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ISO/DIS 9001 - SUPPORT - Documented information ....
Keshav Ram Singhal
Details, format and type of documented information related to the quality management system of one organization may differ from another organization due to various reasons and some of the reasons may be as under:
- size of the organization
- activities of the organization
- processes of the organization
- complexities and interactions of organization's processes
- products and services of the organization
- competence of the people of the organization
The organization is required to ensure appropriate measures (mentioned below) at the time of creating and updating documented information, such as:
- identification and description
- review and approval for suitability and adequacy
Identification of documented information means the action or process of identifying the documented information. Identification and description of documented information can be done by mentioning the classification title, date, author, reference (identification) number, page number etc.
Format of documented information means the way in which the documented information is arranged or set out. Ensure: (i) language used in the documented information, (ii) whether the documented information is in software version, (iii) whether graphics are to be used in the documented version.
Media of documented information means the means of communication used in the documented information. It can be either hard copy (paper) or Soft copy (electronic).
Review of documented information means another look at the documented information and this is a task, which should be carried out at the time of creating and updating of the documented information by the appropriate person, who is linked with the affairs of the documented information. Review of the documented information may be carried out randomly or periodically, but ISO/DIS 9001 requires review of documented information at the time of creating and updating of documented information.
Approval of documented information means that some authority has agreed the contents and data of the documented information.
The organization needs to control the documented information required by the quality management system and ISO/DIS 9001 by ensuring the following:
(i) The documented information is available and suitable for use.
(ii) The documented information is adequately protected from the loss of confidentiality, improper use and loss of integrity.
The organization needs to address the following activities for the control of documented information:
- access (permission to view)
- preservation including preservation of legibility
The organization needs to determine and control documented information of external origin that are necessary for the planning and implementation of the quality management system. In order to control documented information of external origin, the organization should establish appropriate process or mechanism for identification, classification, distribution and availability of such documented information.
ISO/DIS 9001 does not specify requirements to control obsolete (out of date) documented information. However, it is better to have control on such documented information, as use of obsolete documented information may lead to errors, failures or hazards, which can be an evidence of nonconformity. Sometimes superseded or obsolete documented information needs to be retained by an organization for a variety of reasons, such as legal or reference purpose, and for this the organization must have a method of identifying the status of such documented information to prevent their accidental use in place of current documented information. In practice, organizations put 'Obsolete Document' or 'Obsolete Documented Information' stamp in red ink on the face of obsolete documented information.