prEN 9104-001
(Main)Aerospace series - Quality management systems - Part 1: Requirements for Certification of Aviation, Space, and Defense
Aerospace series - Quality management systems - Part 1: Requirements for Certification of Aviation, Space, and Defense
This document defines the industry-accepted requirements for the ICOP scheme, which provides confidence to ASD customers, that organizations with certification of their QMS, issued by accredited CBs, meet applicable AQMS standard requirements. The requirements in this document are applicable to all participants in the ICOP scheme. If there is a conflict between the requirements of this document, and customer or applicable statutory/regulatory requirements, the latter takes precedence.
Luft- und Raumfahrt - Qualitätsmanagementsysteme - Teil 1: Anforderungen an Zertifizierungsverfahren für Qualitätsmanagementsysteme der Luftfahrt, Raumfahrt und Verteidigung
Série aérospatiale - Systèmes de management de la qualité - Partie 1 : Exigences relatives à la certification dans l'aéronautique, l'espace et la défense
Le présent document définit les exigences acceptées par l'industrie pour le schéma ICOP, qui donne l'assurance aux clients ASD que les organismes dont la certification de leurs SMQ a été délivrée par des OC accrédités satisfont aux exigences des normes de SMQA applicables. Les exigences du présent document sont applicables à tous les participants au schéma ICOP. S'il existe un conflit entre les exigences du présent document et les exigences du client ou les exigences légales/réglementaires applicables, ce sont ces dernières qui prévalent.
Aeronavtika - Sistemi vodenja kakovosti - 001. del: Zahteve za certificiranje sistemov vodenja kakovosti v letalstvu, vesoljskih dejavnostih in obrambi
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN 9104-001:2022
01-maj-2022
Aeronavtika - Sistemi vodenja kakovosti - 001. del: Zahteve za certificiranje
sistemov vodenja kakovosti v letalstvu, vesoljskih dejavnostih in obrambi
Aerospace series - Quality management systems - Part 001: Requirements for
Certification of Aviation, Space, and Defense Quality Management Systems
Luft- und Raumfahrt - Qualitätsmanagementsysteme - Teil 001: Anforderungen an
Zertifizierungsverfahren für Qualitätsmanagementsysteme der Luftfahrt, Raumfahrt und
VerteidigungTa slovenski standard je istoveten z: prEN 9104-001
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 9104-001:2022 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 9104-001
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2022
ICS Will supersede EN 9104-001:2013
English Version
Aerospace series - Quality management systems - Part
001: Requirements for Certification of Aviation, Space, and
Defense Quality Management Systems
Luft- und Raumfahrt - Qualitätsmanagementsysteme -
Teil 001: Anforderungen an Zertifizierungsverfahren
für Qualitätsmanagementsysteme der Luftfahrt,
Raumfahrt und Verteidigung
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
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 9104-001:2022 E
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Contents Page
European foreword ...................................................................................................................................................... 4
Introduction .................................................................................................................................................................... 5
1 Scope .................................................................................................................................................................... 7
2 Normative references .................................................................................................................................... 7
3 Terms and definitions ................................................................................................................................... 8
4 Principles ........................................................................................................................................................... 9
5 General requirements ................................................................................................................................. 10
5.1 Policy and ethics ............................................................................................................................................ 10
5.2 Oversight .......................................................................................................................................................... 10
5.3 Documented information ........................................................................................................................... 11
6 Requirements for Industry Controlled Other Party Scheme management structure .......... 11
6.1 General requirements ................................................................................................................................. 11
6.2 Structure and resource requirements .................................................................................................. 12
6.3 Operational process requirements for the Other Party Management Team, SectorManagement Structure, and Regional Management Structure .................................................... 12
6.4 Management system requirements for the Other Party Management Team, SectorManagement Structure, and Regional Management Structure .................................................... 14
7 Industry Controlled Other Party Scheme requirements for Accreditation Bodies ............... 15
7.1 General requirements ................................................................................................................................. 15
7.2 Resource requirements for Accreditation Bodies ............................................................................ 16
7.3 Process requirements for Accreditation Bodies ............................................................................... 17
7.4 Management system requirements for Accreditation Bodies ...................................................... 20
