Quality Management System (QMS) Terms and Definitions

TERMS AND DEFINITIONS (138)

?1.???????? Terms related to person or PEOPLE (6)

2.???????? Terms related to ORGANIZATION (9)

3.???????? Terms related to ACTIVITY (13)

4.???????? Terms related to PROCESS (8)

5.???????? Terms related to SYSTEM (12)

6.???????? Terms related to REQUIREMENT (15)

7.???????? Terms related to RESULT (11)

8.???????? Terms related to DATA, INFORMATION AND DOCUMENT (15)

9.???????? Terms related to CUSTOMER (6)

10.???? Terms related to CHARACTERISTIC (7)

11.???? Terms related to DETERMINATION (9)

12.???? Terms related to ACTION (10)

13.???? Terms related to AUDIT (17)

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1.???????? TERMS RELATED TO PERSON OR PEOPLE

Top Management.????? A person or group of people who directs and controls an organization at the highest level.

Quality Management System (QMS) Consultant. ? Person who assists the organization on QMS realization, giving advice or information.

Involvement.???? Taking part in an activity, event, or situation.

Engagement.???? Involvement in, and contribution to, activities to achieve shared objectives.

Configuration Authority/ Configuration Control Board/ Dispositioning Authority. A person or a group of people with assigned responsibility and authority to make decisions on the configuration.

Dispute Resolver. Individual person assigned by a DRP (Dispute Resolution Process)-provider to assist the parties in resolving a dispute.

2.?? TERMS RELATED TO ORGANIZATION

Organization.??? A person or group of people that has its own functions with responsibilities, authorities, and relationships to achieve its objectives.

Context of the Organization. ????? Combination of internal and external issues that can influence an organization’s approach to developing and achieving its objectives.

Interested Party/ Stakeholder.??? A person or organization that can affect, be affected by, or perceive itself to be affected by a decision or activity.

Customer. Person or organization that could or does receive a product or a service that is intended for or required by this person or organization.

Provider/ Supplier.??? Organization that provides a product or a service.

External Provider/ External Supplier. Provider that is not part of the organization.

DRP-provider/ Dispute Resolution Process Provider.?? A person or organization that supplies and operates an external dispute resolution process.

Association.?????? Organization consisting of member organizations or persons.

Metrological Function.?????? Functional unit with administrative and technical responsibility for defining and implementing the measurement management system.

3.?? TERMS RELATED TO ACTIVITY

Improvement. ?? Activity to enhance performance.

Continual Improvement.??? Recurring activity to enhance performance.

Management.??? Coordinated activities to direct and control an organization.

Quality Management. Management regarding quality.

Quality Planning.?????? Part of quality management focused on setting quality objectives and specifying necessary operational processes, and related resources to achieve the quality objectives.

Quality Assurance. ?? Part of quality management focused on providing confidence that quality requirements will be fulfilled.

Quality Control. Part of quality management focused on fulfilling quality requirements.

Quality Improvement.??????? Part of quality management focused on increasing the ability to fulfil quality requirements.

Configuration Management.?????? Coordinated activities to direct and control configuration.

Change Control. Activities for control of the output after formal approval of its product configuration information.

Activity.??? Smallest identified object of work in a project.

Project Management. Planning, organizing, monitoring, controlling, and reporting of all aspects of a project, and the motivation of all those involved in it to achieve the project objectives.

Configuration Object. Object within a configuration that satisfies an end-use function.

4.?? TERMS RELATED TO PROCESS

Process.??? Set of interrelated or interacting activities that use inputs to deliver an intended result.

Project.???? A unique process, consisting of a set of coordinated and controlled activities with start and finish dates, is undertaken to achieve an objective conforming to specific requirements, including the constraints of time, cost, and resources.

Quality Management System Realization.??? Process of establishing, documenting, implementing, maintaining, and continually improving a quality management system.

Competence Acquisition.??? Process of attaining competence.

Procedure. Specified way to carry out an activity or a process.

