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Conformity |
ISO 9001 list many quality system requirements. If your organization meets these requirements, you can say that it conforms to these requirements. You can say that it is behaving in conformity with these requirements. |
| Contract review |
A contract review is a set of activities
that you must carry out to ensure that all customer
orders or contracts specify all the quality requirements
you must meet and to ensure that you can meet these
requirements. A quality requirement is a characteristic that an entity must have. For example, a customer may require that a product (entity) achieve a specific dependability score (characteristic). |
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Corrective Actions |
Corrective actions are steps that are taken to remove the causes of an existing nonconformity or to make quality improvements. |
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Customers |
A customer is anyone who receives products or services from a supplier. A customer can be either external or internal to the supplier organization. |
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Design Review |
A design review is a set of
activities whose purpose is to evaluate how well a
potential product (a design) meets all quality
requirements. During the course of this review,
problems must be identified and solutions must be
developed. A quality requirement is a property or characteristic (quality) that a product or service must have. |
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Design Validation |
Design validation is a process whose purpose is to examine products and to use objective evidence to confirm that these products meet user needs. |
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Design Verification |
Design verification is a process whose purpose is to examine design outputs and to use objective evidence to confirm that outputs meet input requirements. |
| Elements |
Elements include responsibilities,
authorities, relationships, functions, policies,
procedures, practices, processes, and resources. Quality
system elements combine to form a quality system.
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| Entity |
An entity could be a product, process,
person, activity, machine, service, system, department,
company, institution, or organization.
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| Internal Quality Audits | Internal audits are carried out by your personnel. Internal quality audits examine the elements of a quality system in order to evaluate how well these elements comply with quality system requirements. |
| Nonconforming Products | When one or more characteristics of a product fail to meet specified requirements, it is referred to as a nonconforming product. When a product deviates from quality requirements, it fails to conform. |
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Nonconformity |
ISO 9001 list
quality system requirements. When your organization
deviates from these requirements, a nonconformity occurs.
When a product, process, procedure, system, or structure
deviates from ISO requirements, a formal nonconformity
exists.
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Organisation |
An organization is a company, corporation, firm, or institution that has its own functions and administration. It can be either incorporated or unincorporated, or privately or publicly owned. |
| Organisational Structure | The structure of an organization is the pattern of responsibilities, authorities, and relationships that control how people perform their functions and govern how they interact with one another. |
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Preventive Actions |
Preventive actions are steps that are taken to remove the causes of potential nonconformities or to make quality improvements. |
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Procedures |
Quality procedures control activities.
A well defined procedure controls a logically distinct
set of activities. Such a procedure precisely defines the
work that should be done, and explains how it should be
done, who should do it, and under what circumstances. In
addition, it explains what authority and what
responsibility has been allocated, which supplies and
materials should be used, and which documents and records
must be used to carry out the work. While procedures may
be documented or undocumented, ISO usually expects them
to be documented.
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Process |
A process uses resources to transform
inputs into outputs. Processes can be social, industrial,
agricultural, governmental, chemical, mechanical,
electrical, and so on. In every case, inputs are turned
into outputs because some kind of work, activity, or
function is carried out.
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Product |
A product is an output that results
from a process. Products can be tangible or intangible, a
thing or an idea, hardware or software, information or
knowledge, a process or procedure, a service or function,
or a concept or creation. Please note that when ISO uses
the term product they also mean service.
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Product
Inspection |
Product inspection is an activity
that compares product characteristics with product
requirements in order to establish conformity. More
precisely, product inspection is an activity that
compares one or more characteristics of a product with
specified requirements in order to determine if the
product conforms to these requirements.
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| Product Nonconformity | When one or more characteristics of a product fail to meet specified requirements, they are referred to as product nonconformities. |
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Quality |
An entity has characteristics. Some of these
characteristics are derived from stated or implied needs.
The set of these special need-oriented characteristics
makes up the quality of an entity. In short, a quality
is a characteristic. For example, the need for dependability is met by designing a dependable product. Dependability then becomes a quality (characteristic) of the product (entity). An entity is a product, process, person, activity, machine, service, system, department, company, institution, or organisation. |
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Quality Assurance |
Quality assurance (Q.A.) is defined
as a set of activities whose purpose is to demonstrate
that an entity meets all quality requirements. Q.A.
activities are carried out in order to inspire the
confidence of both customers and managers, confidence
that all quality requirements are being met.
