SIST EN 9100:2018

SLOVENSKI STANDARD
01-julij-2018
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SIST EN 9100:2009
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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 9100:2018
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.

EN 9100
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2018
EUROPÄISCHE NORM
ICS 03.100.70; 03.120.10; 49.020 Supersedes EN 9100:2009
English Version
Quality Management Systems - Requirements for Aviation,
Space and Defence Organizations
Systèmes de Management de la Qualité - Exigences Qualitätsmanagementsysteme - Anforderungen an
pour les Organismes de l'Aéronautique, l'Espace et la Organisationen der Luftfahrt, Raumfahrt und
Défense Verteidigung
This European Standard was approved by CEN on 27 February 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 9100:2018 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
Rationale . 4
Foreword . 4
Intended application . 5
0 Introduction . 5
1 Scope . 10
2 Normative references . 10
3 Terms and definitions . 10
4 Context of the organization . 11
5 Leadership . 14
6 Planning . 16
7 Support . 17
8 Operation . 22
9 Performance evaluation . 39
10 Improvement . 42
(informative) Clarification of new structure, terminology and concepts . 44
(informative) Other international standards on quality management and quality
management systems developed by ISO/TC 176 . 48
(informative) Other standards on quality management and quality management
systems developed by the international aerospace quality group . 52
(informative) Bibliography . 56
(informative) Aviation , space and defence bibliography . 58

Figures
Figure 1 — Schematic representation of the elements of a single process . 7
Figure 2 — Representation of the structure of this international standard in the PDCA cycle . 8

European foreword
This document (EN 9100:2018) 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 November 2018, and conflicting national standards
shall be withdrawn at the latest by November 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 9100:2009.
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,
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.
Rationale
This document has been revised to incorporate the new clause structure and content of
EN ISO 9001:2015. In addition, industry requirements, definitions and notes have been revised in
response to both EN ISO 9001 revisions and stakeholder needs.
Foreword
To assure customer satisfaction, aviation, space and defence organizations must 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 has established the International Aerospace Quality Group (IAQG), with representatives
from aviation, space and defence 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 document 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, cost and delivery performance through the reduction or
elimination of organization-unique requirements, effective implementation of the quality
management system and wider application of good practice. While primarily developed for the
aviation, space and defence industry, this document can also be used in other industry sectors
when a quality management system with additional requirements over an EN ISO 9001 system is
needed.
This document includes EN ISO 9001:2015 quality management system requirements and
specifies additional aviation, space and defence industry requirements, definitions and notes as
shown in bold, italic text.
With the permission of the International Organization for Standardization (ISO). The complete EN ISO 9001
standard can be obtained from any ISO member or from the ISO Central Secretariat: BIBC II, Chemin de Blandonnet 8,
CP 401, 1214 Vernier, Geneva, SWITZERLAND, or visit www.iso.org. Copyright remains with ISO.
Intended application
This document is intended for use by organizations that design, develop, or provide aviation, space
and defence products and services; and by organizations providing post-delivery activities,
including the provision of maintenance, spare parts, or materials for their own products and
services.
NOTE Organizations whose products are deliverable software, or contain deliverable software, should
use the IAQG-developed EN 9115 standard (see Bibliography) when planning and evaluating the software
design, development, or management activities of the organization. The EN 9115 standard provides
guidance to the requirements of the EN 9100 standard when it is desired to add “software” to the EN 9100
quality management system scope.
Organizations whose primary business is providing maintenance or continuing airworthiness
management services for civil or military aviation articles and products; and original equipment
manufacturers with maintenance, repair and overhaul operations that are operated
autonomously, or that are substantially different from their production operations; should use the
IAQG-developed EN 9110 standard (see Bibliography).
Organizations that procure parts, materials and assemblies and resells these products to a
customer in the aviation, space and defence industry should use the IAQG-developed EN 9120
standard (see Bibliography). This includes organizations that procure products and split them into
smaller quantities, as well as those that coordinate a customer or regulatory controlled process on
the product.
0 Introduction
0.1 General
The adoption of a quality management system is a strategic decision for an organization that can help to
improve its overall performance and provide a sound basis for sustainable development initiatives.
