Document Management System
To ensure that pertinent issue of documents which affect product, process and quality system are available at the point of use. To ensure that all documents comprising the environmental management system are controlled and distributed so that those employees requiring them use only current issues. …
Applicable to all documents which affect product, process and quality system.
Documents: Policies, Quality System Procedures, Standard Operating Procedure or any other piece of paper or information that defines a requirement of the company, and/or describes how or what to do, and is subject to change.
Blank Forms are therefore, documents, as they serve the purpose of a checklist, and may be changed to reflect a change in a procedure. However, a form that is filled with information ceases to be a document, and becomes a “record” of some particular action. Records are not subject to this procedure. Records are subject to Quality System Procedure Control of Records (No. 04-03).
Controlled Documents: To ensure that the right information is available at the right place at the right time, documents need to be controlled. This “control” signifies that the Quality Management System will ensure that such distribution occurs as a matter of routine. It is the distribution that is being controlled.
Policies: These are documents that define the requirements to the QMS.
Standard Operating Procedure: These are documents that support Quality System Procedures and/or written to meet the requirements of some other clauses of ISO 9001:2008 which are not covered in by the users of the procedures.
The original document, signed, unstamped and dated, is retained in the Central Quality File.
All Level 1 & 2 documents copies issued to a department are stamped “Controlled Documents” and are recorded on a Controlled Document Master List, , for each department/function.
A Circulation Record, accompanies each original document.
Copies of documents are distributed to the appropriate personnel who sign the Circulation Record
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”.
General Manager, All Department Heads, Management Representative, User of the Documents and Internal Auditor.
Approve all internally generated documents prior to use
Review, and update as necessary and re-approve documents
Ensure changes and the current revision status of documents are identified
Ensure that relevant versions of the current documents are available at points of
Changes required are raised on a Change Proposal, and submitted to the QMR & EMR.
The review and approval of proposed change is only by the functional authorities, which initially wrote and approved the document.
If the changes are approved a new issue is published. The issue number advances, that is, Issue 1 becomes Issue 2, etc.
The change(s)/new addition(s) are identified by underlining the amended section.
Ensure that documents remain legible and readily available
Ensure that documents of external origin are identified and their distribution
Prevent the unauthorized use of obsolete documents and to apply suitable
identification to them, if they retained for any purpose.
The amended document is issued and distributed according to
The Controlled Document Master List is updated.
All obsolete copies are withdrawn and signed for according to the Circulation Record.
The original copy of the obsolete document, along with its Circulation Record and Change Proposal, is collected and give the Obsolete Sill and then its finally destroyed.
All remaining copies are destroyed.
The author of the document shall sign his/her name at the designated place of the document and data.
Document shall be reviewed and approved for adequacy by the Managing Director or any other person designated by him. The signature of the Managing Director/designated person on the designated place of the document shall signify that the document is reviewed for adequacy and approved.
It is the responsibility of the department heads that the current revision of documents is available at all locations that are conveniently accessible to people who need the documents.
Officially distributed copies of controlled Quality System Procedures; Standard Operating Procedure shall be identified by a red “CONTROLLED” stamp on each page. However master copies of all such procedures shall be retained with Management Representative without Controlled seal.
Controlled Procedures shall be distributed according to the distribution list of each document. In case of department / position change the custodian shall hand over the document to the new person designated to perform the function.
Issuing & Amending Formats
Generation of formats is the responsibility of department heads.
They are printed on white paper and include a code number and issue number.
A blank copy is attached to the relevant procedure or work instruction in the Central Quality file.
Each document recipient shall maintain an Index of all controlled
document of his / her possession. The list shall include:
MASTER LIST OF CONTROLLED DOCUMENT
Management Representative shall maintain Master List of control document. The Master List shall include:
Department Head may redistribute photocopy of controlled document to his department personnel if deemed necessary by him.
Such redistributed copy shall be stamped with “REDISTRIBUTED” stamp on each page with “Blue” color.
Department Heads shall redistribute photocopy of controlled documents.
Department Head shall ensure that the obsolete redistributed documents are promptly returned to him by all points of issue or use. These will be destroyed.
DOCUMENTS OF EXTERNAL ORIGIN
Management Representative shall maintain a list of pertinent issue of external documents (such as ISO standards, etc.), which affect the quality of product and process.
Customer sketch, Customer specification, measurement, etc. relevant to the order will be distributed among the concerned department with a mark ORDER NO. P.O. No.
Management Representative and department heads shall ensure that pertinent issue of external documents is available at locations of use.
Management Representative shall ensure that the obsolete documents are promptly returned to him by all points of issue or use. These will be destroyed except for the archival copy.
Copy of obsolete document shall be archived by the Management Representative. All archived documents shall be identified with the word “OBSOLETE” on each page.
Obsolete documents will be maintained for a period of minimum 1 year.
LEGIBILITY OF DOCUMENTS
Only legible copy of controlled documents will be issued.
Person receiving the documents shall ensure that the documents are legible. If any document not legible, he/she shall return it to the Management Representative and request for legible one.
Management Representative shall replace the document.
CONTROL OF AMENDED PURCHASE ORDER
Merchandising department shall issue the amended purchase order or
amendment information in writing to the departments received
original/initial Purchase Order. The page of the order where amended
is made, shall be identified by AMENDED NO. ———— and Date.
Each internally generated document will be reviewed at least once in two years
for continuing suitability.
Management Representative shall check all externally originated documents used
in the system at least once in two years to ensure that use of such documents is
necessary and if the new version of the documents is available.
Documents need to be updated shall be modified as per Quality System Procedure
for Re-Approves of Documents (No.04-02).
User shall check the following points during use:
Legibility and availability of required documents
Pertinent issue is being used
Required signature, mark, etc. available
Continuing suitability of the documents
User shall propose change of the documents as per Quality System Procedure for Re-Approves of Documents (No.04-02) for documents are not suitable at the current practice or when improvement is required.
Management Representative shall initiate document change as per
Quality System Procedure for Re-Approves of Documents (No.04-02)
if request is raised or as a result of audit finding or as a result of
Management Representative shall also assess with users need for
replacing previous version of documents of external origin in use with
the current available version and replace if identified essential.