Terms & Definitions

A

A3 thinking: A problem-solving approach based on the plan-do-check-act cycle, often written on an A3 size paper (11 x 17 inches)

A3 report: A ledger-sized sheet of paper that includes all relevant information about a problem, as well as diagrams, charts, and other visual aids to help clarify the data and improve communication

Acceptance sampling: A statistical method used to evaluate a sample of products or services to determine whether they meet the required specifications

Action plan: A plan that outlines the steps that need to be taken to achieve a specific goal or objective

Affinity diagram: A tool used to organize ideas and information into logical groups or categories

Agile methodology: A project management approach that emphasizes flexibility, collaboration, and adaptability

Analyze phase: The phase in the DMAIC process (define, measure, analyze, improve, control) where the data collected during the measure phase is analyzed to identify the root cause(s) of the problem

Andon: A visual management tool used in lean manufacturing to signal and respond to problems in real time

APQP: Advanced product quality planning, a methodology used to ensure that a product meets or exceeds customer requirements and expectations

ASQ: American Society for Quality, a professional organization that provides education, training, certification, and networking opportunities to quality professionals

Auditing: The process of evaluating a system, process, or organization to determine whether it complies with established standards or requirements

Autonomation: The process of automating a manufacturing process while still allowing operators to intervene and adjust the process as needed

Average: A measure of central tendency that represents the value that is most typical of a set of data

Average cycle time: The average amount of time it takes to complete a process or task

B

Balanced scorecard: A performance measurement tool that uses a combination of financial and non-financial metrics to evaluate an organization's performance

Benchmarking: The process of comparing an organization's processes, products, or services against those of other organizations considered to be best-in-class

Beta testing: The process of testing a product or service by a group of users before it is released to the general public

Black belt: A lean manufacturing term for an expert in Six Sigma methodology who is trained to lead and facilitate improvement projects

Brainstorming: A group activity that involves generating as many ideas as possible without judging or evaluating them

Breakdown maintenance: The process of repairing a machine or equipment only after it has failed or stopped working

Business process reengineering (BPR): The process of redesigning an organization's processes to improve efficiency, effectiveness, and competitiveness

Business Value-added Activities: These activities are required to stay in business but do not add value from the customer's perspective.

C

Capacity: The maximum amount of work that a process or system can handle within a specific period

Capability: The ability of a process or system to produce conforming products or services within specified limits

Cause and effect diagram: A tool used to identify and organize the causes of a problem or issue. This is also called the Fishbone diagram or Ishikawa Diagram.

Certification: The process of verifying that an individual or organization meets a specific set of standards or requirements

Change management: The process of planning, implementing and controlling changes to an organization's processes, products, or services.

Charter: A document that outlines the purpose, goals, and objectives of a project or initiative, as well as the roles, responsibilities, and expectations of the team members involved.

Control phase: The final step in the DMAIC process (define, measure, analyze, improve, control), where the solutions implemented in the improve phase are put into place on a long-term basis and monitored to ensure that the problem does not reoccur

Control chart: A graphical representation of process data over time that is used to identify patterns, trends, and special causes of variation

Control plan: A document that outlines the measures and methods that will be used to ensure that a product or process remains within specified limits

Corrective action: A specific course of action taken to correct a problem or deviation from established standards or requirements to avoid the recurrence of the problem.

Cost of quality (COQ): The total cost of all activities that are associated with ensuring that a product or service meets the required quality standards

Customer satisfaction: The degree to which a product or service meets or exceeds a customer's expectations

D

Data: The facts, figures, or information that are collected and analyzed to support decision making

Data collection: The process of gathering, organizing, and recording data for a specific purpose

Data mining: The process of extracting useful or meaningful information from a large dataset

Data visualization: The process of using graphical techniques, such as charts, graphs, and maps, to represent and communicate data in a clear and concise manner

Design for six sigma (DFSS): A methodology used to design and develop new products, processes, or services that meet or exceed customer requirements and expectations, focusing on reducing defects and variability.

Design of experiments (DOE): A statistical method used to test and evaluate multiple variables simultaneously to determine the effect of each variable on the outcome of a process or experiment

DMAIC: Define, measure, analyze, improve, control, a problem-solving approach used in Six Sigma methodology

Documentation: The process of creating, organizing, and maintaining records or documents that provide evidence of an organization's processes, products, or services

E

Effective: The degree to which a product or service meets or exceeds the intended purpose or objective

Efficiency: The relationship between the output of a process or system and the input of resources, such as time, money, or materials

Employee engagement: The degree to which employees are committed to the success of an organization and are motivated to contribute to its goals and objectives

Error proofing: The process of designing or implementing controls or systems to prevent errors or defects from occurring in a process or product. This is called Poka-yoke in Japanese.

F

Failure mode and effects analysis (FMEA): A systematic method used to identify and evaluate a product's or process's potential failure modes and the effects of those failures on the overall system. Related term: Risk Priority Number (RPN)

Flowchart: A diagram that represents the steps or tasks in a process, as well as the relationships between those steps or tasks

Focus group: A group of individuals who are selected and brought together to discuss a specific topic or issue

Force field analysis: A tool used to identify the forces that are driving or resisting change in a system or process

G

Gantt chart: A graphical representation of the planned and actual progress of a project, typically showing the tasks, resources, and dependencies involved in the project.

Gemba: A Japanese term that means "the real place" or "the place where the work is done," often used in lean manufacturing to refer to the factory floor or the place where value is created

Genchi genbutsu: Literally translated as "go see for yourself." In quality management, this refers to visiting a company's production facilities to observe how it actually makes things happen

Goal: A specific, measurable, achievable, relevant, and time-bound (SMART) objective or target that an organization or individual strives to achieve

Governance: The policies, processes, and practices that are used to manage and control an organization or system

Green belt: A lean manufacturing term for a Six Sigma practitioner who has been trained in the basics of the methodology and is capable of leading and facilitating small improvement projects

H

Hoshin planning: A strategic planning and deployment method that aligns an organization's goals and objectives with its business plans and operational activities

House of quality: A tool used in new product development to identify the relationships between customer requirements, product characteristics, and technical requirements

Hypothesis: A testable statement or prediction that is made based on limited evidence or data and that can be confirmed or rejected through further testing or observation

I

Implementation: The process of putting a plan, solution, or strategy into action

Improvement: The process of making changes to a product, process, or system to increase its effectiveness, efficiency, or quality

Inspection: The process of evaluating a product or service to determine whether it meets the specified standards or requirements

J

Just in Time (JIT): An approach to production scheduling that emphasizes delivering products at just the right time to meet demand

Jidoka: Automation with a human touch. See also Autonomation.

K

Kaikaku: radical change or innovation.

Kaizen: A Japanese term that means "continuous improvement," often used in lean manufacturing to refer to the process of making small, incremental improvements to processes, products, or services on an ongoing basis.

Kanban: A Japanese term that refers to a visual signal or symbol used to indicate what needs to be worked on next. Kanban boards are used to track the flow of materials throughout a manufacturing facility.

Key performance indicator (KPI): A metric that is used to measure the performance of an organization, process, or individual against specific goals or objectives

L

Lean manufacturing: A methodology that focuses on reducing waste and increasing value by eliminating or minimizing activities that do not add value to the end product or service

Learning organization: An organization that fosters continuous learning and development and can adapt and change in response to new information or challenges.

Level loading: The process of balancing the workload of a process or system over time to ensure that it operates at a consistent and optimal level

Limit: A maximum or minimum value that is used to define the acceptable range of a process or product characteristic

Lower specification limit (LSL): the minimum value or threshold that a product or process characteristic can have without being considered defective or out of specification.

M

Maintenance: The process of preserving, repairing, or replacing equipment, machinery, or facilities to ensure that they continue to operate at their intended level of performance

Management review: A systematic evaluation of an organization's processes, products, or services to determine whether they are meeting the intended goals and objectives and to identify opportunities for improvement

Matrix organization: An organizational structure that combines functional and project-based structures and that allows for cross-functional collaboration and coordination

Metric: A measure or indicator that is used to evaluate the performance of a process, product, or system against specific goals or standards

Mission: A statement that defines the purpose or reason for the existence of an organization and that guides its decision-making and actions

Mistake-proofing: See error proofing

Muda: In Japanese, Muda means "waste" or "loss." Muda occurs when resources are wasted because they were not put to use efficiently.

