EN 9100:2009

SLOVENSKI STANDARD
01-oktober-2009
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SIST EN 9100:2004
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Quality Management Systems - Requirements for Aviation, Space and Defense
Organizations
Qualitätsmanagementsysteme — Anforderungen an Organisationen der Luftfahrt,
Raumfahrt und Verteidigung
Systèmes de management de la Qualité — Exigences des Organisations pour l'Aviation,
l'Espace et la Défense
Ta slovenski standard je istoveten z: EN 9100:2009
ICS:
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.

EUROPEAN STANDARD
EN 9100
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2009
ICS 03.120.10; 49.020 Supersedes EN 9100:2003
English Version
Quality Management Systems - Requirements for Aviation,
Space and Defense Organizations
Systèmes de management de la Qualité - Exigences des Qualitätsmanagementsysteme - Anforderungen an
Organisations pour l'Aviation, l'Espace et la Défense Organisationen der Luftfahrt, Raumfahrt und Verteidigung
This European Standard was approved by CEN on 3 July 2009.

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 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 Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.

EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 9100:2009: E
worldwide for CEN national Members.

Contents Page
Foreword .4
0 INTRODUCTION .5
0.1 General .5
0.2 Process approach .5
QUALITY MANAGEMENT SYSTEMS – REQUIREMENTS .7
1 SCOPE .7
1.1 General .7
1.2 Application .7
2 NORMATIVE REFERENCES .8
3 TERMS AND DEFINITIONS .8
3.1 Risk .8
3.2 Special requirements .8
3.3 Critical items .8
3.4 Key characteristic.9
4 QUALITY MANAGEMENT SYSTEM.9
4.1 General requirements .9
4.2 Documentation Requirements . 10
4.2.1 General . 10
4.2.2 Quality Manual . 10
4.2.3 Control of Documents . 10
4.2.4 Control of Records . 11
5 MANAGEMENT RESPONSIBILITY . 11
5.1 Management Commitment . 11
5.2 Customer Focus . 11
5.3 Quality Policy . 12
5.4 Planning . 12
5.4.1 Quality Objectives . 12
5.4.2 Quality Management System Planning . 12
5.5 Responsibility, Authority and Communication . 12
5.5.1 Responsibility and Authority . 12
5.5.2 Management Representative . 12
5.5.3 Internal Communication . 13
5.6 Management Review . 13
5.6.1 General . 13
5.6.2 Review Input . 13
5.6.3 Review Ouput . 13
6 RESOURCE MANAGEMENT . 14
6.1 Provision of Resources . 14
6.2 Human Resources . 14
6.2.1 General . 14
6.2.2 Competence, Training and Awareness . 14
6.3 Infrastructure . 14
6.4 Work Environment. 14
7 PRODUCT REALIZATION . 15
7.1 Planning of Product Realization . 15
7.1.1 Project Management . 15
7.1.2 Risk Management . 15
7.1.3 Configuration Management. 16
7.1.4 Control of Work Transfers . 16
7.2 Customer-related processes. 16
7.2.1 Determination of Requirements Related to the Product . 16
7.2.2 Review of Requirements Related to the Product . 16
7.2.3 Customer Communication . 17
7.3 Design and Development . 17
7.3.1 Design and Development Planning . 17
7.3.2 Design and Development Inputs . 18
7.3.3 Design and Development Outputs . 18
7.3.4 Design and Development Review . 19
7.3.5 Design and Development Verification . 19
7.3.6 Design and Development Validation . 19
7.3.6.1 Design and Development Verification and Validation Testing . 19
7.3.6.2 Design and Development Verification and Validation Documentation . 19
7.3.7 Control of Design and Development Changes. 19
7.4 Purchasing . 20
7.4.1 Purchasing Process . 20
7.4.2 Purchasing Information . 20
7.4.3 Verification of Purchased Product . 21
7.5 Production and Service Provision . 22
7.5.1 Control of Production and Service Provision . 22
7.5.1.1 Production Process Verification . 22
7.5.1.2 Control of Production Process Changes . 23
7.5.1.3 Control of Production Equipment, Tools and Software Programs . 23
7.5.1.4 Post-Delivery Support . 23
7.5.2 Validation of Processes for Production and Service Provision . 23
7.5.3 Identification and Traceability . 24
7.5.4 Customer Property . 24
7.5.5 Preservation of Product . 24
7.6 Control of Monitoring and Measuring Equipment . 25
8 MEASUREMENT, ANALYSIS AND IMPROVEMENT . 26
8.1 General . 26
8.2 Monitoring and Measurement . 26
8.2.1 Customer Satisfaction . 26
