SIST EN 9133:2018
(Main)Aerospace series - Quality Management Systems - Qualification Procedure for Aerospace Standard Products
Aerospace series - Quality Management Systems - Qualification Procedure for Aerospace Standard Products
This document defines a system for the qualification of standard products for aviation, space, and
defenc applications. It defines the principles that shall be adhered to when carrying out product
qualification; applied in conjunction with the rules and procedures of the CA. The system enables the CA
to confirm compliance is achieved and maintained, in accordance with the requirements of its product
definition and associated controlling technical specifications by an Original Component Manufacturer
(OCM) of standard products.
This document requires an OCM that has been granted product qualification approval to ensure
applicable approvals are maintained and renewed in accordance with the CA’s quality system for that
qualified product.
OCMs and OCM designated Value Added Distributors (VADs) requesting product qualification to this
standard, shall as a prerequisite, maintain EN 9100 standard quality management system certification
approval. This certification shall be visible in the Online Aerospace Supplier Information System
(OASIS) database.
Luft- und Raumfahrt - Qualitätsmanagementsystem - Qualifikationsverfahren für genormte Teile der Luft- und Raumfahrt
1.1 Allgemeines
Dieses Dokument legt ein System für die Qualifikation von genormten Produkten für Anwendungen in der Luftfahrt, Raumfahrt und Verteidigung, fest. Sie legt die Grundsätze fest, die bei der Durchführung der Produktqualifikation eingehalten werden müssen und in Verbindung mit den Regeln und Verfahren der Zertifizierungsstelle angewendet werden. Das System ermöglicht der Zertifizierungsstelle, einem Original¬teilhersteller (OCM, en: Original Component Manufacturer) von genormten Produkten das Erreichen und Aufrechterhalten der Übereinstimmung entsprechend den Anforderungen der Produktfestlegung und den zugehörigen maßgebenden technischen Lieferbedingungen zu bestätigen.
Dieses Dokument fordert von einem Originalteilhersteller, dem eine Bauartzulassung für das Produkt erteilt wurde, sicherzustellen, dass die entsprechenden Zulassungen in Übereinstimmung mit dem Qualitäts¬sicherungssystem der Zertifizierungsstelle für das qualifizierte Produkt aufrechterhalten und erneuert werden.
OCM und vom OCM benannte Value-Added-Distributoren (VAD), die eine Produktqualifikation nach dieser Norm beantragen, müssen als Vorbedingung die Zertifizierung und Zulassung nach dem Qualitätsmanage¬mentsystem nach EN 9100 aufrechterhalten. Diese Zertifizierung muss in der Datenbank des Online Aerospace Supplier Information System (OASIS) sichtbar sein.
1.2 Anwendung
Die Anwendung dieses Dokuments wird entweder in der Produktnorm oder den maßgebenden technischen Lieferbedingungen vorgeschrieben. Der Originalteilhersteller, der genormte Produkte der Luft- und Raum¬fahrt herzustellen beabsichtigt, muss eine Bauartzulassung durch eine Zertifizierungsstelle für die Luft- und Raumfahrt anstreben, wenn dies geltend gemacht wird. Die dabei festgelegten Prozesse werden unparteiisch im Interesse der Luft- und Raumfahrtindustrie durch eine Zertifizierungsstelle durchgeführt, um eine fortlaufende Übereinstimmung der genormten Produkte mit den Anforderungen, die in ihren maßgebenden technischen Lieferbedingungen festgelegt sind, sicherzustellen.
Originalteilhersteller werden sicherstellen müssen, dass sie ausreichend Vorlaufzeit für den Abschluss die¬ses Prozesses einräumen, um von der Zertifizierungsstelle eine Produktzulassung für die Unter¬stützung/Er¬füllung der Lieferanforderungen ihrer Kunden zu erhalten. Qualifizierte Produkte, für die dieser Prozess angewendet wird, dürfen ohne Bauartzulassung und ohne ein gültiges Produktqualifikations¬zertifikat (PQC, en: Product Qualification Certificate) nicht geliefert oder verwendet werden.