Mura: Mura is the waste of unevenness or inconsistency.

Muri: Muri means overburdening, beyond one's power, excessive, or unreasonable.

N

Nemawashi: A Japanese word for informal consultation or consensus-building.

Non-value-added Activities: Activities that do not contribute directly to the creation of value for customers, such as administrative tasks, training, and meetings

O

Objective: A specific, measurable, achievable, relevant, and time-bound (SMART) goal or target that an organization or individual strives to achieve

OEE (overall equipment effectiveness): A metric that is used to measure the efficiency and effectiveness of a manufacturing process, typically by calculating the percentage of planned production time that is productive

Operational definition: A clear and specific description of a term, concept, or measurement that is used in a study or experiment

Opportunity cost: The value of the next best alternative that is foregone as a result of choosing a particular course of action

Organizational culture: The shared values, beliefs, attitudes, and behaviours that define an organization and shape its interactions with its employees, customers, and other stakeholders

Outcome: The result or impact of a particular course of action or decision

Outlier: A data point that is significantly different from the other points in a dataset

P

Pareto analysis: A tool used to prioritize a set of issues or problems by identifying the most significant ones that contribute to the majority of the overall impact or effect

Performance measurement: The process of collecting, analyzing, and reporting data on the performance of an organization, process, or individual against specific goals or standards

Poka-yoke: A method of preventing errors through the use of simple checks and procedures that have been designed to eliminate human error

Preventive Action: An action taken before a problem occurs to prevent the problem from happening

Process: A series of steps or activities that are carried out to achieve a specific result or outcome

Process capability: The ability of a process to produce conforming products or services within specified limits.

Process flowchart: A diagram that represents the steps or tasks in a process, as well as the relationships between those steps or tasks

Process mapping: The process of documenting, analyzing, and improving the flow of information, materials, or people within a process or system

Process improvement: The process of making changes to a process or system to increase its effectiveness, efficiency, or quality

Process performance: The degree to which a process meets or exceeds the intended goals or objectives

Productivity: The relationship between the output of a process or system and the input of resources, such as time, money, or materials

Project charter: A document that outlines the scope, objectives, and stakeholders of a project, as well as the roles and responsibilities of the project team

Project management: The process of planning, organizing, and controlling the resources and activities of a project to achieve its specific goals and objectives

Q

Quality: The degree to which a product or service meets or exceeds the intended purpose or objective

Quality assurance (QA): The process of ensuring that a product or service meets the specified standards or requirements

Quality control (QC): The process of inspecting, testing, or evaluating a product or service to ensure that it meets the specified standards or requirements

Quality management: The process of planning, organizing, and controlling the activities and resources of an organization to ensure that its products or services meet or exceed the required quality standards.

Quality policy: A written statement describing how a company intends to implement and manage quality

Quality plan: A detailed description of how a company plans to improve its processes and procedures to ensure that they consistently produce high-quality products or services

Quality system: The policies, processes, and procedures used to manage and control the quality of an organization's products or services. This is also called Quality Management System (QMS)

R

RACI matrix: A tool used to clarify and communicate the roles and responsibilities of individuals or teams within a project or process

Reducing setup time: The process of reducing the time required to change over or set up a machine, process, or system from one product or operation to another. Also, see Single Minute Exchange of Die (SMED)

Reliability: The ability of a product or system to function consistently and dependably over time

Requirements: The specific needs, specifications, or constraints that must be satisfied by a product, process, or system

Risk Priority Number (RPN): An estimate of the relative risk associated with each potential problem or failure. It is calculated by multiplying severity, likelihood and detection numbers.

Robust: The ability of a product or system to perform consistently and effectively under varying conditions or circumstances

Root cause analysis: The process of identifying the underlying or fundamental cause of a problem or issue, as opposed to the symptoms or surface-level causes

S

Single Minute Exchange of Die (SMED): The process of exchanging dies in less than 10 minutes (single digit) to reduce downtime and improve productivity

SIPOC diagram: A tool used to map and document the suppliers, inputs, process, outputs, and customers of a process or system

Six Sigma: A methodology that uses data and statistical analysis to identify and eliminate defects or variations in a process or product. A Six Sigma process produces less than 3.4 defects per million opportunities (DPMO).

Standard: A specific requirement, guideline, or criterion that is used to evaluate the performance of a product, process, or system

Statistical process control (SPC): The use of statistical tools and techniques to monitor and control the performance of a process or system to improve its quality and consistency.

Strategic planning: The process of defining an organization's goals, objectives, and strategies and of allocating the resources and activities needed to achieve those goals

Sustainability: The ability of a system or process to meet the needs of the present without compromising the ability of future generations to meet their own needs

Systems engineering: A discipline that focuses on the design and management of complex systems, processes, or products

T

Takt time: The rate of customer demand.

Target: A specific objective or goal that an organization, process or individual strives to achieve

Theory of constraints (TOC): A management philosophy that focuses on identifying and removing the constraints or bottlenecks that limit the performance of a process or system

Total productive maintenance (TPM): A maintenance strategy that involves all employees in the maintenance and improvement of equipment, machinery, or facilities

Total quality management (TQM): A management philosophy that focuses on achieving continuous improvement in the quality of products, services, or processes through the involvement and participation of all employees

U

Upper specification limit (USL): the maximum value or threshold that a product or process characteristic can have without being considered defective or out of specification.

V

Value: The benefit or utility that is derived from a product, service, or process

Value-added activities: Activities that add value to a product or service

Value stream mapping: A tool used to visualize and analyze the flow of materials, information, and activities in a process or system, from the beginning to the end, to identify opportunities for improvement.

Variation: The difference or deviation from the expected or average value of a process or product characteristic

W

Waste: Any activity, process, or resource that does not add value to the end product or service or that creates excess or unnecessary costs

Work breakdown structure (WBS): A tool used to decompose a project or process into smaller, more manageable units or tasks

World Class Manufacturing (WCM): A set of principles and practices that are used to improve the performance, efficiency, and quality of manufacturing processes and systems.

X

X-bar chart: a statistical control chart used to monitor the process mean or average over time.

Y

Yield: the percentage or proportion of units or items that meet the required quality standards and specifications.

Z

Zero defects: the goal of achieving perfect quality, with no defects or errors in products or processes.

*****************************************************************************************

Terms & Definitions (ISO 9000:2015)

