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 documents 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).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to World Trade Organization (WTO) principles
in the Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foQrueawliotryd m.hatnmalg.ement
and quality assurance Concepts and terminology
The committee responsible for this document is Technical Committee ISO/TC 176,
, Subcommittee SC 1, .
This fourth edition cancels and replaces the third edition (ISO 9000:2005), which has been
technically revised.
--`,,,,,,,,,,,,,,,,```,--,,,,,,,---
Copyright International Organization for Standardization
Provided by IHS Markit under license with ANSI Licensee=Becton Dickinson - Loc 1 - 61, 64/5984713001, User=Chiu, Shelly
No reprodu i ct v ion or networking permitted without license from IHS Not for Resale, 10/14/2019 19:06:05 MDT © ISO 2015 – All rights reserved
ISO 9000:2015(E)
Introduction
This International Standard provides the fundamental concepts, principles and vocabulary for quality
management systems (QMS) and provides the foundation for other QMS standards. This International
Standard is intended to help the user to understand the fundamental concepts, principles and
vocabulary of quality management, in order to be able to effectively and efficiently implement a QMS
and realize value from other QMS standards.
This International Standard proposes a well-defined QMS, based on a framework that integrates
established fundamental concepts, principles, processes and resources related to quality, in order
to help organizations realize their objectives. It is applicable to all organizations, regardless of size,
complexity or business model. Its aim is to increase an organization’s awareness of its duties and
commitment in fulfilling the needs and expectations of its customers and interested parties, and in
achieving satisfaction with its products and services.
This International Standard contains seven quality management principles supporting the fundamental
concepts described in 2.2. In 2.3, for each quality management principle, there is a “statement”
describing each principle, a “rationale” explaining why the organization would address the principle,
“key benefits” that are attributed to the principles, and “possible actions” that an organization can take
in applying the principle.
This International Standard contains the terms and definitions that apply to all quality management
and QMS standards developed by ISO/TC 176, and other sector-specific QMS standards based on those
standards, at the time of publication. The terms and definitions are arranged in conceptual order, with
an alphabetical index provided at the end of the document. Annex A includes a set of diagrams of the
concept systems that form the concept ordering.
NOTE Guidance on some additional frequently-used words in the QMS standards developed by ISO/TC 176,
and which have an identified dictionary meaning, is provided in a glossary available at: http://www.iso.
org/iso/03_terminology_used_in_iso_9000_family.pdf
Copyright International Organization for Standardization
Provided by IHS Markit under license with ANSI Licensee=Becton Dickinson - Loc 1 - 61, 64/5984713001, User=Chiu, Shelly
No reproduction or network©ing pIeSrmOit te2d0 w1ith5ou t– lic Aenlsle rfroimg hIHtSs reserved Not for Resale, 10/14/2019 19:06:05 MDT v
Copyright International Organization for Standardization
Provided by IHS Markit under license with ANSI Licensee=Becton Dickinson - Loc 1 - 61, 64/5984713001, User=Chiu, Shelly
No reproduction or networking permitted without license from IHS Not for Resale, 10/14/2019 19:06:05 MDT
INTERNATIONAL STANDARD ISO 9000:2015(E)
Quality management systems — Fundamentals and
vocabulary
1 Scope
This International Standard describes the fundamental concepts and principles of quality management
which are universally applicable to the following:
— organizations seeking sustained success through the implementation of a quality management system;
— customers seeking confidence in an organization’s ability to consistently provide products and
services conforming to their requirements;
— organizations seeking confidence in their supply chain that product and service requirements will
be met;
— organizations and interested parties seeking to improve communication through a common
understanding of the vocabulary used in quality management;
— organizations performing conformity assessments against the requirements of ISO 9001;
— providers of training, assessment or advice in quality management;
— developers of related standards.
This International Standard specifies the terms and definitions that apply to all quality management
and quality management system standards developed by ISO/TC 176.
2 Fundamental concepts and quality management principles
The quality management concepts and principles described in this International Standard give
the organization the capacity to meet challenges presented by an environment that is profoundly
different from recent decades. The context in which an organization works today is characterized by
accelerated change, globalization of markets and the emergence of knowledge as a principal resource.
The impact of quality extends beyond customer satisfaction: it can also have a direct impact on the
organization’s reputation.
Society has become better educated and more demanding, making interested parties increasingly
more influential. By providing fundamental concepts and principles to be used in the development of
a quality management system (QMS), this International Standard provides a way of thinking about the
organization more broadly.
All concepts, principles and their interrelationships should be seen as a whole and not in isolation of
each other. No individual concept or principle is more important than another. At any one time, finding
the right balance in application is critical.
Copyright International Organization for Standardization
Provided by IHS Markit under license with ANSI Licensee=Becton Dickinson - Loc 1 - 61, 64/5984713001, User=Chiu, Shelly
No reproduction or network©ing pIeSrmOit te2d0 w1ith5ou t– lic Aenlsle rfroimg hIHtSs reserved Not for Resale, 10/14/2019 19:06:05 MDT
---,,,,,,,--,```,,,,,,,,,,,,`,,,,``--
ISO 9000:2015(E)
An organization focused on quality promotes a culture that results in the behaviour, attitudes, activities and processes that deliver value through fulfilling the needs and expectations of customers and other relevant interested parties. The quality of an organization’s products and services is determined by the ability to satisfy customers and the intended and unintended impact on relevant interested parties. The quality of products and services includes not only their intended function and performance, but also their perceived value and benefit to the customer.
A QMS comprises activities by which the organization identifies its objectives and determines the processes and resources required to achieve desired results. The QMS manages the interacting processes and resources required to provide value and realize results for relevant interested parties. The QMS enables top management to optimize the use of resources considering the long and short term consequences of their decision. A QMS provides the means to identify actions to address intended and unintended consequences in providing products and services.
Understanding the context of the organization is a process. This process determines factors which influence the organization’s purpose, objectives and sustainability. It considers internal factors such as values, culture, knowledge and performance of the organization. It also considers external factors such as legal, technological, competitive, market, cultural, social and economic environments. Examples of the ways in which an organization’s purpose can be expressed include its vision, mission, policies and objectives.
The concept of interested parties extends beyond a focus solely on the customer. It is important to consider all relevant interested parties. Part of the process for understanding the context of the organization is to identify its interested parties. The relevant interested parties are those that provide significant risk to organizational sustainability if their needs and expectations are not met. Organizations define what results are necessary to deliver to those relevant interested parties to reduce that risk. Organizations attract, capture and retain the support of the relevant interested parties they depend upon for their success.
Top management support of the QMS and engagement of people enables:
— provision of adequate human and other resources;
—
moni--to,,,r,`,i,,n,,`g,`, `,p,,,r,o,c--e,,s,s,,e,,s-- -and results;
Copyright International Organization for Standardization
Provided by IHS Markit under license with ANSI Licensee=Becton Dickinson - Loc 1 - 61, 64/5984713001, User=Chiu, Shelly
No reproduction or networking permitted without license from IHS Not for Resale, 10/14/2019 19:06:05 MDT © ISO 2015 – All rights reserved
ISO 9000:2015(E)
— determining and evaluating of risks and opportunities;
— implementing appropriate actions.
Responsible acquisition, deployment, maintenance, enhancement and disposal of resources support the
organization in achieving its objectives.
People are essential resources within the organization. The performance of the organization is dependent upon how people behave within the system in which they work. Within an organization, people become engaged and aligned through a common understanding of the quality policy and the organization’s desired results.
A QMS is most effective when all employees understand and apply the skills, training, education and experience needed to perform their roles and responsibilities. It is the responsibility of top management to provide opportunities for people to develop these necessary competencies.
Awareness is attained when people understand their responsibilities and how their actions contribute to the achievement of the organization’s objectives.
Planned and effective internal (i.e. throughout the organization) and external (i.e. with relevant interested parties) communication enhances people’s engagement and increased understanding of: — the context of the organization; — the needs and expectations of customers and other relevant interested parties; — the QMS.
The primary focus of quality management is to meet customer requirements and to strive to exceed customer expectations.
Sustained success is achieved when an organization attracts and retains the confidence of customers and other relevant interested parties. Every aspect of customer interaction provides an opportunity to create more value for the customer. Understanding current and future needs of customers and other interested parties contributes to the sustained success of the organization.