Série aérospatiale - Systèmes de management de la qualité - Procédure de qualification pour pièces aérospatiales normalisées
1.1 Généralités
Le présent document définit un système de qualification des produits normalisés pour les applications aéronautiques, spatiales et de défense. Il définit les principes qui doivent être respectés lors de la qualification du produit ; elle s’applique conjointement avec les règles et procédures de l’AC. Le système permet à l'AC de confirmer que la conformité est atteinte et maintenue, conformément aux exigences de sa définition de produit et des spécifications techniques de contrôle associées, par un Fabricant de pièces d'origine (OCM) de produits normalisés.
Le présent document exige un OCM qui a obtenu l'approbation de la qualification du produit pour garantir que les approbations applicables sont maintenues et renouvelées conformément au système qualité de l'AC pour ce produit qualifié.
Les OCM et les Distributeurs à valeur ajoutée (DVA) désignés par l'OCM qui demandent la qualification du produit selon la présente norme doivent, comme condition préalable, maintenir l'agrément de certification des systèmes de management de la qualité de la norme EN 9100. Cette certification doit être visible dans la base de données du Système d'information en ligne des fournisseurs de l'aérospatiale (OASIS).
1.2 Application
L'application du présent document est rendue obligatoire soit dans la norme de produit, soit dans ses spécifications techniques de contrôle. Lorsqu’appelé, l'OCM qui veut produire des produits normalisés dans le domaine aérospatial doit obtenir l'approbation de qualification d'une AC aérospatiale. Les processus définis dans le présent document doivent être exécutés de manière impartiale au profit de l'industrie aérospatiale, par l’AC, afin d'assurer la conformité continue des produits normalisés aux exigences définies dans leurs spécifications techniques de contrôle.
Les OCM doivent s'assurer qu'ils accordent un délai de mise en œuvre suffisant pour mener à bien ce processus afin d'obtenir l'approbation de l’AC pour appuyer/satisfaire les exigences de livraison de leurs clients. Les produits qualifiés par ce processus ne doivent pas être fournis ou utilisés sans l'approbation de la qualification et l'obtention d'un Certificat de qualification de produit (CQP) valide.
Aeronavtika - Sistemi vodenja kakovosti - Postopek za razvrščanje standardiziranih proizvodov v aeronavtiki
Ta dokument opredeljuje sistem za razvrščanje standardiziranih proizvodov za uporabo na področju zračnega prometa, vesoljskih poletov in obrambe. Opredeljuje načela, ki jih je treba upoštevanju pri razvrščanju proizvodov; uporablja se skupaj s pravili in postopki CA. Sistem omogoča CA, da potrdi doseganje in ohranjanje skladnosti v skladu z zahtevami opredelitve izdelka in povezanih nadzornih tehničnih specifikacij, ki jih zagotovi proizvajalec originalne komponente (OCM) za standardizirane proizvode.
Ta dokument zahteva, da OCM, ki je prejel odobritev kvalifikacije proizvoda, poskrbi za ohranjanje in obnavljanje ustreznih odobritev v skladu s sistemom kakovosti pri CA za zadevni razvrščeni proizvod.
OCM-ji in distributerji z dodano vrednostjo (VAD), ki jih določijo OCM-ji, ki zahtevajo kvalifikacijo proizvoda po tem standardu, morajo kot predpogoj imeti odobritev certifikata za sistem vodenja kakovosti po standardu EN 9100. Ta certifikat mora biti viden v podatkovni bazi sistema Online Aerospace Supplier Information System (OASIS).
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 9133:2018
01-september-2018
1DGRPHãþD
SIST EN 9133:2005
$HURQDYWLND6LVWHPLYRGHQMDNDNRYRVWL3RVWRSHN]DUD]YUãþDQMH
VWDQGDUGL]LUDQLKSURL]YRGRYYDHURQDYWLNL
Aerospace series - Quality Management Systems - Qualification Procedure for
Aerospace Standard Products
Luft- und Raumfahrt - Qualitätsmanagementsystem - Qualifikationsverfahren für
genormte Teile der Luft- und Raumfahrt
Série aérospatiale - Systèmes de management de la qualité - Procédure de qualification
pour pièces aérospatiales normalisées
Ta slovenski standard je istoveten z: EN 9133:2018
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 9133:2018 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN 9133:2018
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SIST EN 9133:2018
EN 9133
EUROPEAN STANDARD
NORME EUROPÉENNE
June 2018
EUROPÄISCHE NORM
ICS 03.100.70; 03.120.10; 49.020 Supersedes EN 9133:2004
English Version
Aerospace series - Quality Management Systems -
Qualification Procedure for Aerospace Standard Products
Série aérospatiale - Systèmes de management de la Luft- und Raumfahrt - Qualitätsmanagementsystem -
qualité - Procédure de qualification pour pièces Qualifikationsverfahren für genormte Teile der Luft-
aérospatiales normalisées und Raumfahrt
This European Standard was approved by CEN on 18 September 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 9133:2018 E
worldwide for CEN national Members.
