DOCUMENT CONTROL

PROCEDURE

SOP-011
1 Version : 01
 Version Control

Rev. History Description Of Page

DCR No.
No. Date Revision No.

00 06/04/2025 First Issuance - -

2 SOP-01
 Contents

1 Terms & Definitions

2 References

3 SOP Purpose

4 SOP Scope

5 Roles and Responsibilities

6 Procedures

7 Relevant Procedures and Forms

8 SOP Approval Cycle

3 SOP-01
Terms & Definitions

Terminology The Definition

Documentation
A set of documents, for example specifications and records.
System
Document information and the medium on which it is contained.
Documented Information required to be controlled and maintained by an
Information organization and the medium on which it is contained.
Procedure Specified way to carry out an activity or a process.
Standard A document that provides an overview of a process,
Operating including its objectives and responsibilities.
Procedure (SOP) A detailed guide that outlines specific steps to perform a
particular task within a process.
Document stating results achieved or providing evidence of
Record
activities performed.
Quality Part of quality management focused on providing
Assurance confidence that quality requirements will be fulfilled.

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Terms & Definitions

Terminology The Definition

IMS Integrated Management System
Information Meaningful data
DCR, the word “change” means addition (i.e.. creation) of a
Document new document to the system, deletion (cancellation) of an
Change Request existing document from the system, modification
(DCR) (updating) in an existing document or merging
(consolidation) of two or more documents.
CCR Change Control Request
Technical Any change that assessed to impact “directly or indirectly”
Change the service quality.
Is the person responsible for managing and overseeing a
specific process within an organization, ensuring it
Process Owner operates effectively, complies with relevant standards, and
achieves its intended outcomes while continuously
improving and meeting organizational objectives.
Information created by an external party outside the
Documented
company but retained by the company for its use. This may
Information of
include items such as customer drawings, regulatory
External Origin
requirements, and standards.
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Terms & Definitions

Terminology The Definition

The original date when the document was first created and
1st Issuance Date released. This date remains unchanged, regardless of any
future revisions or updates.
The date when the document officially becomes applicable
Effective Date and enforceable within the organization, either at its initial
release or after a review.
The scheduled date for assessing the document to
determine if updates or revisions are needed to maintain
Next Review its accuracy and compliance.
Date
Note: Documents are reviewed every 3 years from the
issuance date.
A unique identifier indicating the document's current
Rev No. version, which updates sequentially whenever changes or
revisions are officially implemented (e.g., Rev 00, Rev 01).

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 References

• ISO 9001:2015 titled “Quality management systems Requirements”.

• ISO 9001:2015/Amendment 1:2024 “Quality management systems —
Requirements”.
• ISO 45001:2018 titled “Occupational health and safety management
systems”.
• ISO 14001:2015 titled “Environmental management systems”.
• ISO 9000:2015 titled “Quality management systems — Fundamentals and
vocabulary”.
• ISO 10013:2021 “Quality management systems — Guidance for documented
information”.

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 SOP Purpose

To establish a system for creating, updating, controlling, and maintaining

documented information required by the organization's integrated management
system. This system ensures:
• Documents are properly identified, reviewed, and approved prior to
issuance.
• Controlled documents are distributed and made available where needed.
• Documents are archived and protected to prevent deterioration, loss, or
unauthorized access.
• Document updates follow appropriate version control to ensure only the
latest versions are used.
• Obsolete documents are securely disposed of, and active documents are
retained in accordance with organizational requirements.

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 SOP Scope

This procedure applies to all types of documents within the organization, including
but not limited to:
• Standard Operating Procedures (SOPs), Work Instructions (WIs), policies,
and their associated forms.
• Executed records.
• Quality, Safety, and Environmental Policies.
• Documents from external sources.
• Electronically stored documents and data.

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 Roles and
Responsibilities

Role Responsibility

Review and approve documents.

Reviews Document Change Requests (DCRs) and
Quality Assurance provides reasons for rejection when necessary.
Department Assign unique codes and apply stamps for document
traceability.
Archive and dispose of IMS documents appropriately.

Quality Assurance
Manager Approve SOPs and WIs .

Prepare Document Change Request (DCR) Form F-01-

04 for requesting the creation, update, or cancellation
of documents.
Identify the reasons for the document Change request
Process Owner
(creation, update, or cancellation).
Implement the approved request and submit the draft
document to Quality Assurance for review.
Conduct training on the updated procedure after the
changes have been implemented.

