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3.1 Terms and definitions
3.1.1 System
3.1.2 Process
3.1.3 Requirement
3.1.4 Product and tools
3.2 Abbreviated terms
4 Context of the organization
4.1 Understanding the organization and its context
4.1.1 Understanding the organization and its context — Supplemental
4.1.2 Social responsibility
4.2 Understanding the needs and expectations of interested parties
4.3 Determining the scope of the quality management system
4.3.1 Determining the scope of the quality management system — Supplemental
4.4 Quality management system and its processes
4.4.3 Quality management system and its processes — Supplemental
5 Leadership
5.1 Leadership and commitment
5.1.1 General
5.1.2 Customer focus
5.2 Policy
5.2.1 Establishing the quality policy
5.2.2 Communicating the quality policy
5.2.3 Quality policy — Supplemental
5.3 Organizational roles, responsibilities and authorities
5.3.1 Organizational roles, responsibilities and authorities — Supplemental
5.3.2 Responsibilities and authorities of process owners
6 Planning
6.1 Actions to address risks and opportunities
6.1.3 Actions to address risks and opportunities — Supplemental
6.1.4 Business continuity
6.2 Quality objectives and planning to achieve them
6.3 Planning of changes
7 Support
7.1 Resources
7.1.1 General
7.1.2 People
7.1.3 Infrastructure
7.1.4 Environment for the operation of processes
7.1.5 Monitoring and measuring resources
7.1.6 Organizational knowledge
7.2 Competence
7.2.1 Competence — Supplemental
7.3 Awareness
7.4 Communication
7.4.1 Communication — Supplemental
7.5 Documented information
7.5.1 General
7.5.2 Creating and updating
7.5.3 Control of documented information
8 Operation
8.1 Operational planning and control
8.1.1 Operational planning and control — Supplemental
8.1.2 Tender management
8.1.3 Project management
8.1.4 Configuration management and change control
8.2 Requirements for products and services
8.2.1 Customer communication
8.2.2 Determining the requirements related to products and services
8.2.3 Review of requirements related to products and services
8.2.4 Changes to requirements for products and services
8.2.5 Requirements for products and services — Supplemental
8.3 Design and development of products and services
8.3.1 General
8.3.2 Design and development planning
8.3.3 Design and development inputs
8.3.4 Design and development controls
8.3.5 Design and development outputs
8.3.6 Design and development changes
8.4 Control of externally provided processes, products and services
8.4.1 General
8.4.2 Type and extent of control
8.4.3 Information for external providers
8.4.4 Supply chain management
8.5 Production and service provision
8.5.1 Control of production and service provision
8.5.2 Identification and traceability
8.5.3 Property belonging to customers or external providers
8.5.4 Preservation
8.5.5 Post-delivery activities
8.5.6 Control of changes
8.6 Release of products and services
8.6.1 Release of products and services — Supplemental
8.7 Control of nonconforming outputs
8.7.3 Control of nonconforming outputs — Supplemental
8.8 Reliability, availability, maintainability, safety and life cycle costing
8.8.1 General
8.8.2 Reliability, availability and maintainability
8.8.3 Safety
8.8.4 Life cycle costing
8.9 First article inspection
8.10 Obsolescence management
9 Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.1.1 General
9.1.2 Customer satisfaction
9.1.3 Analysis and evaluation
9.2 Internal audit
9.2.3 Internal audit — Supplemental
9.3 Management review
9.3.1 General
9.3.2 Management review inputs
9.3.3 Management review outputs
9.4 Process reviews
10 Improvement
10.1 General
10.2 Nonconformity and corrective action
10.2.3 Nonconformity and corrective action — Supplemental
10.3 Continual improvement
Annex A (informative) List of processes
Annex B (informative) Subordinate concept of requirements for products and services
Annex C (informative) Performance indicators
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International Standard ISO 22163 | |
Railway applications — Railway quality management system — ISO 9001:2015 and specific requirements for application in the railway sector Applications ferroviaires — Système de management de la qualité ferroviaire — Exigences de l'ISO 9001:2015 et exigences particulières concernant les applications dans le secteur ferroviaire Reference number ISO 22163:2023(en) | First edition 2023-07
© ISO 2023
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© ISO 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of the requester.
