Glossary

 
These definitions are based on terms listed in ISO 9000:2005 (Fundamentals and Vocabulary) and ISO 19011:2002 (Guidelines for Quality and/or Environmental Systems Auditing). For complete definitions, you can order these documents from the American Society for Quality. Visit their web site at www.asq.org.

Audit

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

Audit Client

The organization or person requesting an audit.

Audit Conclusion

The outcome of an audit provided by the audit team after consideration of all the audit findings.

Audit Criteria

The set of policies, procedures, or requirements determined as a reference.

Audit Evidence

The records, statements of fact, or other information relevant to the agreed criteria and which can be cross-checked.

Audit Findings

The results of the evaluation of collected audit evidence against audit criteria.

Audit Plan

The description of the activities and arrangements for an audit.

Audit Program

A set of one or more audits planned for a specific timeframe and directed towards a specific purpose.

Audit Scope

The extent and boundaries of an audit.

Audit Team

One or more auditors conducting an audit, supported if needed by technical experts.

Auditee

The organization being audited.

Auditor

A person appointed to conduct an audit.

Capability

The ability of an organization, system, or process to realize a product that will fulfill the requirements for that product.

Characteristic

A 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., safeety); and functional (e.g., speed).

Competence

The demonstrated ability to apply knowledge and skills.

Concession

Permission to use or release a product that does not conform to specified requirements.

Conformity

The fulfillment of a requirement.
Continual Improvement The recurring activity to increase the ability to fulfill requirements.

Contract

A binding agreement.

Correction

The action taken to eliminate a detected nonconformity.

Corrective Action

The action taken to eliminate the cause of a detected nonconformity or other undesirable situation.

Customer

An organization or person that receives a product.

Customer Satisfaction

A customer’s perception of the degree to which the customer’s requirements have been fulfilled.

Defect

The nonfulfillment of a requirement related to an intended or specified use.

Dependability

The totality of characteristics related to the availability performance and its influencing factors: reliability, maintainability, and support.

Design and Development

The set of processes that transform requirements into specified characteristics or into the specification of a product, process, or system.

Document

Information and its supporting medium. A set of documents is often called documentation.

Deviation Permit

Permission to depart from the originally specified requirementsof a product prior to realization.

Effectiveness

The extent to which planned activities are realized and planned results achieved.

Efficiency

The relationship between the result achieved and the resources used.

Grade

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

Guideline

A document stating recommendations or suggestions.

Information

Meaningful data.

Infrastructure

The system of facilities, equipment, and services needed for the operation of an organization.

Inspection

The conformity evaluation by observation and judgement accompanied as appropriate by measurement, testing, or gauging.

Interested Party

A 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.

Management

The coordinated activities to direct and control an organization.

Management System

The set of interrelated or interacting elements to establish policy and objectives and to achieve those objectives.

Measurement Process

The set of operations to determine the value of a quantity.

Measurement Management System

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

Measuring Equipment

The measuring instrument, software, measurement standard, reference material or auxilliary apparatus, or a combination thereof, necessary to realize a measurement process.

Metrological Characteristic

The distinguishing feature which can influence the results of measurement.

Metrological Confirmation

The set of operations required to ensure that measuring equipment conforms to the requirements for its intended use.

Nonconformity

The nonfulfillment of a requirement.

Objective Evidence

The data supporting the existence or verity of something. It may be obtained through observation, measurement, test, or other means.

Organization

The group of people and facilities with an arrangement of responsibilities, authorities, and relationships.

Organizational Structure

The arrangeent of of responsibilities, authorities, and relationships between people.

Preventive Action

The action taken to eliminate the cause of a potential nonconformity or other potentially undesirable situation.

Procedure

The specified way to carry out an activity or a process.

- purpose

The reason for the procedure. It is important to know the objective of the document and why the reader should follow the process.

- scope

The boundaries of the procedure. It describes which activities are covered and the applicability of the document to functional areas.

- responsibilities

The roles and authority for process users and process managers organized by job titles.

- references

A list of related documents mentioned in the Process section.

- process

A description of the logical sequence of activities to perform a procedure. Covers what, when, where, and by whom.

- records

The information and data saved during the process for use in other processes and as proof of compliance to requirements.

Process

A set of interrelated or interacting activities which transform inputs into outputs.

Product

The result of a process.

Project

A 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 Process

The process to demonstrate the ability to fulfill specified requirements.

Quality

The degree to which a set of inherent characteristics fulfills requirements.

Quality Assurance

The part of quality management focused on providing confidence that quality requirements will be fulfilled.

Quality Characteristic

The inherent characterisitic of a product, process, or system related to a requirements.

Quality Control

The part of quality management focused on fulfilling quality requirements.

Quality Improvement

The part of quality management focused on increasing the ability to fulfill quality requirements.

Quality Management

The coordinated activities to direct and control an organization with regard to quality.

Quality Management System

The management system to direct and control an organization with regard to quality.

Quality Manual

A 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 Objective

Something 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 Plan

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

Quality Planning

The part of quality management focused on setting quality objectives and specifying necessary operational processes and related resources to fulfill quality objectives.

Quality Policy

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

Quality Surveillance

The frequent or constant monitoring and verification of the status of an entity and analysis of records to ensure specified requirements are being fulfilled.

Record

A document stating results achieved or providing evidence of activities performed.

Registrar

A third party organization (Certification Body) that conducts independent audits of a company’s quality system to ensure it conforms to requirements.

Registration

When 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.

Repair

The action taken on a nonconforming product to make it acceptable for the intended usage.

Requirement

A need or expectation that is stated, generally implied, or obligatory.

Review

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

Rework

The action taken on a nonconforming product to make it conform to the requirements.

Scope

The scope of registration defines the company sites, product lines, and operations covered by an ISO 9001 certificate.

Scrap

The action taken on a nonconforming product to preclude its originally intended usage.

Service

An intangible product that is the result of at least one activity performed at the interface between the supplier and the customer.

Software

The intellectual product consisting of information on a support medium. A computer program is an example of software.

Specification

A document stating requirements.

Supplier

The organization or person that provides a product.

System

A set of interrelated or interacting elements.

Technical Expert

The person who provides specific knowledge or expertise to the audit team.

Test

The determination of one or more characteristics according to a specified procedure.

Top Management

The person or group of people who directs and controls an organization at the highest level.

Traceability

The ability to trace the history, application, or location of that which is under consideration.

Validation

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

Verification

The confirmation, through the provision of objective evidence, that specified requirements have been fulfilled.

Work Environment

The set of conditions under which work is performed.

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