Control of Documents and Records
Procedure
Reference Number
Description / Name / Title / Signature / DatePrepared by
Reviewed by
Approved by
Document Change Log Table
Rev. No. / Page No. / Description of Amendment / Approved by / Effective DateTable of Contents
1.Purpose 4
2. Scope 4
3. Terms and Definitions 4
4. Responsibilities 5
5. Procedure Description 5
5.1. General Document Usage 5
5.2. New Document / Manual or Change to the Existing Document / Manual 5
5.3. Document Effective Date & Version Control 5
5.4. Obsolete / Outdated Document 6
5.5. Document Referencing and Numbering System 6
5.6. Control of Records 10
5.7. Standards / External Origin Documents 10
5.8. Electronic Documentation 10
5.9. Managing Development and Changes of Documentation 10
6. Reference Documents and Records 11
1. Purpose
The purpose of the manual is to:
· Ensure that the information contained within Official Documents and Manuals pertaining to the “your organization’s name” are consistently up-to-date.
· Ensure that all transactions (i.e. archiving, exchange and distribution of documents) between internal / external parties are controlled and adhere to prescribed quality standards.
· To ensure that any update or change to Official Documents and/or Manuals is properly reviewed and approved before issuance.
· To control the preparation, identification, review, approval, issue, and changes of quality management system documents as per the requirements of ISO 9001: 2008.
2. Scope
The scope of this procedure will cover:
· All “your organization’s name” process and procedure manuals.
· All documents used to control the quality of the products and/or services provided by all “your organization’s name” Divisions.
· Documents of external origins applicable to QMS of “your organization’s name” Divisions (i.e. standards, contracts, drawings).
3. Terms and Definitions
Term / Definition /Controlled Copy / A copy of the current issue of procedures/manual/forms issued formally and subjected to the distribution control of this procedure /
Official Documents / Documents established such as policies, procedure manual, objective, process manual and plan (originated within “your organization’s name”) /
Electronic Document / Soft-copy of a document /
External Document / Document originated by an external party (outside of “your organization’s name”) /
Record / Data that provides evidence of conformity to the established process /
4. Responsibilities
Owner / Responsibility /5. Procedure Description
5.1. General Document Usage
All the employees shall use the forms and read documents from the “your organization’s name” Network since the latest version of the documents are kept on the Shared Drive (i.e. “your organization’s name” Portal).
Hard copies of the manuals or documents are limited only for individual use. Printing of the manuals or documents should be limited and based on imperative need only. Any hard copies obtained will not be classified or considered as ‘controlled’ documents, except for master copies.
5.2. New Document / Manual or Change to the Existing Document / Manual
A register of the controlled copies of the manuals shall be maintained by each division in a Controlled Copies Register.
All documents within “your organization’s name” should be controlled through the version number and effective date mentioned at the header of each page of the procedure / process manuals.
The manuals / documents are controlled and the MR & appointed quality representative from each division shall be the only persons authorized to edit them in whole or in part.
5.3. Document Effective Date & Version Control
The ‘effective dates’ shall be allocated to each controlled document according to the date of the approval obtained.
All controlled documents are to contain a version number which commences at 1.0.
An updated version of any controlled document will automatically increase the current version by ‘.1’ (i.e. version 1.0 is updated to version 1.1).
Updates to any controlled documents should be briefly described in the ‘Change Log’.
5.4. Obsolete / Outdated Document
Any document with a date older than the latest or different version number should be considered as obsolete and Uncontrolled Copy.
Any obsolete or outdated documents are removed from the Intranet / Shared Drive to prevent improper or unintended use of them.
The contents of the ‘controlled’ manuals or documents should not be modified/written-on (ink or pencil) for any reason. Any type of modification will classify the document(s) obsolete.