*****************************************************************************************
3.1   Terms related to person or people
********************************************************************
3.1.1
top management
person or group of people who directs and controls an organization (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.
Note 2 to entry: If the scope of the management system (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 standards given in Annex SL of the Consolidated ISO Supplement to the ISO/IEC Directives, Part 1.
*****************************************************************************************
3.1.2
quality management system consultant
Note 1 to entry: The quality management system consultant can also assist in realizing parts of a quality management system (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.
[SOURCE:ISO 10019:2005, 3.2, modified]
*****************************************************************************************
3.1.3
involvement
taking part in an activity, event or situation
*****************************************************************************************
3.1.4
engagement
involvement (3.1.3) in, and contribution to, activities to achieve shared objectives (3.7.1)
*****************************************************************************************
3.1.5
configuration authority
configuration control board
dispositioning authority
person or a group of persons with assigned responsibility and authority to make decisions on the configuration (3.10.6)
Note 1 to entry: Relevant interested parties (3.2.3) within and outside the organization (3.2.1) should be represented on the configuration authority.
[SOURCE:ISO 10007:2003, 3.8, modified]
*****************************************************************************************
3.1.6
dispute resolver
<customer satisfaction> individual person assigned by a DRP-provider (3.2.7) to assist the parties in resolving a dispute (3.9.6)
EXAMPLE:
Staff, volunteer, contract (3.4.7) personnel.
[SOURCE:ISO 10003:2007, 3.7, modified]
*****************************************************************************************
3.2   Terms related to organization
*****************************************************************************************
3.2.1
organization
person or group of people that has its own functions with responsibilities, authorities and relationships to achieve its objectives (3.7.1)
Note 1 to entry: The concept of organization includes, but is not limited to, sole-trader, company, corporation, firm, enterprise, authority, partnership, association (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 modified by modifying Note 1 to entry.
*****************************************************************************************
3.2.2
context of the organization
combination of internal and external issues that can have an effect on an organization’s (3.2.1) approach to developing and achieving its objectives (3.7.1)
Note 1 to entry: The organization’s objectives can be related to its products (3.7.6) and services (3.7.7), investments and behaviour towards its interested parties (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 “ecosystem of an organization”.
Note 4 to entry: Understanding the infrastructure (3.5.2) can help to define the context of the organization.
*****************************************************************************************
3.2.3
interested party
stakeholder
person or organization (3.2.1) that can affect, be affected by, or perceive itself to be affected by a decision or activity
EXAMPLE:
Customers (3.2.4), owners, people in an organization, providers (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 definition has been modified by adding the Example.
*****************************************************************************************
3.2.4
customer
person or organization (3.2.1) that could or does receive a product (3.7.6) or a service (3.7.7) that is intended for or required by this person or organization
EXAMPLE:
Consumer, client, end-user, retailer, receiver of product or service from an internal process (3.4.1), beneficiary and purchaser.
Note 1 to entry: A customer can be internal or external to the organization.
*****************************************************************************************
3.2.5
provider
supplier
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.
Note 2 to entry: In a contractual situation, a provider is sometimes called “contractor”.
*****************************************************************************************
3.2.6
external provider
external supplier
provider (3.2.5) that is not part of the organization (3.2.1)
EXAMPLE:
Producer, distributor, retailer or vendor of a product (3.7.6) or a service (3.7.7)
*****************************************************************************************
3.2.7
DRP-provider
dispute resolution process provider
person or organization (3.2.1) that supplies and operates an external dispute (3.9.6) resolution process (3.4.1)
Note 1 to entry: Generally, a DRP-provider is a legal entity, separate from the organization or 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 established within the organization to handle unresolved complaints (3.9.3).
Note 2 to entry: The DRP-provider contracts (3.4.7) with the parties to provide dispute resolution, and is accountable for performance (3.7.8). The DRP-provider supplies dispute resolvers (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.
Note 3 to entry: DRP-providers can take many forms including not-for-profit, for-profit and public entities. An association (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.
[SOURCE:ISO 10003:2007, 3.9, modified]
*****************************************************************************************
3.2.8
association
<customer satisfaction> organization (3.2.1) consisting of member organizations or persons
[SOURCE:ISO 10003:2007, 3.1]
*****************************************************************************************
3.2.9
metrological function
functional unit with administrative and technical responsibility for defining and implementing the measurement management system (3.5.7)
[SOURCE:ISO 10012:2003, 3.6, modified]
*****************************************************************************************
3.3   Terms related to activity
*****************************************************************************************
3.3.1
improvement
activity to enhance performance (3.7.8)
Note 1 to entry: The activity can be recurring or singular.
*****************************************************************************************
3.3.2
continual improvement
recurring activity to enhance performance (3.7.8)
Note 1 to entry: The process (3.4.1) of establishing objectives (3.7.1) and finding opportunities for improvement (3.3.1) is a continual process through the use of audit findings (3.13.9) and audit conclusions (3.13.10), analysis of data (3.8.1)management (3.3.3)reviews (3.11.2) or other means and generally leads to corrective action (3.12.2) or preventive action (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 definition has been modified by adding Note 1 to entry.
*****************************************************************************************
3.3.3
management
coordinated activities to direct and control an organization (3.2.1)
Note 1 to entry: Management can include establishing policies (3.5.8) and objectives (3.7.1), and processes (3.4.1) to achieve these objectives.
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 “management” is used in this 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 “top management (3.1.1) shall…” is acceptable. Otherwise different words should be adopted to convey the concept when related to people, e.g. managerial or managers.
*****************************************************************************************
3.3.4
quality management
Note 1 to entry: Quality management can include establishing quality policies (3.5.9) and quality objectives (3.7.2), and processes (3.4.1) to achieve these quality objectives through quality planning (3.3.5)quality assurance (3.3.6)quality control (3.3.7), and quality improvement (3.3.8).
*****************************************************************************************
3.3.5
quality planning
part of quality management (3.3.4) focused on setting quality objectives (3.7.2) and specifying necessary operational processes (3.4.1), and related resources to achieve the quality objectives
Note 1 to entry: Establishing quality plans (3.8.9) can be part of quality planning.
*****************************************************************************************
3.3.6
quality assurance
part of quality management (3.3.4) focused on providing confidence that quality requirements (3.6.5) will be fulfilled
*****************************************************************************************
3.3.7
quality control
*****************************************************************************************
3.3.8
quality improvement
part of quality management (3.3.4) focused on increasing the ability to fulfil quality requirements (3.6.5)
Note 1 to entry: The quality requirements can be related to any aspect such as effectiveness (3.7.11)efficiency (3.7.10) or traceability (3.6.13).
*****************************************************************************************
3.3.9
configuration management
coordinated activities to direct and control configuration (3.10.6)
Note 1 to entry: Configuration management generally concentrates on technical and organizational activities that establish and maintain control of a product (3.7.6) or service (3.7.7) and its product configuration information (3.6.8) throughout the life cycle of the product.
[SOURCE:ISO 10007:2003, 3.6, modified — Note 1 to entry has been modified]
*****************************************************************************************
3.3.10
change control
<configuration management> activities for control of the output (3.7.5) after formal approval of its product configuration information (3.6.8)
[SOURCE:ISO 10007:2003, 3.1, modified]
*****************************************************************************************
3.3.11
activity
<project management> smallest identified object of work in a project (3.4.2)
[SOURCE:ISO 10006:2003, 3.1, modified]
*****************************************************************************************
3.3.12
project management
planning, organizing, monitoring (3.11.3), controlling and reporting of all aspects of a project (3.4.2), and the motivation of all those involved in it to achieve the project objectives
[SOURCE:ISO 10006:2003, 3.6]
*****************************************************************************************
3.3.13
configuration object
object (3.6.1) within a configuration (3.10.6) that satisfies an end-use function
[SOURCE:ISO 10007:2003, 3.5, modified]
*****************************************************************************************
3.4   Terms related to process
*****************************************************************************************
3.4.1
process
set of interrelated or interacting activities that use inputs to deliver an intended result
Note 1 to entry: Whether the “intended result” of a process is called output (3.7.5)product (3.7.6) or service (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 interrelated and interacting processes in series can also be referred to as a process.
Note 4 to entry: Processes in an organization (3.2.1) are generally planned and carried out under controlled conditions to add value.