8.2.2 Internal Audit . 26
8.2.3 Monitoring and Measurement of Processes . 27
8.2.4 Monitoring and Measurement of Product . 27
8.3 Control of Nonconforming Product . 28
8.4 Analysis of Data . 29
8.5 Improvement . 29
8.5.1 Continual Improvement . 29
8.5.2 Corrective Action . 30
8.5.3 Preventive Action . 30
BIBLIOGRAPHY . 31
Foreword
This document (EN 9100:2009) 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 February 2010, and conflicting national standards shall be withdrawn
at the latest by February 2010.
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 9100:2003.
This standard has been revised to incorporate the requirements of ISO 9001:2008. In addition, industry
requirements, definitions and notes have been revised and additional requirements have been included in
response to stakeholder needs.
Industry has established the International Aerospace Quality Group (IAQG), with representatives from
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.
This document standardizes quality management system requirements to the greatest extent possible and
can be used at all levels of the supply chain by organizations around the world. Its use should result in
improved quality, schedule and cost performance by the reduction or elimination of organization-unique
requirements and wider application of good practice. While primarily developed for the aviation, space and
defense industry, this standard can also be used in other industry sectors where a quality management
system with additional requirements over an ISO 9001 system is needed.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
0 INTRODUCTION
0.1 General
The adoption of a quality management system should be a strategic decision of an organization. The design
and implementation of an organization‘s quality management system is influenced by
a) its organizational environment, changes in that environment, and the risks associated with that
environment,
b) its varying needs,
c) its particular objectives,
d) the products it provides,
e) the processes it employs,
f) its size and organizational structure.
It is not the intent of this International Standard to imply uniformity in the structure of quality management
systems or uniformity of documentation.
The quality management system requirements specified in this International Standard are complementary to
requirements for products. Information marked “NOTE” is for guidance in understanding or clarifying the
associated requirement.
This International Standard can be used by internal and external parties, including certification bodies, to
assess the organization's ability to meet customer, statutory and regulatory requirements applicable to the
product, and the organization's own requirements.
The quality management principles stated in ISO 9000 and ISO 9004 have been taken into consideration
during the development of this International Standard.
0.2 Process approach
This International Standard promotes the adoption of a process approach when developing, implementing and
improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting
customer requirements.
For an organization to function effectively, it has to determine and manage numerous linked activities. An
activity or set of activities using resources, and managed in order to enable the transformation of inputs into
outputs, can be considered as a process. Often the output from one process directly forms the input to the next.
The application of a system of processes within an organization, together with the identification and
interactions of these processes, and their management to produce the desired outcome, can be referred to as
the “process approach”.
An advantage of the process approach is the ongoing control that it provides over the linkage between the
individual processes within the system of processes, as well as over their combination and interaction.
When used within a quality management system, such an approach emphasizes the importance of
a) understanding and meeting requirements,
b) the need to consider processes in terms of added value,
c) obtaining results of process performance and effectiveness, and
d) continual improvement of processes based on objective measurement.
