Quality Definitions



audit - systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled

auditeeorganization being audited

auditor – person with the competence to conduct an audit

audit client - organization or person requesting an audit

audit conclusion - outcome of an audit provided by the audit team after consideration of the audit objectives and all audit findings

audit criteria - set of policies, procedures or requirements used as a reference

audit evidence - records , statements of fact or other information which are relevant to the audit criteria and verifiable

audit findings - results of the evaluation of the collected audit evidence against audit criteria

audit programme - set of one or more audit planned for a specific time frame and directed towards a specific purpose

audit team – one or more auditors conducting an audit

capability - ability of an organization, systems or process to realize a product that will fulfil the
requirements for that product

characteristic - distinguishing feature

competence – demonstrated ability to apply knowledge and skills

concession - permission to use or release a product that does not conform to specified requirements

conformity – fulfilment of a requirements

correction – action to eliminate a detected nonconformity

corrective action – action to eliminate the cause of a detected nonconformity or other undesirable situation

continual improvement - recurring activity to increase the ability to fulfil requirements

customer - organization or person that receives a product

customer satisfaction - customer’s perception of the degree to which the customer’s requirements have been fulfilled

dependability - collective term used to describe the availability performance and its influencing factors: reliability performance, maintainability performance and maintenance support performance

defect - non-fulfilment of a requirements related to an intended or specified use

design and development - set of processes that transforms requirements into specified characteristics or into the specification of a product, process or system

deviation permit – permission to depart from the originally specified requirements of a product prior to realization

documentinformation and its supporting medium

effectiveness - extent to which planned activities are realized and planned results achieved

efficiency - relationship between the result achieved and the resources used

grade – category or rank given to different quality requirements for products, processes or systems having the same functional use

information – meaningful data

infrastructure - system of facilities, equipment and services needed for the operation of an organization

inspection - conformity evaluation by observation and judgement accompanied as appropriate by measurement, testing or gauging

interested party – person or group having an interest in the performance or success of an organization

management - coordinated activities to direct and control an organization

management systemsystem to establish policy and objectives and to achieve those objectives

measurement control system - set of interrelated or interacting elements necessary to achieve metrological confirmation and continual control of measurement processes

measurement process – set of operations to determine the value of a quantity

measuring equipment - measuring instrument, software, measurement standard, reference material or auxiliary apparatus or combination thereof necessary to realize a measurement process

metrological characteristic - distinguishing feature which can influence the results of measurement

metrological confirmation - set of operations required to ensure that measuring equipment conforms to the requirements for its intended use

metrological function - function with organizational responsibility for defining and implementing the measurement control system

nonconformity - non-fulfilment of a requirements

objective evidence - data supporting the existence or verity of something

organization – group of people and facilities with an arrangement of responsibilities, authorities and relationships

organizational structure - arrangement of responsibilities, authorities and relationships between people

preventive action – action to eliminate the cause of a potential nonconformity or other undesirable potential situation
process - set of interrelated or interacting activities which transforms inputs into outputs

procedure - specified way to carry out an activity or a process

product – result of a process

project - unique processes , 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 process - process to demonstrate the ability to fulfil specified requirements

quality - degree to which a set of inherent characteristic fulfils requirements

quality assurance - part of quality management focused on providing confidence that quality requirements will be fulfilled

quality characteristic - inherent characteristics of a product, process or system related to a requirements

quality control - part of quality management focused on fulfilling quality requirements

quality improvement - part of quality management focused on increasing the ability to fulfil quality requirements

quality management - coordinated activities to direct and control an organization with regard to quality

quality management system - management system to direct and control an organization with regard to quality

quality manual - document specifying the quality management system of an organization

quality objective – something sought, or aimed for, related to quality

quality plan - document specifying which procedures and associated resources shall be applied by whom and when to a specific project, product, process or contract

quality planning - part of quality management focused on setting quality objectives and specifying necessary operational processes and related resources to fulfil the quality objectives

quality policy – overall intentions and direction of an organization related to quality as formally expressed by top management

record - document stating results achieved or providing evidence of activities performed

regrade - alteration of the grade of a nonconforming product in order to make it conform to requirements differing from the initial ones

release – permission to proceed to the next stage of a process

repair – action on a nonconforming product to make it acceptable for the intended use

requirement - need or expectation that is stated, generally implied or obligatory

review – activity undertaken to determine the suitability, adequacy and effectiveness of the subject matter to achieve established objectives

rework – action on a nonconforming product to make it conform to the requirements

scrap – action on a nonconforming product to preclude its originally intended use
specification - document stating requirements
supplier - organization or person that provides a product

system - set of interrelated or interacting elements

technical expert - person who provides specific knowledge of or expertise on the subject to be audited
test - determination of one or more characteristics according to a procedure

top management - person or group of people who directs and controls an organization at the highest level
traceability - ability to trace the history, application or location of that which is under consideration

validation - confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled

verification - confirmation, through the provision of objective evidence , that specified requirements have been fulfilled

work environment - set of conditions under which work is performed