8 Requirements for Certification Bodies ................................................................................................. 21
8.1 General requirements ................................................................................................................................. 21
8.2 Information requirements ........................................................................................................................ 22
8.3 Structural requirements for Certification Bodies ............................................................................. 23
8.4 Resource requirements for Certification Bodies ............................................................................... 23
8.5 Process requirements for Certification Bodies .................................................................................. 24
8.5.1 Organization Certification Analysis Process ....................................................................................... 24
8.5.2 Integrated Management System audits ................................................................................................ 31
8.5.3 Performance Based Surveillance/Recertification Process ............................................................ 32
8.5.4 Use of Information and Communication Technology in an audit program ............................. 33
8.5.5 Planning Aerospace Quality Management System audits .............................................................. 33
8.5.6 Aerospace Quality Management System audit teams ...................................................................... 34
8.5.7 Audit team conclusions and reporting .................................................................................................. 34
8.5.8 Certification decisions ................................................................................................................................ 34
8.5.9 Transfer of certificates................................................................................................................................ 34
8.5.10 Special audits .................................................................................................................................................. 35
8.5.11 Suspending, expiring, or withdrawing certification ........................................................................ 36
8.5.12 Complaints and Online Aerospace Supplier Information System Database feedback
process .............................................................................................................................................................. 36
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8.6 Quality Management System Requirements for Certification Bodies ....................................... 37
9 Requirements for certified Aerospace Quality Management System organizations ........... 37
9.1 General requirements ................................................................................................................................. 37
9.2 Requirements for use of Performance Based Surveillance/Recertification Process .......... 38
10 Requirements for Auditor Authentication Bodies ............................................................................ 38
11 Requirements for Training Provider Approval Bodies .................................................................. 38
12 Online Aerospace Supplier Information System Database requirements ............................... 39
Annex A (informative) Acronym log ................................................................................................................... 40
Annex B (normative) Industry Controlled Other Party scheme ............................................................... 42
Annex C (normative) Use of Online Aerospace Supplier Information System Database
functionality ................................................................................................................................................... 43
Annex D (normative) Performance Based Surveillance/Recertification Process .............................. 46
Bibliography ................................................................................................................................................................. 49
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European foreword
This document (prEN 9104-001:2022) 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 9104-001:2013.
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 scheme was built upon the existing
International Accreditation Forum (IAF) and International Organization for Standardization
(ISO)/International Electrotechnical Commission (IEC) requirements for certification of an
organization’s Quality Management System (QMS).The ICOP scheme and ISO/IEC requirements have changed over time, this revision incorporates those
changes and strengthens the alignment between industry and current IAF requirements. Furthermore,
this standard was revised to align with the latest revisions to the other ICOP scheme requirements
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Introduction
To ensure customer satisfaction, ASD organizations have to 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 external providers throughout the world and at all levels of the
supply chain. External providers have the challenge of delivering products and services to multiple
customers having varying quality requirements and expectations.Industry established the IAQG, with representatives from 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 standard has been prepared by the IAQG.The IAQG develops documents that standardize QMS requirements to the greatest extent possible and
can be used at all levels of the supply chain by organizations around the world. Their use should result
in improved quality, cost, and delivery performance through the reduction or elimination of
organization-unique requirements, effective implementation of the QMS, and wider application of good
practices. While primarily developed for the ASD industry, these EN 9100-series standards (i.e.
