To ensure that all documents forming the Quality Management System (QMS) are controlled and distributed so that only latest documents issued are in use by those employees requiring them.
This procedure covers all document control activities regarding the quality management system.
The Management Representative (MR) is responsible for directing activities relating to this procedure. Where other functions have responsibility, they are so indicated.
4.1 Document Hierarchy
|Procedures, Matrix, Work Instructions, Quality Plan & External origin
|Quality Records & Formats
4.2 Document Identification
4.2.1 The documents are identified by their titles, codes or by the ISO 9001:2000 standard clause reference
4.3 Document Coding
4.3.1 The corner of pages contains:
|Page 1 of 4
4.3.2 The document code is of the form AAA/B/CCC, where:
- AAA is the department (see list below). Can be 2 to 4 letters.
- B is the document level, 2, or 3.
- CCC is the individual document number, starting from 01.
The exception is the quality manual, which is coded simply as QM/1.
4.4 Procedures Structure:
The format of the documents is not standardized with respect to design and layout, however, level 1, level 2 (except the External origins) and Level 3 documents contain at least the following information:
- Related Documents (If any)
- Written and reviewed by
- Approved by
- Issue Date & No.
4.5 Document Initiation/Review/Approval
4.5.1 Documents are written by or with the help of the appropriate personnel involved with the activity.
4.5.2 Reviewed by the author of the documents or the person indicated.
Departmental Procedures- Managing Director/Factory Manager/Management Representative
MR Procedures – Managing Director/Factory Manager
Quality Manual – Managing Director
4.6 Issuing Documents
4.6.1 The original document, signed, unstamped and dated, is retained in the Central Quality File. This file comprises separate folders for each department, containing all the quality system documents for that department.
4.6.2 Copies of all Level 1 & 2 documents are made and issued to a department are stamped “Controlled Copy” and are recorded on a Document Master List (MR/3/01) for each department.
4.6.3 A Circulation Record, MR/3/002, accompanies each original document.
4.6.4 Copies of documents are distributed to the appropriate personnel who sign the Circulation Record.
4.6.5 Uncontrolled photocopies are only allowed for use by external parties, e.g. customers, auditors, etc. These are stamped on the front page as “Uncontrolled Copy”. Distribution records are not maintained for these copies.
4.6.6 The preparation and updating the work instructions (if required) is the responsibility of the departmental heads. If the work instructions are to be displayed on the board, the departmental head will ensure that the latest version of the work instruction is displayed. The original, approved text of the work instruction will be retained in the Central Quality File, along with a Circulation Form.
4.6.7 Job Descriptions, Quality Plans, Quality Policy and Objectives are circulated in the same way.
4.6.8 Some level 3 documents are maintained on electronic media (soft copies). These documents are controlled through a custom made software security system. These documents are identified by their name/title. These documents are backed up on a weekly basis.
4.7 Amending Documents
4.7.1 Changes required are raised on a Change Request Form, and submitted to the Management Representative.
4.7.2 Management Representative in consultation with the personnel who initially wrote and approved the document gives approval of proposed change.
4.7.3 If the changes are approved a new issue is published. The issue number advances, that is, Issue 1 becomes Issue 2, etc.
4.7.4 The change(s)/new addition(s) are identified by underline / highlighting the amended section.
4.8 Withdrawal of Obsolete Documents
4.8.1 The amended document is issued and distributed according to procedure (see section 4.6).
4.8.2 The Document Master List (MR/3/01) is updated.
4.8.3 All obsolete copies are withdrawn and signed for according to the Circulation Record.
4.8.4 The original copy of the obsolete document, along with its Circulation Record and Change Proposal, is kept for reference purposes, in an Obsolete Document File, MR/3/04. 4.8.5 The front page is red stamped as “Obsolete”.
4.8.6 Old documents are stamped in red as “Obsolete”. They are retained, if required for reference, or destroyed on the authority of the concerned department head. All remaining copies are destroyed.
4.9 Issuing & Amending Level 3 Formats
4.9.1 Preparation of formats is the responsibility of department heads.
4.9.2 A blank (for sample) copy is attached to the relevant procedure or work instruction in the Central Quality File for reference. If the same format is used for more than one document, then it need not be attached with every procedure.
4.9.3 They are printed on white paper and include a code number and issue number.
4.9.4 Copies are allowed for working activities.
4.9.5 Changes are made according to sections 4.6.1 and 4.6.2 and the issue number is advanced and the previous copy is replaced in the central Quality File.
4.9.6 Amended issues are sent to the Management Representative for inclusion in controlled copies of the relevant document. The Change Proposal and a copy of the obsolete document is kept in the Obsolete Document File.
4.9.7 Department heads are responsible for withdrawal and destruction of old issues and distribution of new issues to the concerned work areas
4.10 Control of External Origin Documents
External Documents are controlled in the same way as internal documents except the copy of the external document may not be retained in the central quality file.
4.11 Document Maintained
A Master List of Documents (MR/3/01) is maintained in a central quality file to identify the latest issue of the document in circulation and the revision status is incorporated in the individual documents.
4.12 Computer Back-up
All the documents of the Quality Management System are stored in the computer and for safety purposes a back up in the form of floppy disks and are kept by the Management Representative.
5.0 Related Documents
|Document Master List