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Example Procedure to control Quality Documentation

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TITLE : CONTROL OF MANUALS & DOCUMENTS

PROCEDURE NO. 1

ISSUE : 1

SHEET 1 OF 1

1.0 OBJECTIVE.
1.1 To ensure that the procedures contained in the Company's Quality and Procedure Manuals are of the current issue.

2.0 SCOPE.
2.1 All copies of the Company's Manuals.

2.2 All the documentation used to control the quality of the Company's products.

3.0 RESPONSIBILITY.
3.1 It is the responsibility of the Quality Manager to ensure the contents of the manuals reflect the needs of the Company and to authorise changes to the procedures or the Quality Manual.

3.2 It is the responsibility of all employees to advise the Quality Manager of any changes to the procedures that would improve the control of the Quality of the services provided by the Company. He is responsible for the contents of the manuals and for authorising changes.

3.3 The QM Secretary is responsible for updating the Manuals and copies as directed by the Quality Manager and maintaining the appropriate records.

4.0 PROCEDURE.
4.1 General
4.1.1 The Quality System is in the form of a Quality Manual and a Procedures Manual. Normally all copies of the manuals are 'controlled' copies. These are issued to certain Company personnel to ensure that all the employees have access to a copy. These manuals are maintained in a current state by the QM Secretary.

4.1.2 The Company may decide to have a copy of the Quality Manual issued to an individual who does not fall under the control of the Company. In this case the Manual is marked "UNCONTROLLED COPY". The QM Secretary records the issue of these copies as described below but they are not maintained in a current state.

4.2 All copies of the Company Manuals are numbered and a register is maintained by the QM Secretary of the holders of these Manuals. When issuing a manual the holders name, date and manual issue level is recorded in the appropriate register by the QM Secretary. If a part manual is required for a specific area then this is controlled in the same manner as a full manual and that the procedures issued are marked on the contents page of the part manual to indicate which procedures are included.

4.3 Manual Changes
4.3.1 When a change to a procedure or the Quality Manual is required then the Quality Manager is contacted and the details of the change discussed in conjunction with other employees as required. A decision is made as to whether the change would reduce the level of control to below the requirements of the Company's Quality Policy, or ISO 9000.

4.3.2 If the change is acceptable the Quality Manager instructs the QM Secretary to alter the appropriate procedure or Quality Manual and record the change on the Details of Modification Form. The Procedure or Quality Manual is raised to the next issue level and the necessary changes are made to the contents list if a procedure is altered. All controlled manuals are withdrawn by the QM Secretary and the old Quality Manual or old procedures and contents page are extracted from the manuals and the new Quality Manual or new procedures and contents page are bound into the manuals by the QM Secretary.

4.3.3 The date the manuals were withdrawn is added to the entries in the appropriate Manual Register and new entries with the new issue level are made for each of the manuals issued. The manuals are then passed to the manual holders.

4.3.4 The master copies of the old Quality Manual or the old procedure(s) and the old contents page are filed with the Details of Modifications form by the QM Secretary.

4.4 Upon leaving the Company or transferring to a position where the manual is non-essential, the holder must return his/her copy to the QM Secretary. All copies of the manuals, both controlled and uncontrolled, remain the property of the Company and holders must return them when requested to do so.

4.5 The Manuals are controlled documents and only the Quality Manager can authorise the copying of them in whole or part. If a temporary copy of a part of the manual is required, e.g. for auditing purposes, then an application is made to the Quality Manager for an uncontrolled copy. These copies are marked 'Uncontrolled' and returned and destroyed after use. Any copy that is not recorded in the Manual Register is deemed to be an unauthorised copy and any such copies will be confiscated.

4.8 Other Documents
4.8.1 Standard documents used within the Quality System are listed as Appendices at the end of the procedure they are first used in. They are also listed in the Appendices Index which records their document reference and the date of their current issue.

4.8.2 When ever a change is required to any of the standard documents then the change is discussed with the Quality Manager. If the change is acceptable then the amended document is reprinted with the present date, this is updated on the Appendix Index and the Procedure Manuals updated as detailed in paragraph 4.3.

5.0 RELATED PROCEDURES.
5.1 All procedures in the Company Manuals

6.0 DOCUMENTATION.

6.1 Procedure Manual Register

Appendix 1A

6.2 Quality Manual Register

Appendix 1B

6.3 Details of Modifications to Procedures

Appendix 1C

6.4 Appendices Index

Appendix 1D


7.0 RECORDS.
7.1 The Registers of the Company manuals and the Appendices Index are kept permanently by the QM Secretary.

7.2 The master copies of the old procedures and the Contents Page are filed together by the QM Secretary and retained for at least five years.

7.3 The Details of Modifications forms are retained by the QM Secretary for at least five years.