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

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Status
Not Published
Publication Date
04-Jun-2023
Current Stage
4060 - Closure of enquiry - Enquiry
Start Date
26-Feb-2022
Completion Date
26-Feb-2022

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

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.

prEN 9104-002:2021 (E)
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

prEN 9104-002:2021 (E)
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.
prEN 9104-002:2021 (E)
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.
prEN 9104-002:2021 (E)
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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