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Audit
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A systematic, independent, and documented process for obtaining
evidence and evaluating it objectively to determine the extent to
which audit criteria are fulfilled.
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Audit Client |
The organization or person requesting an audit.
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Audit Conclusion
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The outcome of an audit provided by the audit team after consideration of the audit objectives and all audit findings. |
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Audit Criteria
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The set of policies, procedures, or requirements used as
a reference against which audit evidence is compared.
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Audit Evidence
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The records, statements of fact, or other information relevant
to the audit criteria and and verifiable
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Audit Findings
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The results of the evaluation of the collected audit evidence against
audit criteria.
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Audit Plan
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The description of the activities and arrangements for an audit.
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Audit Program
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A set of one or more audits planned for a specific timeframe and
directed towards a specific purpose. An audit program includes all the activities necessary for planning, organizing, and conducting the audits.
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Audit Scope
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The extent and boundaries of an audit. The audit scope generally includes the physical locations (where), the organizational units (who), the products, projects, or processes (what), and the time period (when). |
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Audit Team
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One or more auditors conducting an audit, supported if needed by
technical experts.
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Auditee
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The organization being audited.
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Auditor
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A person with the demonstrated personal attributes and competence to conduct an audit.
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Capability
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The ability of an organization, system, or process to realize a
product that will fulfill the requirements for that product.
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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).
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Competence |
The demonstrated ability to apply knowledge and skills. |
Concession
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Permission to use or release a product that does not conform to specified requirements. |
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Conformity
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The fulfillment of a requirement. |
| Continual Improvement |
The recurring activity to
increase the ability to fulfill requirements. |
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Contract
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A binding agreement.
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Correction |
The action taken to eliminate a detected nonconformity. |
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Corrective Action
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The action taken to eliminate the cause of a detected nonconformity
or other undesirable situation.
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Customer
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An organization or person that receives a product.
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Customer Satisfaction |
A customer’s perception of the degree to which the customer’s requirements have been fulfilled. |
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Defect
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The nonfulfillment of a requirement related to an intended or specified
use.
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Dependability
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The totality of characteristics related to the availability performance
and its influencing factors: reliability, maintainability, and support.
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Design and Development |
The set of processes that transform requirements into specified characteristics or into the specification of a product, process, or system. |
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Document
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Information and its supporting medium. A set of documents is often
called documentation.
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Deviation Permit |
Permission to depart from the originally specified requirementsof a product prior to realization. |
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Effectiveness
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The extent to which planned activities are realized and planned
results achieved.
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Efficiency
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The relationship between the result achieved and the resources
used.
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Grade |
The category or rank given to different quality requirements for products, processes, or systems having the same functional use.
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Guideline
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A document stating recommendations or suggestions. |
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Information |
Meaningful data.
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Infrastructure |
The system of facilities, equipment, and services needed for the operation of an organization. |
Inspection
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The conformity evaluation by observation and judgement accompanied as appropriate by measurement, testing, or gauging. |
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Interested Party
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A person or group having an interest in the performance or success
of an organization, for example, customers, owners, employees, suppliers,
bankers, unions, partners, and society.
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Management
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The coordinated activities to direct and control an organization.
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Management System |
The set of interrelated or interacting elements to establish policy and objectives and to achieve those objectives. |
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Measurement Process
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The set of operations to determine the value of a quantity.
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Measurement Management System
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The set of interrelated or interacting elements necessary to achieve
metrological confirmation and continual control of measurement processes.
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Measuring Equipment
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The measuring instrument, software, measurement standard, reference
material or auxilliary apparatus, or a combination thereof, necessary
to realize a measurement process.
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Metrological Characteristic
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The distinguishing feature which can influence the results of measurement.
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Metrological Confirmation
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The set of operations required to ensure that measuring equipment
conforms to the requirements for its intended use.
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Nonconformity
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The nonfulfillment of a requirement.
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Objective Evidence
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The data supporting the existence or verity of something. It may
be obtained through observation, measurement, test, or other means.
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Organization
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The group of people and facilities with an arrangement of responsibilities,
authorities, and relationships.
