Glossary

These definitions are based on terms listed in ISO 9000:2005 (Fundamentals and Vocabulary) and ISO 19011:2011 (Guidelines for Auditing Management Systems). For complete definitions, you can order these documents from the American Society for Quality. Visit their web site at www.asq.org.

AuditA systematic, independent, and documented process for obtaining 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 audit evidence is compared.
Audit EvidenceThe records, statements of fact, or other information relevant to the audit criteria and 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 audit.
Audit PlanThe description of the activities and arrangements for an audit.
Audit ProgramThe arrangeents for a 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.
AuditorA person who conducts an audit.
CapabilityThe ability of an organization, system, or process to realize a product that will fulfill the requirements for that product.
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).
CompetenceThe ability to apply knowledge and skills to achieve intended results.
ConcessionPermission to use or release a product that does not conform to specified requirements.
ConformityThe fulfillment of a requirement.
Continual ImprovementThe recurring activity to increase the ability to fulfill requirements.
ContractA binding agreement.
CorrectionThe action taken to eliminate a detected nonconformity.
Corrective ActionThe action taken to eliminate the cause of a detected nonconformity or other undesirable situation.
CustomerAn organization or person that receives a product.
Customer SatisfactionA customer’s perception of the degree to which the customer’s requirements have been fulfilled.
DefectThe nonfulfillment of a requirement related to an intended or specified use.
DependabilityThe totality of characteristics related to the availability performance and its influencing factors: reliability, maintainability, and support.
Design and DevelopmentThe set of processes that transform requirements into specified characteristics or into the specification of a product, process, or system.
DocumentInformation and its supporting medium. A set of documents is often called documentation.
Deviation PermitPermission to depart from the originally specified requirementsof a product prior to realization.
EffectivenessThe extent to which planned activities are realized and planned results achieved.
EfficiencyThe relationship between the result achieved and the resources used.
GradeThe category or rank given to different quality requirements for products, processes, or systems having the same functional use.
GuidelineA document stating recommendations or suggestions.
InformationMeaningful data.
InfrastructureThe system of facilities, equipment, and services needed for the operation of an organization.
InspectionThe conformity evaluation by observation and judgement accompanied as appropriate by measurement, testing, or gauging.
Interested PartyA person or group having an interest in the performance or success of an organization, for example, customers, owners, employees, suppliers, bankers, unions, partners, and society.
ManagementThe coordinated activities to direct and control an organization.
Management SystemA system to establish policy and objectives and 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 continual 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.
NonconformityThe nonfulfillment of a requirement.
Objective EvidenceThe data supporting the existence or verity of something. It may be obtained through observation, measurement, test, or other means.
OrganizationThe group of people and facilities with an arrangement of responsibilities, authorities, and relationships.
Organizational StructureThe arrangeent of of responsibilities, authorities, and relationships between people.
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 which transform inputs into outputs.
ProductThe result of a process.
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.
Qualification ProcessThe process to demonstrate the ability to fulfill specified requirements.
QualityThe degree to which a set of inherent characteristics fulfills requirements.
Quality AssuranceThe part of quality management focused on providing confidence that quality requirements will be fulfilled.
Quality CharacteristicThe inherent characterisitic of a product, process, or system related to a requirements.
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 coordinated activities to direct and control an organization with regard to quality.
Quality Management SystemThe management system to direct and control an organization with regard to quality.
Quality ManualA document specifying the quality management system of an organization. They vary in detail and format to suit the size and complexity of an individual organization.
Quality ObjectiveSomething sought, or aimed for, related to quality. The objectives are generally based on the quality policy of an organization and specified for relevant functions and levels in the organization.
Quality PlanA document specifying which procedures and associated resources shall be applied by when and by whom to a specific project, product, process, or contract.
Quality PlanningThe part of quality management focused on setting quality objectives and specifying necessary operational processes and related resources to fulfill 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 quality system to ensure it conforms to requirements.
RegistrationWhen a quality system complies with the applicable standard, the registrar issues a certificate of registration and places the company’s name in a directory of registered firms.
RepairThe action taken on a nonconforming product 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 taken on a nonconforming product 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 to preclude its originally intended usage.
ServiceAn intangible product that is the result of at least one activity performed at the interface between the supplier 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.
SupplierThe organization or person that provides a product.
SystemA set of interrelated or interacting elements.
Technical ExpertThe person who provides specific knowledge or expertise to the audit team.
TestThe determination of one or more characteristics according to a specified procedure.
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 that which is under consideration.
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.
Work EnvironmentThe set of conditions under which work is performed.

 

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