The potential benefits to an organization of implementing a quality management system based on this
International Standard are:
a) the ability to consistently provide products and services that meet customer and applicable
statutory and regulatory requirements;
b) facilitating opportunities to enhance customer satisfaction;
c) addressing risks and opportunities associated with its context and objectives;
d) the ability to demonstrate conformity to specified quality management system requirements.
This International Standard can be used by internal and external parties.
It is not the intent of this International Standard to imply the need for:
— uniformity in the structure of different quality management systems;
— alignment of documentation to the clause structure of this International Standard;
— the use of the specific terminology of this International Standard within the organization.
The quality management system requirements specified in this International Standard are
complementary to requirements for products and services.
This International Standard employs the process approach, which incorporates the Plan-Do-Check-Act
(PDCA) cycle and risk-based thinking.
The process approach enables an organization to plan its processes and their interactions.
The PDCA cycle enables an organization to ensure that its processes are adequately resourced and
managed and that opportunities for improvement are determined and acted on.
Risk-based thinking enables an organization to determine the factors that could cause its processes and
its quality management system to deviate from the planned results, to put in place preventive controls
to minimize negative effects and to make maximum use of opportunities as they arise (see clause A.4).
Consistently meeting requirements and addressing future needs and expectations poses a challenge for
organizations in an increasingly dynamic and complex environment. To achieve this objective, the
organization might find it necessary to adopt various forms of improvement in addition to correction
and continual improvement, such as breakthrough change, innovation and re-organization.
In this International Standard, the following verbal forms are used:
— “shall” indicates a requirement;
— “should” indicates a recommendation;
— “may” indicates a permission;
— “can” indicates a possibility or a capability.
Information marked as “NOTE” is for guidance in understanding or clarifying the associated
requirement.
0.2 Quality management principles
This International Standard is based on the quality management principles described in EN ISO 9000.
The descriptions include a statement of each principle, a rationale of why the principle is important for
the organization, some examples of benefits associated with the principle and examples of typical
actions to improve the organization’s performance when applying the principle.
The quality management principles are:
— customer focus;
— leadership;
— engagement of people;
— process approach;
— improvement;
— evidence-based decision making;
— relationship management.
0.3 Process approach
0.3.1 General
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. Specific requirements considered essential to the
adoption of a process approach are included in 4.4.
Understanding and managing interrelated processes as a system contributes to the organization’s
effectiveness and efficiency in achieving its intended results. This approach enables the organization to
control the interrelationships and interdependencies among the processes of the system, so that the
overall performance of the organization can be enhanced.
The process approach involves the systematic definition and management of processes and their
interactions, so as to achieve the intended results in accordance with the quality policy and strategic
direction of the organization. Management of the processes and the system as a whole can be achieved
using the PDCA cycle (see 0.3.2) with an overall focus on risk-based thinking (see 0.3.3) aimed at taking
advantage of opportunities and preventing undesirable results.
The application of the process approach in a quality management system enables:
a) understanding and consistency in meeting requirements;
b) the consideration of processes in terms of added value;
c) the achievement of effective process performance;
d) improvement of processes based on evaluation of data and information.
Figure 1 gives a schematic representation of any process and shows the interaction of its elements. The
monitoring and measuring check points, which are necessary for control, are specific to each process
and will vary depending on the related risks.

Figure 1 — Schematic representation of the elements of a single process
0.3.2 Plan-do-check-act cycle
The PDCA cycle can be applied to all processes and to the quality management system as a whole.
Figure 2 illustrates how clauses 4 to 10 can be grouped in relation to the PDCA cycle.
The PDCA cycle can be briefly described as follows:
— Plan: establish the objectives of the system and its processes and the resources needed to deliver
results in accordance with customers’ requirements and the organization’s policies and identify and
address risks and opportunities;
— Do: implement what was planned;
— Check: monitor and (where applicable) measure processes and the resulting products and services
against policies, objectives, requirements and planned activities and report the results;
— Act: take actions to improve performance, as necessary.

NOTE Numbers in brackets refer to the clauses in this International Standard.