ISO copyright office
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Tel. + 41 22 749 01 11
E-mail copyright@iso.org
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Published in Switzerland
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ContentsPage
4 Context of the organization
4.1 Understanding the organization and its context
4.1.1 Understanding the organization and its context — Supplemental
4.1.2 Social responsibility
4.2 Understanding the needs and expectations of interested parties
4.3 Determining the scope of the quality management system
4.3.1 Determining the scope of the quality management system — Supplemental
4.4 Quality management system and its processes
4.4.3 Quality management system and its processes — Supplemental
5 Leadership
5.1 Leadership and commitment
5.1.1 General
5.1.2 Customer focus
5.2 Policy
5.2.1 Establishing the quality policy
5.2.2 Communicating the quality policy
5.2.3 Quality policy — Supplemental
5.3 Organizational roles, responsibilities and authorities
5.3.1 Organizational roles, responsibilities and authorities — Supplemental
5.3.2 Responsibilities and authorities of process owners
6 Planning
6.1 Actions to address risks and opportunities
6.1.3 Actions to address risks and opportunities — Supplemental
6.1.4 Business continuity
6.2 Quality objectives and planning to achieve them
6.3 Planning of changes
7 Support
7.1 Resources
7.1.1 General
7.1.2 People
7.1.3 Infrastructure
7.1.4 Environment for the operation of processes
7.1.5 Monitoring and measuring resources
7.1.6 Organizational knowledge
7.2 Competence
7.2.1 Competence — Supplemental
7.3 Awareness
7.4 Communication
7.4.1 Communication — Supplemental
7.5 Documented information
7.5.1 General
7.5.2 Creating and updating
7.5.3 Control of documented information
8 Operation
8.1 Operational planning and control
8.1.1 Operational planning and control — Supplemental
8.1.2 Tender management
8.1.3 Project management
8.1.4 Configuration management and change control
8.2 Requirements for products and services
8.2.1 Customer communication
8.2.2 Determining the requirements related to products and services
8.2.3 Review of requirements related to products and services
8.2.4 Changes to requirements for products and services
8.2.5 Requirements for products and services — Supplemental
8.3 Design and development of products and services
8.3.1 General
8.3.2 Design and development planning
8.3.3 Design and development inputs
8.3.4 Design and development controls
8.3.5 Design and development outputs
8.3.6 Design and development changes
8.4 Control of externally provided processes, products and services
8.4.1 General
8.4.2 Type and extent of control
8.4.3 Information for external providers
8.4.4 Supply chain management
8.5 Production and service provision
8.5.1 Control of production and service provision
8.5.2 Identification and traceability
8.5.3 Property belonging to customers or external providers
8.5.4 Preservation
8.5.5 Post-delivery activities
8.5.6 Control of changes
8.6 Release of products and services
8.6.1 Release of products and services — Supplemental
8.7 Control of nonconforming outputs
8.7.3 Control of nonconforming outputs — Supplemental
8.8 Reliability, availability, maintainability, safety and life cycle costing
8.8.1 General
8.8.2 Reliability, availability and maintainability
8.8.3 Safety
8.8.4 Life cycle costing
8.9 First article inspection
8.10 Obsolescence management
9 Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.1.1 General
9.1.2 Customer satisfaction
9.1.3 Analysis and evaluation
9.2 Internal audit
9.2.3 Internal audit — Supplemental
9.3 Management review
9.3.1 General
9.3.2 Management review inputs
9.3.3 Management review outputs
9.4 Process reviews
10 Improvement
10.1 General
10.2 Nonconformity and corrective action
10.2.3 Nonconformity and corrective action — Supplemental
10.3 Continual improvement
Annex A (informative) List of processes
Annex B (informative) Subordinate concept of requirements for products and services
Annex C (informative) Performance indicators
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types of ISO document should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a) patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a) patent(s) which may be required to implement this document. However, implementers are cautioned that this may not represent the latest information, which may be obtained from the patent database available at www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISO's adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 269, Railway applications.