EN 9100, EN 9110, and EN 9120) can also be used in other industry sectors when a QMS with
supplemental requirements, beyond an EN ISO 9001 system, is needed.Subsequently, the IAQG developed a global scheme for the acceptance and recognition of certification of
an organization’s AQMS performed by Certification Bodies (CBs), using the EN 9100-series standards,
and taking into account the existing schemes for QMS certification. The scheme relies on:
• the use of CBs with specific ASD elements and requirements, under the guidance and oversight of
the ASD industry; and• the use of a harmonized approach with the CBs for improving the quality and process control
throughout the entire supply chain.This document defines the scheme requirements for managing AQMS certification (commonly referred
to as the ‘ICOP scheme’). Other standards in this series (i.e. EN 9104-002, EN 9104-003) provide
specific requirements for defining the industry oversight process, and the AQMS requirements for ASD
auditor training, development, competence, and authentication, respectively. The three ICOP scheme
requirements documents are:• EN 9104-001, Aerospace series — Quality Management Systems — Part 001: Requirements for
Certification of Aviation, Space, and Defence;• EN 9104-002, Aerospace series — Quality management systems — Part 002: Requirements for
Oversight of Aerospace Quality Management System Registration/Certification Programs; and
• EN 9104-003, Aerospace series — Quality management systems — Part 003: Requirements for
Aerospace Quality Management System (AQMS) Auditor Training and Qualification.In this document, the following terms are used:
• “shall” indicates a requirement;
• “should” indicates a recommendation;
• “may” indicates a permission;
• “can” indicates a possibility or capability;
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• “annual” or “annually” indicates a 12-month period beginning January 1st and ending December
31st; and• “days” are calendar days, unless otherwise specified.
Words “example” or “e.g.” indicate suggestions given for guidance and information marked “NOTE” is
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1 Scope
This document defines the industry-accepted requirements for the ICOP scheme, which provides
confidence to ASD customers, that organizations with certification of their QMS, issued by accredited
CBs, meet applicable AQMS standard requirements. The requirements in this document are applicable
to all participants in the ICOP scheme. If there is a conflict between the requirements of this document,
and customer or applicable statutory/regulatory requirements, the latter has to take precedence.
2 Normative referencesThe 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 Defense Organizations
EN 9101 , Quality Management Systems — Audit Requirements for Aviation, Space, and Defence
OrganisationsEN 9104-002 , Aerospace series — Quality management systems — Part 002: Requirements for Oversight
of Aerospace Quality Management System Registration/Certification ProgramsEN 9104-003 , Aerospace series — Quality management systems — Part 003: Requirements for Aerospace
Quality Management System (AQMS) Auditor Training and QualificationEN 9110 , Quality Management Systems — Requirements for Aviation Maintenance Organizations
EN 9120 , Quality Management Systems — Requirements for Aviation, Space and Defense Distributors
EN ISO 9000, Quality management systems - Fundamentals and vocabulary (ISO 9000)EN ISO 9001, Quality management systems - Requirements (ISO 9001)
EN ISO 19011, Guidelines for auditing management systems (ISO 19011)
EN ISO/IEC 17000, Conformity assessment — Vocabulary and general principles (ISO/IEC 17000)
EN ISO/IEC 17011, Conformity assessment — Requirements for accreditation bodies accrediting
conformity assessment bodies (ISO/IEC 17011)EN ISO/IEC 17021-1, Conformity assessment — Requirements for bodies providing audit and certification
of management systems — Part 1: Requirements (ISO/IEC 17021-1)IAF MD 1, IAF Mandatory Document for the Audit and Certification of a Management System Operated by
a Multi-Site OrganizationIAF MD 2, IAF Mandatory Document for the Transfer of Accredited Certification of Management Systems
IAF MD 4, IAF Mandatory Document for the Use of Information and Communication Technology (ICT) for
Auditing/Assessment PurposesAs developed under the auspices of the IAQG and published by various standards bodies [e.g., 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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IAF MD 5, IAF Mandatory Document — Determination of Audit Time of Quality, Environmental, and
Occupational Health & Safety Management SystemsIAF MD 11, IAF Mandatory Document for the Application of ISO/IEC 17021 for Audits of Integrated
Management SystemsIAF ML 4, IAF Multilateral Recognition Arrangements — Policies and Procedures for a MLA on the Level of
Single Accreditation Bodies and on the Level of Regional Accreditation Groups3 Terms and definitions
For the purposes of this document, the terms and definitions given in EN ISO 9000, EN ISO/IEC 17000,
the IAQG International Dictionary (located on the IAQG website www.iaqg.org) and the following apply.