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Organizational Structure |
The arrangeent of of responsibilities, authorities, and relationships between people. |
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Preventive Action
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The action taken to eliminate the cause of a potential nonconformity
or other potentially undesirable situation.
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Procedure
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The specified way to carry out an activity or a process.
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- purpose
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The reason for the procedure. It is important to know the objective
of the document and why the reader should follow the process.
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- scope
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The boundaries of the procedure. It describes which activities
are covered and the applicability of the document to functional
areas.
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- responsibilities
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The roles and authority for process users and process managers
organized by job titles.
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- references
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A list of related documents mentioned in the Process section.
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- process
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A description of the logical sequence of activities to perform
a procedure. Covers what, when, where, and by whom.
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- records
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The information and data saved during the process for use in other
processes and as proof of compliance to requirements.
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Process
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A set of interrelated or interacting activities which transform
inputs into outputs.
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Product
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The result of a process.
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Project
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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.
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Qualification Process
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The process to demonstrate the ability to fulfill specified requirements.
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Quality |
The degree to which a set of inherent characteristics fulfills requirements. |
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Quality Assurance
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The part of quality management focused on providing confidence
that quality requirements will be fulfilled.
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Quality Characteristic
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The inherent characterisitic of a product, process, or system related to a requirements.
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Quality Control |
The part of quality management focused on fulfilling quality requirements. |
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Quality Improvement
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The part of quality management focused on increasing the ability
to fulfill quality requirements.
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Quality Management
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The coordinated activities to direct and control an organization
with regard to quality.
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Quality Management System
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The management system to direct and control an organization with
regard to quality.
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Quality Manual
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A document specifying the quality management system of an organization.
They vary in detail and format to suit the size and complexity of
an individual organization.
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Quality Objective
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Something sought, or aimed for, related to quality. The objectives
are generally based on the quality policy of an organization and
specified for relevant functions and levels in the organization.
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Quality Plan
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A document specifying which procedures and associated resources
shall be applied by when and by whom to a specific project, product,
process, or contract.
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Quality Planning
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The part of quality management focused on setting quality objectives
and specifying necessary operational processes and related resources
to fulfill quality objectives.
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Quality Policy
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The overall intentions and direction of an organization related
to quality as formally expressed by top management.
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Quality Surveillance
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The frequent or constant monitoring and verification of the status
of an entity and analysis of records to ensure specified requirements
are being fulfilled.
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Record
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A document stating results achieved or providing evidence of activities
performed.
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Registrar
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A third party organization (Certification Body) that conducts independent audits of
a company’s quality system to ensure it conforms to requirements.
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Registration
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When a quality system complies with the applicable standard, the
registrar issues a certificate of registration and places the company’s
name in a directory of registered firms.
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Repair
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The action taken on a nonconforming product to make it acceptable
for the intended usage.
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Requirement
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A need or expectation that is stated, generally implied, or obligatory.
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Review |
The activity undertaken to determine the suitability, adequacy, and effectiveness of the subject matter to achieve established objectives.
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Rework
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The action taken on a nonconforming product to make it conform to the requirements. |
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Scope
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The scope of registration defines the company sites, product lines,
and operations covered by an ISO 9001 certificate.
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Scrap
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The action taken on a nonconforming product to preclude its originally
intended usage.
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Service
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An intangible product that is the result of at least one activity
performed at the interface between the supplier and the customer.
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Software
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The intellectual product consisting of information on a support
medium. A computer program is an example of software.
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Specification
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A document stating requirements.
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Supplier |
The organization or person that provides a product. |
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System
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A set of interrelated or interacting elements.
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Technical Expert
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The person who provides specific knowledge or expertise to the
audit team.
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Test
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The determination of one or more characteristics according to a
specified procedure.
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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 that which is under consideration. |
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Validation
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The confirmation, through the provision of objective evidence,
that the requirements for a specific intended use or application
have been fulfilled.
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Verification
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The confirmation, through the provision of objective evidence,
that specified requirements have been fulfilled.
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Work Environment
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The set of conditions under which work is performed.
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