4.2.3 Control Of Documents

Purpose

[enter-your-company-name-here] has established procedures for the control of its documentation in compliance with the international standard ISO9001-2008.

These procedures ensure that the documentation is current and authorised by controlling;

the approval of document for use, prior to issue
the review process, updating and the re-approval of the document
the method of identification of changes and the revision status
arrangements for documents to be made available at the point of use
arrangements to ensure that all documents are legible, identifiable and usable
methods by which all documents of external origin, that are determined by the organisation to be necessary for the planning and operation of the Quality Management System, are identified as such and that the distribution of them is controlled
methods by which obsolete documents are identified and their unintended use prevented, together with the application of identification marks where these are retained for any purpose.

(This document states generically the details of how a business may respond to this requirement. Your specific internal response must be completed below in the body of this procedure. Your use of TKO software may impact the nature of the response)

Procedure

Document control is a vital aspect of assuring the image and integrity of [enter-your-company-name-here]’s business.

This procedure controls internal and external documents to ensure that:

Personnel receive procedures and work instructions that are current and approved.
Clients and the general public receive current business information.
Specifications are current.
Current documents are available wherever they are required for the effective functioning of work processes.
Out of date or superseded documents are removed so they cannot be used.
Superseded or obsolete documents that are retained, are identified as such.
New or replacement documents are recorded when changed and issued.
New or changed procedures identify improvements and processes that add value, wherever possible.

Internal documents are procedures, forms, drawings and instructional and advisory material of a permanent nature, designed and written by or for the business. Internal documents are not records.

All internal documents are identified on the form “Master List : Internal Documents List”. (or are identified in the company TKO database)

For each group of documents on the Master List, kept as hard copy:

(Place current hard copies where)
(Fill out and place master list where)

When changing an existing document, the extent of the change is identified and, if minor, the changes are made without printing hard copies.

The changed documents are proof read and checked.

If the change is major or if a new document is being created, a copy is printed. The document is reviewed to determine the impact of the new or changed document on any existing procedures. If procedural changes have occurred or are necessary as a result, these are reviewed by who e.g. MD.

When who has reviewed and approved the changes, the Master copy is printed and filed, new copies are printed and distributed, the old master document is marked superseded and retained for historical purposes where All old copies are located and destroyed and the changes are communicated to all staff.

External documents may include manuals for equipment, brochures, standards, statutory regulations, and codes of practice etc. These items may be considered as the business’s technical library.

An External Documents Register is maintained to track the location, use and currency of all external documents.

Copies of Operations Manuals, procedures or work instructions may be issued to interested parties on request. Whether they are issued as controlled or uncontrolled, is recorded on the Controlled Documents Register.

Uncontrolled copies are marked “UNCONTROLLED COPY: NOT SUBJECT TO UPDATE” on the front cover in red ink, prior to issue.

Controlled copies are marked “CONTROLLED COPY” on the front cover in red ink, prior to issue.