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SIST EN 9133:2018
EN 9133:2018 (E)
Contents Page
European foreword . 3
Rationale . 4
Foreword . 4
1 Scope . 5
1.1 General . 5
1.2 Application . 5
2 Normative references . 5
3 Terms and definitions . 6
4 Qualification process . 10
5 Mandated body representative registration . 12
6 Qualification procedure . 12
7 Qualification activity report . 14
8 Qualification requested by analogy . 15
9 Qualification requested by grandfather product status . 16
10 Certification procedure . 16
11 Qualified products list . 17
12 Qualified product certification maintenance and renewal . 17
13 Manufacturing change request for a manufacturing sealed route . 18
14 Value added distributors . 18
15 Quality failures, noncompliance, and customer complaints . 19
(informative) Acronym log . 20
(informative) Mandated Body — Product Qualification Activity Report (QAR)
Template example . 21
2
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EN 9133:2018 (E)
European foreword
This document (EN 9133:2018) 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 December 2018, and conflicting national standards
shall be withdrawn at the latest by December 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 9133:2004.
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.
3
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EN 9133:2018 (E)
Rationale
This document has undergone full technical revision to reflect improvements introduced to the product
qualification process and incorporate identified best practices since its initial release.
This document defines the process by which a manufacturer wishing to manufacture aviation, space,
and defence standard products may obtain qualification approval from the controlling Certification
Authority (CA). It defines the procedures to be followed by a manufacturer to request, carry out, obtain,
and maintain certification approval by confirming the manufactured products meet the minimum
technical and performance requirements defined by the product standard and controlling technical
specifications.
Foreword
To assure customer satisfaction, the aviation, space, and defence industry organizations must produce
and continually improve safe, reliable products that meet or exceed customer and regulatory authority
requirements. The globalization of the industry and the complexity of resulting organizations’ supply
chains have complicated this objective. End-product organizations face the challenge of assuring the
quality of, and integrating, product purchased from suppliers throughout the world and at all levels
within the supply chain. Furthermore, the aviation, space, and defence suppliers and processors, within
the industry, face the challenge of delivering product to multiple customers having varying quality
expectations and requirements.
The aviation, space, and defence industry established the International Aerospace Quality Group (IAQG)
for the purpose of achieving significant improvements in quality and safety, and reductions in cost,
throughout the value stream. This organization includes representation from aviation, space, and
defence companies in the Americas, Asia/Pacific, and Europe. This document defines the qualification of
standard products and should result in improved quality and safety, and decreased cost, due to the
standardization of this process.
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EN 9133:2018 (E)
1 Scope
1.1 General
This document defines a system for the qualification of standard products for aviation, space, and
defenc applications. It defines the principles that shall be adhered to when carrying out product
qualification; applied in conjunction with the rules and procedures of the CA. The system enables the CA
to confirm compliance is achieved and maintained, in accordance with the requirements of its product
definition and associated controlling technical specifications by an Original Component Manufacturer
(OCM) of standard products.
This document requires an OCM that has been granted product qualification approval to ensure
applicable approvals are maintained and renewed in accordance with the CA’s quality system for that
qualified product.
OCMs and OCM designated Value Added Distributors (VADs) requesting product qualification to this
standard, shall as a prerequisite, maintain EN 9100 standard quality management system certification
approval. This certification shall be visible in the Online Aerospace Supplier Information System
(OASIS) database.
1.2 Application
The application of this document will be mandated either in the product standard or its controlling
technical specifications. When invoked, the OCM wanting to produce aerospace standard products will
need to gain qualification approval from an aerospace CA. The processes defined herein will be
performed impartially for the benefit of the aerospace industry, by the CA, to ensure continued
compliance of standard products to the requirements defined in their controlling technical
specifications.
OCMs will need to ensure they allow sufficient lead-time to complete this process to gain product
approval from the CA to support/satisfy their customer delivery requirements. Qualified products using
this process shall not be supplied or used without qualification approval and a valid Product
Qualification Certificate (PQC) being granted.
