Procedure
Document Control
Document code : QA-P-01 Issue Date : Page 1 of 3
Prepared By : Reviewed By : Approval By :
1. PURPOSE
The purpose of this document is to describe the document control procedure used at
XYZ Company.
2. Scope:
This procedure is applicable to all internal Quality Management System documentation
as well as relevant external/confidential documentation.
3. Responsibility:
3.1. Quality Manager is responsible to ensure this procedure is implemented.
3.2. All employees need to be aware of the contents of this procedure & comply with the
requirements.
3.3. It is the responsibility of each departmental manager/supervisor to ensure that all
documents/records remain legible & readily identifiable.
4. Definitions
4.1. Document: A written, printed or electronic paper that bears the original, official, or legal
form of something and can be used to furnish decisive evidence or information.
4.2. Record: A record provides objective evidence that some type of required systems
activity has occurred. This is a completed form.
4.3. Process owner: Person who has the ultimate responsibility for the performance of a
process in realizing its objectives measured by key process indicators, and has the
authority and ability to make necessary changes.
5. Abbreviations
I: Work Instruction
SOP: Standard Operating Procedure
P: procedure
F: Form
QM: Quality Manager
6. Coding and Characterization
If the document is in hardcopy it considered UNCONTROLED document – Check last version on the server
Page 1 of 3
Procedure
Document Control
Document code : QA-P-01 Issue Date : Page 2 of 3
Prepared By : Reviewed By : Approval By :
Each element within the Quality Management System has been allocated a code as per
below:
Code ELEMENT
QA Quality Assurance
QC Quality Control
PU Purchasing
MS Marketing and Sales
HR Human Resource
PR Production
IM Incoming Material
RD Research and Development
AC Accounting
MS Maintenance
Example:
PU-P Refers to the Purchasing procedure.
PU-I-01 First work instruction under the Purchasing procedure.
PU-F-02 Second form under the first work instruction or SOP under the Purchasing
procedure.
7. Creation /Change of a Document
7.1. Anyone within XYZ Company is able to create a document but must ensure that all of
the document control procedures are followed in order for the document to be classified
as controlled.
7.2. The requestor of Creation /Change of a Document fills a (creation, change, cancellation)
request (QA-F-02), Accompanied by a copy of the proposal and must be approved by
the respective head of department before it can be issued by the QM.
7.3. The QM reviews the request and if it conforms to ISO 9001:2008.
7.4. The QM implements the request.
7.5. The QM updates the master document register (QA-F-03).
7.6. The new document is stored within the X:/Quality_Assurance QMS Docshare.
7.7. The QM will issue the new document to the respective people via email.
7.8. In the case of rejection of the proposal by QM or the management representative, the
QM informs the requestor and the respective head of department why the request is
rejected.
8. DOCUMENT APPROVAL AND DISTRIBUTION
If the document is in hardcopy it considered UNCONTROLED document – Check last version on the server
Page 2 of 3
Procedure
Document Control
Document code : QA-P-01 Issue Date : Page 3 of 3
Prepared By : Reviewed By : Approval By :
8.1. Prior to the distribution of a controlled document it shall first be approved by the
designated Process Owner. The QM will forward, via email, the document to the owner
for approval.
8.2. The owner will review the contents of the document ensuring to consult with the relevant
standards, codes etc. Once approved, the document will be emailed back to the QM
who will distribute the document to all relevant parties.
8.3. When distributing a new or revised document, the QM will ensure the following
conditions have been satisfied:
•The issue and superseded issue versions are correct.
•The document identification Code is correct.
•The owner’s position title is correct.
•Arrange for the procedure to be posted at the correct location(s).
9. Document Review
All procedures/work instructions/records shall be reviewed during the Internal Audit
procedure process & reference made to the relevant documentation.
10. Documents of External Origin
10.1. External documents: include but are not limited to permits, licenses, MSDS’s,
COA’s, legal requirements e.g. Acts, bylaws etc. All hard copies of external origin shall
be recorded on External Document Register (QA-F-04). Suppliers will be responsible for
the issuing of the latest revision of all their documents.
10.2. Electronic Media: Computerized back up files of all the latest revision quality
documents are kept in a safe. Access to edit the System Documentation is controlled
and accessible only by the Quality Department.
11. Document & Form References
Retention
Document Name Document Code Retrieval
Period
Master Document Register QA-F-03 N/A
External Document Register QA-F-04 N/A
Document Distribution Register QA-F-01 N/A
Document Creation, Change or N/A
QA-F-02
Cancellation Request
If the document is in hardcopy it considered UNCONTROLED document – Check last version on the server
Page 3 of 3
