ISO 9001 Lead Auditor Training

Glossary of ISO 9001 Auditing Terms

Appendix A  

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

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.
 
Quality - The degree to which a set of inherent characteristics fulfill requirements.

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

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 requirements.

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

Quality Management System - A 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 organization. 

Quality Objective - Something sought, or aimed for, related to quality. The objectives should be based on the quality policy of an organization. Another term for quality objective is quality target.
 
Quality Plan - A document specifying which procedures and associated resources shall to be applied by whom and when 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 the quality objectives.

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

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

Release - The permission to proceed to the next stage of a process.

Repair - The action 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 - An activity undertaken to ensure the suitability, adequacy, and effectiveness of the subject matter to achieve established objectives.

Rework - The action on a nonconforming product to make it conform to the requirements.
 
Scrap - The action on a nonconforming product to preclude its originally intended usage.

ISO 9001 Lead Auditor Terms - Continued

Specification - A document stating requirements.

Supplier - The person or organization that provides a product.

System - A set of interrelated or interacting elements.

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

Top Management - The person or group of people who direct and control 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 work is performed.

The following additional definitions are offered for guidance during this course:

Accreditation - The act whereby, for example, the Registrar Accreditation Board (RAB) approves a Registrar (within a defined scope) to operate an assessment and registration scheme and licenses that body to use a special RAB logo on certificates issued within the scope of accreditation.

Audit Scope - The extent and boundaries of a given audit.

Calibration - All the operations for the purpose of determining the values of errors of inspection, measuring or test equipment, and if necessary, to determine other metrological properties.

Registration - The authoritative act of documenting conformity with agreed requirements.

ISO Acronym - from the Greek “isos” (equal to) adopted by the International Organization for Standardization.

Registrar - An independent, accredited, third party organization that conducts assessments of a company’s quality management system to ensure it conforms to requirements. Now also known as a Certification Body.

Registration - When a quality management system conforms to ISO 9001, the registrar issues a certificate of registration and places the company’s name in a directory of registered firms.

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

Qualified Auditor - A combination of interacting personal attributes and education, training, work and audit experience, and areas of competence that need to be demonstrated to enable a person to be appointed as an auditor.

Quality Requirement - A requirement for inherent characteristics of a product, process, or system. 

"Understanding ISO 9001" provides a detailed explanation of each ISO 9001 clause (requirements).

ISO 9001 FAQ provides answers to commonly asked questions about the ISO 9000 family of quality management standards.