Some potential key benefits are: — increased customer value; Copyright International Organization for Standardization Provided by IHS Markit under license with ANSI Licensee=Becton Dickinson - Loc 1 - 61, 64/5984713001, User=Chiu, Shelly No reproduction or network©ing pIeSrmOit te2d0 w1ith5ou t– lic Aenlsle rfroimg hIHtSs reserved Not for Resale, 10/14/2019 19:06:05 MDT ISO 9000:2015(E) — increased customer satisfaction; — improved customer loyalty; — enhanced repeat business; — enhanced reputation of the organization; — expanded customer base; — increased revenue and market share.
Possible actions include: — recognize direct and indirect customers as those who receive value from the organization; — understand customers’ current and future needs and expectations; — link the organization’s objectives to customer needs and expectations; — communicate customer needs and expectations throughout the organization; — plan, design, develop, produce, deliver and support products and services to meet customer needs and expectations; — measure and monitor customer satisfaction and take appropriate actions; — determine and take action on relevant interested parties’ needs and appropriate expectations that can affect customer satisfaction; — actively manage relationships with customers to achieve sustained success.
Leaders at all levels establish unity of purpose and direction and create conditions in which people are engaged in achieving the organization’s quality objectives.
Creation of unity of purpose and the direction and engagement of people enable an organization to align its strategies, policies, processes and resources to achieve its objectives.
Some potential key benefits are: — increased effectiveness and efficiency in meeting the organization’s quality objectives; — better coordination of the organization’s processes; — improved communication between levels and functions of the organization; — development and improvement of the capability of the organization and its people to deliver desired results. Copyright International Organization for Standardization Provided by IHS Markit under license with ANSI Licensee=Becton Dickinson - Loc 1 - 61, 64/5984713001, User=Chiu, Shelly No reproduction or networking permitted without license from IHS Not for Resale, 10/14/2019 19:06:05 MDT © ISO 2015 – All rights reserved ISO 9000:2015(E)
Possible actions include: — communicate the organization’s mission, vision, strategy, policies and processes throughout the organization; — create and sustain shared values, fairness and ethical models for behaviour at all levels of the organization; — establish a culture of trust and integrity; — encourage an organization-wide commitment to quality; — ensure that leaders at all levels are positive examples to people in the organization; — provide people with the required resources, training and authority to act with accountability; — inspire, encourage and recognize the contribution of people.
Competent, empowered and engaged people at all levels throughout the organization are essential to enhance the organization’s capability to create and deliver value.
In order to manage an organization effectively and efficiently, it is important to respect and involve all people at all levels. Recognition, empowerment and enhancement of competence facilitate the engagement of people in achieving the organization’s quality objectives.
Some potential key benefits are: — improved understanding of the organization’s quality objectives by people in the organization and increased motivation to achieve them; — enhanced involvement of people in improvement activities; — enhanced personal development, initiatives and creativity; — enhanced people satisfaction; — enhanced trust and collaboration throughout the organization; — increased attention to shared values and culture throughout the organization.
Possible actions include:
— communicate with people to promote understanding of the importance of their individual
contribution;
— promote collaboration throughout the organization;
— facilitate open discussion and sharing of knowledge and experience;
— empower--`p,,,,e,,o,,,p,l,e,,, ,t,o`,-d-e,,t,,e,r,,m--- ine constraints to performance and to take initiatives without fear;
Copyright International Organization for Standardization
Provided by IHS Markit under license with ANSI Licensee=Becton Dickinson - Loc 1 - 61, 64/5984713001, User=Chiu, Shelly
No reproduction or network©ing pIeSrmOit te2d0 w1ith5ou t– lic Aenlsle rfroimg hIHtSs reserved Not for Resale, 10/14/2019 19:06:05 MDT
ISO 9000:2015(E)
— recognize and acknowledge people’s contribution, learning and improvement;
— enable self-evaluation of performance against personal objectives;
— conduct surveys to assess people’s satisfaction, communicate the results and take appropriate actions.
Consistent and predictable results are achieved more effectively and efficiently when activities are understood and managed as interrelated processes that function as a coherent system.
The QMS consists of interrelated processes. Understanding how results are produced by this system enables an organization to optimize the system and its performance.
Some potential key benefits are: — enhanced ability to focus effort on key processes and opportunities for improvement; — consistent and predictable outcomes through a system of aligned processes; — optimized performance through effective process management, efficient use of resources and reduced cross-functional barriers; — enabling the organization to provide confidence to interested parties related to its consistency, effectiveness and efficiency.
Possible actions include: — define objectives of the system and processes necessary to achieve them; — establish authority, responsibility and accountability for managing processes; — understand the organization’s capabilities and determine resource constraints prior to action; — determine process interdependencies and analyse the effect of modifications to individual processes on the system as a whole; — manage processes and their interrelations as a system to achieve the organization’s quality objectives effectively and efficiently; — ensure the necessary information is available to operate and improve the processes and to monitor, analyse and evaluate the performance of the overall system; — manage risks which can affect outputs of the processes and overall outcomes of the QMS.
Successful organizations have an ongoing focus on improvement.
Copyright International Organization for Standardization
Provided by IHS Markit under license with ANSI Licensee=Becton Dickinson - Loc 1 - 61, 64/5984713001, User=Chiu, Shelly
No reproduction or networking permitted without license from IHS Not for Resale, 10/14/2019 19:06:05 MDT © ISO 2015 – All rights reserved
---,,,,,,,--,```,,,,,,,,,,,,`,,,,``--
ISO 9000:2015(E)
Improvement is essential for an organization to maintain current levels of performance, to react to changes in its internal and external conditions and to create new opportunities.
Some potential key benefits are: — improved process performance, organizational capability and customer satisfaction; — enhanced focus on root cause investigation and determination, followed by prevention and corrective actions; — enhanced ability to anticipate and react to internal and external risks and opportunities; — enhanced consideration of both incremental and breakthrough improvement; — improved use of learning for improvement; — enhanced drive for innovation.
Possible actions include: — promote establishment of improvement objectives at all levels of the organization; — educate and train people at all levels on how to apply basic tools and methodologies to achieve improvement objectives; — ensure people are competent to successfully promote and complete improvement projects; — develop and deploy processes to implement improvement projects throughout the organization; — track, review and audit the planning, implementation, completion and results of improvement projects; — integrate improvement consideration into development of new or modified products and services and processes; — recognize and acknowledge improvement.
Decisions based on the analysis and evaluation of data and information are more likely to produce desired results.
Decision-making can be a complex process and it always involves some uncertainty. It often involves multiple types and sources of inputs, as well as their interpretation, which can be subjective. It is important to understand cause and effect relationships and potential unintended consequences. Facts, evidence and data analysis lead to greater objectivity and confidence in decision making.
Some potential key benefits are: — improved decision making processes; Copyright International Organization for Standardization Provided by IHS Markit under license with ANSI Licensee=Becton Dickinson - Loc 1 - 61, 64/5984713001, User=Chiu, Shelly No reproduction or network©ing pIeSrmOit te2d0 w1ith5ou t– lic Aenlsle rfroimg hIHtSs reserved Not for Resale, 10/14/2019 19:06:05 MDT ISO 9000:2015(E) — improved assessment of process performance and ability to achieve objectives; — improved operational effectiveness and efficiency; — increased ability to review, challenge and change opinions and decisions; — increased ability to demonstrate the effectiveness of past decisions.
Possible actions include: — determine, measure and monitor key indicators to demonstrate the organization’s performance; — make all data needed available to the relevant people; — ensure that data and information are sufficiently accurate, reliable and secure; — analyse and evaluate data and information using suitable methods; — ensure people are competent to analyse and evaluate data as needed; — make decisions and take actions based on evidence, balanced with experience and intuition.
For sustained success, organizations manage their relationships with relevant interested parties, such as providers.
Relevant interested parties influence the performance of an organization. Sustained success is more likely to be achieved when the organization manages relationships with all of its interested parties to optimize their impact on its performance. Relationship management with its provider and partner networks is of particular importance.
