Quality Management Definitions: A Useful Resource

For ease of reference, we offer a round-up of quality management definitions – including commonly used terms in both project management and quality management circles.

Below we’ve included:

general quality definitions
definitions of some key ISO 9001 terms
definitions of a range of quality management tools and techniques.

General quality management definitions

The following table offers succinct definitions of general terms associated with the concepts of quality and quality management.

Term	Explanation
CAPA	Abbreviation for corrective action and preventive action – key aspects of risk management.
CAPA system	Software that identifies and tracks the performance of corrective and preventive actions. It facilitates analysis of an issue (or a complaint, defect, or non-conformance), finding the root cause, correcting it, and documenting the correction.
continuous improvement	Ongoing and incremental improvement of processes, products, or services. It’s also referred to as continual improvement.
corrective action	Corrective action is a step-by-step process to identify, define and contain a problem, determine its cause and take action to prevent it from happening again. The objective of corrective action is to ensure existing non-conformities do not recur.
corrective action and preventive action	Abbreviated as CAPA, action to prevent an issue or risk from occurring or to mitigate its potential impact.
critical to quality	Abbreviated as CTQ, term describing measurable attributes of a product or process that must meet certain standards or fall within specification limits to satisfy the customer.
CTQ	Abbreviation for critical to quality.
defects per million opportunities	Abbreviated as DPMO and deriving from process improvement methodologies like Six Sigma, a measure of process performance based on the number of defects – or failures – to fall within specification limits that occur during an average production run, normalized to one million and divided by the number of opportunities for a defect to occur.
key performance indicator	Abbreviated as KPI, a measurable value that shows how well an organization is achieving its core goals.
KPI	Abbreviation for key performance indicator.
nonconformance	A failure to meet a specification or standard.
operational discipline	The commitment of every member of an organization to operational excellence and continual improvement – often summarized as “everyone do it right every time.”
operational excellence	Highly efficient, effective execution of business strategy with a focus on continual improvement. It’s a source of competitive advantage and is essential for long-term success and growth.
preventive action	Action to prevent an issue or risk from occurring or to mitigate its potential impact.
process	A series of steps or actions taken to convert one or more inputs into outputs.
QM	Abbreviation for quality management.
QMS	Abbreviation for quality management system.
quality	The degree to which a product or service fulfills requirements and conforms to users’ expectations.
quality at the source	The Lean manufacturing principle of making sure it’s right the first time. Preventing defects from being passed through to later steps and processes reduces the need for later inspections and rework and enables faster delivery to customers.
quality management	A broad term for management activities designed to enhance an organization’s performance. QM supports product and service consistency, and involves four key components – quality policy, quality assurance, quality control and quality improvement.
quality management system	The ISO 9001 definition of quality management system is a set of “policies, processes and procedures required for planning and execution in the core business area of an organization”. It’s a system that coordinates and directs an organization’s activities by documenting processes, procedures and responsibilities within that organization. QMS helps an organization remain compliant, and consistently deliver products or services that promote optimal customer satisfaction.
quality manual	A document describing the scope of the QMS of an organization. Its objective is to serve as a roadmap for meeting quality system requirements. It conveys policies for the essentials of the QMS and describes how all the critical quality processes unfold.
quality objectives	The set of quality-oriented goals an organization aims to achieve. They are measurable quality control methods, focusing on key factors such as process efficiency, improved delivery and enhanced customer satisfaction.
quality plan	An organizational blueprint specifying the people, processes and resources required to carry out an organizational activity.
quality policy	A general documented statement of an organization’s commitment to quality. It aligns with the organization’s mission, purpose and strategic direction. It’s a key requirement of any quality management system.
value stream	The series of steps or actions involved in delivering value to the customer.
waste	In the Lean methodology, any activity or aspect of a process that does not add value for the customer.

ISO 9001 terms and definitions

We offer definitions of a range of terms used in (or in relation to) ISO 9001 and other ISO quality standards. Many are used in relation to quality management generally but the terms may have slightly specialised meanings – or receive particular emphasis – under ISO 9001:2015.

