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Terms and Definitions (Ref: ISO 9000:2005)

Sl. Terms No. Systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled. Organization or person requesting an audit. Outcome of an audit provided by the audit team after consideration of the audit objectives and all audit findings. Set of policies, procedures or requirements used as a reference. Records, statements of fact or other information which are relevant to the audit criteria and verifiable. Results of the evaluation of the collected audit evidence against audit criteria. Description of the activities and arrangements for an audit. Set of one or more audits planned for a specific time frame and directed towards a specific purpose. Extent and boundaries of an audit. One or more auditors conducting an audit, supported if needed by technical experts. Organization (person) being audited. Person with the demonstrated personal attributes and competence to conduct an audit. Ability of an organization, system or process to realize a product that will fulfill the requirements for that product. Distinguishing feature. Demonstrated personal attributes and demonstrated ability to apply knowledge and skills. Permission to use or release a product that does not conform to specified requirements. Fulfillment of a requirement. Recurring activity to increase the ability to fulfill requirements. Binding agreement. Action to eliminate a detected nonconformity. Definitions

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Audit

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Audit Client Audit conclusion Audit criteria Audit evidence

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Audit findings Audit Plan Audit Programme Audit Scope Audit Team

Auditee Auditor

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Capability Characteristic Competence

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Concession Conformity Continual Improvement Contract Correction

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Terms and Definitions (Ref: ISO 9000:2005)


Action to eliminate the cause of a detected nonconformity or undesirable potential situation. Organization or person that receives a product. 22 Customer (Example: Consumer, client, end-user, retailer, beneficiary and purchaser.) Customers perception of the degree to which the customers requirements have been fulfilled. Non-fulfillment of a requirement related to an intended or specified use Collective term used to describe the availability performance and its influencing factors: reliability performance, maintainability performance and maintenance support performance. Set of processes, that transforms requirements into specified characteristics or into the specification of a product, process or system. Permission to depart from the originally specified requirements of a product prior to realization. Information and its supporting medium. Extent to which planned activities are realized and planned results achieved. Relationship between result achieved and resources used. Category or rank given to different quality requirements for products, processes or systems having the same functional use. Meaningful data. System of facilities, equipment and services needed for the operation of an organization. Conformity evaluation by observation and judgment accompanied as appropriate by measurement, testing or gauging. Person or group having an interest in the performance or success of an organization. Coordinated activities to direct and control an organization. System to establish policy and objectives and to achieve those objectives. Set of interrelated and interacting elements necessary to achieve metrological confirmation and continual control of measurement processes. Set of operations to determine the value of a quantity. Page: 2 of 5
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Corrective Action

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Customer Satisfaction

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Defect

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Dependability

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Design and development Deviation Permit

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Document Effectiveness Efficiency Grade Information Infrastructure

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Inspection Interested Party

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Management Management System

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Measurement Management System Measurement Process

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Terms and Definitions (Ref: ISO 9000:2005)


Measuring instrument, software, measurement standard, reference material or auxiliary apparatus or combination thereof necessary to realize a measurement process. Distinguishing feature which can influence the results of measurement. Set of operations required to ensure that measuring equipment conforms to the requirements for its intended use. Function with administrative and technical responsibility for defining and implementing the measurement management system. Non-fulfillment of a requirement. Data supporting the existence or verity of something. Group of people and facilities with an arrangement of responsibilities, authorities and relationships. Arrangement of responsibilities, authorities and relationships between people. Action to eliminate the cause of a potential nonconformity or undesirable potential situation. Specified way to carry out an activity or a process. Set of interrelated or interacting activities, which transforms inputs into outputs. The systematic identification and management of the processes employed within an organization and particularly the interactions between, such processes, is referred to as the process approach. Result of a process. 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. Process to demonstrate the ability to fulfill specified requirements. Degree to which a set of inherent characteristics fulfills requirements. Part of quality management focused on providing confidence that quality requirements will be fulfilled Inherent characteristic of a product, process or system related to a requirement.

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Measuring Equipment

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Metrological Characteristic Metrological Confirmation

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Metrological Function

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Nonconformity Objective Evidence Organization Organizational Structure Preventive Action Procedure Process

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Process Approach

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Product

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Project

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Qualification Process Quality

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Quality Assurance

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Quality Characteristic

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Terms and Definitions (Ref: ISO 9000:2005)


Part of quality management focused on fulfilling quality requirements Part of quality management focused on increasing the ability to fulfill quality requirements. Coordinated activities to direct and control an organization with regard to quality Management system to direct and control an organization with regard to quality. Document specifying the Quality Management System of an Organization. Something sought, or aimed for, related to quality. Document specifying which procedures and associated resources shall be applied by whom and when to a specific project, product, process or contract. Part of quality management focused on setting quality objectives and specifying necessary operational processes and related resources to fulfill the quality objectives Overall intentions and direction of an organization related to quality as formally expressed by top management. Document stating results achieved or providing evidence of activities performed. Alteration of the grade of a nonconforming product in order to make it conform to requirements differing from the initial ones. Permission to proceed to the next stage of a process. Action on nonconforming product to make it acceptable for intended use. Need or expectation that is stated, generally implied or obligatory. Activity undertaken to determine the suitability, adequacy and effectiveness of the subject matter to achieve established objectives. Action on nonconforming product to make it conform to the requirements. Action on a nonconforming product to preclude its originally intended use. A process where the conformity of the resulting product cannot be readily or economically verified is frequently referred to as a special process.

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Quality Control

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Quality Improvement

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Quality Management Quality Management System Quality Manual Quality Objective

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Quality Plan

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Quality Planning

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Quality Policy

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Record

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Re-grade Release Repair Requirement

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Review

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Rework

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Scrap

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Special Process

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Terms and Definitions (Ref: ISO 9000:2005)


75 Specification Document stating requirements. Organization or person that provides a product. 76 Supplier (Example: Producer, distributor, retailer or vendor of a product, or provider of a service or information.) Set of interrelated or interacting elements. Person who provides specific knowledge or expertise to the audit team. Determination of one or more characteristics according to a procedure. Person or group of people, who, directs and control an organization at the highest level. Ability to trace the history, application or location of that which is under consideration. Confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled. Confirmation, through the provision of objective evidence, that specified requirements have been fulfilled. Set of conditions under which work is performed.

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System Technical Expert

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Test

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Top Management

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Traceability

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Validation

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Verification Work Environment

Ref: ISO 9004:2009 85 Sustained Success Result of the ability of an organization to achieve and maintain its objectives in the long term. Combination of internal and external factors and conditions that can affect the achievement of an organization's objectives and its behavior towards its interested parties.

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Organization's Environment

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