Some potential key benefits are: — enhanced performance of the organization and its relevant interested parties through responding to the opportunities and constraints related to each interested party; — common understanding of objectives and values among interested parties; — increased capability to create value for interested parties by sharing resources and competence and managing quality related risks; — a well-managed supply chain that provides a stable flow of products and services.
Possible actions include: — determine relevant interested parties (such as providers, partners, customers, investors, employees or society as a whole) and their relationship with the organization; — determine and prioritize interested party relationships that need to be managed; Copyright International Organization for Standardization Provided by IHS Markit under license with ANSI Licensee=Becton Dickinson - Loc 1 - 61, 64/5984713001, User=Chiu, Shelly No reproduction or networking permitted without license from IHS Not for Resale, 10/14/2019 19:06:05 MDT © ISO 2015 – All rights reserved ISO 9000:2015(E) — establish relationships that balance short-term gains with long-term considerations; — gather and share information, expertise and resources with relevant interested parties; — measure performance and provide performance feedback to interested parties, as appropriate, to enhance improvement initiatives; — establish collaborative development and improvement activities with providers, partners and other interested parties; — encourage and recognize improvements and achievements by providers and partners.
Organizations share many characteristics with humans as a living and learning social organism. Both are adaptive and comprise interacting systems, processes and activities. In order to adapt to their varying context, each needs the ability to change. Organizations often innovate to achieve breakthrough improvements. An organization’s QMS model recognizes that not all systems, processes and activities can be predetermined; therefore it needs to be flexible and adaptable within the complexities of the organizational context.
Organizations seek to understand the internal and external context to identify the needs and expectations of relevant interested parties. This information is used in the development of the QMS to achieve organizational sustainability. The outputs from one process can be the inputs into other processes and are interlinked into the overall network. Although often appearing to be comprised of similar processes, each organization and its QMS is unique.
The organization has processes that can be defined, measured and improved. These processes interact to deliver results consistent with the organization’s objectives and cross functional boundaries. Some processes can be critical while others are not. Processes have interrelated activities with inputs to deliver outputs.
People collaborate within a process to carry out their daily activities. Some activities are prescribed and depend on an understanding of the objectives of the organization, while others are not and react to external stimuli to determine their nature and execution.
A QMS is a dynamic system that evolves over time through periods of improvement. Every organization
has quality management activities, whether they have been formally planned or not. This International
Standard provides guidance on how to develop a formal system to manage these activities. It is
necessary to determine activities which already exist in the organization and their suitability regarding
the context of the organization. This International Standard, along with ISO 9004 and ISO 9001, can
then be used to assist the organization to develop a cohesive QMS.
A formal QMS provides a framework for planning, executing, monitoring and improving the performance
of quality management activities. The QMS does not need to be complicated; rather it needs to accurately
--`,,,,,,,,,,,,,,,,```,-- ,,,,,,,--- 9
Copyright International Organization for Standardization
Provided by IHS Markit under license with ANSI Licensee=Becton Dickinson - Loc 1 - 61, 64/5984713001, User=Chiu, Shelly
No reproduction or network©ing pIeSrmOit te2d0 w1ith5ou t– lic Aenlsle rfroimg hIHtSs reserved Not for Resale, 10/14/2019 19:06:05 MDT
ISO 9000:2015(E)
reflect the needs of the organization. In developing the QMS, the fundamental concepts and principles
given in this International Standard can provide valuable guidance.
QMS planning is not a singular event, rather it is an ongoing process. Plans evolve as the organization
learns and circumstances change. A plan takes into account all quality activities of the organization and
ensures that it covers all guidance of this International Standard and requirements of ISO 9001. The
plan is implemented upon approval.
It is important for an organization to regularly monitor and evaluate both the implementation of the
plan and the performance of the QMS. Carefully considered indicators facilitate these monitoring and
evaluation activities.
Auditing is a means of evaluating the effectiveness of the QMS, in order to identify risks and to
determine the fulfilment of requirements. In order for audits to be effective, tangible and intangible
evidence needs to be collected. Actions are taken for correction and improvement based upon analysis
of the evidence gathered. The knowledge gained could lead to innovation, taking QMS performance to
higher levels.
The approaches to a QMS described in QMS standards developed by ISO/TC 176, in other management system standards and in organizational excellence models are based on common principles. They all enable an organization to identify risks and opportunities and contain guidance for improvement. In the current context, many issues such as innovation, ethics, trust and reputation could be regarded as parameters within the QMS. Standards related to quality management (e.g. ISO 9001), environmental management (e.g. ISO 14001) and energy management (e.g. ISO 50001), as well as other management standards and organizational excellence models, have addressed this. The QMS standards developed by ISO/TC 176 provide a comprehensive set of requirements and guidelines for a QMS. ISO 9001 specifies requirements for a QMS. ISO 9004 provides guidance on a wide range of objectives of a QMS for sustainable success and improved performance. Guidelines for components of a QMS include ISO 10001, ISO 10002, ISO 10003, ISO 10004, ISO 10008, ISO 10012 and ISO 19011. Guidelines for technical subjects in support of a QMS include ISO 10005, ISO 10006, ISO 10007, ISO 10014, ISO 10015, ISO 10018 and ISO 10019. Technical reports in support of a QMS include ISO/TR 10013 and ISO/TR 10017. Requirements for a QMS are also provided in sector-specific standards, such as ISO/TS 16949. The various parts of an organization’s management system, including its QMS, can be integrated as a single management system. The objectives, processes and resources related to quality, growth, funding, profitability, environment, occupational health and safety, energy, security and other aspects of the organization can be more effectively and efficiently achieved and used when the QMS is integrated with other management systems. The organization can perform an integrated audit of its management system against the requirements of multiple International Standards, such as ISO 9001, ISO 14001, ISO/IEC 27001 and ISO 50001. NOTE The ISO handbook “The integrated use of management system standards” can provide useful guidance. 3 Terms and definitions
3.1.1 top management organization person or group of people who directs and controls an (3.2.1) at the highest level Note 1 to entry: Top management has the power to delegate authority and provide resources within the organization. Copyright International Organization for Standardization Provided by IHS Markit under license with ANSI Licensee=Becton Dickinson - Loc 1 - 61, 64/5984713001, User=Chiu, Shelly No reproduction or networking permitted without license from IHS Not for Resale, 10/14/2019 19:06:05 MDT © ISO 2015 – All rights reserved ISO 9000:2015(E) management system Note 2 to entry: If the scope of the (3.5.3) covers only part of an organization, then top management refers to those who direct and control that part of the organization. Note 3 to entry: This constitutes one of the common terms and core definitions for ISO management system s3t.a1n.2dards given in Annex SL of the Consolidated ISO Supplement to the ISO/IEC Directives, Part 1. quality management system consultant organization quality management system realization information person who assists the (3.2.1) on (3.4.3), giving advice or (3.8.2) quality management system Note 1 to entry: The quality management system consultant can also assist in realizing parts of a (3.5.4). Note 2 to entry: ISO 10019:2005 provides guidance on how to distinguish a competent quality management system consultant from one who is not competent. [3S.1O.U3RCE: ISO 10019:2005, 3.2, modified] involvement t3a.1k.i4ng part in an activity, event or situation engagement involvement objectives 3.1.5 (3.1.3) in, and contribution to, activities to achieve shared (3.7.1) configuration authority configuration control board dcoisnpfiogsuirtiaotnioinng authority person or a group of persons with assigned responsibility and authority to make decisions on the (3.10.6) interested parties organization Note 1 to entry: Relevant (3.2.3) within and outside the (3.2.1) should be represented on the configuration authority. [3S.1O.U6RCE: ISO 10007:2003, 3.8, modified] dispute resolver DRP-provider dispute
3.2.1
organization
objectives
person or group of people that has its own functions with responsibilities, authorities and relationships
to achieve its (3.7.1)
association
Note 1 to entry: The concept of organization includes, but is not limited to, sole-trader, company, corporation,
firm, enterprise, authority, partnership, (3.2.8), charity or institution, or part or combination thereof,
whether incorporated or not, public or private.
Note 2 to entry: This constitutes one of the common terms and core definitions for ISO management system
standards given in Annex SL of the Consolidated ISO Supplement to the ISO/IEC Directives, Part 1. The original
definition has been mo--d,i,,f,`i,e,,,d,`, `b,`,,y,, ,`m,o--d,,i,f,y,,i,`n---g Note 1 to entry.