Outsource (verb).?????? Arrange where an external organization performs part of an organization’s function or process.

Contract. ? Binding agreement.

Design and Development.?? Set of processes that transform requirements for an object into more detailed requirements for that object.

5.?? TERMS RELATED TO SYSTEM

System.?????? Set of interrelated or interacting elements.

Infrastructure.??? System of facilities, equipment and services needed for the operation of an organization.

Management System. Set of interrelated or interacting elements of an organization to establish policies and objectives, and processes to achieve those objectives.

Quality Management System.?????? Part of a management system about quality

Work Environment.????? Set of conditions under which work is performed.

Metrological Confirmation. Set of operations required to ensure that measuring equipment conforms to the requirements for its intended use.

Measurement Management System.???? Set of interrelated or interacting elements necessary to achieve metrological confirmation and control of measurement processes.

Policy.???????? Intentions and direction of an organization as formally expressed by its top management.

Quality Policy.??? Policy related to quality.

Vision.???????? Aspiration of what an organization would like to become as expressed by top management.

Mission.????? Organization’s purpose for existence as expressed by top management.

Strategy.???? Plan to achieve a long-term or overall objective.

?6.?? TERMS RELATED TO REQUIREMENT

Object/ Entity/ Item. Anything perceivable or conceivable.

Quality.?????? The degree to which a set of inherent characteristics of an object fulfils requirements.

Grade.????????? Category or rank given to different requirements for an object having the same functional use.

Requirement. ????? Need or expectation that is stated, generally implied or obligatory.

Quality Requirement. Requirements related to quality.

Statutory Requirement.???????? Obligatory requirement specified by a legislative body.

Regulatory Requirement.???? Obligatory requirement specified by an authority mandated by a legislative body.

Product Configuration Information.?????? Requirement or other information for product design, realization, verification, operation, and support.

Nonconformity.? Non-fulfilment of a requirement.

Defect.???????? Nonconformity related to an intended or specified use.

Conformity.????????? Fulfilment of a requirement.

Capability. Ability of an object to realize an output that will fulfil the requirements for that output.

Traceability.??????? Ability to trace the history, application, or location of an object.

Dependability.??? Ability to perform as and when required.

Innovation.?????????? New or changed object realizing or redistributing value.

7.?? TERMS RELATED TO RESULT

Objective.? Result to be achieved.

Quality Objective.??????? Objective related to quality.

Success.????? Achievement of an objective.

Sustained Success.?????? Success over a period of time.

Output.?????? Result of a process.

Product.????? Output of an organization that can be produced without any transaction taking place between the organization and the customer.

Service.?????? Output of an organization with at least one activity necessarily performed between the organization and the customer.

Performance.?????? Measurable result.

Risk. Effect of uncertainty.

Efficiency.? Relationship between the result achieved and the resources used.

Effectiveness.????? Extent to which planned activities are realized and planned results are achieved.

8.?? TERMS RELATED TO DATA, INFORMATION AND DOCUMENT

Data. Facts about an object.

Information.???????? meaningful data.

Objective Evidence.???? Data supporting the existence or verity of something.

Information System.??? Network of communication channels used within an organization.

Document. Information and the medium in which it is contained.

Documented Information.??? Information required to be controlled and maintained by an organization and the medium on which it is contained.

Specification.?????? Document stating requirements.

Quality Manual. Specification for the quality management system of an organization.

Quality Plan.??????? Specification of the procedures and associated resources to be applied when and by whom to a specific object.

Record.??????? Document stating results achieved or providing evidence of activities performed.

Project Management Plan.? Document specifying what is necessary to meet the objective(s) of the project.

Verification.???????? Confirmation, through the provision of objective evidence, that specified requirements have been fulfilled.

Validation. Confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled.

Configuration Status Accounting.???????Formalized recording and reporting of product configuration information, the status of proposed changes and the status of the implementation of approved changes.

Specific Case.????? subject of the quality plan.