The model of a process-based quality management system shown in Figure 1 illustrates the process linkages
presented in Clauses 4 to 8. This illustration shows that customers play a significant role in defining requirements
as inputs. Monitoring of customer satisfaction requires the evaluation of information relating to customer
perception as to whether the organization has met the customer requirements. The model shown in Figure 1
covers all the requirements of this International Standard, but does not show processes at a detailed level.
NOTE In addition, the methodology known as “Plan-Do-Check-Act” (PDCA) can be applied to all processes. PDCA
can be briefly described as follows.
Plan: establish the objectives and processes necessary to deliver results in accordance with customer requirements and
the organization's policies.
Do: implement the processes.
Check: monitor and measure processes and product against policies, objectives and requirements for the product and
report the results.
Act: take actions to continually improve process performance.

Continual improvement of
the quality management system
Management
responsibility
Customers
Customers
Measurement,
Resource
Satisfaction
analysis and
management
improvement
Input Output
Product
Requirements
Product
realization
Key
Value-adding activities
Information flow
Figure 1 — Model of a process-based quality management system
QUALITY MANAGEMENT SYSTEMS – REQUIREMENTS

1 SCOPE
1.1 General
This standard includes ISO 9001:2008 quality management system requirements and specifies
additional aviation, space and defense industry requirements, definitions and notes as shown in bold,
italic text.
It is emphasized that the requirements specified in this standard are complementary (not alternative)
to contractual and applicable statutory and regulatory requirements. Should there be a conflict
between the requirements of this standard and applicable statutory or regulatory requirements, the
latter shall take precedence.
This International Standard specifies requirements for a quality management system where an organization
a) needs to demonstrate its ability to consistently provide product that meets customer and applicable
statutory and regulatory requirements, and
b) aims to enhance customer satisfaction through the effective application of the system, including
processes for continual improvement of the system and the assurance of conformity to customer and
applicable statutory and regulatory requirements.
NOTE 1 In this International Standard, the term “product” only applies to
a) product intended for, or required by, a customer,
b) any intended output resulting from the product realization processes.
NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements.
1.2 Application
All requirements of this International Standard are generic and are intended to be applicable to all
organizations, regardless of type, size and product provided.
Where any requirement(s) of this International Standard cannot be applied due to the nature of an
organization and its product, this can be considered for exclusion.
Where exclusions are made, claims of conformity to this International Standard are not acceptable unless
these exclusions are limited to requirements within Clause 7, and such exclusions do not affect the
organization's ability, or responsibility, to provide product that meets customer and applicable statutory and
regulatory requirements.
This standard is intended for use by organizations that design, develop and/or produce aviation,
space and defense products; and by organizations providing post-delivery support, including the
provision of maintenance, spare parts or materials for their own products.

1 With the permission of the International Organization for Standardization (ISO). The complete standard can be
obtained from any ISO member or from the ISO Central Secretariat: 1, ch. de la Voie-Creuse, Case postale 56,
CH-1211 Geneva 20, SWITZERLAND, or visit www.iso.org. Copyright remains with ISO.
Organizations whose primary business is providing maintenance, repair and overhaul services for
aviation commercial and military products; and original equipment manufacturers with maintenance,
repair and overhaul operations that operate autonomously, or that are substantially different from
their manufacturing/production operations; should use the IAQG-developed 9110 standard (see
Bibliography).
Organizations that procure parts, materials and assemblies and resell these products to a customer in
the aviation, space and defense industries, including organizations that procure products and split
them into smaller quantities for resale, should use the IAQG-developed 9120 standard (see
Bibliography).
2 NORMATIVE REFERENCES
The following referenced documents are indispensable for the application 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.
ISO 9000:2005, Quality management systems — Fundamentals and vocabulary
ISO 9001:2008, Quality management systems — Requirements
3 TERMS AND DEFINITIONS
For the purposes of this document, the terms and definitions given in ISO 9000:2005 apply.
Throughout the text of this International Standard, wherever the term “product” occurs, it can also mean
“service”.
3.1 Risk
An undesirable situation or circumstance that has both a likelihood of occurring and a potentially
negative consequence.