Copyright International Organization for Standardization
Provided by IHS Markit under license with ANSI Licensee=Becton Dickinson - Loc 1 - 61, 64/5984713001, User=Chiu, Shelly
No reproduction or network©ing pIeSrmOit te2d0 w1ith5ou t– lic Aenlsle rfroimg hIHtSs reserved Not for Resale, 10/14/2019 19:06:05 MDT
ISO 9000:2015(E)
3.2.2
context of the organization
organization’s
objectives
combination of internal and external issues that can have an effect on an (3.2.1) approach
to developing and achieving its (3.7.1) products services
interested parties
Note 1 to entry: The organization’s objectives can be related to its (3.7.6) and (3.7.7), investments
and behaviour towards its (3.2.3).
Note 2 to entry: The concept of context of the organization is equally applicable to not-for-profit or public service
organizations as it is to those seeking profits.
Note 3 to entry: In English, this concept is often referred to by other terms such as “business environment”,
“organizational environment” or “ecinofsryassttermuc otuf raen organization”.
3N.o2te.3 4 to entry: Understanding the (3.5.2) can help to define the context of the organization.
interested party
organization
stakeholder
person or (3.2.1) that can affect, be affected by, or perceive itself to be affected by a
Customers providers
decision or activity
EXAMPLE (3.2.4), owners, people in an organization, (3.2.5), bankers, regulators,
unions, partners or society that can include competitors or opposing pressure groups.
Note 1 to entry: This constitutes one of the common terms and core definitions for ISO management system
standards given in Annex SL of the Consolidated ISO Supplement to the ISO/IEC Directives, Part 1. The original
d3e.2fi.n4ition has been modified by adding the Example.
customer
organization product service
person or (3.2.1) that could or does receive a (3.7.6) or a (3.7.7) that is
process
intended for or required by this person or organization
EXAMPLE Consumer, client, end-user, retailer, receiver of product or service from an internal (3.4.1),
beneficiary and purchaser.
N3.o2te.5 1 to entry: A customer can be internal or external to the organization.
provider
organization product service
supplier
(3.2.1) that provides a (3.7.6) or a (3.7.7)
EXAMPLE Producer, distributor, retailer or vendor of a product or a service.
Note 1 to entry: A provider can be internal or external to the organization.
3N.o2te.6 2 to entry: In a contractual situation, a provider is sometimes called “contractor”.
external provider
provider organization
external supplier
product service
(3.2.5) that is not part of the (3.2.1)
EXAMPLE Producer, distributor, retailer or vendor of a (3.7.6) or a (3.7.7)
Copyright International Organization for Standardization
Provided by IHS Markit under license with ANSI Licensee=Becton Dickinson - Loc 1 - 61, 64/5984713001, User=Chiu, Shelly
No reproduction or networking permitted without license from IHS Not for Resale, 10/14/2019 19:06:05 MDT © ISO 2015 – All rights reserved
ISO 9000:2015(E)
organization dispute pdrisopcuestes resolution process provider person or (3.2.1) that supplies and operates an external (3.9.6) resolution (3.4.1) Note 1 to entry: Generally, a DRP-provider is a legal entity, separate from the orgacnoimzaptliaoinn tosr person as an individual and the complainant. In this way, the attributes of independence and fairness are emphasized. In some situations, a separate unit is establishecdon wtriathcitns the organization to handle unresolved (3.9.3). performance dispute resolvers Note 2 to entry: The DRP-provider (3.4.7) with the parties to provide dispute resolution, and is accountable for (3.7.8). The DRP-provider supplies (3.1.6). The DRP-provider also utilizes support, executive and other managerial staff to supply financial resources, clerical support, scheduling assistance, training, meeting rooms, supervision and similar functions. association Note 3 to entry: DRP-providers can take many forms including not-for-profit, for-profit and public entities. An (3.2.8) can also be a DRP-provider. Note 4 to entry: In ISO 10003:2007 instead of the term DRP-provider, the term “provider” is used. [3S.O2.U8RCE: ISO 10003:2007, 3.9, modified] association organization
3.3.1
improvement
performance
activity to enhance (3.7.8)
N3.o3te.2 1 to entry: The activity can be recurring or singular.
continual improvement
performance
recurring activity top reonchesasnce (3.7.8o)bjectives improvement
audit findings audit conclusions
dNaottae 1 to entmrayn: aTgheem ent (3.4r.1e)v ioefw esstablishing (3.7.1) and finding opporctuornrieticetsiv feo ar ction
(3.p3r.1e)v eisn tai vceo natcitniounal process through the use of (3.13.9) and (3.13.10), analysis of
(3.8.1), (3.3.3) (3.11.2) or other means and generally leads to (3.12.2)
or (3.12.1).
Note 2 to entry: This constitutes one of the common terms and core definitions for ISO management system
standards given in Annex SL of the Consolidated ISO Supplement to the ISO/IEC Directives, Part 1. The original
d3e.3fi.n3ition has been modified by adding Note 1 to entry.
management
organization
coordinated activities to direct and control an policies (3.2.1) objectives processes
Note 1 to entry: Management can include establishing (3.5.8) and (3.7.1), and (3.4.1)
to achieve these objectives.
Copyright International Organization for Standardization
Provided by IHS Markit under license with ANSI Licensee=Becton Dickinson - Loc 1 - 61, 64/5984713001, User=Chiu, Shelly
No reproduction or network©ing pIeSrmOit te2d0 w1ith5ou t– lic Aenlsle rfroimg hIHtSs reserved Not for Resale, 10/14/2019 19:06:05 MDT
---,,,,,,,--,```,,,,,,,,,,,,`,,,,``--
ISO 9000:2015(E)
Note 2 to entry: The word “management” sometimes refers to people, i.e. a person or group of people with
authority and responsibility for the conduct and control of an organization. When “managementto” pis m uasneadg ienm tehnist
sense, it should always be used with some form of qualifier to avoid confusion with the concept of “management”
as a set of activities defined above. For example, “management shall…” is deprecated whereas “
(3.1.1) shall…” is acceptable. Otherwise different words should be adopted to convey the concept when related to
p3e.3o.p4le, e.g. managerial or managers.
quality management
management quality
(3.3.3) with regard to (3.6.2) quality policies quality objectives
processes quality planning quality assurance
qNuoatlei t1y tcoo nentrtorly: Quality maqnuaagleitmy eimntp craonve imncelnutde establishing (3.5.9) and (3.7.2),
and (3.4.1) to achieve these quality objectives through (3.3.5), (3.3.6),
3.3.5 (3.3.7), and (3.3.8).
quality planning
quality management quality objectives
processes
part of (3.3.4) focused on setting (3.7.2) and specifying necessary
operational (3.4.1q)u, aalnitdy prelalnasted resources to achieve the quality objectives
N3.o3te.6 1 to entry: Establishing (3.8.9) can be part of quality planning.
quality assurance
quality management quality requirements
part of (3.3.4) focused on providing confidence that (3.6.5)
w3.i3ll.7 be fulfilled
quality control
quality management quality requirements
3pa.3r.t8 of (3.3.4) focused on fulfilling (3.6.5)
quality improvement
quality management quality requirements
part of (3.3.4) focused on increasing the ability to fulfile ffectiveness ef f(i3ci.6en.5cy)
traceability
Note 1 to entry: The quality requirements can be related to any aspect such as (3.7.11),
(33.3.7..910) or (3.6.13).
configuration management
configuration
coordinated activities to direct and control (3.10.6)
product service product configuration information
Note 1 to entry: Configuration management generally concentrates on technical and organizational activities
that establish and maintain control of a (3.7.6) or (3.7.7) and its
(3.6.8) throughout the life cycle of the product.
3[S.O3.U1R0CE: ISO 10007:2003, 3.6, modified — Note 1 to entry has been modified]
change control
output
product configuration information
3.4.1
process
set of interrelated or interacting activities that use inputs to deliveoru atpnu itntendedp rreosduulctt service
Note 1 to entry: Whether the “intended result” of a process is called (3.7.5), (3.7.6) or
(3.7.7) depends on the context of the reference.
Note 2 to entry: Inputs to a process are generally the outputs of other processes and outputs of a process are
generally the inputs to other processes.