This first edition of ISO 22163 cancels and replaces ISO/TS 22163:2017.
The main changes are as follows:
—
the scope has been simplified;
—
the terms and definitions in Clause 3 have been revised;
—
the previous subclause 6.4 “Business planning” has been moved to 4.1.1;
—
a new subclause 4.1.2 on “Social responsibility” has been added;
—
subclause 7.2.1 “Competence — Supplemental” has been revised;
—
the previous subclause 8.11 “Innovation management” has been moved to 8.1.1.1;
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“Project review management” has been separated from the previous subclause 8.1.3.7 “Project communications management” as a new subclause 8.1.3.11;
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the previous subclauses 8.1.4 “Configuration management” and 8.1.5 “Change management” have been combined in 8.1.4 “Configuration management and change control”;
—
product safety requirements have been integrated in the quality requirements;
—
reliability, availability, maintainability, safety and life cycle costing requirements have been clarified in 8.8;
—
the notion of performance indicators versus key performance indicators has been added;
—
the performance indicators have been revised;
—
Annex A on “List of processes” has been added;
—
Annex B on “Subordinate concept of requirements for products and services” has been added;
—
Annex C on “Performance indicators” has been added.
Any feedback or questions on this document should be directed to the user's national standards body. A complete listing of these bodies can be found at www.iso.org/members.html.
Introduction
0.1 General
The aim of this document is to develop and continually improve a railway quality management system to ensure product quality including safety in the global railway sector, in order to satisfy customer needs.
This document adds the supplemental railway sector specific requirements to ISO 9001:2015.
The content inside the boxed text of this document is ISO 9001:2015 text.
Whenever the ISO 9001:2015 text in this document refers to “quality management system”, this term is understood hereinafter as “railway quality management system”, not limited to quality, so that it encompasses all railway quality processes of the organization. Therefore, in the supplemental railway sector specific requirements, the term “railway quality management system” is used outside the boxed text.
Whenever the ISO 9001:2015 text refers to “this International Standard”, this applies to this document, including the text outside the boxes.
Whenever this document refers to clause numbers, it is to be understood that all the requirements under this clause including subclauses are to be considered.
Whenever this document refers to “safety”, the term is to be understood as “safety of products and services”, not to be confused with “occupational safety”.
Whenever this document requires a process, this process can be either
—
defined within a single process,
—
combined with another process or other processes, or
—
split in several processes
according to the railway quality management system defined by the organization.
| ISO 9001:2015, Quality management systems — Requirements |
| 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. |
| 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
| ISO 9001:2015, Quality management systems — Requirements |
| 0.2 Quality management principles |
| This International Standard is based on the quality management principles described in 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
| ISO 9001:2015, Quality management systems — Requirements |
| 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
| ISO 9001:2015, Quality management systems — Requirements 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. |
 |
NOTENumbers in brackets refer to the clauses in this International Standard. |
| Figure 2 — Representation of the structure of this International Standard in 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. |
0.3.3 Risk-based thinking
| ISO 9001:2015, Quality management systems — Requirements |
| 0.3.3 Risk-based thinking |
| Risk-based thinking 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
| ISO 9001:2015, Quality management systems — Requirements |
| 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. |
| 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 ISO 9000 and ISO 9004 as follows: |
— ISO 9000 Quality management systems — Fundamentals and vocabulary provides essential background for the proper understanding and implementation of this International Standard; |
— 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. |
| 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 (ISO 9001:2008) can be found on the ISO/TC 176/SC 2 open access website at: https://www.iso.org/tc176/sc02/public. |
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1Scope
| ISO 9001:2015, Quality management systems — Requirements |
| 1 Scope |
| 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 1In this International Standard, the terms “product” or “service” only apply to products and services intended for, or required by, a customer. |
NOTE 2Statutory and regulatory requirements can be expressed as legal requirements. |
1.1Scope — Supplemental
This document specifies the requirements for a railway quality management system (RQMS)
—
applicable throughout the whole supply chain of the railway sector related to industrial products and services,
—
providing continual improvement, emphasizing defect prevention and defect reduction in the supply chain, and
—
enhancing and sustaining product quality, including its safety aspects.