Figure 2 — Representation of the structure of this international standard in the PDCA cycle
0.3.3 Risk-based thinking
Risk-based thinking (see clause A.4) is essential for achieving an effective quality management system.
The concept of risk-based thinking has been implicit in previous editions of this International Standard
including, for example, carrying out preventive action to eliminate potential nonconformities, analysing
any nonconformities that do occur and taking action to prevent recurrence that is appropriate for the
effects of the nonconformity.
To conform to the requirements of this International Standard, an organization needs to plan and
implement actions to address risks and opportunities. Addressing both risks and opportunities
establishes a basis for increasing the effectiveness of the quality management system, achieving
improved results and preventing negative effects.
Opportunities can arise as a result of a situation favourable to achieving an intended result, for example,
a set of circumstances that allow the organization to attract customers, develop new products and
services, reduce waste, or improve productivity. Actions to address opportunities can also include
consideration of associated risks. Risk is the effect of uncertainty and any such uncertainty can have
positive or negative effects. A positive deviation arising from a risk can provide an opportunity, but not
all positive effects of risk result in opportunities.
0.4 Relationship with other management system standards
This International Standard applies the framework developed by ISO to improve alignment among its
International Standards for management systems (see clause A.1).
This International Standard enables an organization to use the process approach, coupled with the
PDCA cycle and risk-based thinking, to align or integrate its quality management system with the
requirements of other management system standards.
This International Standard relates to EN ISO 9000 and EN ISO 9004 as follows:
— ISO EN ISO 9000, Quality management systems — Fundamentals and vocabulary, provides essential
background for the proper understanding and implementation of this International Standard;
— EN ISO 9004, Managing for the sustained success of an organization — A quality management
approach, provides guidance for organizations that choose to progress beyond the requirements of
this International Standard.
Annex B provides details of other International Standards on quality management and quality
management systems that have been developed by ISO/TC 176.
This International Standard does not include requirements specific to other management systems, such
as those for environmental management, occupational health and safety management, or financial
management.
Sector-specific quality management system standards based on the requirements of this International
Standard have been developed for a number of sectors. Some of these standards specify additional
quality management system requirements, while others are limited to providing guidance to the
application of this International Standard within the particular sector.
A matrix showing the correlation between the clauses of this edition of this International Standard and
the previous edition (EN ISO 9001:2008) can be found on the ISO/TC 176/SC 2 open access web site at:
www.iso.org/tc176/sc02/public.

1 Scope
This document includes EN ISO 9001:2015 quality management system requirements and
specifies additional aviation, space and defence industry requirements, definitions and notes.
It is emphasized that the requirements specified in this document are complementary
(not alternative) to customer and applicable statutory and regulatory requirements.
If there is a conflict between the requirements of this document and customer or applicable
statutory or regulatory requirements, the latter shall take precedence.
This International Standard specifies requirements for a quality management system when an
organization:
a) needs to demonstrate its ability to consistently provide products and services that meet customer
and applicable statutory and regulatory requirements and
b) aims to enhance customer satisfaction through the effective application of the system, including
processes for improvement of the system and the assurance of conformity to customer and
applicable statutory and regulatory requirements.
All the requirements of this International Standard are generic and are intended to be applicable to any
organization, regardless of its type or size, or the products and services it provides.
NOTE 1 In this International Standard, the terms “product” or “service” only apply to products and services
intended for, or required by, a customer.
NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements.
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 ISO 9000:2015, Quality management systems — Fundamentals and vocabulary
EN ISO 9001:2015, Quality management systems — Requirements
3 Terms and definitions
For the purposes of this document, the terms and definitions given in EN ISO 9000:2015 and the
following apply.
3.1
Counterfeit part
An unauthorized copy, imitation, substitute, or modified part (e. g., material, part, component),
which is knowingly misrepresented as a specified genuine part of an original or authorized
manufacturer.
With the permission of the International Organization for Standardization (ISO). The complete EN ISO 9001
standard can be obtained from any ISO member or from the ISO Central Secretariat: BIBC II, Chemin de Blandonnet 8,
CP 401, 1214 Vernier, Geneva, SWITZERLAND, or visit www.iso.org. Copyright remains with ISO.