Note 3 to entry: Two or more interroerlgaatendiz aantido ninteracting processes in series can also be referred to as a process.
Note 4 to entry: Processes in an (3.2.1) are generally planned and carried out under controlled
conditions to add value. conformity
Note 5 to entry: A process where the (3.6.11) of the resulting output cannot be readily or economically
validated is frequently referred to as a “special process”.
Note 6 to entry: This constitutes one of the common terms and core definitions for ISO management system
standards given in Annex SL of the Consolidated ISO Supplement to the ISO/IEC Directives, Part 1. The original
definition has been modified to prevent circularity between process and output, and Notes 1 to 5 to entry
h3a.4v.e2 been added.
project
process
objective requirements
unique (3.4.1), consisting of a set of coordinated and controlled activities with start and finish
dates, undertaken to achieve an (3.7.1) conforming to specific (3.6.4), including
the constraints of time, cost and resources
Note 1 to entry: An individual project can form part of a larger project structure and generally has a defined start
and finish date. product service
characteristics
Note 2 to entry: In some projects the objectives and scope are updated and the (3.7.6) or (3.7.7)
(3.10.1o)u tdpeuftined progressively as the project proceeds.
Note 3 to entry: The (3.7o.r5g)a onfi zaa ptrioonject can be one or several units of product or service.
Note 4 to entry: The project’s (3.2.1) is normally temporary and established for the lifetime of the
project.
Note 5 to entry: The complexity of the interactions among project activities is not necessarily related to the
project size.
[SOURCE: ISO 10006:2003, 3.5, modified — Notes 1 to 3 have been modified]
--`,,,,,,,,,,,,,,,,```,--,,,,,,,--- 15
Copyright International Organization for Standardization
Provided by IHS Markit under license with ANSI Licensee=Becton Dickinson - Loc 1 - 61, 64/5984713001, User=Chiu, Shelly
No reproduction or network©ing pIeSrmOit te2d0 w1ith5ou t– lic Aenlsle rfroimg hIHtSs reserved Not for Resale, 10/14/2019 19:06:05 MDT
ISO 9000:2015(E)
3.4.3
quality management system realization
process
quality management system
(3.4.1) of establishing, documenting, implementing, maintaining and continually improving a
(3.5.4)
[3S.4O.U4RCE: ISO 10019:2005, 3.1, modified — Notes have been deleted]
competence acquisition
process competence
(3.4.1) of attaining (3.10.4)
[3S.4O.U5RCE: ISO 10018:2012, 3.2, modified]
procedure
process
specified way to carry out an activity or a (3.4.1)
N3.o4t.e6 1 to entry: Procedures can be documented or not.
outsource
organization
(pvreorcbe)ss
make an arrangement where an external (3.2.1) performs part of an organization’s
function or (3.4.1) management system
Note 1 to entry: An external organization is outside the scope of the (3.5.3), although the
outsourced function or process is within the scope.
Note 2 to entry: This constitutes one of the common terms and core definitions for ISO management system
s3t.a4n.7dards given in Annex SL of the Consolidated ISO Supplement to the ISO/IEC Directives, Part 1.
contract
b3i.4nd.8ing agreement
design and development
processes requirements object
set of (3.4.1) that transform (3.6.4) for an (3.6.1) into more detailed
requirements for that object
output
Note 1 to entry: The requirements forming input to design and developcmhaernatc aterrei sotfitcesn the result ofp rreosjeecatrch and
can be expressed in a broader, more general sense than the requirements forming the (3.7.5) of design
and development. The requirements are generally defined in terms of (3.10.1). In a (3.4.2)
there can be several design and development stages.
Note 2 to entry: In English the words “design” and “development” and the term “design and development” are
sometimes used synonymously and sometimes used to define different stages of the overall design and development.
In French the words “conception” and “développement” and the term “conception et développement” are sometimes
used synonymously and sometimes used to define different stages of the overall design and development.
product service
Note 3 to entry: A qualifier can be applied to indicate the nature of what is being designed and developed
(e.g. (3.7.6) design and development, (3.7.7) design and development or process design and
development).
3.5.1 system set of interrelated or interacting elements Copyright International Organization for Standardization Provided by IHS Markit under license with ANSI Licensee=Becton Dickinson - Loc 1 - 61, 64/5984713001, User=Chiu, Shelly No reproduction or networking permitted without license from IHS Not for Resale, 10/14/2019 19:06:05 MDT © ISO 2015 – All rights reserved ISO 9000:2015(E) 3.5.2 infrastructure system services organization
3.6.1
object
entity
item
Product service process organization system
anything perceivable or conceivable
EXAMPLE (3.7.6), (3.7.7), (3.4.1), person, (3.2.1), (3.5.1), resource.
Note 1 to entry: Objects can be material (e.g. an engine, a sheet of paper, a diamond), non-material (e.g. conversion
ratio, a project plan) or imagined (e.g. the future state of the organization).
[3S.6O.U2RCE: ISO 1087-1:2000, 3.1.1, modified]
quality
characteristics object requirements
degree to which a set of inherent (3.10.1) of an (3.6.1) fulfils (3.6.4)
Note 1 to entry: The term “quality” can be used with adjectives such as pooro, bgjoeoctd or excellent.
3N.o6te.3 2 to entry: “Inherent”, as opposed to “assigned”, means existing in the (3.6.1).
grade
requirements object
category or rank given to different (3.6.4) for an (3.6.1) having the same functional use
EXAMPLE Class of airline ticket aqnuda lcitayt ergeqouryir eomf heonttel in a hotel brochure.
Note 1 to entry: When establishing a (3.6.5), the grade is generally specified.
--`,,,,,,,,,,,,,,,,```,--,,,,,,,---
Copyright International Organization for Standardization
Provided by IHS Markit under license with ANSI Licensee=Becton Dickinson - Loc 1 - 61, 64/5984713001, User=Chiu, Shelly
No reproduction or networking permitted without license from IHS Not for Resale, 10/14/2019 19:06:05 MDT © ISO 2015 – All rights reserved
ISO 9000:2015(E)
3.6.4
requirement
need or expectation that is stated, generally implied or obligatory organization
interested parties
Note 1 to entry: “Generally implied” means that it is custom or common practice for the (3.2.1) and
(3.2.3) that the need or expectation under consideration is dimocpulmieedn.ted information
Note 2 to entry: A specified requirement is one that is stated, for example in product (3.8.6).
quality management customer quality requirement
Note 3 to entry: A qualifier can be used to denote a specific type of requirement, e.g. (3.7.6) requirement,
(3.3.4) requirement, (3.2.4) requirement, (3.6.5).
Note 4 to entry: Requirements can be generated by diffecruenstto imnteerr esasttiesdfa pcatirotnies or by the organization itself.
Note 5 to entry: It can be necessary for achieving high (3.9.2) to fulfil an expectation of a
customer even if it is neither stated nor generally implied or obligatory.
Note 6 to entry: This constitutes one of the common terms and core definitions for ISO management system
standards given in Annex SL of the Consolidated ISO Supplement to the ISO/IEC Directives, Part 1. The original
3de.6fi.n5ition has been modified by adding Notes 3 to 5 to entry.
quality requirement
requirement quality
3.6.6 (3.6.4) related to (3.6.2)
statutory requirement
requirement
o3b.6li.g7atory (3.6.4) specified by a legislative body
regulatory requirement
requirement
o3b.6li.g8atory (3.6.4) specified by an authority mandated by a legislative body
product configuration information
requirement product verification
(3.6.4) or other information for (3.7.6) design, realization, (3.8.12),
operation and support
[3S.6O.U9RCE: ISO 10007:2003, 3.9, modified]
nonconformity
requirement
non-fulfilment of a (3.6.4)
Note 1 to entry: This constitutes one of the common terms and core definitions for ISO management system
s3t.a6n.1d0ards given in Annex SL of the Consolidated ISO Supplement to the ISO/IEC Directives, Part 1.
defect
nonconformity
(3.6.9) related to an intended or specified use
product service
Note 1 to entry: The distinction between the concepts defect and nonconformity is important as it has legal
connotations, particularly those associated with c(3u.s7t.o6m) aernd (3.7.7) liability issues.
information provider
Note 2 to entry: The intended use as intended by the (3.2.4) can be affected by the nature of the
3.6.11 (3.8.2), such as operating or maintenance instructions, provided by the (3.2.5).
conformity
requirement
fulfilment of a (3.6.4)
Note 1 to entry: In English the word “conformance” is synonymous but deprecated. In French the word
“compliance” is synonymous but deprecated.