Note 5 to entry: A process where the conformity (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 have been added.
*****************************************************************************************
3.4.2
project
unique process (3.4.1), consisting of a set of coordinated and controlled activities with start and finish dates, undertaken to achieve an objective (3.7.1) conforming to specific requirements (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.
Note 2 to entry: In some projects the objectives and scope are updated and the product (3.7.6) or service (3.7.7)characteristics (3.10.1) defined progressively as the project proceeds.
Note 3 to entry: The output (3.7.5) of a project can be one or several units of product or service.
Note 4 to entry: The project’s organization (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]
*****************************************************************************************
3.4.3
quality management system realization
process (3.4.1) of establishing, documenting, implementing, maintaining and continually improving a quality management system (3.5.4)
[SOURCE:ISO 10019:2005, 3.1, modified — Notes have been deleted]
*****************************************************************************************
3.4.4
competence acquisition
[SOURCE:ISO 10018:2012, 3.2, modified]
*****************************************************************************************
3.4.5
procedure
specified way to carry out an activity or a process (3.4.1)
Note 1 to entry: Procedures can be documented or not.
*****************************************************************************************
3.4.6
outsource (verb)
make an arrangement where an external organization (3.2.1) performs part of an organization’s function or process (3.4.1)
Note 1 to entry: An external organization is outside the scope of the management system (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 standards given in Annex SL of the Consolidated ISO Supplement to the ISO/IEC Directives, Part 1.
*****************************************************************************************
3.4.7
contract
binding agreement
*****************************************************************************************
3.4.8
design and development
set of processes (3.4.1) that transform requirements (3.6.4) for an object (3.6.1) into more detailed requirements for that object
Note 1 to entry: The requirements forming input to design and development are often the result of research and can be expressed in a broader, more general sense than the requirements forming the output (3.7.5) of design and development. The requirements are generally defined in terms of characteristics (3.10.1). In a project (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.
Note 3 to entry: A qualifier can be applied to indicate the nature of what is being designed and developed (e.g. product (3.7.6) design and development, service (3.7.7) design and development or process design and development).
*****************************************************************************************
3.5   Terms related to system
*****************************************************************************************
3.5.1
system
set of interrelated or interacting elements
*****************************************************************************************
3.5.2
infrastructure
<organization> system (3.5.1) of facilities, equipment and services (3.7.7) needed for the operation of an organization (3.2.1)
*****************************************************************************************
3.5.3
management system
set of interrelated or interacting elements of an organization (3.2.1) to establish policies (3.5.8) and objectives (3.7.1), and processes (3.4.1) to achieve those objectives
Note 1 to entry: A management system can address a single discipline or several disciplines, e.g. quality management (3.3.4), financial management or environmental management.
Note 2 to entry: The management system elements establish the organization’s structure, roles and responsibilities, planning, operation, policies, practices, rules, beliefs, objectives and processes to achieve those objectives.
Note 3 to entry: The scope of a management system can include the whole of the organization, specific and identified functions of the organization, specific and identified sections of the organization, or one or more functions across a group of organizations.
Note 4 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 Notes 1 to 3 to entry.
*****************************************************************************************
3.5.4
quality management system
part of a management system (3.5.3) with regard to quality (3.6.2)
*****************************************************************************************
3.5.5
work environment
set of conditions under which work is performed
Note 1 to entry: Conditions can include physical, social, psychological and environmental factors (such as temperature, lighting, recognition schemes, occupational stress, ergonomics and atmospheric composition).
*****************************************************************************************
3.5.6
metrological confirmation
set of operations required to ensure that measuring equipment (3.11.6) conforms to the requirements (3.6.4) for its intended use
Note 1 to entry: Metrological confirmation generally includes calibration or verification (3.8.12), any necessary adjustment or repair (3.12.9), and subsequent recalibration, comparison with the metrological requirements for the intended use of the equipment, as well as any required sealing and labelling.
Note 2 to entry: Metrological confirmation is not achieved until and unless the fitness of the measuring equipment for the intended use has been demonstrated and documented.
Note 3 to entry: The requirements for intended use include such considerations as range, resolution and maximum permissible errors.
Note 4 to entry: Metrological requirements are usually distinct from, and are not specified in, product (3.7.6) requirements.
[SOURCE:ISO 10012:2003, 3.5, modified — Note 1 to entry has been modified]
*****************************************************************************************
3.5.7
measurement management system
set of interrelated or interacting elements necessary to achieve metrological confirmation (3.5.6) and control of measurement processes (3.11.5)
[SOURCE:ISO 10012:2003, 3.1, modified]
*****************************************************************************************
3.5.8
policy
<organization> intentions and direction of an organization (3.2.1) as formally expressed by its top management (3.1.1)
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.
*****************************************************************************************
3.5.9
quality policy
Note 1 to entry: Generally the quality policy is consistent with the overall policy of the organization (3.2.1), can be aligned with the organization’s vision (3.5.10) and mission (3.5.11) and provides a framework for the setting of quality objectives (3.7.2).
Note 2 to entry: Quality management principles presented in this International Standard can form a basis for the establishment of a quality policy.
*****************************************************************************************
3.5.10
vision
<organization> aspiration of what an organization (3.2.1) would like to become as expressed by top management (3.1.1)
*****************************************************************************************
3.5.11
mission
<organization> organization’s (3.2.1) purpose for existing as expressed by top management (3.1.1)
3.5.12
strategy
plan to achieve a long-term or overall objective (3.7.1)
*****************************************************************************************
3.6   Terms related to requirement
*****************************************************************************************
3.6.1
object
entity
item
anything perceivable or conceivable
EXAMPLE:
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).
[SOURCE:ISO 1087‑1:2000, 3.1.1, modified]
*****************************************************************************************
3.6.2
quality
degree to which a set of inherent characteristics (3.10.1) of an object (3.6.1) fulfils requirements (3.6.4)
Note 1 to entry: The term “quality” can be used with adjectives such as poor, good or excellent.
Note 2 to entry: “Inherent”, as opposed to “assigned”, means existing in the object (3.6.1).
*****************************************************************************************
3.6.3
grade
category or rank given to different requirements (3.6.4) for an object (3.6.1) having the same functional use
EXAMPLE:
Class of airline ticket and category of hotel in a hotel brochure.
Note 1 to entry: When establishing a quality requirement (3.6.5), the grade is generally specified.
*****************************************************************************************
3.6.4
requirement
need or expectation that is stated, generally implied or obligatory
Note 1 to entry: “Generally implied” means that it is custom or common practice for the organization (3.2.1) and interested parties (3.2.3) that the need or expectation under consideration is implied.
Note 2 to entry: A specified requirement is one that is stated, for example in documented information (3.8.6).
Note 3 to entry: A qualifier can be used to denote a specific type of requirement, e.g. product (3.7.6) requirement, quality management (3.3.4) requirement, customer (3.2.4) requirement, quality requirement (3.6.5).
Note 4 to entry: Requirements can be generated by different interested parties or by the organization itself.
Note 5 to entry: It can be necessary for achieving high customer satisfaction (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 definition has been modified by adding Notes 3 to 5 to entry.
*****************************************************************************************
3.6.5
quality requirement
*****************************************************************************************
3.6.6
statutory requirement
obligatory requirement (3.6.4) specified by a legislative body
*****************************************************************************************
3.6.7
regulatory requirement
obligatory requirement (3.6.4) specified by an authority mandated by a legislative body
*****************************************************************************************
3.6.8
product configuration information
requirement (3.6.4) or other information for product (3.7.6) design, realization, verification (3.8.12), operation and support
[SOURCE:ISO 10007:2003, 3.9, modified]
*****************************************************************************************
3.6.9
nonconformity
non-fulfilment of a requirement (3.6.4)
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.
*****************************************************************************************
3.6.10
defect
nonconformity (3.6.9) related to an intended or specified use
Note 1 to entry: The distinction between the concepts defect and nonconformity is important as it has legal connotations, particularly those associated with product (3.7.6) and service (3.7.7) liability issues.
Note 2 to entry: The intended use as intended by the customer (3.2.4) can be affected by the nature of the information (3.8.2), such as operating or maintenance instructions, provided by the provider (3.2.5).
*****************************************************************************************
3.6.11