Note 1 to entry: Examples of a counterfeit part can include, but are not limited to, the false identification of
marking or labelling, grade, serial number, date code, documentation, or performance characteristics.
3.2
Critical items
Those items (e. g., functions, parts, software, characteristics, processes) having significant effect on
the provision and use of the products and services; 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.
3.3
Key characteristic
An attribute or feature whose variation has a significant effect on product fit, form, function,
performance, service life, or producibility, that requires specific actions for the purpose of
controlling variation.
3.4
Product safety
The state in which a product is able to perform to its designed or intended purpose without causing
unacceptable risk of harm to persons or damage to property.
3.5
Special requirements
Those requirements identified by the customer, or determined by the organization, which have
high risks of not being met, thus requiring their inclusion in the operational 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.
Note 1 to entry: Special requirements (3.5) and critical items (3.2), along with key characteristics (3.3), are
interrelated. Special requirements are identified when determining and reviewing requirements related to
the product (see 8.2.2 and 8.2.3). Special requirements can require the identification of critical items. Design
output (see 8.3.5) 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 Context of the organization
4.1 Understanding the organization and its context
The organization shall determine external and internal issues that are relevant to its purpose and its
strategic direction and that affect its ability to achieve the intended result(s) of its quality management
system.
The organization shall monitor and review information about these external and internal issues.
NOTE 1 Issues can include positive and negative factors or conditions for consideration.
NOTE 2 Understanding the external context can be facilitated by considering issues arising from legal,
technological, competitive, market, cultural, social and economic environments, whether international, national,
regional, or local.
NOTE 3 Understanding the internal context can be facilitated by considering issues related to values, culture,
knowledge and performance of the organization.
4.2 Understanding the needs and expectations of interested parties
Due to their effect or potential effect on the organization’s ability to consistently provide products and
services that meet customer and applicable statutory and regulatory requirements, the organization
shall determine:
a) the interested parties that are relevant to the quality management system;
b) the requirements of these interested parties that are relevant to the quality management system.
The organization shall monitor and review information about these interested parties and their
relevant requirements.
4.3 Determining the scope of the quality management system
The organization shall determine the boundaries and applicability of the quality management system to
establish its scope.
When determining this scope, the organization shall consider:
a) the external and internal issues referred to in 4.1;
b) the requirements of relevant interested parties referred to in 4.2;
c) the products and services of the organization.
The organization shall apply all the requirements of this International Standard if they are applicable
within the determined scope of its quality management system.
The scope of the organization’s quality management system shall be available and be maintained as
documented information. The scope shall state the types of products and services covered and provide
justification for any requirement of this International Standard that the organization determines is not
applicable to the scope of its quality management system.
Conformity to this International Standard may only be claimed if the requirements determined as not
being applicable do not affect the organization’s ability or responsibility to ensure the conformity of its
products and services and the enhancement of customer satisfaction.
4.4 Quality management system and its processes
4.4.1 The organization shall establish, implement, maintain and continually improve a quality
management system, including the processes needed and their interactions, 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 determine the processes needed for the quality management system and their
application throughout the organization and shall:
a) determine the inputs required and the outputs expected from these processes;
b) determine the sequence and interaction of these processes;
c) determine and apply the criteria and methods (including monitoring, measurements and related
performance indicators) needed to ensure the effective operation and control of these processes;
d) determine the resources needed for these processes and ensure their availability;
e) assign the responsibilities and authorities for these processes;
f) address the risks and opportunities as determined in accordance with the requirements of 6.1;
g) evaluate these processes and implement any changes needed to ensure that these processes
achieve their intended results;
h) improve the processes and the quality management system.
4.4.2 To the extent necessary, the organization shall:
a) maintain documented information to support the operation of its processes;
b) retain documented information to have confidence that the processes are being carried out as
planned.
The organization shall establish and maintain documented information that includes:
— a general description of relevant interested parties (see 4.2 a);
— the scope of the quality management system, including boundaries and applicability (see 4.3);
— a description of the processes needed for the quality management system and their application
throughout the organization;
— the sequence and interaction of these processes;
— assignment of the responsibilities and authorities for these processes.
NOTE The above description of the quality management system can be compiled into a single source of
documented information and referred to as a quality manual.