3.2 Special requirements
Those requirements identified by the customer, or determined by the organization, which have high
risks to being achieved, thus requiring their inclusion in the risk management process. Factors used
in the determination of special requirements include product or process complexity, past experience
and product or process maturity. Examples of special requirements include performance
requirements imposed by the customer that are at the limit of the industry’s capability, or
requirements determined by the organization to be at the limit of its technical or process capabilities.
3.3 Critical items
Those items (e.g., functions, parts, software, characteristics, processes) having significant effect on
the product realization and use of the product; including safety, performance, form, fit, function,
producibility, service life, etc.; that require specific actions to ensure they are adequately managed.
Examples of critical items include safety critical items, fracture critical items, mission critical items,
key characteristics, etc.
3.4 Key characteristic
An attribute or feature whose variation has a significant effect on product form, fit, function,
performance, service life or producibility, that requires specific actions for the purpose of controlling
variation.
NOTE Special requirements and critical items are new terms and, along with key characteristics, are
interrelated. Special requirements are identified when determining and reviewing requirements related to the
product (see 7.2.1 and 7.2.2). Special requirements can require the identification of critical items. Design output
(see 7.3.3) can include identification of critical items that require specific actions to ensure they are adequately
managed. Some critical items will be further classified as key characteristics because their variation needs to be
controlled.
4 QUALITY MANAGEMENT SYSTEM
4.1 General requirements
The organization shall establish, document, implement and maintain a quality management system and
continually improve its effectiveness in accordance with the requirements of this International Standard.
The organization’s quality management system shall also address customer and applicable statutory
and regulatory quality management system requirements.
The organization shall
a) determine the processes needed for the quality management system and their application throughout the
organization (see 1.2),
b) determine the sequence and interaction of these processes,
c) determine criteria and methods needed to ensure that both the operation and control of these processes
are effective,
d) ensure the availability of resources and information necessary to support the operation and monitoring of
these processes,
e) monitor, measure where applicable, and analyse these processes, and
f) implement actions necessary to achieve planned results and continual improvement of these processes.
These processes shall be managed by the organization in accordance with the requirements of this
International Standard.
Where an organization chooses to outsource any process that affects product conformity to requirements, the
organization shall ensure control over such processes. The type and extent of control to be applied to these
outsourced processes shall be defined within the quality management system.
NOTE 1 Processes needed for the quality management system referred to above include processes for management
activities, provision of resources, product realization, measurement, analysis and improvement.
NOTE 2 An “outsourced process” is a process that the organization needs for its quality management system and
which the organization chooses to have performed by an external party.
NOTE 3 Ensuring control over outsourced processes does not absolve the organization of the responsibility of
conformity to all customer, statutory and regulatory requirements. The type and extent of control to be applied to the
outsourced process can be influenced by factors such as
a) the potential impact of the outsourced process on the organization’s capability to provide product that
conforms to requirements,
b) the degree to which the control for the process is shared,
c) the capability of achieving the necessary control through the application of 7.4.
4.2 Documentation Requirements
4.2.1 General
The quality management system documentation shall include
a) documented statements of a quality policy and quality objectives,
b) a quality manual,
c) documented procedures and records required by this International Standard, and
d) documents, including records, determined by the organization to be necessary to ensure the effective
planning, operation and control of its processes.
The organization shall ensure that personnel have access to, and are aware of, relevant quality
management system documentation and changes.
NOTE 1 Where the term “documented procedure“ appears within this International Standard, this means that the
procedure is established, documented, implemented and maintained. A single document may address the requirements
for one or more procedures. A requirement for a documented procedure may be covered by more than one document.
NOTE 2 The extent of the quality management system documentation can differ from one organization to another due to
a) the size of organization and type of activities,
b) the complexity of processes and their interactions, and
c) the competence of personnel.
NOTE 3 The documentation can be in any form or type of medium.