Copyright International Organization for Standardization
Provided by IHS Markit under license with ANSI Licensee=Becton Dickinson - Loc 1 - 61, 64/5984713001, User=Chiu, Shelly
No reproduction or network©ing pIeSrmOit te2d0 w1ith5ou t– lic Aenlsle rfroimg hIHtSs reserved Not for Resale, 10/14/2019 19:06:05 MDT
ISO 9000:2015(E)
Note 2 to entry: This constitutes one of the common terms and core definitions for ISO management system
standards given in Annex SL of the Consolidated ISO Supplement to the ISO/IEC Directives, Part 1. The original
d3e.6fi.n1i2tion has been modified by adding Note 1 to entry.
capability
object output requirements
ability of an Pro c(e3s.6s.1) to realize an (3.7.5) that will fulfil the (3.6.4) for that output
N3.o6te.1 13 to entry: (3.4.1) capability terms in the field of statistics are defined in ISO 3534-2.
traceability
object
ability to trace the history, applicaptrioodnu octr location osf earnv ice (3.6.1)
Note 1 to entry: When considering a (3.7.6) or a (3.7.7), traceability can relate to:
— the origin of materials and parts;
— the processing history;
— the distribution and location of the product or service after delivery.
3N.o6te.1 24 to entry: In the field of metrology, the definition in ISO/IEC Guide 99 is the accepted definition.
dependability
ability to perform as and when required
[3S.6O.U1R5CE: IEC 60050-192, modified — Notes have been deleted]
innovation
object
new or changed (3.6.1) realizing or redistributing value
Note 1 to entry: Activities resulting in innovation are generally managed.
Note 2 to entry: Innovation is generally significant in its effect.
3.7.1
objective
result to be achieved
Note 1 to entry: An objective can be strategic, tactical, or operational.
organization project
Note 2 ptroo deuncttry: Objectivperso cceasns relate to different disciplines (such as financial, health and safety, and
environmental objectives) and can apply at different levels (such as strategic, (3.2.1)-wide,
(3.4.2), (3.7.6) and (3.4.1)).
quality objective
Note 3 to entry: An objective can be expressed in other ways, e.g. as an intended outcome, a purpose, an
operational criterion, as a (3.7.2) or by the use of other words with similar meaning (e.g. aim,
goal, or target). quality management systems quality objectives
organization quality policy
Note 4 to entry: In the context of (3.5.4) (3.7.2) are set by the
(3.2.1), consistent with the (3.5.9), to achieve specific results.
Note 5 to entry: This constitutes one of the common terms and core definitions for ISO management system
standards given in Annex SL of the Consolidated ISO Supplement to the ISO/IEC Directives, Part 1. The original
definition has been modified by modifying Note 2 to entry.
Copyright International Organization for Standardization
Provided by IHS Markit under license with ANSI Licensee=Becton Dickinson - Loc 1 - 61, 64/5984713001, User=Chiu, Shelly
No reproduction or networking permitted without license from IHS Not for Resale, 10/14/2019 19:06:05 MDT © ISO 2015 – All rights reserved
---,,,,,,,--,```,,,,,,,,,,,,`,,,,``--
ISO 9000:2015(E)
3.7.2
quality objective
objective quality
(3.7.1) related to (3.6.2) organization’s quality policy
Note 1 to entry: Quality objectives are generally based on the (3.2.1) pro (c3e.s5s.e9s).
organization
Note 2 to entry: Quality objectives are generally specified for relevant functions, levels and (3.4.1) in
3th.7e .3 (3.2.1).
success
objective
3.8.1 data object 3fa.c8t.s2 about an (3.6.1) information data m3.e8a.3ningful (3.8.1) objective evidence data (3.8.1) supporting the existence or verity of something measurement test Note 1 to entry: Objective evidence can be obtained through observation, (3.11.4), (3.11.8), or by other means. audit records information audit criteria Note 2 to entry: Objective evidence for the purpose of (3.13.1) generally consists of (3.8.10), 3st.a8t.e4ments of fact or other (3.8.2) which are relevant to the (3.13.7) and verifiable. information system organization
<3q.8u.a5lity management system> network of communication channels used within an (3.2.1) document information Record specification (3.8.2) and the medium on which it is contained EXAMPLE (3.8.10), (3.8.7), procedure document, drawing, report, standard. Note 1 to entry: The medium can be paper, magnetic, electronic or optical computer disc, photograph or master sample, or combination thereof. Note 2 to entry: A set orf edqouciuremmeennttss, for example specifications and records, is frequently called “documentation”. Note 3 to entry: Some (3.6.4) (e.g. the requirement to be readable) relate to all types of documents. However there can be different requirements for specifications (e.g. the requirement to be revision controlled) 3an.8d. f6or records (e.g. the requirement to be retrievable). documented information information organization (3.8.2) required to be controlled and maintained by an (3.2.1) and the medium on which it is contained Note 1 to entry: Documented information can be in any format and media and from any source. Note 2 tmo aennatrgye:m Deonctu smysetnemted information can refer top:rocesses — the (3.5.3), including related (3.4.1); — information created in order froerc othrdes organization to operate (documentation); — evidence of results achieved ( (3.8.10)). Note 3 to entry: This constitutes one of the common terms and core definitions for ISO management system 3st.a8n.7dards given in Annex SL of the Consolidated ISO Supplement to the ISO/IEC Directives, Part 1. specification document requirements Quality manual quality plan (3.8.5) stating (3.6.4) EXAMPLE (3.8.8), (3.8.9), technical drawing, procedure document, work instruction. --``,,,,`,,,,,`,`,`,,,,,```,`-`-`,,`,,`,`,,`--- Copyright International Organization for Standardization Provided by IHS Markit under license with ANSI Licensee=Becton Dickinson - Loc 1 - 61, 64/5984713001, User=Chiu, Shelly No reproduction or network©ing pIeSrmOit te2d0 w1ith5ou t– lic Aenlsle rfroimg hIHtSs reserved Not for Resale, 10/14/2019 19:06:05 MDT ISO 9000:2015(E) process test products performance Note 1 to entry: A specification can be related to activities (e.g. procedure document, (3.4.1) specification and (3.11.8) specification), or (3.7.6) (e.g. product specification, (3.7.8) specification and drawing). design and development record Note 2 to entry: It can be that, by stating requirements, a specification additionally is stating results achieved by 3.8.8 (3.4.8) and thus in some cases can be used as a (3.8.10). quality manual specification quality management system organization (3.8.7) for the (3.5.4) of an (3.2.1) organization Note 1 to entry: Quality manuals can vary in detail and format to suit the size and complexity of an individual 3.8.9 (3.2.1). quality plan specification procedures object (3.8.7) of the (3.4.5) and associated resources to be applied when and by whom to a specific (3.6.1) quality management processes product service Note 1 to entry: These procedures generally include those referring to (3.3.4) (3.4.1) and to (3.7.6) and (3.7.7) realization processes. quality manual documents Note 2 to entry: A quality plan often makes reference to parts of the (3.8.8) or to procedure (3.8.5). quality planning 3N.o8te.1 30 to entry: A quality plan is generally one of the results of (3.3.5). record document (3.8.5) stating results achieved or providing evidetnraccee oafb ialicttyivities performed verification preventive action corrective action Note 1 to entry: Records can be used, for example, to formalize (3.6.13) and to provide evidence of (3.8.12), (3.12.1) and (3.12.2). 