NOTE An acronym log for this document is presented in Annex A.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/
3.1
Aerospace Quality Management System
AQMS
QMS based upon EN ISO 9001 that includes additional ASD requirements, as established in EN 9100,
EN 9110, and EN 9120 standards3.2
Aerospace Quality Management System (AQMS) Auditor
person with the demonstrated attributes (i.e., training, audit experience, industry experience) and
competence to conduct an audit on ASD organizations. An AQMS auditor is either an Authenticated
Experienced Auditor (AEA) or an Authenticated Auditor (AA), and shall have met the requirements set
forth in EN 9104-0033.3
Industry Controlled Other Party (ICOP) Scheme
IAQG and industry managed scheme for the audit and certification of an organization’s AQMS by
accredited other party CBs, in accordance with the requirements defined in the EN 9104-series
standards3.4
International Aerospace Quality Group
IAQG
non-profit global association comprised of member companies from the ASD industries, whose mission
is to achieve significant performance improvements world-wide in terms of quality, delivery, and cost,
through the development and deployment of standards, industry oversight, and guidance materials for
use at all levels of the global supply chain3.5
International Aerospace Quality Group (IAQG) Other Party Management Team (OPMT)
organization comprised of member companies within the ASD industries who design, develop,
manufacture, and support original equipment at system or subsystem levels; established by the IAQG to
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3.6
International Aerospace Quality Group (IAQG) Sector
sub-structure of the IAQG that consists of members in a specific geographic area (i.e., Americas, Europe,
Asia/Pacific)3.7
Online Aerospace Supplier Information System (OASIS™) Database
web-based IAQG application containing information on participating National Aerospace Industry
Associations (NAIAs), Accreditation Bodies (ABs), Training Provider Approval Bodies (TPABs), Auditor
Authentication Bodies (AABs), accredited CBs, AQMS auditors, certified organizations, and audits, which
are approved and recognized by the Sector Management Structure (SMS) through the ICOP scheme
3.8Organization Certification Analysis Process
OCAP
interactive process between the organization and CB to determine the organization’s AQMS scope and
associated certification audit program, and conduct a risk assessment for certification within the ICOP
scheme3.9
Performance Based Surveillance/Recertification Process
PBS/RP
ICOP scheme AQMS surveillance and recertification optional process based on objective evidence and
demonstration that a certified organization continually maintains a conforming, effective, and high
performing AQMS3.10
Regional Management Structure
RMS
committee within a SMS that operates at the regional level, responsible for EN 9104-series standards
conformance in their respective regions. They perform the same functions as the SMS, under control of
the SMS within their sector3.11
Sector Management Structure
SMS
committee established in an IAQG sector that manages the application and oversight of the ICOP scheme
Note 1 to entry: Each sector may use a different name for this organization.3.12
Training Provider Approval Body
TPAB
body approved by the SMS or RMS that has the primary responsibility to conduct the review and
approval of training courses and Training Providers (TPs)4 Principles
4.1 The ICOP scheme (see Annex B) is globally recognized, and includes AQMS certifications, auditor
authentications, and the bodies and entities approved in accordance with the EN 9104-series of
standards (i.e. EN 9104-001, EN 9104-002, and EN 9104-003) and all published resolutions.
4.2 The IAQG has established the IAQG Other Party Management Team (OPMT) to act as the scheme
owner that develops, implements, maintains, and improves the requirements of the ICOP scheme.
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4.3 The IAQG OPMT is supported by a SMS for each sector (i.e. Americas, Europe, Asia-Pacific).
