This text is from the second edition of ISO 9001, The Standard Companion. It is based on the now obsolete 1987 version of the ISO 9001 Standard. The third edition, based on the current 1994 standard, is available from Simply Quality.

Glossary and Index

Many terms used in the Standard either have specialized meanings or are unfamiliar to people newly involved with quality systems and standards. This glossary clarifies the terms used in this manual. Terms defined in this glossary are indicated by use of italics. To provide an index, the page number where the topic is discussed in the text appears immediately after selected terms.

Audit: See Quality Audit.

Auditor: A person who is qualified to carry out a Quality Audit.

Calibration: 16, Adjusting a measuring instrument to make it accurate. The set of operations which establish, under specified conditions, the relationship between values indicated by a measuring instrument or measuring system and the corresponding values of a quantity realized by a reference standard.

Concession: 18, Use of known bad materials or sale of known bad product or a rebate given in return for accepting bad product. Written authorization to use or release a quantity of material, components or stores already produced but which do not conform to the specified requirements.

Controlled Orderly, repeatable, manageable, predictable.

Defect The nonfulfilment of intended use requirements.

Design Input 10, Design objectives, typically provided in the form of product performance specifications, product descriptions with specifications relating to configuration, composition, incorporated elements and other design features.

Design Output 10, The end result of the design activity, such as drawings, specifications, instructions, computer programs or other software or servicing procedures.

Design Review 10, A formal, documented, comprehensive and systematic examination of a design to evaluate the design requirements and the capability of the design to meet these requirements and to identify problems and propose solutions.

Gantt Chart 9, A bar chart that depicts project progress or planned tasks in relation to time. It is often used in planning or tracking a project.

Inspection 15, Activities such as measuring, examining, testing, gauging one or more characteristics of a product or service and comparing these with specified requirements to determine conformity.

Management Representative 7, The person with the defined authority and responsibility to carry out the requirements of ISO 9001.

Noncompliance A deviation from the requirements of the Standard.

Nonconformity 17, The nonfulfilment of specified requirements.

Objective Evidence 21, Qualitative or quantitative information, records or statements of fact pertaining to the quality of an item or service or to the existence and implementation of a quality system element, which is based on observation, measurement or test and which can be verified.

Procedural Manual 8, A written description of what operations are to be performed to carry out a particular process.

Procedure See Procedural Manual.

Process A series of steps resulting in an output e.g. a product.

Process Control 13, A system of measurements and actions within a process intended to insure the output of the process conforms with pertinent specifications.

Quality The totality of features and characteristics of a product or service that bear on its ability to satisfy stated or implied needs.

Quality Assurance All those planned and systematic actions necessary to provide adequate confidence that a product or service will satisfy given requirements for quality.

Quality Audit 20, A systematic and independent examination to determine whether quality activities and related results comply with planned arrangements. The audit also determines whether these arrangements are implemented effectively and are suitable to achieve objectives.

Quality Control The operational techniques and activities that are used to fulfill requirements for quality.

Quality Management That aspect of the overall management function that determines and implements the quality policy. Notes: 1) The attainment of desired quality requires the commitment and participation of all members of the organization whereas the responsibility for quality management belongs to top management. 2) Quality management includes strategic planning, allocation of resources and other systematic activities for quality, such as quality planning, operations and evaluations.

Quality Manual 8, The top level document defining the Quality System.

Quality Plan A document setting out the specific quality practices, resources and sequence of activities relevant to a particular product, service, contract or project.

Quality Policy 6, The overall intentions and direction of an organization regarding quality, as formally expressed by top management.

Quality Records 20, Written records that are retained in accordance with the requirements of Section 4.16 of ISO 9001.

Quality System 6, The organizational structure, responsibilities, procedures, processes and resources for implementing quality management.

Registration A certification, made by an accredited registration agency, declaring that the processes in an organization comply with the requirements of ISO 9000.

Registration Agency An organization, accredited by a registration board, authorized to provide registration of client companies.

Registration Audit A comprehensive quality audit, conducted by a registration agency, for the purposes of establishing registration of an organization.

Responsibility Being obliged to answer, as for one's actions, to an authority that may impose a penalty for failure.

Special Processes 14, Processes used in the production of products whose quality cannot be fully verified later by nondestructive inspection of the product. Examples include welding, soldering, heat treating or plating metal, forming plastic, baking foods, writing software or writing a legal document.

Specifications The documents that prescribe the requirements with which the product or service has to conform. Note: A specification would refer to or include drawings, patterns or other relevant documents and should also indicate the means and the criteria whereby conformity can be checked.

Standard An acknowledged measure of comparison for quantitative or qualitative value; a criterion, especially ISO 9000, ISO 9001 or a related Standard.

System A group of interacting, interrelated, or interdependent elements forming a complex whole. An organized set of interrelated ideas or principles. See Quality System.

Traceability 13, The ability to trace the history, application or location of an item or activity by means of recorded identification.

Verification 7, Reviewing, inspecting, testing, checking, auditing, or otherwise establishing and documenting whether items, processes, or services, or documents conform to specified requirements.

Waiver See concession

Work Instructions 8, A written description of how to carry out the operations of a particular process.

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