4.2.2 Quality Manual
The organization shall establish and maintain a quality manual that includes
a) the scope of the quality management system, including details of and justification for any exclusions
(see 1.2),
b) the documented procedures established for the quality management system, or reference to them, and
c) a description of the interaction between the processes of the quality management system.
4.2.3 Control of Documents
Documents required by the quality management system shall be controlled. Records are a special type of
document and shall be controlled according to the requirements given in 4.2.4.
A documented procedure shall be established to define the controls needed
a) to approve documents for adequacy prior to issue,
b) to review and update as necessary and re-approve documents,
c) to ensure that changes and the current revision status of documents are identified,
d) to ensure that relevant versions of applicable documents are available at points of use,
e) to ensure that documents remain legible and readily identifiable,
f) to ensure that documents of external origin determined by the organization to be necessary for the
planning and operation of the quality management system are identified and their distribution controlled,
and
g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they
are retained for any purpose.
4.2.4 Control of Records
Records established to provide evidence of conformity to requirements and of the effective operation of the
quality management system shall be controlled.
The organization shall establish a documented procedure to define the controls needed for the identification,
storage, protection, retrieval, retention and disposition of records.
The documented procedure shall define the method for controlling records that are created by and/or
retained by suppliers.
Records shall remain legible, readily identifiable and retrievable.
5 MANAGEMENT RESPONSIBILITY
5.1 Management Commitment
Top management shall provide evidence of its commitment to the development and implementation of the
quality management system and continually improving its effectiveness by
a) communicating to the organization the importance of meeting customer as well as statutory and
regulatory requirements,
b) establishing the quality policy,
c) ensuring that quality objectives are established,
d) conducting management reviews, and
e) ensuring the availability of resources.
5.2 Customer Focus
Top management shall ensure that customer requirements are determined and are met with the aim of
enhancing customer satisfaction (see 7.2.1 and 8.2.1).
Top management shall ensure that product conformity and on-time delivery performance are
measured and that appropriate action is taken if planned results are not, or will not be, achieved.

5.3 Quality Policy
Top management shall ensure that the quality policy
a) is appropriate to the purpose of the organization,
b) includes a commitment to comply with requirements and continually improve the effectiveness of the
quality management system,
c) provides a framework for establishing and reviewing quality objectives,
d) is communicated and understood within the organization, and
e) is reviewed for continuing suitability
5.4 Planning
5.4.1 Quality Objectives
Top management shall ensure that quality objectives, including those needed to meet requirements for
product [see 7.1 a)], are established at relevant functions and levels within the organization. The quality
objectives shall be measurable and consistent with the quality policy.
5.4.2 Quality Management System Planning
Top management shall ensure that
a) the planning of the quality management system is carried out in order to meet the requirements given in
4.1, as well as the quality objectives, and
b) the integrity of the quality management system is maintained when changes to the quality management
system are planned and implemented.
5.5 Responsibility, Authority and Communication
5.5.1 Responsibility and Authority
Top management shall ensure that responsibilities and authorities are defined and communicated within the
organization.
5.5.2 Management Representative
Top management shall appoint a member of the organization’s management who, irrespective of other
responsibilities, shall have responsibility and authority that includes
a) ensuring that processes needed for the quality management system are established, implemented and
maintained,
b) reporting to top management on the performance of the quality management system and any need for
improvement,
c) ensuring the promotion of awareness of customer requirements throughout the organization, and
d) the organizational freedom and unrestricted access to top management to resolve quality
management issues.
NOTE The responsibility of a management representative can include liaison with external parties on matters relating
to the quality management system.
5.5.3 Internal Communication
Top management shall ensure that appropriate communication processes are established within the
organization and that communication takes place regarding the effectiveness of the quality management
system
5.6 Management Review
5.6.1 General
Top management shall review the organization's quality management system, at planned intervals, to ensure
its continuing suitability, adequacy and effectiveness. This review shall include assessing opportunities for
improvement and the need for changes to the quality management system, including the quality policy and
quality objectives.