2Normative references
| ISO 9001:2015, Quality management systems — Requirements |
| 2 Normative references |
| The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. |
| ISO 9000:2015, Quality management systems — Fundamentals and vocabulary |
3Terms, definitions and abbreviated terms
| ISO 9001:2015, Quality management systems — Requirements |
| 3 Terms and definitions |
| For the purposes of this document, the terms and definitions given in ISO 9000:2015 apply. |
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/
3.1Terms and definitions
3.1.1System
3.1.1.1
business continuity
capability of an organization to continue the delivery of products and services within acceptable time frames at predefined capacity during a disruption
[SOURCE: ISO 22301:2019, 3.3]
3.1.1.2
business continuity plan
documented information that guides an organization to respond to a disruption and resume, recover and restore the delivery of products and services consistent with its business continuity objectives
[SOURCE: ISO 22301:2019, 3.4]
3.1.1.3
configuration audit
audit performed in accordance with documented information to determine whether a product or service conforms to its requirements and configuration information (3.1.1.5)
[SOURCE: ISO 10007:2017, 5.6]
3.1.1.4
configuration baseline
approved configuration information (3.1.1.5) that establishes the characteristics of a product or a service at a point in time that serves as reference for activities throughout the life cycle of the product or service
[SOURCE: ISO 10007:2017, 3.2]
3.1.1.5
configuration information
requirements for product or service design, realization, verification (3.1.3.12), operation and support
[SOURCE: ISO 10007:2017, 3.5]
3.1.1.6
configuration status accounting
formalized recording and reporting of configuration information (3.1.1.5), the status of proposed changes and the status of the implementation of approved changes
[SOURCE: ISO 10007:2017, 3.4]
3.1.1.7
critical
criticality
characteristic having the potential of introducing high risks that can threaten quality, safety or business performance, based on a risk assessment
3.1.1.8
information security
preservation of confidentiality, integrity and availability of information
Note 1 to entry: In addition, other properties, such as authenticity, accountability, non- repudiation, and reliability can also be involved.
Note 2 to entry: Information security includes cybersecurity.
[SOURCE: ISO/IEC 27000:2018, 3.28, modified — Note 2 to entry has been added.]
3.1.1.9
multidisciplinary approach
way of working involving different functions and expertise in one team on a specific subject
EXAMPLE Engineering, safety and procurement.
3.1.1.10
process owner
person who has the responsibility for the definition, application, performance and improvement of a process in realizing its objectives measured by performance indicators, and has the authority and ability to make necessary changes
3.1.1.11
safety
freedom from unacceptable risk of harm
[SOURCE: IEC 62278:2002, 3.35]
3.1.1.12
safety integrity level
SIL
one of a number of defined discrete levels for specifying the safety integrity requirements of the safety functions to be allocated to the safety (3.1.1.11) related systems
[SOURCE: IEC 62278:2002, 3.38]
3.1.1.13
3.1.1.14
site
location of an organization, having activities related to industrial products and services
3.1.1.15
supply chain
system of organizations, people, activities, information and resources involved in transforming materials and knowledge in a product or a service for the customer
3.1.2Process
3.1.2.1
commissioning
phase before handover (3.1.2.8) to a customer, in which a product is tested under operational conditions to verify that it functions according to its specifications
Note 1 to entry: The product is then prepared to start operation.
3.1.2.2
critical path
sequence of activities that determine the earliest possible completion date for the project (3.1.2.18) or phase
[SOURCE: ISO 21502:2020, 3.8]
3.1.2.3
deferred work
activity which is part of a predetermined sequence in a process that is delayed or postponed
3.1.2.4
3.1.2.5
gate criteria
acceptance criteria for deliverables (3.1.4.3) at gates in order to support the decisions to be taken, e.g. accepted, conditionally accepted or rejected
3.1.2.6
gate methodology
project management practice to evaluate, at the end of each significant phase, the maturity of deliverables (3.1.4.3) for moving to the next phase, with the proper risk assessment and mitigation plan
Note 1 to entry: The transition between two phases is formalized by control milestones.
