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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 agreed 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 all the audit findings. |
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Audit Criteria
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The set of policies, procedures, or requirements determined as
a reference.
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Audit Evidence
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The records, statements of fact, or other information relevant
to the agreed criteria and which can be cross-checked.
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Audit Findings
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The results of the evaluation of 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.
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Audit Scope
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The extent and boundaries of an audit.
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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 appointed 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., safeety); 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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