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Quality Audits |
Quality audits examine the elements
of a quality system in order to evaluate how well these
elements comply with quality system requirements. Elements include responsibilities, authorities, relationships, functions, procedures, processes, and resources. Elements combine to form a quality system. |
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Quality Control |
Quality control is defined as a set
of activities or techniques whose purpose is to ensure
that all quality requirements are being met. In order to
achieve this purpose, processes are monitored and
performance problems are solved.
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Quality Improvement |
Quality improvement refers to a set
of activities whose purpose is to enhance the efficiency
and effectiveness of the organization for the benefit of
both the organization and its customers. We believe that quality improvement ought to focus on quality, not on efficiency. Let's leave that to the "efficiency experts". |
| Quality Management | Quality management includes all the activities that Managers carry out in an effort to implement their quality policy. These activities include quality planning, quality control, quality assurance, and quality improvement. |
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Quality Manual |
A quality manual is a document that
states your quality policy and describes your quality
system. It describes the roles, relationships, functions,
processes, procedures, systems, and resources that affect
quality. It can be a paper manual or an electronic manual.
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Quality Planning |
Quality planning is defined as a set
of activities whose purpose is to define quality system
policies, objectives, and requirements, and to explain
how these policies will be applied, how these objectives
will be achieved, and how these requirements will be met.
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Quality Plan |
A quality plan explains how you intend to apply your quality policies, achieve your quality objectives, and meet your quality system requirements. |
| Quality Policy |
A quality policy statement defines
your organization's commitment to quality.
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Quality Record |
A quality record contains objective evidence that shows how well a quality requirement is being met or how well a quality system element is performing. |
| Quality Requirement | A quality requirement is a characteristic that an entity must have. For example, a customer may require that a particular product (entity) achieve a specific dependability score (characteristic). |
| Quality Surveillance | Quality surveillance is a set of activities whose purpose is to monitor an entity and review its records to prove that quality requirements are being met. |
| Quality System |
A quality system is a network of
processes made up of elements. Elements include
responsibilities, authorities, relationships, functions,
plans, policies, procedures, practices, processes, and
resources. The purpose of a quality system is to satisfy
quality requirements and to assure that customers receive
quality products and services.
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| Quality System Element | Quality system elements include responsibilities, authorities, relationships, functions, plans, policies, procedures, practices, processes, and resources. Quality system elements combine to form a quality system. |
| Quality System Requirement | A quality is a characteristic. A system is a set of interrelated elements, and a requirement is an obligation. Therefore, a quality system requirement is a characteristic that a systemic element must have. |
| Record |
A record is a document that contains
objective evidence which shows how well activities are
being performed or what kind of results are being
achieved.
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Resources |
Resources include people, money, information, knowledge, skill, energy, facilities, machines, tools, equipment, technologies, and techniques. |
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Service |
Service is a customer-oriented result. This result is produced when suppliers perform activities that are oriented towards meeting customer needs. |
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Service Delivery |
Service delivery is a customer-oriented activity. Service delivery activities are carried out by suppliers and are oriented towards meeting customer needs. |
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Standard |
Surprisingly, ISO does not seem to define
the term standard (or at least not in ISO 8402).
Since they call every chapter or publication a standard,
it may just mean that all their publications are standards,
by definition. However, we believe that ISO also uses the
term standard to suggest the concept of an
expectation, obligation, requirement, or norm that they
want organizations to accept. In addition, ISO seems to
use the term standard to refer to a way of being
or doing things as in the phrase: "this is the
standard way we do this". |
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Supplier |
A supplier is an organization that provides products to customers. Customers can be either internal or external to the supplier organization. |
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Total Quality Management |
Total quality management is defined
as a management approach that tries to achieve and
sustain long-term organizational success by encouraging
employee feedback and participation, satisfying customer
needs and expectations, respecting societal values and
beliefs, and obeying governmental statutes and
regulations. |
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