3.1.2.7
good practice
process or method that has been shown to work well, succeeds in achieving its objective(s), is acknowledged and therefore can be recommended as an approach
3.1.2.8
handover
passing control authority of the subject item from one organization to another, including transfer of responsibilities to the receiving organization
3.1.2.9
installation
phase after delivery at customer premises and prior to commissioning (3.1.2.1)
Note 1 to entry: Installation is a typical phase of infrastructure activities.
3.1.2.10
life cycle cost
LCC
sum of the costs generated during the life cycle of the item
Note 1 to entry: For a user or an owner of an item, the total life cycle cost may include only those costs pertaining to acquisition, operation, maintenance (3.1.2.12) and disposal.
[SOURCE: EN 13306:2017, 11.1]
3.1.2.11
life cycle costing
process of evaluating the difference between the life cycle cost (3.1.2.10) of two or more alternative options
Note 1 to entry: Life cycle costing can involve quantitative and/or qualitative assessment.
[SOURCE: ISO 15663:2021, 3.1.27]
3.1.2.12
maintenance
combination of all technical and management actions intended to retain an item in, or restore it to a state in which it can perform as required
Note 1 to entry: Management is assumed to include supervision activities.
[SOURCE: IEC 60050-192:2015, 192-06-01]
3.1.2.13
new technology
set of techniques which offer a significant improvement over the established techniques for the development and production (3.1.2.16) of products and services which have never been part of the controlled activities of the organization, and which can be beyond the state of art
Note 1 to entry: The inputs are generally originated from research or innovation activities.
Note 2 to entry: A new technology can be linked to a complete system, e.g. brakes, HVAC, electronics.
3.1.2.14
overhaul
comprehensive set of preventive maintenance (3.1.2.15) actions carried out, in order to maintain the required level of performance of an item
Note 1 to entry: Overhaul may be performed at prescribed intervals of time or number of operations.
Note 2 to entry: Overhaul may require a complete or partial dismantling of the item.
[SOURCE: EN 13306:2017, 8.6]
3.1.2.15
preventive maintenance
maintenance (3.1.2.12) carried out to mitigate degradation and reduce the probability of failure
[SOURCE: IEC 60050-192:2015, 192-06-05, modified — Note 1 to entry has been deleted.]
3.1.2.16
3.1.2.17
product life cycle
time of the entire life cycle of a product from inception to design and manufacture, service, maintenance (3.1.2.12) and disposal
3.1.2.18
project
unique process undertaken to achieve an objective
Note 1 to entry: A project generally consists of a set of coordinated and controlled activities with start and finish dates, undertaken to achieve an objective conforming to specific requirements, including the constraints of time, cost and resources.
Note 2 to entry: An individual project can form part of a larger project structure and generally has a defined start and finish date.
Note 3 to entry: In some projects, the objectives and scope are updated and the product or service characteristics defined progressively as the project proceeds.
Note 4 to entry: The output of a project can be one or several units of product or service.
Note 5 to entry: The project's organization is normally temporary and established for the lifetime of the project.
Note 6 to entry: The complexity of the interactions among project activities is not necessarily related to the project size.
[SOURCE: ISO 10006:2017, 3.3]
3.1.2.19
project core team
people from different functions appointed to support the project manager in leading and controlling the project (3.1.2.18)
3.1.2.20
project management
planning, organizing, monitoring, controlling and reporting of all aspects of a project (3.1.2.18), and the motivation of all those involved in it to achieve the project objectives
[SOURCE: ISO 10006:2017, 3.4]
3.1.2.21
project management plan
document specifying what is necessary to meet the objective(s) of the project (3.1.2.18)
Note 1 to entry: A project management plan should include or refer to the project quality plan.