Records from management reviews shall be maintained (see 4.2.4).
5.6.2 Review Input
The input to management review shall include information on
a) results of audits,
b) customer feedback,
c) process performance and product conformity,
d) status of preventive and corrective actions,
e) follow-up actions from previous management reviews,
f) changes that could affect the quality management system, and
g) recommendations for improvement.
5.6.3 Review Ouput
The output from the management review shall include any decisions and actions related to
a) improvement of the effectiveness of the quality management system and its processes,
b) improvement of product related to customer requirements, and,
c) resource needs.
6 RESOURCE MANAGEMENT
6.1 Provision of Resources
The organization shall determine and provide the resources needed
a) to implement and maintain the quality management system and continually improve its effectiveness, and
b) to enhance customer satisfaction by meeting customer requirements.
6.2 Human Resources
6.2.1 General
Personnel performing work affecting conformity to product requirements shall be competent on the basis of
appropriate education, training, skills and experience.
NOTE Conformity to product requirements can be affected directly or indirectly by personnel performing any task
within the quality management system.
6.2.2 Competence, Training and Awareness
The organization shall
a) determine the necessary competence for personnel performing work affecting conformity to product
requirements,
b) where applicable, provide training or take other actions to achieve the necessary competence,
c) evaluate the effectiveness of the actions taken,
d) ensure that its personnel are aware of the relevance and importance of their activities and how they
contribute to the achievement of the quality objectives, and
e) maintain appropriate records of education, training, skills and experience (see 4.2.4).
6.3 Infrastructure
The organization shall determine, provide and maintain the infrastructure needed to achieve conformity to
product requirements. Infrastructure includes, as applicable,
a) buildings, workspace and associated utilities,
b) process equipment (both hardware and software), and
c) supporting services (such as transport, communication or information systems).
6.4 Work Environment
The organization shall determine and manage the work environment needed to achieve conformity to product
requirements.
NOTE The term "work environment" relates to those conditions under which work is performed including physical,
environmental and other factors (such as noise, temperature, humidity, lighting or weather).
7 PRODUCT REALIZATION
7.1 Planning of Product Realization
The organization shall plan and develop the processes needed for product realization. Planning of product
realization shall be consistent with the requirements of the other processes of the quality management system
(see 4.1).
In planning product realization, the organization shall determine the following, as appropriate:
a) quality objectives and requirements for the product.
NOTE Quality objectives and requirements for the product include consideration of aspects such as
– product and personal safety,
– reliability, availability and maintainability,
– producibility and inspectability,
– suitability of parts and materials used in the product,
– selection and development of embedded software, and
– recycling or final disposal of the product at the end of its life.
b) the need to establish processes and documents, and to provide resources specific to the product;
c) required verification, validation, monitoring, measurement, inspection and test activities specific to the
product and the criteria for product acceptance;
d) records needed to provide evidence that the realization processes and resulting product meet
requirements (see 4.2.4);
e) configuration management appropriate to the product;
f) resources to support the use and maintenance of the product.
The output of this planning shall be in a form suitable for the organization's method of operations.
NOTE 1 A document specifying the processes of the quality management system (including the product realization
processes) and the resources to be applied to a specific product, project or contract can be referred to as a quality plan.
NOTE 2 The organization may also apply the requirements given in 7.3 to the development of product realization
processes.
7.1.1 Project Management
As appropriate to the organization and the product, the organization shall plan and manage product
realization in a structured and controlled manner to meet requirements at acceptable risk, within
resource and schedule constraints.
7.1.2 Risk Management
The organization shall establish, implement and maintain a process for managing risk to the
achievement of applicable requirements, that includes as appropriate to the organization and the
product
a) assignment of responsibilities for risk management,
b) definition of risk criteria (e.g., likelihood, consequences, risk acceptance),
SIST EN 9100:20
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