These definitions are based on terms listed in ISO 9000:2015 (Fundamentals and Vocabulary) and ISO 19011:2018 (Guidelines for Auditing Management Systems). For complete definitions and other concepts, you can order these standards from the American Society for Quality (ASQ), American National Standards Institute (ANSI), or International Organization for Standardization (ISO).
| Audit | A systematic, independent, and documented process for obtaining objective evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled. |
| Audit Client | The organization or person requesting an audit. |
| Audit Conclusion | The outcome of an audit, after consideration of the audit objectives and all audit findings. |
| Audit Criteria | The set of requirements used as a reference against which objective evidence is compared. |
| Audit Evidence | The records, statements of fact, or other information which are relevant to the audit criteria and verifiable. |
| Audit Findings | The results of the evaluation of the collected audit evidence against audit criteria. |
| Audit Guide | A person appointed by the auditee to assist the audit team. |
| Audit Observer | A person who accompanies the audit team, but does not act as an auditor. |
| Audit Plan | The description of the activities and arrangements for an audit. |
| Audit Program | The arrangements for 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 as a whole, or parts thereof, being audited. |
| Auditor | The person who conducts an audit. |
| Capability | The ability of an object to realize an output that will fulfill the requirements for that output. |
| Change Control | The activities for control of the output after formal approval of its product configuration information. |
| 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., safety); and functional (e.g., speed). |
| Combined Audit | An audit carried out together at a single auditee on two or more management systems. |
| Competence | The ability to apply knowledge and skills to achieve intended results. |
| Complaint | An expression of dissatisfaction made to an organization related to its product or service, or the complaints-handling process itself, where a response or resolution is explicitly or implicitly expected. |
| Concession | Permission to use or release a product or service that does not conform to specified requirements. |
| Configuration Management | The coordinated activities to direct and control a configuration (interrelated functional and physical characteristics of a product or service defined in product configuration information). |
| Conformity | The fulfillment of a requirement. |
| Continual Improvement | The recurring activity to enhance performance. |
| Context of the Organization | The combination of internal and external issues that can have an effect on an organization’s approach to developing and achieving its objectives. |
| 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 and to prevent recurrence. |
| Customer | A person or organization that could or does receive a product or a service that is intended for or required by this person or organization. |
| Customer Satisfaction | A customer’s perception of the degree to which the customer’s expectations have been fulfilled. |
| Defect | The nonfulfillment of a requirement related to an intended or specified use. |
| Dependability | The ability to perform as and when required.. |
| Design and Development | The set of processes that transform requirements for an object into more detailed requirements for that object. |
| Deviation Permit | Permission to depart from the originally specified requirements of a product or service prior to its realization. |
| Dispute | A disagreement, arising from a complaint submitted to a dispute resolution process provider. |
| Document | Information and the medium on which it is contained. The medium can be paper, magnetic, electronic or optical disk, photograph, or master sample. |
| Documented Information | The information required to be controlled and maintained by an organization and the medium on which it is contained. |
| Effectiveness | The extent to which planned activities are realized and planned results achieved. |
| Efficiency | The relationship between the result achieved and the resources used. |
| External Provider | An external supplier that is not part of the organization. |
| Feedback | The opinions, comments, and expressions of interest in a product, a service, or a complaints-handling process. |
| Grade | The category or rank given to different quality requirements for an object having the same functional use. |
| Guideline | A document stating recommendations or suggestions. |
| Human Factor | A characteristic of a person having an impact on an object under consideration. The characteristic can be physical, cognitive, or social. |
| Improvement | The activity to enhance performance. |
| Information | Meaningful data. |
| Infrastructure | The system of facilities, equipment, and services needed for the operation of an organization. |
| Innovation | A new or changed object realizing or redistributing value. |
| Inspection | The determination of conformity to specified requirements. |
| Interested Party | A person or organization that can affect, be affected by, or perceive itself to be affected by a decision or activity, for example, customers, owners, employees, suppliers, bankers, unions, partners, or society. |
| Joint Audit | An audit carried out at a single auditee by two or more auditing organizations. |
| Management | The coordinated activities to direct and control an organization. |
| Management System | A system to establish policies and objectives, and processes 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 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. |
| Mission | The organization’s purpose for existing as expressed by top management. |
| Monitoring | Determining the status of a system, a process, a product, a service, or an activity. |
| Nonconformity | The nonfulfillment of a requirement. |
| Objective | The results to be achieved. |
| Objective Evidence | The data supporting the existence or verity of something. It may be obtained through observation, measurement, test, or by other means. |
| Organization | The person or group of people that has its own functions with responsibilities, authorities, and relationships to achieve its objectives. |
| Organizational Structure | The arrangeent of of responsibilities, authorities, and relationships between people. |
| Output | The result of a process. |
| Performance | A measurable result. |
| Policy | The intentions and direction of an organization as formally expressed by its top management. |
| 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 that use inputs to deliver an intended result. |
| Product | The output of an organization that can be produced without any transaction taking place between the organization and the customer. |
| 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. |
| Provider | A supplier, for example, producer, distributor, retailer, or vendor of a product or a service. |
| Qualification Process | The process to demonstrate the ability to fulfill specified requirements. |
| Quality | The degree to which a set of inherent characteristics of an object 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 an object related to a requirement. |
| 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 management (coordinated activities to direct and control an organization) with regard to quality. |
| Quality Management System | The part of a management system with regard to quality. |
| Quality Manual | The specification for the quality management system of an organization. The manuals can vary in detail and format to suit the size and complexity of an individual organization. |
| Quality Objective | The result to be achieved related to quality. The objectives are generally based on the quality policy of an organization and specified for relevant functions, levels, and processes in the organization. |
| Quality Plan | The specification of the procedures and associated resources to be applied when and by whom to a specific object. |
| Quality Planning | The part of quality management focused on setting quality objectives and specifying necessary operational processes and related resources to achieve the 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 management system to ensure it conforms to requirements. |
| Registration | When a management system complies with the applicable standard, the registrar issues a certificate of registration. |
| Regulatory Requirement | An obligatory requirement specified by an authority mandated by a legislative body. |
| Release | The permission to proceed to the next stage of a process or the next process. |
| Repair | The action taken on a nonconforming product or service 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 on a nonconforming product or service to make it conform to the requirements. |
| Risk | The effect of uncertainty (on objectives). |
| 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 or service to preclude its originally intended usage, for example, recycling or destruction. For service, use is precluded by discontinuing the service. |
| Service | The output of an organization with at least one activity necessarily performed between the organization 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. |
| Statutory Requirement | An obligatory requirement specified by a legislative body. |
| Strategy | The plan to achieve a long-term or overall objective. |
| Success | The achievement of an objective. |
| Supplier | The organization or person that provides a product. |
| Sustained Success | Success over a period of time. |
| 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 according to requirements for a specific intended use or application. |
| 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 an object. |
| 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. |
| Vision | The aspiration of what an organization would like to become as expressed by top management. |
| Work Environment | The set of conditions under which work is performed. |