conformity
fulfilment of a requirement (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.
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 modified by adding Note 1 to entry.
*****************************************************************************************
3.6.12
capability
ability of an object (3.6.1) to realize an output (3.7.5) that will fulfil the requirements (3.6.4) for that output
Note 1 to entry: Process (3.4.1) capability terms in the field of statistics are defined in ISO 3534-2.
*****************************************************************************************
3.6.13
traceability
ability to trace the history, application or location of an object (3.6.1)
Note 1 to entry: When considering a product (3.7.6) or a service (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.
Note 2 to entry: In the field of metrology, the definition in ISO/IEC Guide 99 is the accepted definition.
*****************************************************************************************
3.6.14
dependability
ability to perform as and when required
[SOURCE:IEC 60050‑192, modified — Notes have been deleted]
*****************************************************************************************
3.6.15
innovation
new or changed object (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   Terms related to result
*****************************************************************************************
3.7.1
objective
result to be achieved
Note 1 to entry: An objective can be strategic, tactical, or operational.
Note 2 to entry: Objectives can relate to different disciplines (such as financial, health and safety, and environmental objectives) and can apply at different levels (such as strategic, organization (3.2.1)-wide, project (3.4.2)product (3.7.6) and process (3.4.1)).
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 quality objective (3.7.2) or by the use of other words with similar meaning (e.g. aim, goal, or target).
Note 4 to entry: In the context of quality management systems (3.5.4)quality objectives (3.7.2) are set by the organization (3.2.1), consistent with the quality policy (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.
*****************************************************************************************
3.7.2
quality objective
Note 1 to entry: Quality objectives are generally based on the organization's (3.2.1)quality policy (3.5.9).
Note 2 to entry: Quality objectives are generally specified for relevant functions, levels and processes (3.4.1) in the organization (3.2.1).
*****************************************************************************************
3.7.3
success
<organization> achievement of an objective (3.7.1)
Note 1 to entry: The success of an organization (3.2.1) emphasizes the need for a balance between its economic or financial interests and the needs of its interested parties (3.2.3), such as customers (3.2.4), users, investors/shareholders (owners), people in the organization, providers (3.2.5), partners, interest groups and communities.
*****************************************************************************************
3.7.4
sustained success
<organization> success (3.7.3) over a period of time
Note 1 to entry: Sustained success emphasizes the need for a balance between economic-financial interests of an organization (3.2.1) and those of the social and ecological environment.
Note 2 to entry: Sustained success relates to the interested parties (3.2.3) of an organization, such as customers (3.2.4), owners, people in an organization, providers (3.2.5), bankers, unions, partners or society.
*****************************************************************************************
3.7.5
output
result of a process (3.4.1)
Note 1 to entry: Whether an output of the organization (3.2.1) is a product (3.7.6) or a service (3.7.7) depends on the preponderance of the characteristics (3.10.1) involved, e.g. a painting for sale in a gallery is a product whereas supply of a commissioned painting is a service, a hamburger bought in a retail store is a product whereas receiving an order and serving a hamburger ordered in a restaurant is part of a service.
*****************************************************************************************
3.7.6
product
output (3.7.5) of an organization (3.2.1) that can be produced without any transaction taking place between the organization and the customer (3.2.4)
Note 1 to entry: Production of a product is achieved without any transaction necessarily taking place between provider (3.2.5) and customer, but can often involve this service (3.7.7) element upon its delivery to the customer.
Note 2 to entry: The dominant element of a product is that it is generally tangible.
Note 3 to entry: Hardware is tangible and its amount is a countable characteristic (3.10.1) (e.g. tyres). Processed materials are tangible and their amount is a continuous characteristic (e.g. fuel and soft drinks). Hardware and processed materials are often referred to as goods. Software consists of information (3.8.2) regardless of delivery medium (e.g. computer programme, mobile phone app, instruction manual, dictionary content, musical composition copyright, driver's license).
*****************************************************************************************
3.7.7
service
output (3.7.5) of an organization (3.2.1) with at least one activity necessarily performed between the organization and the customer (3.2.4)
Note 1 to entry: The dominant elements of a service are generally intangible.
Note 2 to entry: Service often involves activities at the interface with the customer to establish customer requirements (3.6.4) as well as upon delivery of the service and can involve a continuing relationship such as banks, accountancies or public organizations, e.g. schools or hospitals.
Note 3 to entry: Provision of a service can involve, for example, the following: —   an activity performed on a customer-supplied tangible product (3.7.6) (e.g. a car to be repaired); —   an activity performed on a customer-supplied intangible product (e.g. the income statement needed to prepare a tax return); —   the delivery of an intangible product (e.g. the delivery of information (3.8.2) in the context of knowledge transmission); —   the creation of ambience for the customer (e.g. in hotels and restaurants);
Note 4 to entry: A service is generally experienced by the customer.
*****************************************************************************************
3.7.8
performance
measurable result
Note 1 to entry: Performance can relate either to quantitative or qualitative findings.
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 definition has been modified by modifying Note 2 to entry.
*****************************************************************************************
3.7.9
risk
effect of uncertainty
Note 1 to entry: An effect is a deviation from the expected — positive or negative.
Note 2 to entry: Uncertainty is the state, even partial, of deficiency of information (3.8.2) related to, understanding or knowledge of, an event, its consequence, or likelihood.
Note 3 to entry: Risk is often characterized by reference to potential events (as defined in ISO Guide 73:2009, 3.5.1.3) and consequences (as defined in ISO Guide 73:2009, 3.6.1.3), or a combination of these.
Note 4 to entry: Risk is often expressed in terms of a combination of the consequences of an event (including changes in circumstances) and the associated likelihood (as defined in ISO Guide 73:2009, 3.6.1.1) of occurrence.
Note 5 to entry: The word “risk” is sometimes used when there is the possibility of only negative consequences.
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 by adding Note 5 to entry.
*****************************************************************************************
3.7.10
efficiency
relationship between the result achieved and the resources used
*****************************************************************************************
3.7.11
effectiveness
extent to which planned activities are realized and planned results are achieved
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 definition has been modified by adding “are” before “achieved”.
*****************************************************************************************
3.8   Terms related to data, information and document
*****************************************************************************************
3.8.1
data
facts about an object (3.6.1)
*****************************************************************************************
3.8.2
information
meaningful data (3.8.1)
*****************************************************************************************
3.8.3
objective evidence
data (3.8.1) supporting the existence or verity of something
Note 1 to entry: Objective evidence can be obtained through observation, measurement (3.11.4)test (3.11.8), or by other means.
Note 2 to entry: Objective evidence for the purpose of audit (3.13.1) generally consists of records (3.8.10), statements of fact or other information (3.8.2) which are relevant to the audit criteria (3.13.7) and verifiable.
*****************************************************************************************
3.8.4
information system
<quality management system> network of communication channels used within an organization (3.2.1)
*****************************************************************************************
3.8.5
document
information (3.8.2) and the medium on which it is contained
EXAMPLE:
Record (3.8.10)specification (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 of documents, for example specifications and records, is frequently called “documentation”.
Note 3 to entry: Some requirements (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) and for records (e.g. the requirement to be retrievable).
*****************************************************************************************
3.8.6
documented information
information (3.8.2) required to be controlled and maintained by an organization (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 to entry: Documented information can refer to: —   the management system (3.5.3), including related processes (3.4.1); —   information created in order for the organization to operate (documentation); —   evidence of results achieved (records (3.8.10)).
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.
*****************************************************************************************
3.8.7
specification
EXAMPLE:
Quality manual (3.8.8)quality plan (3.8.9), technical drawing, procedure document, work instruction.
Note 1 to entry: A specification can be related to activities (e.g. procedure document, process (3.4.1) specification and test (3.11.8) specification), or products (3.7.6) (e.g. product specification, performance (3.7.8) specification and drawing).
Note 2 to entry: It can be that, by stating requirements, a specification additionally is stating results achieved by design and development (3.4.8) and thus in some cases can be used as a record (3.8.10).
*****************************************************************************************
3.8.8
quality manual
Note 1 to entry: Quality manuals can vary in detail and format to suit the size and complexity of an individual organization (3.2.1).
*****************************************************************************************
3.8.9
quality plan
specification (3.8.7) of the procedures (3.4.5) and associated resources to be applied when and by whom to a specific object (3.6.1)
