Glossary

These definitions are based on terms listed in ISO 9000:2015 (Fundamentals and Vocabulary) and ISO 19011:2011 (Guidelines for Auditing Management Systems). For complete definitions and other concepts, you can order these documents from the American Society for Quality (ASQ), American National Standards Institute (ANSI), or International Organization for Standardization (ISO).

AuditA systematic, independent, and documented process for obtaining objective evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled.
Audit ClientThe organization or person requesting an audit.
Audit ConclusionThe outcome of an audit, after consideration of the audit objectives and all audit findings.
Audit CriteriaThe set of policies, procedures, or requirements used as a reference against which objective evidence is compared.
Audit EvidenceThe records, statements of fact, or other information which are relevant to the audit criteria and verifiable.
Audit FindingsThe results of the evaluation of the collected audit evidence against audit criteria.
Audit Guide A person appointed by the auditee to assist the audit team.
Audit Observer A person who accompanies the audit team, but does not act as an auditor.
Audit PlanThe description of the activities and arrangements for an audit.
Audit ProgramA set of one or more audits planned for a specific timeframe and directed towards a specific purpose.
Audit ScopeThe extent and boundaries of an audit.
Audit TeamOne or more auditors conducting an audit, supported if needed by technical experts.
AuditeeThe organization being audited.
AuditorThe person who conducts an audit.
CapabilityThe ability of an object to realize an output that will fulfill the requirements for that output.
Change ControlThe activities for control of the output after formal approval of its product configuration information.
CharacteristicA distinguishing feature. The classes of characteristics include physical (e.g., mechanical); sensory (e.g., smell); behavioral (e.g., honesty); temporal (e.g., reliability); ergonomic (e.g., safety); and functional (e.g., speed).
Combined Audit An audit carried out together at a single auditee on two or more management systems.
CompetenceThe ability to apply knowledge and skills to achieve intended results.
Complaint An expression of dissatisfaction made to an organization related to its product or service, or the complaints-handling process itself, where a response or resolution is explicitly or implicitly expected.
ConcessionPermission to use or release a product or service that does not conform to specified requirements.
Configuration Management The coordinated activities to direct and control a configuration (interrelated functional and physical characteristics of a product or service defined in product configuration information).
ConformityThe fulfillment of a requirement.
Continual ImprovementThe recurring activity to enhance performance.
Context of the Organization The combination of internal and external issues that can have an effect on an organization’s approach
to developing and achieving its objectives.
ContractA binding agreement.
CorrectionThe action taken to eliminate a detected nonconformity.
Corrective ActionThe action taken to eliminate the cause of a detected nonconformity and to prevent recurrence.
CustomerA person or organization that could or does receive a product or a service that is intended for or required by this person or organization.
Customer SatisfactionA customer’s perception of the degree to which the customer’s expectations have been fulfilled.
DefectThe nonfulfillment of a requirement related to an intended or specified use.
DependabilityThe ability to perform as and when required..
Design and DevelopmentThe set of processes that transform requirements for an object into more detailed requirements for that object.
Deviation PermitPermission to depart from the originally specified requirements of a product or service prior to its realization.
Dispute A disagreement, arising from a complaint submitted to a dispute resolution process provider.
Document Information and the medium on which it is contained. The medium can be paper, magnetic, electronic or optical disk, photograph, or master sample.
Documented Information The information required to be controlled and maintained by an organization and the medium
on which it is contained.
EffectivenessThe extent to which planned activities are realized and planned results achieved.
EfficiencyThe relationship between the result achieved and the resources used.
External Provider An external supplier that is not part of the organization.
Feedback The opinions, comments, and expressions of interest in a product, a service, or a complaints-handling process.
GradeThe category or rank given to different quality requirements for an object having the same functional use.
GuidelineA document stating recommendations or suggestions.
Human Factor A characteristic of a person having an impact on an object under consideration. The characteristic can be physical, cognitive, or social.
Improvement The activity to enhance performance.
InformationMeaningful data.
InfrastructureThe system of facilities, equipment, and services needed for the operation of an organization.
Innovation A new or changed object realizing or redistributing value.
InspectionThe determination of conformity to specified requirements.
Interested PartyA person or organization that can affect, be affected by, or perceive itself to be affected by a decision or activity, for example, customers, owners, employees, suppliers, bankers, unions, partners, or society.
Joint Audit An audit carried out at a single auditee by two or more auditing organizations.
ManagementThe coordinated activities to direct and control an organization.
Management SystemA system to establish policies and objectives, and processes to achieve those objectives.
Measurement ProcessThe set of operations to determine the value of a quantity.
Measurement Management SystemThe set of interrelated or interacting elements necessary to achieve metrological confirmation and control of measurement processes.
Measuring EquipmentThe measuring instrument, software, measurement standard, reference material or auxilliary apparatus, or a combination thereof, necessary to realize a measurement process.
Metrological CharacteristicThe distinguishing feature which can influence the results of measurement.
Metrological ConfirmationThe set of operations required to ensure that measuring equipment conforms to the requirements for its intended use.
Mission The organization’s purpose for existing as expressed by top management.
Monitoring Determining the status of a system, a process, a product, a service, or an activity.
NonconformityThe nonfulfillment of a requirement.
