If you are searching for the explanation of certain terms our extensive Glossary will help you. The glossary is sorted alphabetical and offers short, concise definitions for fast information.
systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled. Internal audits, sometimes called first-party audits, are conducted by, or on behalf of, the organization itself for internal purposes and can form the basis for an organization?? self-declaration of conformity External audits include what are generally termed "second-" or "third-party audits". Second-party audits are conducted by parties having an interest in the organization, such as customers, or by other persons on their behalf. Third-party audits are conducted by external independent organizations. Such organizations provide certification or registration of conformity with requirements such as those of ISO 9001 and ISO 14001. When quality and environmental management systems are audited together, this is termed a "combined audit". When two or more auditing organizations cooperate to audit a single auditee jointly, this is a "joint audit."
outcome of an audit provided by the audit team after consideration of the audit objectives and all audit findings.
result of the evaluation of the collected audit evidence against audit criteria. Audit findings can indicate either conformity or nonconformity with audit criteria set of one or more audits planned for a specific time frame and directed towards a specific purpose.
set of one or more audits planned for a specific time frame and directed towards a specific purpose.
organization being audited.
person with the competence to conduct an audit capability ability of an organization, system or process to realize a product that will fulfill the requirements for that product. Process capability terms in the field of statistics are defined in ISO 3534-2.
distinguishing feature. A characteristic can be inherent or assigned. There are various classes of characteristic, such as the following: physical (e. g. mechanical, electrical, chemical or biological characteristics); sensory (e. g. related to smell, touch, taste, sight, hearing); behavioral (e. g. courtesy, honesty, veracity); temporal (e. g. punctuality, reliability, availability); ergonomic (e. g. physiological characteristic, or related to human safety); Functional (e. g. maximum speed of an aircraft).
term used to describe the availability performance and its influencing factors: reliability performance, maintainability performance, and maintenance support performance. Dependability is used only for genera descriptions in non-quantitative terms. [IEC 60050-191:1990]
demonstrated ability to apply knowledge and skills dependability.
permission to use or release a product that does not conform to specified requirements. A concession is generally limited to the delivery of a product that has nonconforming characteristics within specified limits for an agreed time or quantity of that product.
recurring activity to increase the ability to fulfill requirements. The process of establishing objectives and finding opportunities for improvement is a continual process through the use of audit findings and audit conclusions, analysis of data, management reviews or other means and generally leads to corrective action or preventive action
action to eliminate a detected nonconformity. A correction can be made in conjunction with a corrective action. A correction can be, for example, rework
action to eliminate the cause of a detected nonconformity or other undesirable situation. There can be more than one cause for a nonconformity. Corrective action is taken to prevent recurrence whereas preventive action is taken to prevent occurrence. There is a distinction between correction and corrective action.
Customer - organization or person that receives a product. Consumer, client, end-user, retailer, beneficiary and purchaser. A customer can be internal or external to the organization.
relationship between the result achieved and the resources used.
category or rank given to different quality requirements for products, processes or systems having the same functional use. Class of airline ticket and category of hotel in a hotel guide. When establishing a quality requirement, the grade is generally specified.
person or group having an interest in the performance or success of an organization. Customers, owners, people in an organization, suppliers, bankers, unions, partners or society. A group can comprise an organization, a part thereof, or more than one organization.
coordinated activities to direct and control an organization. In English, the term "management" sometimes refers to people, i.e. a person or group of people with authority and responsibility for the conduct and control of an organization. When "management" is used in this sense it should always be used with some form of qualifier to avoid confusion with the concept "management" defined above. For example, "management shall..." is deprecated whereas "top management shall..." is acceptable.
set of operations required to ensure that measuring equipment conforms to the requirements for its intended use. Metrological confirmation generally includes calibration or verification, any necessary adjustment or repair, and subsequent recalibration, comparison with the metrological requirements for the intended use of the equipment, as well as any required sealing and labeling. Metrological confirmation is not achieved until and unless the fitness of the measuring equipment for the intended use has been demonstrated and documented. The requirements for the intended use include such considerations as range, resolution, maximum permissible errors, etc. Metrological confirmation requirements are usually distinct from and are not specified in product requirements.
non-fulfillment of a requirement.
action to eliminate the cause of a potential nonconformity or other undesirable potential situation. There can be more than one cause for a potential nonconformity. Preventive action is taken to prevent occurrence whereas corrective action is taken to prevent recurrence.
specified way to carry out an activity or a process. Procedures can be documented or not. When a procedure is documented, the term "written procedure" or "documented procedure" is frequently used. The document that contains a procedure can be called a "procedure document."
set of interrelated or interacting activities which transform inputs into outputs. Inputs to a process are generally outputs of other processes. Processes in an organization are generally planned and carried out under controlled conditions to add value. A process where the conformity of the resulting product cannot be readily or economically verified is frequently referred to as a "special process".