Note 1 to entry: These procedures generally include those referring to quality management (3.3.4)processes (3.4.1) and to product (3.7.6) and service (3.7.7) realization processes.
Note 2 to entry: A quality plan often makes reference to parts of the quality manual (3.8.8) or to procedure documents (3.8.5).
Note 3 to entry: A quality plan is generally one of the results of quality planning (3.3.5).
*****************************************************************************************
3.8.10
record
document (3.8.5) stating results achieved or providing evidence of activities performed
Note 1 to entry: Records can be used, for example, to formalize traceability (3.6.13) and to provide evidence of verification (3.8.12)preventive action (3.12.1) and corrective action (3.12.2).
Note 2 to entry: Generally records need not be under revision control.
*****************************************************************************************
3.8.11
project management plan
document (3.8.5) specifying what is necessary to meet the objective(s) (3.7.1) of the project (3.4.2)
Note 1 to entry: A project management plan should include or refer to the project’s quality plan (3.8.9).
Note 2 to entry: The project management plan also includes or references such other plans as those relating to organizational structures, resources, schedule, budget, risk (3.7.9)management (3.3.3), environmental management, health and safety management, and security management, as appropriate.
[SOURCE:ISO 10006:2003, 3.7]
*****************************************************************************************
3.8.12
verification
confirmation, through the provision of objective evidence (3.8.3), that specified requirements (3.6.4) have been fulfilled
Note 1 to entry: The objective evidence needed for a verification can be the result of an inspection (3.11.7) or of other forms of determination (3.11.1) such as performing alternative calculations or reviewing documents (3.8.5).
Note 2 to entry: The activities carried out for verification are sometimes called a qualification process (3.4.1).
Note 3 to entry: The word “verified” is used to designate the corresponding status.
*****************************************************************************************
3.8.13
validation
confirmation, through the provision of objective evidence (3.8.3), that the requirements (3.6.4) for a specific intended use or application have been fulfilled
Note 1 to entry: The objective evidence needed for a validation is the result of a test (3.11.8) or other form of determination (3.11.1) such as performing alternative calculations or reviewing documents (3.8.5).
Note 2 to entry: The word “validated” is used to designate the corresponding status.
Note 3 to entry: The use conditions for validation can be real or simulated.
*****************************************************************************************
3.8.14
configuration status accounting
formalized recording and reporting of product configuration information (3.6.8), the status of proposed changes and the status of the implementation of approved changes
[SOURCE:ISO 10007:2003, 3.7]
*****************************************************************************************
3.8.15
specific case
<quality plan> subject of the quality plan (3.8.9)
Note 1 to entry: This term is used to avoid repetition of “process (3.4.1)product (3.7.6)project (3.4.2) or contract (3.4.7)” within ISO 10005.
[SOURCE:ISO 10005:2005, 3.10, modified — Note 1 to entry has been modified]
*****************************************************************************************
3.9   Terms related to customer
*****************************************************************************************
3.9.1
feedback
<customer satisfaction> opinions, comments and expressions of interest in a product (3.7.6), a service (3.7.7) or a complaints-handling process (3.4.1)
[SOURCE:ISO 10002:2014, 3.6, modified — The term “service” has been included in the definition]
*****************************************************************************************
3.9.2
customer satisfaction
customer’s (3.2.4) perception of the degree to which the customer’s expectations have been fulfilled
Note 1 to entry: It can be that the customer’s expectation is not known to the organization (3.2.1), or even to the customer in question, until the product (3.7.6) or service (3.7.7) is delivered. It can be necessary for achieving high customer satisfaction to fulfil an expectation of a customer even if it is neither stated nor generally implied or obligatory.
Note 2 to entry: Complaints (3.9.3) are a common indicator of low customer satisfaction but their absence does not necessarily imply high customer satisfaction.
Note 3 to entry: Even when customer requirements (3.6.4) have been agreed with the customer and fulfilled, this does not necessarily ensure high customer satisfaction.
[SOURCE:ISO 10004:2012, 3.3, modified — Notes have been modified]
*****************************************************************************************
3.9.3
complaint
<customer satisfaction> expression of dissatisfaction made to an organization (3.2.1), related to its product (3.7.6) or service (3.7.7), or the complaints-handling process (3.4.1) itself, where a response or resolution is explicitly or implicitly expected
[SOURCE:ISO 10002:2014, 3.2, modified — The term “service” has been included in the definition]
*****************************************************************************************
3.9.4
customer service
interaction of the organization (3.2.1) with the customer (3.2.4) throughout the life cycle of a product (3.7.6) or a service (3.7.7)
[SOURCE:ISO 10002:2014, 3.5, modified — The term “service” has been included in the definition]
*****************************************************************************************
3.9.5
customer satisfaction code of conduct
promises, made to customers (3.2.4) by an organization (3.2.1) concerning its behaviour, that are aimed at enhanced customer satisfaction (3.9.2) and related provisions
Note 1 to entry: Related provisions can include objectives (3.7.1), conditions, limitations, contact information (3.8.2), and complaints (3.9.3) handling procedures (3.4.5).
Note 2 to entry: In ISO 10001:2007, the term “code” is used instead of “customer satisfaction code of conduct”.
[SOURCE:ISO 10001:2007, 3.1, modified — The term “code” has been removed as an admitted term, and Note 2 to entry has been modified]
*****************************************************************************************
3.9.6
dispute
<customer satisfaction> disagreement, arising from a complaint (3.9.3), submitted to a DRP-provider (3.2.7)
Note 1 to entry: Some organizations (3.2.1) allow their customers (3.2.4) to express their dissatisfaction to a DRP-provider in the first instance. In this situation, the expression of dissatisfaction becomes a complaint when sent to the organization for a response, and becomes a dispute if not resolved by the organization without DRP-provider intervention. Many organizations prefer their customers to first express any dissatisfaction to the organization before utilizing dispute resolution external to the organization.
[SOURCE:ISO 10003:2007, 3.6, modified]
*****************************************************************************************
3.10   Terms related to characteristic
*****************************************************************************************
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); f)   functional (e.g. maximum speed of an aircraft).
*****************************************************************************************
3.10.2
quality characteristic
Note 1 to entry: Inherent means existing in something, especially as a permanent characteristic.
Note 2 to entry: A characteristic assigned to an object (e.g. the price of an object) is not a quality characteristic of that object.
*****************************************************************************************
3.10.3
human factor
characteristic (3.10.1) of a person having an impact on an object (3.6.1) under consideration
Note 1 to entry: Characteristics can be physical, cognitive or social.
Note 2 to entry: Human factors can have a significant impact on a management system (3.5.3).
*****************************************************************************************
3.10.4
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 definition has been modified by adding Note 1 to entry.
*****************************************************************************************
3.10.5
metrological characteristic
characteristic (3.10.1) which can influence the results of measurement (3.11.4)
Note 1 to entry: Measuring equipment (3.11.6) usually has several metrological characteristics.
Note 2 to entry: Metrological characteristics can be the subject of calibration.
*****************************************************************************************
3.10.6
configuration
interrelated functional and physical characteristics (3.10.1) of a product (3.7.6) or service (3.7.7) defined in product configuration information (3.6.8)
[SOURCE:ISO 10007:2003, 3.3, modified — The term “service” has been included in the definition]
*****************************************************************************************
3.10.7
configuration baseline
approved product configuration information (3.6.8) that establishes the characteristics (3.10.1) of a product (3.7.6) or service (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   Terms related to determination
*****************************************************************************************
3.11.1
determination
activity to find out one or more characteristics (3.10.1) and their characteristic values
*****************************************************************************************
3.11.2
review
determination (3.11.1) of the suitability, adequacy or effectiveness (3.7.11) of an object (3.6.1) to achieve established objectives (3.7.1)
EXAMPLE:
Management review, design and development (3.4.8) review, review of customer (3.2.4)requirements (3.6.4), review of corrective action (3.12.2) and peer review.
Note 1 to entry: Review can also include the determination of efficiency (3.7.10).
*****************************************************************************************
3.11.3
monitoring
Note 1 to entry: For the determination of the status there can be a need to check, supervise or critically observe.
Note 2 to entry: Monitoring is generally a determination of the status of an object (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 definition and Note 1 to entry have been modified, and Note 2 to entry has been added.
*****************************************************************************************
3.11.4
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 definition has been modified by adding Note 1 to entry.
*****************************************************************************************
3.11.5
measurement process
set of operations to determine the value of a quantity
*****************************************************************************************
3.11.6
measuring equipment
measuring instrument, software, measurement standard, reference material or auxiliary apparatus or combination thereof necessary to realize a measurement process (3.11.5)
*****************************************************************************************
3.11.7
inspection
Note 1 to entry: If the result of an inspection shows conformity, it can be used for purposes of verification (3.8.12).