9.?? TERMS RELATED TO CUSTOMER

Feedback.????? Opinions, comments, and expressions of interest in a product, a service, or a complaints-handling process.

Customer Satisfaction.???????Customer’s perception of the degree to which the customer’s expectations have been fulfilled.

Complaint.???? 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.

Customer Service.???? Interaction of the organization with the customer throughout the life cycle of a product or a service.

Customer Satisfaction Code of Conduct.??? Promises, made to customers by an organization concerning its behavior, that are aimed at enhanced customer satisfaction and related provisions.

Dispute.?????? Disagreement, arising from a complaint, submitted to a DRP-provider.

10. TERMS RELATED TO CHARACTERISTIC

Characteristic.??? Distinguishing feature.

Quality Characteristic.?????? Inherent characteristic of an object related to a requirement.

Human Factor.?? Characteristics of a person having an impact on an object under consideration.

Competence.?????Ability to apply knowledge and skills to achieve intended results.

Metrological Characteristic.?????????? Characteristics (3.10.1) which can influence the results of measurement (3.11.4).

Configuration. ??? Interrelated functional and physical characteristics of a product or service are defined in product configuration information.

Configuration Baseline.??? Approved product configuration information that establishes the characteristics of a product or service at a point in time that serves as reference for activities throughout the life cycle of the product or service.

11. TERMS RELATED TO DETERMINATION

Determination.?? Activity to find out one or more characteristics and their characteristic values.

Review.????? Determination of the suitability, adequacy, or effectiveness of an object to achieve established objectives.

Monitoring.???????? Determining the status of a system, a process, a product, a service, or an activity.

Measurement.??? Process to determine a value.

Measurement Process.???????? Set of operations to determine the value of a Quantity.

Measuring Equipment.??????Measuring instrument, software, measurement standard, reference material or auxiliary apparatus or combination thereof necessary to realize a measurement process.

Inspection.???????Determination of conformity to specified requirements.

Test. Determination according to requirements for a specific intended use or application.

Progress Evaluation.?? Assessment of progress made on achievement of the project objectives.

12. TERMS RELATED TO ACTION

Preventive Action.?????? Action to eliminate the cause of a potential nonconformity or other potential undesirable situation.

Corrective Action.?????? Action to eliminate the cause of nonconformity and to prevent recurrence.

Correction.???????Action to eliminate a detected nonconformity.

Regrade.???? Alteration of the grade of a nonconforming product or service to make it conform to requirements differing from the initial requirements.

Concession.???????Permission to use or release a product or service that does not conform to specified requirements.

Deviation Permit.???????Permission to depart from the originally specified requirements of a product or service prior to its realization.

Release.????? Permission to proceed to the next stage of a process or the next process.

Rework.????? Action on a nonconforming product or service to make it conform to the requirements.

Repair.???????? Action on a nonconforming product or service to make it acceptable for the intended use.

Scrap.?????????? Action on a nonconforming product or service to preclude its originally intended use.

13. TERMS RELATED TO AUDIT

Audit Scope.????Extent and boundaries of an audit.

Audit Plan.???????Description of the activities and arrangements for an audit.

Audit Criteria.??? Set of policies, procedures or requirements used as a reference against which objective evidence is compared.

Audit Evidence. Records, statements of fact or other information, which are relevant to the audit criteria and verifiable.

Audit Findings.? Results of the evaluation of the collected audit evidence against audit criteria.

Audit Conclusion.??????? Outcome of an audit, after consideration of the audit objectives and all audit findings.

Audit Client.?????? Organization or person requesting an audit.

Auditee.???? Organization being audited.

Guide.??????? A person appointed by the auditee to assist the audit team.

Audit Team.??????? One or more people conduct an audit, supported if needed by technical experts.

Auditor.???? Person who conducts an audit (3.13.1).

Technical Expert.??????? Person who provides specific knowledge or expertise to the audit team.

Observer.? A person who accompanies the audit team but does not act as an auditor.

Reference:? ISO 9001:2015

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