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 series — Quality systems — First article inspection requirements
EN 9103, Aerospace series — Quality management systems — Variation management of key
characteristics
NOTE Equivalent versions (e.g. AS, EN, JISQ, SJAC, NBR) of the IAQG standards listed above are published
internationally in each IAQG sector.
EN ISO 9000, Quality management systems — Fundamentals and vocabulary
EN ISO 9001, Quality management systems — Requirements
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ISO 10012, Measurement management systems — Requirements for measurement processes and
measuring equipment
ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories
ASD-CERT Quality Manual (see www.asd-cert.org)
1
AC7101/1 , Nadcap Audit Criteria for Materials Testing Laboratories — General Requirements for all
Laboratories
1
AC7102 , Nadcap Audit Criteria for Heat Treating
1
AC7108 , Nadcap Audit Criteria for Chemical Processing
1
AC7114 , Nadcap Audit Criteria for Nondestructive Testing (NDT) Suppliers — Accreditation Program
1
PD2000 , Governance and Administration of an Industry Managed Product Qualification Program
1
PD2001 , Manufacturer Request for Product Approval and Qualification Process
3 Terms and definitions
For the purpose of this document, the terms and definitions provided in EN ISO 9000 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
analogy
act of granting product qualification certification approval based on testing that has been carried out on
similar qualified product; where the new standard product’s manufacturing method is substantially the
same as the manufacturing method of the existing qualified product
3.2
Certification Authority
CA
authority that administers a certification system for qualification of standard products (e.g. ASD-CERT,
SAE-PRI); acknowledged by the aviation, space, and defence industry Original Equipment
Manufacturers (OEMs) and associated regulatory agencies [i.e. Federal Aviation Administration (FAA),
European Aviation Safety Agency (EASA), or similar]
3.3
end user
organization purchasing aviation, space, and defence ualified standard products. Could be an OEM,
OCM, and/or government agency purchasing standard products to be utilized within an assembly, part,
or finished product
1
Documents published by Performance Review Institute (PRI) and available from www.eAuditNet.com
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3.4
First Article Inspection
FAI
planned, complete, independent, and documented inspection and verification process to ensure that
prescribed production processes have produced an item conforming to engineering drawings, Digital
Product Definition (DPD), planning, purchase order, engineering specifications, and/or other applicable
design documents as defined by the EN 9102 standard
3.5
First Article Inspection Report
FAIR
forms and package of documentation for a part number, sub-assembly, or assembly, including
associated FAI results as defined by the EN 9102 standard
3.6
grandfather qualified product status
act of an OCM requesting qualified product approval from a CA based on them having existing and
current approval for the product standard listed on a Qualified Products List (QPL) with another OEM,
government, or military organization
3.7
Mandated Body
MB
OEM who benefits from the qualification of standard products and use of qualified products; nominates
the Mandated Body Representatives (MBRs)
3.8
Mandated Body Representative
MBR
individual accepted by the CA, based on their knowledge and experience as an industry Subject Matter
Expert (SME), to act as agent on behalf of the CA; tasked with assessing if an OCM’s products comply
with applicable controlling product standards and technical specifications
3.9
Manufacturing Change Request
MCR
process employed by the qualified OCM to request a change to a manufacturing sealed route for
qualified product from the CA
3.10
manufacturing sealed route
list of the manufacturing drawings, significant manufacturing operations, manufacturing flowchart, raw
materials, components, subcontracted and/or VAD activities, and processes identified by name and
controlling document number that are used to manufacture the product being qualified
3.11
Memorandum of Understanding
MoU
written agreement between two organizations to work together in support of a common goal or
deliverable
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3.12
Original Component Manufacturer
OCM
company or organization manufacturing standard products (see 3.23) requiring qualification approval
from a CA
3.13
Original Equipment Manufacturer
OEM
manufacturer of an end user item, system, or subsystem [e.g. an airframe, power system (engine),
auxiliary power unit]
3.14
Product Qualification Certificate
PQC
serialized document that certifies an OCM of standard product has been granted qualification approval
by a CA, according to the relevant product standard and technical specifications. It defines the qualified
product part numbers, applicable technical specifications, the approved OCM and applicable
manufacturing site(s), period of approval, and the certificate renewal date (i.e. expiry date)
3.15
product qualification review
act of confirming compliance to an OCM’s Qualification Test Program (QTP) for product being qualified
to applicable product standards and technical specifications; activity overseen by either a MBR or
carried out by an independent Nadcap approved test laboratory (e.g. AC7101/1) culminating in a