Note 2 to entry: The project management plan also includes or references other plans such as those relating to organizational structures, resources, schedule, budget, risk management, environmental management, health and safety (3.1.1.11) management and security management, as appropriate.
[SOURCE: ISO 10006:2017, 3.5]
3.1.2.22
project organization
temporary structure that includes project roles, responsibilities and levels of authority and boundaries that need to be defined and communicated to all interested parties of the project (3.1.2.18)
[SOURCE: ISO 10006:2017, 3.6]
3.1.2.23
quality assurance method
method applied to qualify, verify or validate the implementation of requirements in order to focus on error prevention rather than on error detection
EXAMPLE Failure mode and effects analysis (FMEA), failure mode, effects and criticality analysis (FMECA), quality function deployment, design reviews, finite element analysis.
Note 1 to entry: Quality assurance method can be used, for example, in design and development.
3.1.2.24
quality deficiency cost
additional costs resulting from nonconforming products, services, processes or equipment
Note 1 to entry: Quality deficiency cost can be distinguished by causes (e.g. failures in tender-, design and development-, production-, purchasing-project management processes) and by phase of occurrence (e.g. tender, design, production (3.1.2.16), post-delivery).
Note 2 to entry: Quality deficiency cost can include:
—
additional labour, material or other direct costs in the context of failures or changes due to incorrect design and the resulting actions taken (e.g. rework, redesign, repair, repurchase, special shipments);
—
costs due to downtimes;
—
costs of scrap;
—
costs of products rendered unusable or oversupply of storage;
—
costs due to accepted third-party claims and costs due to claims not asserted by the organization against third parties;
—
costs due to penalties for default or delays.
EXAMPLE Some examples of quality deficiency cost include nonconformity cost, cost of non-quality, cost of poor quality, lost cost, compensation cost.
3.1.2.25
project quality plan
specification of the actions, responsibilities and associated resources to be applied to a specific project (3.1.2.18)
[SOURCE: ISO 10005:2018, 3.2, modified — the term has been changed from “quality plan” to “project quality plan” and “object” has been changed to “project” in the definition.]
3.1.2.26
transfer
complete or partial handover (3.1.2.8) of processes to an internal site (multi-site organizations) or an external organization
3.1.3Requirement
3.1.3.1
availability
ability of a product to be in a state to perform a required function under given conditions at a given instant of time or over a given time interval assuming that the required external resources are provided
[SOURCE: IEC 60050-821:2017, 821-05-82]
3.1.3.2
functional requirement
requirement that specifies a function that a product or a service performs
EXAMPLE Railway loading gauge, possibility to add a car in a metro vehicle.
Note 1 to entry: See Annex B.
3.1.3.3
integration requirement
requirement of a product or service to describe how a constitutive system/subsystem/component interfaces with others, to perform an integrated function
EXAMPLE Weight, external dimension, kinematic envelope, power supply requirements, network (communication).
Note 1 to entry: See Annex B.
3.1.3.4
maintainability
ability of an item under given conditions of use, to be retained in, or restored to, a state in which it can perform a required function, when maintenance (3.1.2.12) is performed under given conditions and using stated procedures and resources
Note 1 to entry: Given conditions include aspects that affect maintainability, such as: location for maintenance (3.1.2.12), accessibility, maintenance procedures and maintenance resources.
[SOURCE: EN 13306:2017, 4.5, modified — Note 1 to entry from IEC 60050-192:2015, 192-01-27 has been added.]
3.1.3.5
non-functional requirement
technical requirement that defines attributes serving as constraints or restrictions and ensuring the usability and effectiveness but not affecting the functionality of products and services
Note 1 to entry: As shown in Annex B, non-functional requirements include:
Note 2 to entry: Some examples of other non-functional requirements are:
—
colour;
—
corrosion control;
—
electro-magnetic interference/electro-magnetic compatibility (EMI/EMC);
—
noise;
—
reliability, availability, maintainability, safety (RAMS);
—
aluminium car body;
—
labels;
—
obsolescence;
—
usability.