result of a process. There are four generic product categories, as follows:
• services (e. g. transport);
• software (e. g. computer program, dictionary);
• hardware (e. g. engine mechanical part);
• Processed materials (e. g. lubricant). Many products comprise elements belonging to different generic product categories. Whether the product is then called service, software, hardware or processed material depends on the dominant element. For example the offered product "automobile" consists of hardware (e.g. tires), processed materials (e.g. fuel, cooling liquid), software (e.g. engine control software, driver's manual), and service (e.g. operating explanations given by the salesman). Service is the result of at least one activity necessarily performed at the interface between the supplier and customer and is generally intangible. Provision of a service can involve, for example, the following:
• an activity performed on a customer-supplied tangible product (e.g. automobile to be repaired);
• an activity performed on a customer-supplied intangible product (e. g. the income statement needed to prepare a tax return);
• the delivery of an intangible product (e. g. the delivery of information in the context of knowledge transmission);
Service is the creation of ambience for the customer (e. g. in hotels and restaurants). Software consists of information and is generally intangible and can be in the form of approaches, transactions or procedure. Hardware is generally tangible and is a countable characteristic. Processed materials are generally tangible and their amount is a continuous characteristic. Hardware and processed materials often are referred to as goods. Quality assurance is mainly focused on intended product.
unique process, consisting of a set of coordinated and controlled activities with start and finish dates, under taken to achieve an objective conforming to specific requirements, including the constraints of time, cost and resources. An individual project can form part of a larger project structure. In some projects the objectives are refined and the product characteristics defined progressively as the project proceeds. The outcome of a project may be one or several units of product. Adapted from ISO 10006:1997.
degree to which a set of inherent characteristics fulfils requirements. The term "quality" can be used with adjectives such as poor, good or excellent. "Inherent", as opposed to "assigned", means existing in something, especially as a permanent characteristic.
Characteristic - inherent characteristic of a product, process or system related to a requirement. Inherent means existing in something, especially as a permanent characteristic. A characteristic assigned to a product, process or system (e.g. the price of a product, the owner of a product) is not a quality characteristic of that product, process or system.
part of quality management focused on fulfilling quality requirements.
part of quality management focused on increasing the ability to fulfill quality requirements. The requirements can be related to any aspect such as effectiveness efficiency or traceability.
coordinated activities to direct and control an organization with regard to quality. Direction and control with regard to quality generally includes establishment of the quality policy and quality objectives, quality planning, quality control, quality assurance and quality improvement.
Quality Management System (QMS)
management system to direct and control an organization with regard to quality.
document specifying the quality management system of an organization. Quality manuals can vary in detail and format to suit the size and complexity of an individual organization.
something sought, or aimed for, related to quality. Quality objectives are generally based on the organization's quality policy. Quality objectives are generally specified for relevant functions and levels in the organization.
document specifying which procedures and associated resources shall be applied by whom and when to a specific project, product, process or contract. These procedures generally include those referring to quality management processes and to product realization processes. A quality plan often makes reference to parts of the quality manual or to procedure documents. A quality plan is generally one of the results of quality planning
overall intentions and direction of an organization related to quality as formally expressed by top management. Generally the quality policy is consistent with the overall policy of the organization and provides a framework for the setting of quality objectives. Quality management principles presented in this International Standard can form a basis for the establishment of a quality policy.
alteration of the grade of a nonconforming product in order to make it conform to requirements differing from the initial ones.
document stating results achieved or providing evidence of activities performed. Records can be used, for example, to document traceability and to provide evidence of verification preventive action and corrective action. Generally records need not be under revision control.
activity undertaken to determine the suitability, adequacy and effectiveness of the subject matter to achieve established objectives. Review can also include the determination of efficiency. Examples include: management review, design and development review, review of customer requirements and nonconformity review. Rework, action on a nonconforming product to make it conform to the requirements. Unlike rework, repair can affect or change parts of the nonconforming product.
document stating requirements. A specification can be related to activities (e. g. procedure document, process specification and test specification), or products (e. g. product specification, performance specification and drawing). System - set of interrelated or interacting elements.
person who provides specific knowledge of or expertise on subject to be audited. Specific knowledge or expertise includes knowledge of or expertise on the organization, process or activity to be audited, as well as language or cultural guidance. A technical expert does not act as an auditor in the audit team.
ability to trace the history, application or location of that which is under consideration. When considering product, traceability can relate to:
• the origin of materials and parts,
• the processing history, and
• the distribution and location of the product after delivery. In the field of metrology the definition in VIM:1993, 6.10, is the accepted definition.
confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled. The term "validated" is used to designate the corresponding status. The use conditions for validation can be real or simulated.
confirmation, through the provision of objective evidence, that specified requirements have been fulfilled. The term "verified" is used to designate the corresponding status. Confirmation can comprise activities such as: Performing alternative calculations, Comparing a new design specification with a similar proven design specification, undertaking tests and demonstrations