3N.o8te.1 21 to entry: Generally records need not be under revision control. project management plan document objective(s) project (3.8.5) specifying what is necessary to meet the (3.7.1)q oufa ltihtye plan (3.4.2) Note 1 to entry: A project management plan should include or refer to the project’s (3.8.9). risk management Note 2 to entry: The project management plan also includes or references such other plans as those relating to organizational structures, resources, schedule, budget, (3.7.9) (3.3.3), environmental management, health and safety management, and security management, as appropriate. [3S.O8.U1R2CE: ISO 10006:2003, 3.7] verification objective evidence requirements confirmation, through the provision of (3.8.3), that specified (3.6.4) have been fulfilled inspection determination documents Note 1 to entry: The objective evidence needed for a verification can be the result of an (3.11.7) or of other forms of (3.11.1) such as performing alternative calculations or reviewing process (3.8.5). Note 2 to entry: The activities carried out for verification are sometimes called a qualification (3.4.1). Note 3 to entry: The word “verified” is used to designate the corresponding status. Copyright International Organization for Standardization Provided by IHS Markit under license with ANSI Licensee=Becton Dickinson - Loc 1 - 61, 64/5984713001, User=Chiu, Shelly No reproduction or networking permitted without license from IHS Not for Resale, 10/14/2019 19:06:05 MDT © ISO 2015 – All rights reserved ---`,,`,`,,`,,`-`-`,```,,,,,`,`,`,,,,,`,,,,``-- ISO 9000:2015(E) 3.8.13 validation objective evidence requirements confirmation, through the provision of (3.8.3), that the (3.6.4) for a specific intended use or application have been fulfilled test determination documents Note 1 to entry: The objective evidence needed for a validation is the result of a (3.11.8) or other form of (3.11.1) such as performing alternative calculations or reviewing (3.8.5). Note 2 to entry: The word “validated” is used to designate the corresponding status. 3N.o8te.1 34 to entry: The use conditions for validation can be real or simulated. configuration status accounting product configuration information formalized recording and reporting of (3.6.8), the status of proposed changes and the status of the implementation of approved changes [3S.O8.U1R5CE: ISO 10007:2003, 3.7] specific case quality plan3.9.1 feedback product service process
3.10.1 characteristic distinguishing feature Note 1 to entry: A characteristic can be inherent or assigned. Note 2 to entry: A characteristic can be qualitative or quantitative. Note 3 to entry: There are various classes of characteristic, such as the following: a) physical (e.g. mechanical, electrical, chemical or biological characteristics); b) sensory (e.g. related to smell, touch, taste, sight, hearing); c) behavioural (e.g. courtesy, honesty, veracity); d) temporal (e.g. punctuality, reliability, availability, continuity); e) ergonomic (e.g. physiological characteristic, or related to human safety); f3). 1 f0u.n2ctional (e.g. maximum speed of an aircraft). quality characteristic characteristic object requirement inherent (3.10.1) of an (3.6.1) related to a (3.6.4) Note 1 to entry: Inherent means existing in something, especially as a permanent characteristic. Copyright International Organization for Standardization Provided by IHS Markit under license with ANSI Licensee=Becton Dickinson - Loc 1 - 61, 64/5984713001, User=Chiu, Shelly No reproduction or networking permitted without license from IHS Not for Resale, 10/14/2019 19:06:05 MDT © ISO 2015 – All rights reserved ISO 9000:2015(E) Note 2 to entry: A characteristic assigned to an object (e.g. the price of an object) is not a quality characteristic o3f. 1th0a.3t object. human factor characteristic object (3.10.1) of a person having an impact on an (3.6.1) under consideration Note 1 to entry: Characteristics can be physical, cognitive or sociaml.anagement system 3N.o1t0e .24 to entry: Human factors can have a significant impact on a (3.5.3). competence ability to apply knowledge and skills to achieve intended results Note 1 to entry: Demonstrated competence is sometimes referred to as qualification. Note 2 to entry: This constitutes one of the common terms and core definitions for ISO management system standards given in Annex SL of the Consolidated ISO Supplement to the ISO/IEC Directives, Part 1. The original d3e.1fi0n.i5tion has been modified by adding Note 1 to entry. metrological characteristic characteristic measurement (M3.e1a0s.u1r)i nwgh eiqcuhi pcmane nitnfluence the results of (3.11.4) Note 1 to entry: (3.11.6) usually has several metrological characteristics. 3N.o1t0e .26 to entry: Metrological characteristics can be the subject of calibration. configuration characteristics product service product configuration information interrelated functional and physical (3.10.1) of a (3.7.6) or (3.7.7) defined in (3.6.8) 3[S.1O0U.7RCE: ISO 10007:2003, 3.3, modified — The term “service” has been included in the definition] configuration baseline product configuration information characteristics product service approved (3.6.8) that establishes the (3.10.1) of a (3.7.6) or (3.7.7) at a point in time that serves as reference for activities throughout the life cycle of the product or service [SOURCE: ISO 10007:2003, 3.4, modified — The term “service” has been included in the definition]
3.11.1 determination characteristics a3c.1ti1v.i2ty to find out one or more (3.10.1) and their characteristic values review determination ffectiveness object objectives (3.11.1) of the suitability, adequacy or e (3.7.11) of an (3.6.1) to achieve design and development customer established (3.7.1) requirements corrective action EXAMPLE Management review, (3.4.8) review, review of (3.2.4) (3.6.4), review of (3.12.2) and peefefric rieenvcieyw. Note 1 to entry: Review can also include the determination of (3.7.10). Copyright International Organization for Standardization Provided by IHS Markit under license with ANSI Licensee=Becton Dickinson - Loc 1 - 61, 64/5984713001, User=Chiu, Shelly No reproduction or network©ing pIeSrmOit te2d0 w1ith5ou t– lic Aenlsle rfroimg hIHtSs reserved Not for Resale, 10/14/2019 19:06:05 MDT ISO 9000:2015(E) 3.11.3 monitoring determining system process product service (3.11.1) the status of a (3.5.1), a (3.4.1), a (3.7.6), a (3.7.7), or an activity Note 1 to entry: For the determination of the status there can be a need to choebcjekc, tsupervise or critically observe. Note 2 to entry: Monitoring is generally a determination of the status of an (3.6.1), carried out at different stages or at different times. Note 3 to entry: This constitutes one of the common terms and core definitions for ISO management system standards given in Annex SL of the Consolidated ISO Supplement to the ISO/IEC Directives, Part 1. The original d3e.1fi1n.i4tion and Note 1 to entry have been modified, and Note 2 to entry has been added. measurement process (3.4.1) to determine a value Note 1 to entry: According to ISO 3534-2, the value determined is generally the value of a quantity. Note 2 to entry: This constitutes one of the common terms and core definitions for ISO management system standards given in Annex SL of the Consolidated ISO Supplement to the ISO/IEC Directives, Part 1. The original d3e.1fi1n.i5tion has been modified by adding Note 1 to entry. measurement process s3e.1t 1o.f6 operations to determine the value of a quantity measuring equipment measurement process measuring instrument, software, measurement standard, reference material or auxiliary apparatus or 3co.1m1b.7ination thereof necessary to realize a (3.11.5) inspection determination conformity requirements (3.11.1) of (3.6.11) to specified (3.6.4) verification Note 1 to entry: If the result of an inspection shows conformity, it cnaonn bceo nufsoerdm fiotry purposes of (3.8.12). 3N.o1t1e .28 to entry: The result of an inspection can show conformity or (3.6.9) or a degree of conformity. test determination requirements (3.11.1) according to conformit y(3.6.4) for a specific intended use or avaplpidliactaiotnion N3.o1t1e .19 to entry: If the result of a test shows (3.6.11), it can be used for purposes of (3.8.13). progress evaluation project objectives
3.12.1
preventive action
nonconformity
action to eliminate the cause of a potential (3.6.9) or other potential undesirable situation
Note 1 to entry: There can be more than one cause for a potential nonconformcoirtrye.ctive action
Note 2 to entry: Preventive action is taken to prevent occurrence whereas (3.12.2) is taken to
p3r.1ev2e.n2t recurrence.
corrective action
nonconformity
action to eliminate the cause of a (3.6.9) and to prevent recurrence
Note 1 to entry: There can be more than one cause for a nonconformity. preventive action
Note 2 to entry: Corrective action is taken to prevent recurrence whereas (3.12.1) is taken to
prevent occurrence.
Note 3 to entry: This constitutes one of the common terms and core definitions for ISO management system
standards given in Annex SL of the Consolidated ISO Supplement to the ISO/IEC Directives, Part 1. The original
d3e.1fi2n.i3tion has been modified by adding Notes 1 and 2 to entry.
correction
nonconformity
action to eliminate a detected (3.6.9) corrective action
Note 1 to entry: A correction can be made in advanrecwe oorfk, in conjunctiroeng wraidthe or after a (3.12.2).