5.5. Document Referencing and Numbering System
a. Describe your organization’s document referencing and numbering system by detailing all protocols and abbreviations for internal and external recipients including:
- Company Name Codes
- Organizational Units and Sub Units Codes
- Document Types and Abbreviations for each ex. Procedure (P), Policy (PO), Manual, Form, Template, etc
b. Document Serial Number: The document serial number will consist of three (3) digits which is set according to its relevant sequential order maintained by the MR in the Controlled Copies Register, in exception of records which consists of five (5) digits (see section 5.5). All documents shall be maintained in the Controlled Copies Register for Internal Documents and therefore shall be allocated a reference number only by the MR.
c. Documents Referencing Sequence: In cases for controlled documents, the document reference structure will be as follows:
General Documentation:
“your organization’s name abbreviation” / Organizational Unit Code Higher Level / Organizational Unit Code Mid Level / Organizational Unit Code Low Level (if applicable) / Document Type + serial number
Example: Procedure Manuals of a Customer Care Division (CCD) within Support Services Sector (SS) would be “your organization’s name abbreviation”/SS/CCD/P001
d. In cases where the document is a Letter or Memo, i.e. record, by also using the codes in the tables mentioned previously, the reference structure will be as follows:
Describe your organization’s method of numbering and recording incoming and outgoing communications including memos, letters, reports, etc and describe any record or document management system that is used for the control of records
e. In cases where the document is a Contract or Purchase Requisitions / Petty Cash, by also using the codes in the tables mentioned previously, the reference structure will be as follows:
Describe your organization’s referencing system for procurement and purchasing documents including tenders, contracts, and other purchasing documents that are used
5.6. Control of Records
a. The process owner (concerned organizational unit) shall be responsible for ensuring that all records are maintained in proper manner, retrievable and accessible to the concerned persons and protected from damage or loss.
b. Describe your organization’s procedure for the storage and filing of hard copy and electronic records. Describe any record management systems that may be used and how to use them as well as refer to any user manuals or procedures that may detail this further
c. The records are retained for the appropriate retention period as mentioned in the relevant procedure.
5.7. Standards / External Origin Documents
a. It is advisable that all external origin documents required for the divisions work or stated in the contracts agreements with external parties (such as; national and international standards like ISO 9000, etc.) are made available on the Intranet / Shared Drive (i.e. “your organization’s name” Portal) for the concerned personnel. The MR, in coordination with concerned divisions, ensures the validity of such document and that it has the latest issue/revision. If a standard is obsolete and retained for reference, it shall be removed from the Shared Drive Network and all relevant parties are informed.
b. External documents are retained by the concerned division in the Controlled Copy Register for External Documents.
5.8. Electronic Documentation
Where documentation is held in an electronic format/media, safe and proper procedure shall be considered, such procedure should include but is not limited to the following:
a. Limited access rights for personnel to the master files and documents (i.e. PDF Format), except for the MR and any authorized parties.
5.9. Document Change Control Procedure
Any changes required to the QMS documents of “your organization’s name” should be discussed with the MR and if the change is acceptable, the change becomes effective and appears in the next issue of the related document. The original document shall be saved with the Controlled Copies Register for reference.
The following table describes further procedural tasks for managing development and changes of the documents:
Task No. / Description / Owner / Form / Document /1 / When an employee considers a need for a new document / form or change to an existing manual to improve the quality of work/service, the employee will review the suggested change with his/her line manager and the assigned document controller. If endorsed, the ‘document change request form’ should be completed and then submitted to the MR. / Section-Head / Document Controller / Document Change request Form
2 / The MR would then discuss the details of the suggested amendment with relevant parties to assess the impact of the amendment on other functions within the “your organization’s name”. / MR
3 / If the request is accepted, the concerned divisions will update any relevant change whereas the MR will ensure the details of the change are reflected in the concerned documents / forms / document. The final updated version of the document or manual is then approved by the concerned Director.
Note: Changes to forms can be approved at the section-head level. / MR
4 / Upon re-issuing any documents / forms, the revision number and date are updated by the MR and a formal approval must then be obtained by the relevant parties on the hard-copy document. / MR
5 / The Division Document Controller will archive the approved/signed version as the Master copy. The Controlled Copies Register is updated accordingly. The old versions of the master copies are marked as “Obsolete” and filed by the QR with a copy of the revised pages in the Master File. / Document Controller / Controlled Copies Register
6 / The MR has to inform all concerned individuals of the amendments via email or internal memo. The MR shall also ensure that all new or revised documents are saved on the Intranet / Shared Drive and available to the concerned individuals in protected format such as PDF files. Appropriate backup shall be maintained in any format (diskettes, “your organization’s name” Network) every month at least. / MR / Email / internal memo
6. Reference Documents and Records
No. / Name / Reference No. / Internal/ External / Retained By / Record Retention Period1.
2.
3.
4.