prEN 9212

SLOVENSKI STANDARD
01-april-2024
Aeronavtika - Industrializacija - Smernice za vzpostavitev proizvodne in
inšpekcijske dokumentacije ter s tem povezane utemeljitve
Aerospace series - Industrialization - Guidelines for establishing the manufacturing and
inspection file and the associated justifications
Luft- und Raumfahrt - Industrialisierung - Leitfaden für die Erstellung der Herstellungs-
und Kontrollakte und der dazugehörigen Begründungen
Série aérospatiale - Industrialisation - Guide pour l’élaboration du dossier de fabrication
et de contrôle et des justifications associées
Ta slovenski standard je istoveten z: prEN 9212
ICS:
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
NORME EUROPÉENNE
EUROPÄISCHE NORM
February 2024
ICS 49.020
English Version
Aerospace series - Industrialization - Guidelines for
establishing the manufacturing and inspection file and the
associated justifications
Série aérospatiale - Industrialisation - Guide pour Luft- und Raumfahrt - Industrialisierung - Leitfaden für
l'élaboration du dossier de fabrication et de contrôle et die Erstellung der Herstellungs- und Kontrollakte und
des justifications associées der dazugehörigen Begründungen
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, Türkiye 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
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 9212:2024 E
worldwide for CEN national Members.

Contents Page
European foreword . 4
Introduction . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 6
4 List of acronyms . 11
5 Concepts . 12
5.1 Scope and interactions . 12
5.2 Aim of the MIF and the justifications provided . 13
5.3 Structure of the documented information . 13
5.4 Impacted stakeholders in the organization . 14
5.5 Recipients of the MIF and the associated justifications . 14
6 Elaboration process of the MIF and the associated justifications . 15
6.1 Data to be taken into account . 15
6.2 Position in the execution logic . 16
6.3 Improvement logic of the MIF . 17
7 Content of the MIF . 19
7.1 Global overview of the MIF . 19
7.2 Detailed composition of the MIF. 21
7.2.1 Manufacturing and inspection flowchart (MIFC) . 21
7.2.2 Manufacturing bill of materials (M-BOM) . 23
7.2.3 Manufacturing and inspection routine (or manufacturing and inspection operating
instruction) . 24
7.2.4 External procurement file . 25
7.2.5 Operations . 26
7.2.6 Processes . 27
7.2.7 Instruction . 29
7.2.8 Associated tooling, means and computer programmes . 30
7.2.9 Documented manufacturing and inspection information records (DMIIR) . 32
7.2.10 Skills . 34
7.2.11 Workstation . 35
8 Elaboration process and content of the justifications associated with the MIF . 36
8.1 Objective . 36
8.2 Establishment and content of the MIJP . 36
8.2.1 Establishment of the MIJP . 36
8.2.2 Content of the MIJP . 37
8.3 Establishment and content of the MIJF . 39
8.3.1 Establishment of the MIJF . 39
8.3.2 Content of the MIJF . 40
8.4 Qualification and certification of the processes . 41
9 Validation of the MIF and the MIJF . 41
10 Use of the MIF . 42
11 Change of the MIF and the associated justifications . 42
Annex A (informative) Example of the presentation of a manufacturing and inspection
justification plan (MIJP) . 44
Annex B (informative) Example of the presentation of a manufacturing and inspection
justification file – MIJF . 45
Annex C (informative) Examples of justification works to be performed . 48
Annex D (informative) Example of the transformation of the definition bill of materials into
a manufacturing bill of materials according to the industrial organization . 51
Bibliography . 52

European foreword
This document (prEN 9212:2024) has been prepared by 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.
Introduction
This document belongs to the documents supporting EN 9200 relating to the programme management
specification.
EN 9212 is written in accordance with the documentary system linked to EN 9200 and takes account of
the current and almost systematic interconnection between the manufacturing and inspection activities
of the product, in keeping with quality management practices.
The manufacturing and inspection file (MIF), and the associated justifications (MIJF), form part of the
output data of the industrialization process. They are intended mainly for actors of the production
process and provide the justifications required by the design and development processes, and by the
acquiring customer. They are elaborated by the actors of industrialization, in partnership with the
actors of development and production.
1 Scope
The aim of a MIF and the associated justifications is to ensure that manufacturing and/or inspection
operations are realized in a compliant and reproducible manner, in accordance with the regulations in
force.
The purpose of this document is to provide a guide to the elaboration of the MIF and the associated
justifications by:
— positioning them within the framework:
o of a programme and its objectives, on the one hand,
o of the realization of a product, on the other;
— describing, until production of the product ceases:
o the principles and conditions applying to the elaboration and then the validation of the MIF
within the framework of the industrialization process,
o the principles and conditions applying to the elaboration and then the validation of the MIJF
associated with the MIF, within the framework of the industrialization process,
o the principles and change and control conditions applying to the MIF and the MIJF.
This document can be used for all processes or sets of processes implemented on a tangible product,
which may incorporate software associated with the product. It does not apply to purely software
product, commercial-off-the-shelf product (catalogue part) or service (intangible product).
This document applies more particularly to serial production. Nevertheless, the principles and
conditions set forth in this document may be applied, making any necessary adaptations, to unit
production or to the realization of products to meet development needs (prototypes,
demonstrators, etc.).
This document covers the MIF and the MIJF of a product, including the activities related to procurement
and the associated industrial means in particular.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology 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
measurement systems analysis
MSA
study of the effects of selected elements of
...