Qualification Activity Report (QAR) being submitted to the CA for review and approval
3.16
product standard
standard defined and approved by consensus agreement of industry SMEs; issued by a Standards
Development Organization (SDO)
3.17
Qualification Activity Report
QAR
report submitted by the MBR with the relevant supporting data and their recommendation to the CA
(see Clause 7 and Annex B)
3.18
Qualification Test Program
QTP
program defined by the product manufacturer (i.e. OCM) or OCM designated VAD to confirm
compliance of their standard product to the requirements of applicable product standards and
associated technical specifications. Standard product qualification may be a combination of tests,
analysis, or other supporting documentation or declarations of compliance
3.19
Qualification Test Report
QTR
report compiled by the OCM or OCM designated VAD that contains the associated test results in
accordance with the QTP and EN 9102 standard FAIR requirements
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3.20
qualified product
aerospace standard product that has been confirmed by witness assessment and approval by a CA as
complying with applicable key characteristics and defined product standard and technical
specification(s) requirements
3.21
Qualified Products List
QPL
directory of qualified products and their OCMs (e.g. ASD-Cert qualified products directory is available at
www.asd-cert.org, PRI qualified products directory is available at www.eAuditNet.com) and OCMs
granted approval for a specific product part number designation, including identification of applicable
manufacturing facilities
3.22
quality manual or program document
document that defines the management system, organization management structure, and processes to
be administered; enables an OCM to obtain standard product qualification approval, be issued a PQC,
and listed in a QPL (e.g. ASD-CERT Quality Manual, PD2000, PD2001)
3.23
standard product
product (see 3.16) controlled by product standard definition produced by a SDO (see 3.24). The term
can apply to hardware (e.g. fasteners, connectors, fittings), materials, coatings, sealants, and products
that can have their key characteristics assessed for compliance by product qualification to this standard.
This may also apply to products referred to as standard catalogue items, as defined by the EN 9102
standard
3.24
Standards Development Organization
SDO
recognized national or international organization commissioned to develop standards and technical
specifications for aerospace applications through the input of industry SMEs to achieve consensus
agreement for the product standards developed
3.25
Subject Matter Expert
SME
individual who has been accepted by industry peers as having gained expert knowledge of specific
products/subjects obtained through academic study, continued training, and/or product standard
development experience for a SDO
3.26
technical specification
specification identified on the product standard that defines the procedures, technical requirements,
manufacturing process(es), and testing and inspection requirements to be performed on a product
manufactured by an OCM. It defines the product’s key attributes that must be achieved by testing and
inspection at the initial product qualification review and for each production batch of products
manufactured
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3.27
Value Added Distributor
VAD
manufacturer or distributor designated and monitored by the qualified OCM to complete the final
assembly of the constituent components of a qualified product and act as a distributor of the finished
product assembled on behalf of the qualified OCM
4 Qualification process
4.1 The qualification process shall follow the stages defined in the application flow chart
(see Figure 1).
4.2 An OCM seeking to obtain approval to manufacture a qualified product shall apply to the CA, using
the appropriate process(es) defined in the CA’s quality manual or program document. The following
data/information shall be provided:
a) description of the product to be qualified; identifying the applicable technical specifications and the
relevant qualification standard to be used;
b) an overview of the company (e.g. organization, shareholders and parent companies, products
manufactured, manpower, facilities);
c) a list of quality approvals and/or qualifications already granted to the OCM, including additional
supporting information on similar qualified products;
d) a copy of the OCM’s EN 9100 quality management system certificate (registered on the OASIS
database) and any other applicable certifications/accreditations (e.g. Nadcap accreditations), if
applicable to the product manufacturing process and/or relevant to the request being submitted.
Any external subcontractors (e.g. machining, heat treatment, or plating suppliers) identified shall
have EN 9100 Quality Management System Certification and the applicable Nadcap accreditations
for the operations being conducted;
e) details of product manufacturing route, including details of all special processes and inspection
techniques to be used (see 4.2 d)).
4.3 On receipt of a request from an OCM, the CA shall identify a MBR (see Clause 5) to act on their
behalf to carry out the product qualification review, which can include the need to witness product
testing in accordance with the applicable product standard and technical specification requirements.
