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© ISO 2000 – All rights reserved
4.3 Use of quality management principles
To lead and operate an organization successfully, it is necessary to manage it in a systematic and visible manner. The guidance to management offered in this International Standard is based on eight quality management principles.
These principles have been developed for use by top management in order to lead the organization toward improved performance. These quality management principles are integrated in the contents of this International Standard and
are listed below
a Customer focus
Organizations depend on their customers and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations.
NOTE 2 The extent of the quality management system documentation can differ from one organization to another due to a
the size of organization and type of activities, b
the complexity of processes and their interactions, and c
the competence of personnel. NOTE 3 The documentation can be in any form or type of medium.
4.2.2 Quality manual
The organization shall establish and maintain a quality manual that includes a the scope of the quality management system, including details of and justification for any exclusions,
b the documented procedures established for the quality management system, or reference to them, and c a description of the interaction between the processes of the quality management system.
4.2.3 Control of documents
Documents required by the quality management system shall be controlled. Records are a special type of document and shall be controlled according to the requirements given in 4.2.4.
A documented procedure shall be established to define the controls needed a to approve documents for adequacy prior to issue,
b to review and update as necessary and re-approve documents, c to ensure that changes and the current revision status of documents are identified,
d to ensure that relevant versions of applicable documents are available at points of use, e to ensure that documents remain legible and readily identifiable,
f to ensure that documents of external origin are identified and their distribution controlled, and
g to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.
4.2.4 Control of records
Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system. Records shall remain legible, readily identifiable and retrievable. A
documented procedure shall be established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records.
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b Leadership
Leaders establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organizations objectives.
c Involvement of people
People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organizations benefit.
d Process approach
A desired result is achieved more efficiently when activities and related resources are managed as a process.
e System approach to management
Identifying, understanding and managing interrelated processes as a system contributes to the organizations effectiveness and efficiency in achieving its objectives.
f Continual improvement
Continual improvement of the organizations overall performance should be a permanent objective of the organization.
g Factual approach to decision making
Effective decisions are based on the analysis of data and information.
h Mutually beneficial supplier relationships
An organization and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value.
Successful use of the eight management principles by an organization will result in benefits to interested parties, such as improved monetary returns, the creation of value and increased stability.
5 Management responsibility
5.1 General guidance