3N.o1t2e .24 to entry: A correction can be, for example, (3.12.8) or (3.12.4).
regrade
grade nonconforming product service
requirements
alteration of the (3.6.3) of a (3.6.9) (3.7.6) or (3.7.7) in order to
m3.1ak2e.5 it conform to (3.6.4) differing from the initial requirements
concession
release product service
requirements
permission to use or (3.12.7) a (3.7.6) or (3.7.7) that does not conform to specified
(3.6.4) nonconforming
characteristics
Note 1 to entry: A concession is generally limited to the delivery of products and services that have
(3.6.9) (3.10.1) within specified limits and is generally given for a limited quantity of products and
s3e.1rv2ic.6es or period of time, and for a specific use.
deviation permit
requirements product service
permission to depart from the originally specified (3.6.4) of a (3.7.6) or
(3.7.7) prior to its realization
Note 1 to entry: A deviation permit is generally given for a limited quantity of products and services or period of
t3i.m1e2, .7and for a specific use.
release
process
permission to proceed to the next stage of a (3.4d.1o)c uomr etnhtes next process
Note 1 to entry: In English, in the context of software and (3.8.5), the word “release” is frequently
used to refer to a version of the software or the document itself.
Copyright International Organization for Standardization
Provided by IHS Markit under license with ANSI Licensee=Becton Dickinson - Loc 1 - 61, 64/5984713001, User=Chiu, Shelly
No reproduction or network©ing pIeSrmOit te2d0 w1ith5ou t– lic Aenlsle rfroimg hIHtSs reserved Not for Resale, 10/14/2019 19:06:05 MDT
---,,,,,,,--,```,,,,,,,,,,,,`,,,,``--
ISO 9000:2015(E)
3.12.8
rework
nonconforming product service
requirements
action on a (3.6.9) (3.7.6) or (3.7.7) to make it conform to the
(3.6.4)
N3.o1t2e .19 to entry: Rework can affect or change parts of the nonconforming product or service.
repair
nonconforming product service
action on a (3.6.9) (3.7.6) or (3.7.7) to make it acceptable for the intended
use
requirements concession
Note 1 to entry: A successful repair of a nonconforming product or service does not necessarily make the
product or service conform to the (3.6.4). It can be that in conjunction with a repair a
(3.12.5) is required.
Note 2 to entry: Repair includes remedial action taken on a previously conforming product or service to restore it
for use, for example as part of maintenance.
N3.o1t2e .31 0to entry: Repair can affect or change parts of the nonconforming product or service.
scrap
nonconforming product service
action on a (3.6.9) (3.7.6) or (3.7.7) to preclude its originally intended use
EXAMPLE Recycling, destruction.
Note 1 to entry: In a nonconforming service situation, use is precluded by discontinuing the service.
3.13.1
audit
process objective evidence
audit criteria
systematic, independent and documented (3.4.1) for obtaining (3.8.3) and
evaluating it objectively to determine the extent to which the determina t(i3on.13.7) are fulfillecdonformity
object procedure
Note 1 to entry: The fundamental elements of an audit include the (3.11.1) of the
(3.6.11) of an (3.6.1) according to a (3.4.5) carried out by personnel not being responsible for
the object audited.
combined audit joint audit
Note 2 to entry: An audit can be an internal audit (first party), or an external audit (second party or third party),
and it can be a (3.13.2) or a (3.13.3).
organization management review
Note 3 to entry: Internal audits, sometimes called first-party audits, are conducted by, or on behalf of, the
(3.2.1) itself for (3.3.3) (3.11.2) and other internal purposes, and can form the
basis for an organization’s declaration of conformity. Independence can be demonstrated by the freedom from
responsibility for the activity being audited.
customers
Note 4 to entry: External audits include those generally called second and third-party audits. Second party audits
are conducted by parties having an interest in the organization, such as (3.2.4), or by other persons
on their behalf. Third-party audits are conducted by external, independent auditing organizations such as those
providing certification/registration of conformity or governmental agencies.
Note 5 to entry: This constitutes one of the common terms and core definitions for ISO management system
standards given in Annex SL of the Consolidated ISO Supplement to the ISO/IEC Directives, Part 1. The original
definition and Notes to entry have been modified to remove effect of circularity between audit criteria and audit
evidence term entries, and Notes 3 and 4 to entry have been added.
30 --,,,,`,,,,,`,`,`,,,,,```,`-`-`,,`,,`,`,,`--- Copyright International Organization for Standardization Provided by IHS Markit under license with ANSI Licensee=Becton Dickinson - Loc 1 - 61, 64/5984713001, User=Chiu, Shelly No reproduction or networking permitted without license from IHS Not for Resale, 10/14/2019 19:06:05 MDT © ISO 2015 – All rights reserved ISO 9000:2015(E) 3.13.2 combined audit audit auditee management systems (3.13.1) carried out together at a single (3.13.12) on two or more (3.5.3) Note 1 to entryo:r Tghaen ipzaartitosn of a management system that can be involved in a combined audit can be identified by the relevant management system standards, product standards, service standards or process standards being a3p.1p3lie.3d by the (3.2.1). joint audit audit auditee organizations 3.13. 4(3.13.1) carried out at a single (3.13.12) by two or more auditing (3.2.1) audit programme audits set of one or more (3.13.1) planned for a specific time frame and directed towards a specific purpose 3[S.1O3U.R5CE: ISO 19011:2011, 3.13, modified] audit scope audit extent and boundaries of an (3.13.1) processes Note 1 to entry: The audit scope generally includes a description of the physical locations, organizational units, activities and (3.4.1). [3S.1O3U.R6CE: ISO 19011:2011, 3.14, modified — Note to entry has been modified] audit plan audit description of the activities and arrangements for an (3.13.1) [3S.1O3U.R7CE: ISO 19011:2011, 3.15] audit criteria policies procedures requirements objective evidence set of (3.5.8), (3.4.5) or (3.6.4) used as a reference against which (3.8.3) is compared [SOURCE: ISO 19011:2011, 3.2, modified — The term “audit evidence” has been replaced by “3o.1b3je.8ctive evidence”] audit evidence audit criteria records, statements of fact or other information, which are relevant to the (3.13.7) and verifiable [3S.1O3U.R9CE: ISO 19011:2011, 3.3, modified — Note to entry has been deleted] audit findings audit evidence audit criteria results of the evaluation of the collecctoendfo rmity (3n.1on3c.8on) faogrmaiintyst (3.13.7) Note 1 to entry: Audit findings indicate (3.6.11) or (3.6im.9)p.rovement Note 2 to entry: Audit findings can lead to the identification of opportunities for (3.3.1) or recording good practices. audit criteria statutory requirements regulatory requirements Note 3 to entry: In English, if the (3.13.7) are selected from (3.6.6) or (3.6.7), the audit finding can be called compliance or non-compliance. [SOURCE: ISO 19011:2011, 3.4, modified — Note 3 to entry has been modified] --,,,,,,,,,,,,,,,,``,--,,,,,,,---
Copyright International Organization for Standardization
Provided by IHS Markit under license with ANSI Licensee=Becton Dickinson - Loc 1 - 61, 64/5984713001, User=Chiu, Shelly
No reproduction or network©ing pIeSrmOit te2d0 w1ith5ou t– lic Aenlsle rfroimg hIHtSs reserved Not for Resale, 10/14/2019 19:06:05 MDT
ISO 9000:2015(E)
3.13.10
audit conclusion
audit audit findings
outcome of an (3.13.1), after consideration of the audit objectives and all (3.13.9)
[3S.1O3U.R1C1E: ISO 19011:2011, 3.5]
audit client
organization audit
(3.2.1) or person requesting an (3.13.1)
[3S.1O3U.R1C2E: ISO 19011:2011, 3.6, modified — Note to entry has been deleted]
auditee
organization
(3.2.1) being audited
[3S.1O3U.R1C3E: ISO 19011:2011, 3.7]
guide
auditee audit team
Applying these regulatory guidelines in practice? Use our free validated calculators for risk management, sampling, and environmental monitoring.