5 Leadership
5.1 Leadership and commitment
5.1.1 General
Top management shall demonstrate leadership and commitment with respect to the quality
management system by:
a) taking accountability for the effectiveness of the quality management system;
b) ensuring that the quality policy and quality objectives are established for the quality management
system and are compatible with the context and strategic direction of the organization;
c) ensuring the integration of the quality management system requirements into the organization’s
business processes;
d) promoting the use of the process approach and risk-based thinking;
e) ensuring that the resources needed for the quality management system are available;
f) communicating the importance of effective quality management and of conforming to the quality
management system requirements;
g) ensuring that the quality management system achieves its intended results;
h) engaging, directing and supporting persons to contribute to the effectiveness of the quality
management system;
i) promoting improvement;
j) supporting other relevant management roles to demonstrate their leadership as it applies to their
areas of responsibility.
NOTE Reference to “business” in this International Standard can be interpreted broadly to mean those
activities that are core to the purposes of the organization’s existence, whether the organization is public, private,
for profit, or not for profit.
5.1.2 Customer focus
Top management shall demonstrate leadership and commitment with respect to customer focus by
ensuring that:
a) customer and applicable statutory and regulatory requirements are determined, understood and
consistently met;
b) the risks and opportunities that can affect conformity of products and services and the ability to
enhance customer satisfaction are determined and addressed;
c) the focus on enhancing customer satisfaction is maintained;
d) product and service conformity and on-time delivery performance are measured and
appropriate action is taken if planned results are not, or will not be, achieved.
5.2 Policy
5.2.1 Establishing the quality policy
Top management shall establish, implement and maintain a quality policy that:
a) is appropriate to the purpose and context of the organization and supports its strategic direction;
b) provides a framework for setting quality objectives;
c) includes a commitment to satisfy applicable requirements;
d) includes a commitment to continual improvement of the quality management system.
5.2.2 Communicating the quality policy
The quality policy shall:
a) be available and maintained as documented information;
b) be communicated, understood and applied within the organization;
c) be available to relevant interested parties, as appropriate.
5.3 Organizational roles, responsibilities and authorities
Top management shall ensure that the responsibilities and authorities for relevant roles are assigned,
communicated and understood within the organization.
Top management shall assign the responsibility and authority for:
a) ensuring that the quality management system conforms to the requirements of this International
Standard;
b) ensuring that the processes are delivering their intended outputs;
c) reporting on the performance of the quality management system and on opportunities for
improvement (see 10.1), in particular to top management;
d) ensuring the promotion of customer focus throughout the organization;
e) ensuring that the integrity of the quality management system is maintained when changes to the
quality management system are planned and implemented.
Top management shall appoint a specific member of the organization’s management, identified as
the management representative, who shall have the responsibility and authority for oversight of
the above requirements.
The management representative shall have 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.
6 Planning
6.1 Actions to address risks and opportunities
6.1.1 When planning for the quality management system, the organization shall consider the issues
referred to in 4.1 and the requirements referred to in 4.2 and determine the risks and opportunities
that need to be addressed to:
a) give assurance that the quality management system can achieve its intended result(s);
b) enhance desirable effects;
c) prevent, or reduce, undesired effects;
d) achieve improvement.
6.1.2 The organization shall plan:
a) actions to address these risks and opportunities;
b) how to:
1) integrate and implement the actions into its quality management system processes (see 4.4);
2) evaluate the effectiveness of these actions.
Actions taken to address risks and opportunities shall be proportionate to the potential impact on the
conformity of products and services.
NOTE 1 Options to address risks can include avoiding risk, taking risk in order to pursue an opportunity,
eliminating the risk source, changing the likelihood or consequences, sharing the risk, or retaining risk by
informed decision.
NOTE 2 Opportunities can lead to the adoption of new practices, launching new products, opening new
markets, addressing new customers, building partnerships, using new technology and other desirable and viable
possibilities to address the organization’s or its customers’ needs.
6.2 Quality objectives and planning to achieve them
6.2.1 The organization shall establish quality objectives at relevant functions, levels and processes
needed for the quality management system.