4.4 The IAQG has established the OASIS database as the mandated repository for ICOP scheme
certification data.4.5 The OASIS database supports the collection, issuance, and management of feedback between
various stakeholders in the ICOP scheme, as depicted in Annex C.a) OASIS database users can provide feedback to ICOP scheme stakeholders (e.g. CBs, ABs, IAQG
Leadership, Document Representatives).b) Feedback can include ICOP scheme information, complaints, questions, or suggestions users have
with respect to:• management of the ICOP scheme;
• AQMS certificates;
• AQMS audit data;
• certified organization performance;
• clarification of standards; or
• support needed.
4.6 The ICOP scheme participants identified within the OASIS database have demonstrated their
initial and continuing conformance to the applicable requirements.a) The OASIS database identifies the status of ICOP scheme participants.
b) ICOP scheme entities that are suspended are at risk and their status is temporarily invalid.
c) ICOP scheme participants that are expired, withdrawn, or deleted are no longer in conformance
with the scheme requirements.5 General requirements
5.1 Policy and ethics
5.1.1 IAQG member company representatives and other ICOP scheme participants shall be in
compliance with local and national laws and anti-trust regulations.5.1.2 All participants in the IAQG ICOP scheme shall report conduct that adversely affects the
integrity of the scheme to the appropriate entity(ies).5.1.3 When an AB, CB, SMS, or Regional Management Structure (RMS) representative encounters an
AQMS auditor misconduct issue, they shall share relevant documented information detailing the
misconduct with the AAB responsible for the subject auditor’s AQMS authentication.
5.2 Oversight5.2.1 The ICOP scheme oversight process and associated activities, including the management and
performance of oversight, shall be in accordance with the requirements defined in EN 9104-002.
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5.2.2 Entities participating in the ICOP scheme shall agree to EN 9104-002 oversight by the IAQG
OPMT and the applicable SMS or RMS.5.2.3 Complaints generated from the ICOP scheme shall be directed to the entity of the complaint. If
not resolved, the complaint may be escalated in accordance with Table 1.Escalated complaints should focus on process issues and not process decisions.
Table 1 — Complaint resolution escalation
If complaint is Certified
Auditor Assessor AB CB RMS SMS
against the: Organization
The issue shall be
Assessor’s SMS or IAQG
communicated to CB CB AB SMS
Organization RMS OPMT
the:
5.3 Documented information
5.3.1 Documented information and data in the form of audit reports, nonconformities, checklists, or
other company specific information, generated by the application of this standard, shall be considered
confidential (also referred to as proprietary or sensitive) between the parties generating, collecting, or
using the data; and be managed as such, except as required by law.a) Organizations using this information shall keep it confidential (both internally and externally),
unless otherwise agreed by the consenting parties.b) IAQG OPMT ICOP scheme participants shall not be provided with access to records of their
competitors.NOTE Documented information retained by ABs and CBs on certified organizations may be subject to an
audit or review, at any time, by applicable ABs, SMS, RMS, government, or regulatory authorities.
5.3.2 Access to documented information required by the ICOP scheme, shall be available to the IAQG
OPMT, SMS, or RMS (if applicable) for evaluating operation of the scheme and conformance with this
standard.5.3.3 Records demonstrating conformance to the ICOP scheme requirements of the EN 9104-series
standards shall be retained by the originator for a minimum period of ten years.6 Requirements for Industry Controlled Other Party Scheme management
structure
6.1 General requirements
6.1.1 The IAQG SMS may be supported by a RMS. When established, a RMS shall operate as a part of
the SMS, performing the same functions on a regional level.6.1.2 The IAQG OPMT, SMS, and RMS (if applicable) shall be in conformance with IAQG published
policies and Operating Management System (OMS) written rules and procedures that pertain to the
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6.2 Structure and resource requirements
6.2.1 The IAQG OPMT shall be composed of the following:
a) three IAQG member company representatives with voting rights, which are members of and
appointed by each SMS;b) alternate voting members from IAQG member companies, appointed by each SMS, to ensure full
representation at all meetings or votes; andc) other non-voting stakeholder representatives that may include sector AB representatives, sector CB
representatives, regulatory authorities, IAF representatives, IAQG sector member companies, IAQG
strategy streams representatives, and other invited organizations or persons (as necessary) to
support the opera...
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