The approved individual shall either be an employee of an OEM or an individual employed by an
organization that has a Memorandum of Understanding (MOU) with the CA for carrying out product
qualifications.
4.4 The information provided by the OCM shall be forwarded by the CA to the MBR selected to carry
out the product qualification review in accordance with Clause 6.
4.5 The manufacturing sealed route shall be provided by the OCM and sealed (i.e. frozen) by the MBR
(see 6.1). The EN 9103 standard may be used at the discretion of the MBR. The key characteristics of the
standard product and the associated technical specifications shall be identified and may be used to
assess the competency and capability of the OCM identified to produce the qualified product.
4.6 The OCM or OCM designated VAD shall conduct a FAI, if applicable, for the product to be qualified
in accordance with the EN 9102 standard requirements.
4.7 An OCM that wishes to add a designated VAD to their PQC shall submit a separate qualification
request, supplying details (see 4.2 and 4.5) for each VAD they want to incorporate into their
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manufacturing sealed route. The OCM shall be responsible for and represent each designated VAD
(see Clause 14).
Figure 1 — Qualification process flow chart
4.8 Any supporting documentation, drawings, processes, manufacturing methods, etc., provided to
rd
parties without the
the MBR and CA shall be treated as "private data" and shall not be supplied to 3
written approval of the OCM. All other data [e.g. test reports, quality certificates, MBR QAR Report
11
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(without attachments)] shall be treated as "confidential" (consistent with the organization’s
confidentiality requirements) and may be examined by an OEM or regulatory organization (i.e. FAA,
EASA, or similar).
5 Mandated body representative registration
5.1 Prospective MBR candidates shall arrange for a proposal, approved by their MB management
representative, to be submitted to the CA confirming the willingness of the MB to support the CA
activities via the identified candidate. The proposal shall contain letter of introduction and details of the
candidate’s industry knowledge, field of experience, and curriculum vitae.
5.2 The CA shall review each application to determine the suitability of each candidate to carry out
specific MBR functions and approve the requests, as appropriate. A register shall be maintained of
MBRs approved to carry out qualification reviews on behalf of the aviation, space, and defence industry.
5.3 The CA shall have the responsibility to select a MBR to carry out a qualification review, based on
the MBR’s experience and knowledge of the product to be qualified.
5.4 The MBR shall act impartially on behalf of the CA in accordance with the policies and procedures
defined by the CA’s quality system.
6 Qualification procedure
6.1 In support of standard product qualification, the MBR shall:
a) request the OCM or OCM designated VAD to produce a QTP (see 6.2). For qualified products
assembled by an OCM designated VAD, the testing to be carried out shall be sufficient to
demonstrate continued compliance to the defined requirements of the product standard and
agreed with by the MBR;
b) verify with the OCM that sufficient test samples, as defined by the applicable product standard and
associated technical specifications, are available to meet the requirements of the submitted QTP;
c) request a declaration that the test samples have been selected from a single manufacturing batch,
unless otherwise stated by the product standard’s technical specification, produced in accordance
with the manufacturing sealed route intended for future production;
d) evaluate the QTP against the product standards and applicable technical specification requirements
to ensure all the tests and inspection criteria defined are listed in the QTP for MBR assessment,
including any required witnessed evaluations that will need to be performed;
e) in accordance with the QTP, establish a schedule for the MBR to visit the OCM to oversee any
required witnessed evaluations and/or tests to be performed by an independent Nadcap approved
laboratory (e.g. AC7101) on behalf of the OCM;
f) review and record Nadcap laboratory accreditations (e.g. AC7101/1) for tests planned to be
conducted by an independent laboratory;
g) review and confirm acceptance of the QTP with the OCM; ensure satisfactory completion;
h) if during testing in accordance with the QTP the product being tested is found to be noncompliant, a
root cause analysis report shall be produced and corrective actions proposed by the OCM which can
be reviewed with the MBR to either enable the product qualification process to proceed or be
halted, and for a QAR to be produced and submitted to the CA for action (see 6.5);
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SIST EN 9133:2018
EN 9133:2018 (E)
i) request a QTR documenting the results of the QTP is prepared by the OCM. The QTR shall contain
the following data/information:
— a FAIR in accordance with EN 9102 standard requirements;
— a summary sheet identifying each of
...
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