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Standard Documentation System

The document outlines requirements for maintaining a standardized documentation system for a quality management system. It states that documentation must include anything required by quality standards as well as anything an organization deems necessary. Documentation should be properly identified, formatted, reviewed, and approved. It also must be controlled to ensure availability, protection from improper use/loss, as well as procedures for distribution, storage, changes, retention and external documents.

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Amal Tharaka
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74 views

Standard Documentation System

The document outlines requirements for maintaining a standardized documentation system for a quality management system. It states that documentation must include anything required by quality standards as well as anything an organization deems necessary. Documentation should be properly identified, formatted, reviewed, and approved. It also must be controlled to ensure availability, protection from improper use/loss, as well as procedures for distribution, storage, changes, retention and external documents.

Uploaded by

Amal Tharaka
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Maintain a standard documentation system

7.5 Documented information

7.5.1 General
The organization's quality management system shall include:
a) documented information required by this International Standard;
b] documented information determined by the organization as being necessary for the effectiveness
of the quality management system.

NOTE: The extent of documented information for a quality management system can differ from one
organization to another due to:
— the size of organization and its type of activities, processes, products and services;
— the complexity of processes and their interactions;
— the competence of persons.

7.5.2 Creating and updating


When creating and updating documented information, the organization shall ensure appropriate:
a) identification and description (e.g. a title, date, author, or reference number);
b) format (e.g. language, software version, graphics) and media (e.g. paper, electronic);
c) review and approval for suitability and adequacy.

7.5.3 Control of documented information

7.5.3.1 Documented information required by the quality management system and by this International
Standard shall be controlled to ensure:
a) it is available and suitable for use, where and when it is needed;
b) it is adequately protected (e.g. from loss of confidentiality, improper use, or loss of integrity).

7.5.3.2 For the control of documented information, the organization shall address the following activities
as applicable:
— distribution, access, retrieval and use,
— storage and preservation, including preservation of legibility;
— control of changes (e.g. version control);
— retention and disposition.

Documented information of external origin determined by the organization to be necessary for the
planning and operation of the quality management system shall be identified, as appropriate,
and be controlled.

Documented information retained as evidence of conformity shall be protected from unintended


alterations.

NOTE: Access can imply a decision regarding the permission to view the documented information only, or
the permission and authority to view and change the documented information.
7.4 Communication
The organization shall determine the internal and external communications relevant to the quality
management system, including:
a] on what it will communicate;
b] when to communicate;
c] with whom to communicate;
d] how to communicate;
e] who communicates.

7.2 Competence
The organization shall:
a) determine the necessary competence of person(s) doing work under its control that affects the
performance and effectiveness of the operation;
b) ensure that these persons are competent on the basis of appropriate education, training or experience;
c) where applicable, take actions to acquire the necessary competence, and evaluate the effectiveness
of the actions taken.
d) retain appropriate documented information as evidence of competence.

NOTE Applicable actions can include, for example, the provision of training to, the mentoring of, or the
reassignment of currently employed persons; or the hiring or contracting of competent persons.

7.3 Awareness
The organization shall ensure that persons doing work under the organization's control are aware of:
a) the quality policy;
b) relevant quality objectives;
c) their contribution to the effectiveness of the quality management system, including the
benefits of improved performance;
d) the implications of not conforming with the quality management system requirements.

(ISO 9001:2015 For training purposes only)

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