Note 2 to entry: The result of an inspection can show conformity or nonconformity (3.6.9) or a degree of conformity.
*****************************************************************************************
3.11.8
test
determination (3.11.1) according to requirements (3.6.4) for a specific intended use or application
Note 1 to entry: If the result of a test shows conformity (3.6.11), it can be used for purposes of validation (3.8.13).
*****************************************************************************************
3.11.9
progress evaluation
<project management> assessment of progress made on achievement of the project (3.4.2)objectives (3.7.1)
Note 1 to entry: This assessment should be carried out at appropriate points in the project life cycle across projectprocesses (3.4.1), based on criteria for project processes and product (3.7.6) or service (3.7.7).
Note 2 to entry: The results of progress evaluations can lead to revision of the project management plan (3.8.11).
[SOURCE:ISO 10006:2003, 3.4, modified — Notes to entry have been modified]
*****************************************************************************************
3.12   Terms related to action
*****************************************************************************************
3.12.1
preventive action
action to eliminate the cause of a potential nonconformity (3.6.9) or other potential undesirable situation
Note 1 to entry: There can be more than one cause for a potential nonconformity.
Note 2 to entry: Preventive action is taken to prevent occurrence whereas corrective action (3.12.2) is taken to prevent recurrence.
*****************************************************************************************
3.12.2
corrective action
action to eliminate the cause of a nonconformity (3.6.9) and to prevent recurrence
Note 1 to entry: There can be more than one cause for a nonconformity.
Note 2 to entry: Corrective action is taken to prevent recurrence whereas preventive action (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 definition has been modified by adding Notes 1 and 2 to entry.
*****************************************************************************************
3.12.3
correction
action to eliminate a detected nonconformity (3.6.9)
Note 1 to entry: A correction can be made in advance of, in conjunction with or after a corrective action (3.12.2).
Note 2 to entry: A correction can be, for example, rework (3.12.8) or regrade (3.12.4).
*****************************************************************************************
3.12.4
regrade
alteration of the grade (3.6.3) of a nonconforming (3.6.9)product (3.7.6) or service (3.7.7) in order to make it conform to requirements (3.6.4) differing from the initial requirements
*****************************************************************************************
3.12.5
concession
permission to use or release (3.12.7) a product (3.7.6) or service (3.7.7) that does not conform to specified requirements (3.6.4)
Note 1 to entry: A concession is generally limited to the delivery of products and services that have nonconforming (3.6.9)characteristics (3.10.1) within specified limits and is generally given for a limited quantity of products and services or period of time, and for a specific use.
*****************************************************************************************
3.12.6
deviation permit
permission to depart from the originally specified requirements (3.6.4) of a product (3.7.6) or service (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 time, and for a specific use.
*****************************************************************************************
3.12.7
release
permission to proceed to the next stage of a process (3.4.1) or the next process
Note 1 to entry: In English, in the context of software and documents (3.8.5), the word “release” is frequently used to refer to a version of the software or the document itself.
*****************************************************************************************
3.12.8
rework
Note 1 to entry: Rework can affect or change parts of the nonconforming product or service.
*****************************************************************************************
3.12.9
repair
action on a nonconforming (3.6.9)product (3.7.6) or service (3.7.7) to make it acceptable for the intended use
Note 1 to entry: A successful repair of a nonconforming product or service does not necessarily make the product or service conform to the requirements (3.6.4). It can be that in conjunction with a repair a concession (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.
Note 3 to entry: Repair can affect or change parts of the nonconforming product or service.
*****************************************************************************************
3.12.10
scrap
action on a nonconforming (3.6.9)product (3.7.6) or service (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   Terms related to audit
*****************************************************************************************
3.13.1
audit
systematic, independent and documented process (3.4.1) for obtaining objective evidence (3.8.3) and evaluating it objectively to determine the extent to which the audit criteria (3.13.7) are fulfilled
Note 1 to entry: The fundamental elements of an audit include the determination (3.11.1) of the conformity (3.6.11) of an object (3.6.1) according to a procedure (3.4.5) carried out by personnel not being responsible for the object audited.
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 combined audit (3.13.2) or a joint audit (3.13.3).
Note 3 to entry: Internal audits, sometimes called first-party audits, are conducted by, or on behalf of, the organization (3.2.1) itself for management (3.3.3)review (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.
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 customers (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.
*****************************************************************************************
3.13.2
combined audit
audit (3.13.1) carried out together at a single auditee (3.13.12) on two or more management systems (3.5.3)
Note 1 to entry: The parts 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 applied by the organization (3.2.1).
*****************************************************************************************
3.13.3
joint audit
audit (3.13.1) carried out at a single auditee (3.13.12) by two or more auditing organizations (3.2.1)
*****************************************************************************************
3.13.4
audit programme
set of one or more audits (3.13.1) planned for a specific time frame and directed towards a specific purpose
[SOURCE:ISO 19011:2011, 3.13, modified]
*****************************************************************************************
3.13.5
audit scope
extent and boundaries of an audit (3.13.1)
Note 1 to entry: The audit scope generally includes a description of the physical locations, organizational units, activities and processes (3.4.1).
[SOURCE:ISO 19011:2011, 3.14, modified — Note to entry has been modified]
*****************************************************************************************
3.13.6
audit plan
description of the activities and arrangements for an audit (3.13.1)
[SOURCE:ISO 19011:2011, 3.15]
*****************************************************************************************
3.13.7
audit criteria
set of policies (3.5.8)procedures (3.4.5) or requirements (3.6.4) used as a reference against which objective evidence (3.8.3) is compared
[SOURCE:ISO 19011:2011, 3.2, modified — The term “audit evidence” has been replaced by “objective evidence”]
*****************************************************************************************
3.13.8
audit evidence
records, statements of fact or other information, which are relevant to the audit criteria (3.13.7) and verifiable
[SOURCE:ISO 19011:2011, 3.3, modified — Note to entry has been deleted]
*****************************************************************************************
3.13.9
audit findings
results of the evaluation of the collected audit evidence (3.13.8) against audit criteria (3.13.7)
Note 1 to entry: Audit findings indicate conformity (3.6.11) or nonconformity (3.6.9).
Note 2 to entry: Audit findings can lead to the identification of opportunities for improvement (3.3.1) or recording good practices.
Note 3 to entry: In English, if the audit criteria (3.13.7) are selected from statutory requirements (3.6.6) or regulatory requirements (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]
*****************************************************************************************
3.13.10
audit conclusion
outcome of an audit (3.13.1), after consideration of the audit objectives and all audit findings (3.13.9)
[SOURCE:ISO 19011:2011, 3.5]
*****************************************************************************************
3.13.11
audit client
organization (3.2.1) or person requesting an audit (3.13.1)
[SOURCE:ISO 19011:2011, 3.6, modified — Note to entry has been deleted]
*****************************************************************************************
3.13.12
auditee
organization (3.2.1) being audited
[SOURCE:ISO 19011:2011, 3.7]
*****************************************************************************************
3.13.13
guide
<audit> person appointed by the auditee (3.13.12) to assist the audit team (3.13.14)
[SOURCE:ISO 19011:2011, 3.12]
*****************************************************************************************
3.13.14
audit team
one or more persons conducting an audit (3.13.1), supported if needed by technical experts (3.13.16)
Note 1 to entry: One auditor (3.13.15) of the audit team is appointed as the audit team leader.
Note 2 to entry: The audit team can include auditors-in-training.
[SOURCE:ISO 19011:2011, 3.9, modified]
*****************************************************************************************
3.13.15
auditor
person who conducts an audit (3.13.1)
[SOURCE:ISO 19011:2011, 3.8]
*****************************************************************************************
3.13.16
technical expert
<audit> person who provides specific knowledge or expertise to the audit team (3.13.14)
Note 1 to entry: Specific knowledge or expertise relates to the organization (3.2.1), the process (3.4.1) or activity to be audited, or language or culture.
Note 2 to entry: A technical expert does not act as an auditor (3.13.15) in the audit team (3.13.14).
[SOURCE:ISO 19011:2011, 3.10, modified — Note 1 to entry has been modified]
*****************************************************************************************
3.13.17
observer
<audit> person who accompanies the audit team (3.13.14) but does not act as an auditor (3.13.15)
Note 1 to entry: An observer can be a member of the auditee (3.13.12), a regulator or other interested party (3.2.3) who witnesses the audit (3.13.1).
[SOURCE:ISO 19011:2011, 3.11, modified — The verb “audit” has been removed from the definition; Note to entry has been modified]
***********************************************************
Table of common words used in ISO 9000:2015 and in ISO 9001:2015
Word  (and clauses where it is used, if used in different dictionary meanings)Meaning
1abilitynounbeing able
2 in accordance with)nounin a manner conforming with
3action  (see ISO 9000: A.5 fig. A.15)nounactivity to achieve something
4activity  (see ISO 9000: A.5 fig. A.6)noundoing something
5Adequacynounsufficiency
6adjustmentnounact of making something different
7analysisnoundetailed determination
8appropriateadjectivesuitable (for, to)
9applicable (requirement)