Objective The results to be achieved.
Objective EvidenceThe data supporting the existence or verity of something. It may be obtained through observation, measurement, test, or by other means.
OrganizationThe person or group of people that has  its own functions with responsibilities, authorities, and relationships to achieve its objectives.
Organizational StructureThe arrangeent of of responsibilities, authorities, and relationships between people.
Output The result of a process.
Performance A measurable result.
Policy The intentions and direction of an organization as formally expressed by its top management.
Preventive ActionThe action taken to eliminate the cause of a potential nonconformity or other potentially undesirable situation.
ProcedureThe specified way to carry out an activity or a process.
– purposeThe reason for the procedure. It is important to know the objective of the document and why the reader should follow the process.
– scopeThe boundaries of the procedure. It describes which activities are covered and the applicability of the document to functional areas.
– responsibilitiesThe roles and authority for process users and process managers organized by job titles.
– referencesA list of related documents mentioned in the Process section.
– processA description of the logical sequence of activities to perform a procedure. Covers what, when, where, and by whom.
– recordsThe information and data saved during the process for use in other processes and as proof of compliance to requirements.
ProcessA set of interrelated or interacting activities that use inputs to deliver an intended result.
ProductThe output of an organization that can be produced without any transaction taking place between the organization and the customer.
ProjectA unique process, consisting of a set of coordinated and controlled activities with start and finish dates, undertaken to achieve an objective conforming to specific requirements, including the constraints of time, cost, and resources.
ProviderA supplier, for example, producer, distributor, retailer, or vendor of a product or a service.
Qualification ProcessThe process to demonstrate the ability to fulfill specified requirements.
QualityThe degree to which a set of inherent characteristics of an object fulfills requirements.
Quality AssuranceThe part of quality management focused on providing confidence that quality requirements will be fulfilled.
Quality CharacteristicThe inherent characterisitic of an object related to a requirement.
Quality ControlThe part of quality management focused on fulfilling quality requirements.
Quality ImprovementThe part of quality management focused on increasing the ability to fulfill quality requirements.
Quality ManagementThe management (coordinated activities to direct and control an organization) with regard to quality.
Quality Management SystemThe part of a management system with regard to quality.
Quality ManualThe specification for the quality management system of an organization. The manuals can vary in detail and format to suit the size and complexity of an individual organization.
Quality ObjectiveThe result to be achieved related to quality. The objectives are generally based on the quality policy of an organization and specified for relevant functions, levels, and processes in the organization.
Quality PlanThe specification of the procedures and associated resources to be applied when and by whom
to a specific object.
Quality PlanningThe part of quality management focused on setting quality objectives and specifying necessary operational processes and related resources to achieve the quality objectives.
Quality PolicyThe overall intentions and direction of an organization related to quality as formally expressed by top management.
Quality SurveillanceThe frequent or constant monitoring and verification of the status of an entity and analysis of records to ensure specified requirements are being fulfilled.
RecordA document stating results achieved or providing evidence of activities performed.
RegistrarA third party organization (Certification Body) that conducts independent audits of a company’s management system to ensure it conforms to requirements.
RegistrationWhen a management system complies with the applicable standard, the registrar issues a certificate of registration.
Regulatory Requirement An obligatory requirement specified by an authority mandated by a legislative body.
Release The permission to proceed to the next stage of a process or the next process.
RepairThe action taken on a nonconforming product or service to make it acceptable for the intended usage.
RequirementA need or expectation that is stated, generally implied or obligatory.
ReviewThe activity undertaken to determine the suitability, adequacy, and effectiveness of the subject matter to achieve established objectives.
ReworkThe action on a nonconforming product or service to make it conform to the requirements.
Risk The effect of uncertainty (on objectives).
ScopeThe scope of registration defines the company sites, product lines, and operations covered by an ISO 9001 certificate.
ScrapThe action taken on a nonconforming product or service to preclude its originally intended usage, for example, recycling or destruction. For service, use is precluded by discontinuing the service.
ServiceThe output of an organization with at least one activity necessarily performed between the
organization and the customer.
SoftwareThe intellectual product consisting of information on a support medium. A computer program is an example of software.
SpecificationA document stating requirements.
Statutory Requirement An obligatory requirement specified by a legislative body.
Strategy The plan to achieve a long-term or overall objective.
Success The achievement of an objective.
SupplierThe organization or person that provides a product.
Sustained Success Success over a period of time.
SystemA set of interrelated or interacting elements.
Technical ExpertThe person who provides specific knowledge or expertise to the audit team.
TestThe determination according to requirements for a specific intended use or application.
Top ManagementThe person or group of people who directs and controls an organization at the highest level.
TraceabilityThe ability to trace the history, application, or location of an object.
ValidationThe confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled.
VerificationThe confirmation, through the provision of objective evidence, that specified requirements have been fulfilled.
Vision The aspiration of what an organization would like to become as expressed by top management.
Work EnvironmentThe set of conditions under which work is performed.

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