Guidelines for documentation of
Quality Management Systems ISO 10013
IV. Quality management systems documentation
Generalities
The structure of the documentation used in the quality management system can be described
hierarchically. This structure facilitates the distribution, conservation and understanding of the
documentation. The extent of the quality management system documentation may differ from one organization to another.
to another due to:
a) the size of the organization and the type of activities,
b) the complexity of the processes and their interactions; Y
c) the competence of the personnel.
The quality management system documentation usually includes the following:
a) quality policy and its objectives;
b) quality manual;
c) documented procedures;
d) work instructions;
e) forms;
f) quality plans;
g) specifications;
h) external documents;
i) records.
The quality management system documentation can be in any type of medium, such as such as paper or electronic media.
Purposes and benefits
The purposes and benefits of having the quality management system documented for a
organization include, but are not limited to, the following:
a) describe the organization's quality management system;
b) provide information for groups of related functions, in such a way that they can understand better interrelationships;
c) communicate to employees management's commitment to quality;
d) help employees understand their role within the organization, thus giving them greater sense of purpose and importance of their work;
e) facilitate mutual understanding between employees and management;
f) provide a basis for job performance expectations;
g) declare the way in which activities will be carried out to achieve the specified requirements;
h) provide objective evidence that the specified requirements have been met;
Quality policy and its objectives
The quality policy and its objectives should be documented and can be in a document independent or included in the quality manual.
Quality manual
Content
The quality manual is unique for each organization. This Technical Report allows flexibility in the definition of the structure, form, content, or method of presentation of the documentation of the quality management system for all types of organizations.
Title and scope
The title and / or scope of the quality manual should define the organization to which the manual applies. He The manual should refer to the specific quality management system standard on which the quality management system is based.
Table of Contents
The table of contents of the quality manual should include the number and title of each section and its
location.
Review, approval and modification
Evidence of the review, approval and modification status and date of the quality manual should
be clearly indicated in the manual. Where practicable, the nature of the change should be identified in the document or in the appropriate annex.
Quality policy and objectives
When the organization chooses to include the quality policy in the quality manual, the quality manual. Quality may include a statement of quality policy and objectives. Quality goals actual goals to achieve these objectives may be specified elsewhere in the documentation of the quality management system as determined by the organization. The quality policy should include a commitment to meet requirements and continually improve system effectiveness quality management.
The objectives are usually derived from the quality policy of the organization and must be achieved. When the objectives are quantifiable they become goals and are measurable.
Subto Organization, responsibility and authorityic
The quality manual should provide a description of the organization's structure. The Responsibility, authority and interrelationship can be indicated by means of organization charts, diagrams of flow and / or job descriptions. These may be included or referenced in the quality manual.
References
The quality manual should contain a list of documents that are referenced, but which are they are not included in the manual.
Description of the quality management system
Annexes
Documented procedures
Structure and format
Content
Review, approval and modification
Identification of changes
-Work instructions.
-Forms.
-Quality plans.
-Specs.
-External documents
-Records
V. Process for preparing the quality management system documentation.
5. Process for preparing the quality management system documentation.
Responsibility for the elaboration
Methods for preparing the quality management system documentation
Use of references
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Use of references
VI. Process of approval, issuance and control of management system documents
of quality
6. Process of approval, issuance and control of management system documents
of quality
Review and approval
Distribution
Incorporation of changes
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Issuance and control of changes
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Uncontrolled copies
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Bibliographies
Definite article
Indefinite article
I. Object and field of application
This Technical Report provides guidelines for the development and maintenance of documentation necessary to ensure an effective quality management system, tailored to specific needs of the organization. Using these guidelines will help establish a documented system such as the required by the applicable quality management system standard.
This technical report can be used to document management systems other than the one of the ISO 9000 family, for example environmental management systems and safety management systems.
II. Normative references
The regulations listed below contain valid provisions for this Report Technical. At the time of publication, the editions indicated were in force. Every rule is subject to review so the parties that base their agreements on this Technical Report should study the possibility of applying the most recent edition of the standards listed below. The members of IEC and ISO have the registry of international standards in force at all times.
III. Terms and definitions
For the purpose of this Technical Report, the terms and definitions given in the Standard are applicable.
ISO 9000 and the following. The quality management system of an organization can use different terminology for defined documentation types.
Form
Document used to record the data required by the quality management system.
Work instructions
Detailed description of how to perform and record tasks
Conjunction
Coordinating
Subordinating conjunctions