3.1.3.6
non-technical requirement
requirement affecting the delivery of the product or service
Note 1 to entry: See Annex B.
EXAMPLE Warranty, payments, quality assurance, training, communication, time, commercial.
3.1.3.7
operational maturity
degree of fulfilment of the technical requirements (3.1.3.10) of a product or service
EXAMPLE 1 Not existing, under development, ready to use, in use.
EXAMPLE 2 Not fulfilling, partially fulfilling, fully fulfilling.
3.1.3.8
performance requirement
requirement that specifies the result that a product or a service reaches
Note 1 to entry: See Annex B.
EXAMPLE Maximum speed, maximum acceleration.
3.1.3.9
reliability
ability to perform as required, without failure, for a given time interval, under given conditions
Note 1 to entry: The reliability of an item can be calculated from the observed failures of it or/and a set of comparable items during a given time interval.
Note 2 to entry: The forecasted reliability of an item expresses the level of confidence on it, estimated from the observed reliability of comparable items and the knowledge about its actual state.
Note 3 to entry: In some cases, a given number of unit of use can be considered instead of a given time interval (number of cycles, number of running hours, number of km, etc.).
Note 4 to entry: The given conditions may include preventive maintenance (3.1.2.15) actions and operational modes and conditions.
[SOURCE: IEC 60050-192:2015, 192-01-24, modified — Notes 1, 2, 3 and 4 to entry from EN 13306:2017, 4.1 have been added.]
3.1.3.10
technical requirement
requirement that defines the features of the product or service
Note 1 to entry: A technical requirement can be functional or non-functional.
Note 2 to entry: See Annex B.
3.1.3.11
validation
confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled
[SOURCE: ISO 9000:2015, 3.8.13, modified — Notes 1, 2 and 3 to entry have been deleted.]
3.1.3.12
verification
confirmation, through the provision of objective evidence, that specified requirements have been fulfilled
[SOURCE: ISO 9000:2015, 3.8.12, modified — Notes 1, 2 and 3 to entry have been deleted.]]
[SOURCE: ISO 9000:2015, 3.8.12, modified — Notes 1, 2 and 3 to entry have been deleted.]]
3.1.4Product and tools
3.1.4.1
component
uniquely identifiable product that is considered indivisible for particular planning or control purpose and/or which cannot be disassembled without it being destroyed
Note 1 to entry: A component for one organizational group may be the final assembly of another group, e.g. an electric motor.
[SOURCE: EN 15380-2:2006, 3.11]
3.1.4.2
consignment stock
inventory owned by an external provider but held by the organization to ensure the availability (3.1.3.1) of parts
3.1.4.3
deliverable
output for the scope of supply to fulfil defined requirements
EXAMPLE Product, services, user manual, training manual, maintenance manual, test reports, test equipment, training, spare and support parts.
3.1.4.4
eight disciplines (of problem solving)
8D
team-oriented and systematic approach defining a sequence of steps to resolve problems in products, services and processes
Note 1 to entry: Its purpose is to identify, correct and eliminate recurring problems.
Note 2 to entry: The 8D problem solving model establishes a corrective action based on the analysis of the problem and focuses on the origin of the problem by determining its root causes.
Note 3 to entry: The 8D model can be reduced to four steps (4D).
3.1.4.5
failure reporting analysis and corrective action system
FRACAS
closed loop process used to improve dependability of current and future designs by feedback of testing, modification and use experience
[SOURCE: IEC 60050-192:2015, 192-12-04]
3.1.4.6
key performance indicator
KPI
performance indicator, selected by the top management, to evaluate the performance of the RQMS and its business objectives that is critical (3.1.1.7) to the sustained success of an organization
Note 1 to entry: A KPI can be a combination of several performance indicator (PIs).
Note 2 to entry: See Figure 3.
Figure 3 — Relation of PIs and KPIs | ||||||||
|
3.1.4.7
performance indicator
PI
indicator measuring the effective and/or efficient operation and control of a process but that is not limited to processes
Note 1 to entry: A performance indicator can be related to a single process or to multiple processes or any activity.
