NQA * USA :: Glossary of Terms

The following Glossary was compiled from various sources and includes many of the terms most commonly used by, or in discussions of, the international ISO 9001:2000 quality system standard. It is written in layman's terms and some definitions may thus differ slightly from those provided in ISO and IAF guidance documents. More information may be found on the AIR "Q & A" (Frequently Asked Questions) and "Useful Links" pages. Your comments and suggestions are encouraged.

Audit (also: Assessment):

A systematic and independent examination to determine whether quality activities are suitably implemented, effective, and compliant with planned arrangements.

Auditor (also: Assessor):

A person who has the appropriate education and experience to be qualified to carry out an Audit. (also see "Lead Auditor")

Calibration:

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 identified by a recognized standard.

Certification (also: Registration):

The issuance of a written declaration by a third party, stating that the quality management system of an organization has been examined and found to comply with the requirements of a specified quality or environmental standard.

Compliance (also: Conformity):

The fulfilment of specified requirements.

Controlled:

Managed so as to be consistent, orderly and predictable.

Defect:

A failure to meet requirements for intended use.

Document (also: Documentation):

Information and its supporting medium. Documents may exist in hard copy (such as a written document, photograph or chart, or electronic (such as a CD or data on a computer).

Inspection:

Activities such as measuring, examining, and testing the characteristics of a product or service and comparing these with specified requirements to determine conformity.

Lead Auditor (also: Lead Assessor):

A person who is qualified to lead an Audit. Lead Auditors generally have more experience and must satisfy more requirements than "regular" Auditors. (also see "Auditor")

Non-conformance (also: Non-conformity):

Failure to meet specified requirements.

Objective Evidence:

Verifiable information or records pertaining to the quality of an item or service or to the existence of a quality system element which is based on observation, measurement or test.

Organization:

In ISO 9001:2000, a company that has a quality management system for providing products or services. (Formerly known as ÒsupplierÓ in ISO 9000:1994).

Procedure:

A specified way to carry out an activity or a process (Procedures may or may not be documented)

Procedures Manual:

A written description of the operations that are performed to carry out activities or processes.

Process:

An activity or series of activities* resulting in an output such as a product or service. *One process often serves as the input to other processes.

Process Control:

Measurements or actions taken to insure a process and its output conforms with stated specifications.

Quality:

The characteristics of a product or service that determine its ability to meet stated or implied requirements.

Quality Control:

The activities that are used to measure and fulfill requirements for quality.

Quality Manual:

A document describing the quality management system of an organization.

Quality Plan:

A document defining the practices, resources and sequence of activities required to achieve a particular outcome, product, or service.

Quality System:

The organizational structure, activities, responsibilities and resources for implementing quality management.

Record:

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

Registration (also: Certification):

A declaration made by a third party, stating that the quality management system of an organization has been examined and found to comply with the requirements of a specified quality or environmental standard.

Registrar:

A qualified, independent and impartial organization that provides registration services.

Scope:

A description of the activities of an organization, i.e. what a company does. ISO requires a company's scope description to be comprehensive and to list any exclusions. Scopes are also used to describe the qualifications of Auditors and are used to determine the types of businesses that an Auditor is qualified to audit.

Special Processes:

Processes whose results cannot be fully verified by nondestructive testing and thus require validation in actual use.

Specification:

A document stating requirements.

Supplier:

In ISO 9001:2000 a company that provides products or services to an organization. (Formerly referred to as the ÒsubcontractorÓ in ISO 9000:1994).

Traceability:

The ability to trace the use, history, or location of an item or activity by means of recorded information.

Work Instructions:

A written description of how to perform a particular activity.