any role
Employment or
engagement as an AB
Assessor during a joint X X X X X X
team assessment
activity
Employment or
engagement by an AAB 1 1 X X
in any role
Authentication or
2 2
certification by an AAB
Employment or
engagement by a TPAB X X
in any role
Direct interface with
certifying CB sales or
audit personnel on
behalf of the OP 3 3 3
Assessors’ employing
organization within the
last two years
Key:
AR Activity Review
OA Office Assessment
WA Witness Assessment
1 Indicates that conducting the oversight activity is permissible, except when the auditor
or assessor being witnessed is authenticated by the AAB that employs or engages the OP
Assessor.
2 Indicates that conducting the oversight activity is permissible, except for the AAB that
authenticates or certifies the OP Assessor.
3 Indicates that conducting the oversight activity is permissible except for the CB that
certifies the organization that employs the OP Assessor.
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5.4 Oversight chair
5.4.1 The IAQG OPMT and each applicable SMS and RMS shall appoint an oversight chair.
5.4.2 Each oversight chair shall be responsible for the following:
a. the conduct and reporting of required oversight assessment activities in accordance with this
standard and EN 9104-1, including:
• ensuring that only approved OP Assessors are assigned to support oversight assessments,
• budgeting and requesting funding for interpreter and/or translator services to support
oversight activities, in advance, from the IAQG OPMT,
• obtaining interpreter and/or translator support, when deemed necessary, to support an
oversight activity;
b. managing any appeals and complaints relating to oversight assessment activities in accordance
with the requirements of EN 9104-1;
c. conducting and reporting an annual performance review of oversight assessment activities to
ensure continued effectiveness that includes:
• the results and trends of all oversight assessments, including any supplemental oversight,
• potential ICOP scheme process improvements, and
• a summary of appeals and complaints.
NOTE These review reports are used by the IAQG OPMT to support improvement of the ICOP scheme.
6 Requirements for a risk-based approach to oversight
6.1 General
6.1.1 Each SMS shall carry out annual risk analysis for any RMS(s) within the sector and for all
entities where they have direct oversight responsibility.
6.1.2 Each RMS shall carry out annual risk analysis for all entities where they have direct oversight
responsibility.
6.1.3 Each risk analysis shall be completed, prior to annual oversight assessment planning.
6.1.4 Data required for the risk analysis shall be made available within 30 days of a request from a
SMS or RMS. Where data are not made available for the risk-based analysis, each applicable entity shall
be placed into the highest risk category.
6.2 Risk analysis
6.2.1 The SMS or RMS shall use Table 3
...
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