3.1.4.8
poka yoke
prevention method designed as a simple technique to prevent either anyone from making unplanned or unwanted changes to a system, or any errors from negatively impacting on a system
[SOURCE: ISO 13053-2:2011, 2.19]
3.1.4.9
production equipment
tool or device to make products and provide services
EXAMPLE Machineries, tools, jigs, fixtures, templates, textures, test benches, software production tools.
Note 1 to entry: Handcraft equipment (e.g. hammer, screwdrivers) is not considered as production equipment.
3.1.4.10
shelf life control
technique aimed at ensuring that the inventory is not overaged or regarded as unserviceable for the purposes for which it was originally manufactured
EXAMPLE First-in-first-out (FIFO), monitoring of shelf life.
3.1.4.11
software tool
computer programme that performs a set of functions to support the execution of a process
EXAMPLE Software programme, database, computerized spreadsheet, electronic file or web tool, bought from the market or developed by the organization.
3.2Abbreviated terms
| ATE | automated test equipment |
| EPPPS | externally provided processes, products and services |
| FAI | first article inspection |
| FMEA | failure mode and effects analysis |
| FMECA | failure mode, effects and criticality analysis |
| FRACAS | failure reporting analysis and corrective action system |
| KPI | key performance indicator |
| LCC | life cycle cost |
| LLRU | lowest line replaceable unit |
| OTD | on time delivery index |
| PI | performance indicator |
| RAM | reliability, availability, maintainability |
| RAMS | reliability, availability, maintainability, safety |
| RFT | right first time |
| RQMS | railway quality management system |
| SIL | safety integrity level |
| SMART | specific, measurable, achievable, relevant, time framed |
| SWOT | strengths weaknesses opportunities threats |
| 8D | eight disciplines (of problem solving) |
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Bibliography
References from ISO 9001:2015
ISO 9004:2018, Quality management — Quality of an organization — Guidance to achieve sustained success
ISO 10002, Quality management — Customer satisfaction — Guidelines for complaints handling in organizations
ISO 10004, Quality management — Customer satisfaction — Guidelines for monitoring and measuring
ISO 10005:2018, Quality management — Guidelines for quality plans
ISO 10006:2017, Quality management — Guidelines for quality management in projects
ISO 10007:2017, Quality management — Guidelines for configuration management
ISO 10017, Quality management — Guidance on statistical techniques for ISO 9001:2015
ISO 19011, Guidelines for auditing management systems
References specific to the railway sector
EN 15380-2:2006, Railway applications — Designation system for railway vehicles — Part 2: Product groups
CENELEC CLC/TS 50701:2022, Railway applications — Cybersecurity
IEC 60050-821:2017, International Electrotechnical Vocabulary — Part 821: Signalling and security apparatus for railways
IEC 62278:2002, Railway Applications Specification and Demonstration of Reliability — Availability, Maintainability and Safety (RAMS)
IEC 62279, Railway applications — Communication, signalling and processing systems — Software for railway control and protection systems
IEC 62425:2007, Railway applications — Communication, signalling and processing systems — Safety related electronic systems for signalling
Other references
EN 13306:2017, Maintenance — Maintenance terminology
ISO 10012, Measurement management systems — Requirements for measurement processes and measuring equipment
ISO 13053-2:2011, Quantitative methods in process improvement — Six Sigma — Part 2: Tools and techniques
ISO 15663:2021, Petroleum, petrochemical and natural gas industries — Life cycle costing
ISO 21502:2020, Project, programme and portfolio management — Guidance on project management
ISO 22301:2019, Security and resilience — Business continuity management systems — Requirements
ISO 26000, Guidance on social responsibility
ISO/IEC 27000:2018, Information technology — Security techniques — Information security management systems — Overview and vocabulary
IEC 60050-192:2015, International electrotechnical vocabulary — Part 192: Dependability
IEC 62402, Obsolescence management
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ICS 03.100.70; 45.020 Price based on 76 pages
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