ISO 9001: 0.1, 1 para 1 1a), 1 para 1 1b), 4.2, 5.1.2, 5.2.1, 6.2.1, 8.2.2, 8.2.3.1, 8.3.2, 8.4.2, A3 para 1 line 6

adjectivenecessary to apply
10applicable (as applicable) ISO 9000: Introduction, 1, 3.2.2;

ISO 9001: 0.3.2, 1 para 2, 4.3, 7.2, 7.5.3.2, 8.2.3.2, 8.5.1, 10.2.1, A.3 para 1 line 5, A.5, Annex B

adjectivepossible to apply
11applicable (as applicable) ISO 9001: 8.6adjectivewhen required
12authority

ISO 9000: 2.3.2.4, 2.3.4.4, 3.1.1, 3.1.5 (def), 3.3.3;

ISO 9001: 4.4.1 e), 5.3, 8.3.2, A.1

nounpower to command or give a decision
13authority

ISO 9000:3.1.5 (term), 3.2.1, 3.6.7;

ISO 9001: 8.6, 8.7.2

nounperson or body that has powers and rights
14authority  ISO 9001: 7.5.3.2nounpermission to do something
15availableadjectiveable to be used or obtained

 

16aware (to be aware, to make aware)adverb/ verbto have or to create knowledge or perception of a situation or fact
17awarenessnounknowledge or perception of a situation or

fact

18boundarynounlimit
19calibrationnounSee VIM: 2007, Clause 2.39
20canverbISO/IEC Directives Part 2, 2016, Clause 7.5, Table 6

– be able to

– there is a possibility of

– it is possible to

21cannotverbISO/IEC Directives Part 2, 2016, Clause 7.5, Table 6

– be unable to

– there is no possibility of

– it is not possible to

22commitmentnounobligation and promise to do something
23communicationnounsharing or exchanging information
24confirmverbestablish as true
25conform (to/with)verbfulfill
26consistent (with)adjectiveconforming to or in agreement with
27consistentlyadverbchanging over time
28controlnounpart of management focused on fulfilling requirements
29controlverbmanage focusing on fulfilling requirements
30defineverbstate or describe exactly
31demonstrateverbshow clearly
32determineverbfind out (one or more characteristics and their characteristic values)
33distributionnounbringing objects to their destination
34dispositionnoundefine what to do with an object
35documentationnounset of documents
36enhanceverb/nounimprove/improvement
37ensureverbmake sure
38essential

ISO 9001: 0.3.1, 0.4, 7.1.5.2, 8.3.3, 8.3.5, Annex B

adjectivenecessary
39essential

ISO 9000: 2.2.5.2, 2.3.3.1,2.3.5.2;

ISO 9001: 0.3.3

adjectiveimportant
40essential characteristics ISO 9001: A.8nouncharacter
41establish

ISO 9000: 2.3.3.1, 2.3.4.4, 2.3.5.4, 3.3.3, 3.3.4, 3.5.9, 3.6.3, 3.7.7, 3.10.7, 3.11.2

verbdefine

 

42establish

ISO 9000: 2.3.2.4, 2.3.7.4, 3.2.7, 3.3.2, 3.3.5, 3.3.9, 3.4.2, 3.4.3, 3.5.3;

ISO 9001: 0.3.2, 0.3.3, 4.3, 4.4.1, 5.1.1, 5.2.1, 6.2.1, 7.1.1, 8.1, 8.2.1, 8.3.1, 9.2.2,

Annex B

verbmake
43evaluateverbjudge
44expectationnounwish to be fulfilled
45experienceverbperceive
46experiencenounpractice
47facilitateverbmake easier
48focusnouncenter of interest
49ISO 9001 framework : 0.4nounhigh level structure, identical core text, common terms and core definitions (ISO/IEC Directives, Part 1, Consolidated ISO supplement 2014, Annex SL, Appendix 2)
50framework

ISO 9000 intro, 2.4.2, 3.5.9;

ISO 9001: 5.2.1

nounset of principles
51function

ISO 9000: 2.2.1, 3.3.13, A.4

nounpurpose
52function

ISO 9000: 3.2.7

nounresources
53function

ISO 9000: 2.3.2.3, 3.2.1, 3.2.9, 3.4.6, 3.5.3, 3.7.2;

ISO 9001: 6.2.1

nounorganizational unit
54functionaladjectivepractical and for use
55hardwarenounSee ISO 9000:2015 Clause 3.7.6

“product” especially Note 3

56identify

ISO 9000: 2.2.2, 2.2.4, 2.4.1.2, 2.4.2, 2.4.3, 3.13.2;

ISO 9001: 0.3.2, 7.5.3.2, 8.3.6, 8.5.2 (para 2)

verbfind out
57identify/identification

ISO 9000: 3.3.11, 3.5.3;

ISO 9001: 7.1.5.2, 7.5.2, 8.5.2 (title, para 1 & 3), 8.5.3, 8.5.4, 8.7.1, Annex B

verb/nounmark or label
58identify/identification

ISO 9000: intro, 3.13.9, A.4;

ISO 9001: 8.7.2

verb/nounshow
59Impartialitynounevenhandedness
60implementverbput into effect or practice

 

61integrity

ISO 9000: 2.3.2.4

nounmoral soundness
62integrity

ISO 9001: 5.3, 6.3, 7.5.3.1

nounwholeness
63justificationnounreason
64knowledgenounavailable collection of information being a justified belief and having a high certainty

to be true

65maintainverbenable to continue
66maintenancenounenabling to continue
67MayverbISO/IEC Directives Part 2, 2016, Clause

7.4, Table 5

– is permitted

– is allowed

– is permissible

68measurableadjectiveable to be measured
69measureverbdetermine a value
70monitorverbdetermine a status
71necessaryadjectiveneeded
72neednounnecessity
73opportunitynounchance
74originnounprovenance
75perceptionnouncognition
76periodicadjectiveregular
77person  (see ISO 9000: A.5 fig. A.4)nounindividual human
78planverbprearrange
79preservationnounmaintaining something in its original or existing state
80propertynounobject owned by a person or organization
81provideverbsupply
82relevantadjectiverelated to and important to that which is being considered
83responsibility/responsiblenoun/ adjectiveaccountable
84resultnounoutput
85retainverbkeep
86safeguardverbprotect
87scopenounarea of ​​application
88sequencenounorder
89shall

 

 

Note: “shall” is used 136 times in ISO 9001:2015

verbISO/IEC Directives Part 2, 2016, Clause 7.2, Table 3

– is to

– is required to

– it is required that

– has to

– only … is permitted

– it is necessary

 

90shall notverbISO/IEC Directives Part 2, 2016, Clause 7.2, Table 3

– is not allowed [permitted] [acceptable] [permissible]

– is required to be not

– is required that … be not

– is not to be

91shouldverbISO/IEC Directives Part 2, 2016, Clause 7.3, Table 4

– it is recommended that

– ought to

92softwarenounSee ISO 9000:2015 Clause 3.7.6 “product” especially Note 3
93specificadjectiveparticular
94specifyverbdefine
95suitableadjectiveappropriate
96supplyverbprovide
97systematicadjectiveorderly
98unambiguousadjectiveclear
99validitynounstate of being valid
100verifyverbcarry out verification (see ISO 9000:2015 Clause 3.8.12)
*****************************************************************************************