Term	Explanation
audit	An audit is a structured and formal evaluation of an organization’s compliance or non-compliance with ISO requirements. It’s a systematic process of gathering evidence to determine how effectively audit criteria have been fulfilled. Audits can be internal or external. Processes are referred to as first-party audits and second- and third-party audits, respectively.
audit criteria	International standards define audit criteria as a set of policies, procedures and requirements to audit against. It is the benchmark against which audit evidence is compared to determine the level of compliance with ISO requirements within an organization.
audit evidence	Audit evidence is a collection of verifiable facts and figures used to support the conclusion of an audit. It includes records, statements and other documentation.
audit scope	In ISO terms, the meaning of audit scope is basically the extent of an audit. It defines which organizational units, activities, people and processes are being audited, and over what period of time.
compliance	ISO 9001 compliance refers to an organization’s adherence to ISO 9001 standards.
compliance	Compliance refers to an organization’s fulfillment of compliance obligations; legal requirements and standards an organization has to obey.
conformity	Adherence to ISO requirements.
context of the organization	ISO defines the context of the organization as the “business environment” of the internal and external processes and functions, which have an impact on the organization’s goals, culture, products, process flow and markets.
continuous improvement	Continuous improvement is a general term for recurring improvements of systems and processes that are undertaken by an organization. It’s a required aspect of commitment to ISO standards. Audits, assessments and management reviews are used to support continual improvement within an organization.
document control	A series of practices for ensuring that documents are created, reviewed, distributed, and disposed of in a systematic, verifiable manner.
documented information	Documented information refers to data and information, in any format, that an organization must organize, control and maintain. It includes information about the management system and what an organization requires to operate optimally.
infrastructure	ISO standards define infrastructure as all the facilities required for organizational operations – software, hardware, real estate, utilities, tools and equipment.
input	An input is a resource used in the execution of a process, such as a raw material or specific information.
measuring equipment	A broad term for the instruments, apparatus, standards, software and reference materials used to determine a measurable value – temperature indicators, diagnostic equipment, competence testing software and so on.
non-conformance	ISO non-conformance is the failure of a process to meet a requirement set by the standard. It may also refer generally to the failure of an organization to meet one or more existing ISO requirements.
objective evidence	As per ISO 9001, data collected by performing tests, measurements or observations, which proves the veracity of something. It is proof the organization did or did not fulfill its requirements.
output	A tangible, or intangible, result of a process.
performance	ISO standards define performance as “measurable results” in the context of the management of systems, processes, products and activities. Performance can be good, or poor, based on an organization’s ability to achieve acceptable results.
process	A process is a series of interrelated activities that use resources to convert inputs into outputs.
process approach	Stakeholders define a process approach as a management strategy that uses the organization’s processes, rather than people, products and departments, to operate as a complete and integrated system.
process validation	Process validation is the act of controlling a process. It involves conducting tests and calculations to validate process performance, according to design requirements.
re-certification audit	A re-certification audit is a check to ensure that all ISO 9001 requirements are still being met. Re-certification audits usually take place every three years.
requirement	ISO standards define a requirement as a “need, obligation or expectation” that can be specified or implied by an organization. Requirements focus on the ISO standard itself and include quality requirements, product requirements, regulatory requirements and contractual requirements.
risk	According to ISO 9001:2015, the effect of uncertainty on an expected result.
risk-based thinking	A central concept in ISO 9001:2015. Risk-based thinking is a systematic approach to risk that’s built into all aspects of quality management, rather than being viewed as a single, separate component of quality management. It prioritizes preventive action.
traceability	ISO standards define traceability as the ability to identify and track down the location, history, distribution and application of products and services.
verification	An acknowledgment that an organization has met ISO 9001 requirements, and is duly accredited.

Quality management processes, tools, and techniques

The following table offers simple, straightforward definitions of quality management tools and processes. Many more tools exist and continue to be developed, but here we cover a range of the best-known ones.