The quality objectives shall:
a) be consistent with the quality policy;
b) be measurable;
c) take into account applicable requirements;
d) be relevant to conformity of products and services and to enhancement of customer satisfaction;
e) be monitored;
f) be communicated;
g) be updated, as appropriate.
The organization shall maintain documented information on the quality objectives.
6.2.2 When planning how to achieve its quality objectives, the organization shall determine:
a) what will be done;
b) what resources will be required;
c) who will be responsible;
d) when it will be completed;
e) how the results will be evaluated.
6.3 Planning of changes
When the organization determines the need for changes to the quality management system, the changes
shall be carried out in a planned manner (see 4.4).
The organization shall consider:
a) the purpose of the changes and their potential consequences;
b) the integrity of the quality management system;
c) the availability of resources;
d) the allocation or reallocation of responsibilities and authorities.
7 Support
7.1 Resources
7.1.1 General
The organization shall determine and provide the resources needed for the establishment,
implementation, maintenance and continual improvement of the quality management system.
The organization shall consider:
a) the capabilities of and constraints on, existing internal resources;
b) what needs to be obtained from external providers.
7.1.2 People
The organization shall determine and provide the persons necessary for the effective implementation of
its quality management system and for the operation and control of its processes.
7.1.3 Infrastructure
The organization shall determine, provide and maintain the infrastructure necessary for the operation
of its processes and to achieve conformity of products and services.
NOTE Infrastructure can include:
a) buildings and associated utilities;
b) equipment, including hardware and software;
c) transportation resources;
d) information and communication technology.
7.1.4 Environment for the operation of processes
The organization shall determine, provide and maintain the environment necessary for the operation of
its processes and to achieve conformity of products and services.
NOTE A suitable environment can be a combination of human and physical factors, such as:
a) social (e. g., non-discriminatory, calm, non-confrontational);
b) psychological (e. g., stress-reducing, burnout prevention, emotionally protective);
c) physical (e. g., temperature, heat, humidity, light, airflow, hygiene, noise).
These factors can differ substantially depending on the products and services provided.
7.1.5 Monitoring and measuring resources
7.1.5.1 General
The organization shall determine and provide the resources needed to ensure valid and reliable results
when monitoring or measuring is used to verify the conformity of products and services to
requirements.
The organization shall ensure that the resources provided:
a) are suitable for the specific type of monitoring and measurement activities being undertaken;
b) are maintained to ensure their continuing fitness for their purpose.
The organization shall retain appropriate documented information as evidence of fitness for purpose of
the monitoring and measurement resources.
7.1.5.2 Measurement traceability
When measurement traceability is a requirement, or is considered by the organization to be an
essential part of providing confidence in the validity of measurement results, measuring equipment
shall be:
a) calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards
traceable to international or national measurement standards; when no such standards exist, the
basis used for calibration or verification shall be retained as documented information;
b) identified in order to determine their status;
c) safeguarded from adjustments, damage, or deterioration that would invalidate the calibration
status and subsequent measurement results.
The organization shall establish, implement and maintain a process for the recall of monitoring
and measuring equipment requiring calibration or verification.
The organization shall maintain a register of the monitoring and measuring equipment. The
register shall include the equipment type, unique identification, location and the calibration or
verification method, frequency and acceptance criteria.
NOTE Monitoring and measuring equipment can include, but are not limited to: test hardware, test
software, automated test equipment (ATE) and plotters used to produce verification data. It also includes
personally owned and customer supplied equipment used to provide evidence of product and service
conformity.
Calibration or verification of monitoring and measuring equipment shall be carried out under
suitable environmental conditions (see 7.1.4).
The organization shall determine if the validity of previous measurement results has been adversely
affected when measuring equipment is found to be unfit for its intended purpose and shall take
appropriate action as necessary.
7.1.6 Organizational knowledge
The organization shall determine the knowledge necessary for the operation of its processes and to
achieve conformity of products and services.
This knowledge shall be maintained and be made available to the extent necessary.
When addressing changing needs and trends, the organization shall consider its current knowledge and
determine how to acquire or access any necessary additional knowledge and required updates.
NOTE 1 Organizational knowledge is knowledge specific to the organization; it is generally gained by
experience. It is informa
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