Term	Explanation
cost of quality (COQ)	As it pertains to QM, a methodology that determines the extent to which an organization’s resources are used to meet quality standards. That data is then compared to the cost of producing products or services that fail to fulfill quality standards.
cost-benefit analysis	A financial tool that weighs the benefits of providing quality against the costs.
Delphi technique	A group creativity technique that involves obtaining a cycle of feedback from a group of independent experts. After each person in the group responds to an initial questionnaire, the responses are compiled and sent back to the group members. Group members then revise and add to their original feedback. The process can continue until all members reach consensus. The Delphi technique is useful for moving from a list of possible project requirements to a final list of refined requirements.
Design for Six Sigma	Abbreviated as DFSS, a process management methodology derived from Six Sigma that’s used specifically for process or product design. It relies on statistical techniques and is comprised of the DMADV project phases: define, measure, analyze, design, and verify.
DFSS	Abbreviation for Design For Six Sigma.
DPMO	Abbreviation for defects per million opportunities.
failure modes and effects analysis	Abbreviated as FMEA, a structured approach for identifying ways a system or process could fail and prioritizing these for risk mitigation, based on their scored probability of occurring, severity, and likelihood of being detected.
FMEA	Abbreviation for failure modes and effects analysis.
force field analysis (FFA)	A technique used by organizations to evaluate the pros and cons of a proposed change or idea and deliver an indication of possible success.
Gemba walk-through	Physical inspection of work as it’s being performed in the workplace, to aid process analysis and improvement.
Kaizen	A process improvement methodology that focuses on involving people at all levels of an organization in continuous improvement. It was first practiced in Japan in the late 1940s, most famously by Toyota. Today, it’s most often implemented in the form of Kaizen events or “blitzes” – highly focused sessions, lasting up to a week, in which participants focus on addressing particular performance issues.
Lean	A process improvement methodology that emphasizes removing waste or eliminating any activities that don’t add value for the customer. First developed in manufacturing as part of the Toyota Production System, it has since been adapted and used across industries.
nominal group technique (NGT)	A series of formalized brainstorming sessions, where everyone is encouraged to provide input in order to facilitate quick resolution to an issue or problem.
Pareto analysis	Based on the 80/20 rule, a formal technique for determining the 20% of causes responsible for roughly 80% of problems.
poka yoke	A mechanism for preventing, correcting, or detecting errors as they occur. A Japanese term, it means error or mistake proofing. It was first adopted as part of the Toyota Production System.
process analysis	A systematic review of the procedures followed to perform organizational activities. The aim is to identify improvements that may be required to address problems and optimize activities.
quality function deployment	Abbreviated as QFD, a quality management tool that uses customer feedback to define product quality objectives.
root cause analysis	Assessment with the aim of uncovering the underlying reasons for issues or failures.
SIPOC	A table used to record the inputs and outputs of one or more processes. SIPOC stands for suppliers, inputs, process, outputs, and customers, which are included as columns in the table.
Six Sigma	A process improvement methodology that focuses on identifying and removing causes of defects and minimizing the variability in processes. It relies on statistical tools and techniques and uses the DMAIC project phases: define, measure, analyze, improve, and control.
standard deviation	A statistical measure of how far a set of numbers is dispersed around the mean, calculated as the square root of variance. High standard deviation indicates that the values in a set are highly variable. See also variance.
value stream mapping	The process of representing the steps involved in creating and delivering value to the customer. It’s typically used as an aid for removing waste and improving process efficiency.
variance	A statistical measure of how far a set of numbers are spread out from their average value, calculated as the average squared distance between the mean and each data value. In Six Sigma, process variance is the extent to which the outcomes of a process vary. It’s desirable to minimize variance, which indicates a lack of stability or control.

How isoTracker can help: QMS software that’s affordable and modular

isoTracker offers modular, subscription-based quality management software that’s secure, cloud-based and affordable. It includes a document control module, as well as complaints management, audit management, and training modules, with built-in CAPA capabilities.

Digital quality management is one straightforward way for small to medium manufacturing businesses to start realizing value from Industry 4.0 – and with isoTracker’s QMS, it’s easy and cost-effective to implement.