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 Roles and
Responsibilities

Role Responsibility

Contribute to organizing training on updated

Human Resources
documents.

Information
Conduct regular backups to preserve all data.
Technology
Support the distribution of electronic documents

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 Procedures

1 Procedure for Document Preparation and Approval by Authorized

Personnel:
• Integrated management system documentation should be developed by
those personnel involved with the processes and activities. This will lead
to a better understanding of the necessary requirements and provide a
sense of involvement and ownership by personnel; these personnel shall
be determined in form # F-01-01.
• QA manager shall approve SOPs & WIs for adequacy prior to issue.
• For work policies, it should be approved by top management.
• Personnel responsible for preparing and updating documents shall:
- Use the templates for forms, SOPs, WIs, and policies attached to this
SOP.
- Consider QA evaluation comments, if any, along with regulatory
requirements, applicable standards, customer and stakeholder
requirements, and any company-specific requirements.
- Ensure data integrity across all documents within the IMS.
- Take into account any comments from audit results.

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Procedures

• SOPs, manual, policies and WIs shall be prepared as soft files by computer
not handwritten.
• The language (e.g. Arabic or English) used in the document shall be
suitable for document users and documents can be prepared in English
Only or translated into Arabic if required.
• QA shall assign a unique code for each document according to the
following:
• Coding system must be unique to ensure the traceability of all generated
documents and to prevent the repetition of the same code number for
more than one document.
• Each code number must be assigned only once. If any document (e.g.,
SOP) is removed from the system, its code shall not be given to another
document to ensure the appropriate traceability.
• Coding system of documents shall be as follow:

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Procedures

S.N. Document Coding Interpretation Examples

Type System

SOP is an abbreviation SOP-01

Procedures for standard operating It means it’s
1. (SOP) SOP – XX Procedure. the 1st
XX is the serial number procedure in
of SOP in IMS. IMS.
POL is an abbreviation POL-03
for policy. It means it’s
2. Work Policies POL – YY YY is the serial number the 3rd work
of policies in IMS. policy in IMS.

WI is an abbreviation WI-04
for Work instruction. It means it’s
Work ZZ is the serial number the 4th work
3. Instructions WI – ZZ of Work instructions in instruction in
IMS. IMS.

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Procedures

S. Document Type Coding Interpretation Examples

N. System

IMSM is an IMSM-01
abbreviation for
Integrated
Integrated It means it’s
Management
4. IMSM-KK Management System the 1st manual
System Manual
Manual. in the
KK is the serial number company.
of the manual.
5. Forms/ Records
F stands for form F-01-03
associated with a It means it’s
procedure. the form # 3
Forms associated XX is the serial number in SOP coded
5.1 with SOPs. F – XX-RR of SOP related to this as SOP-01.
form.
RR is the serial number
of forms in this
procedure.
* For external documents generated by external parties: initiator shall send a
draft copy for review by the company before final approval.
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 Procedures

2 Document Preparation/Updating/Cancellation
• Process owners identified in List of Individuals Authorized to Prepare
Documents form # F-01-01 shall prepare form # F-01-04 if there any
need to (prepare, update, or cancel) any documents required by IMS.
• Form # F-01-04 shall be sent to quality assurance department for review
and approval.
• Process owners shall clearly determine the rational of (preparation,
updating or cancellation) of document and quality assurance shall
evaluate it.
• The Quality Assurance Department shall review the request, evaluate it,
and assess its impact on the IMS and other documents.
• After receiving a request, the Quality Assurance department shall
determine whether the change is a technical change or a documentation
change.:

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 Procedures

1 - Incase of documentation change , QA shall review the request to

decide whether to approve or reject it..
- Incase of technical change , QA shall refer to the change control
procedure SOP-11.
• If QA has rejected the request, the cause of rejection shall be clearly
determined and sent to process owner.
• If QA has approved the request, process owner can start to implement it
and send a draft copy of prepared or updated document to QA for review
if appropriate and approval.

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 Procedures

Documents Training & Distribution:

3
• Training on new or updated documents, as determined by QA and the
document initiator, shall be conducted for all relevant personnel. The
period between the document's issue date and its effective date shall not
exceed one month, and all necessary training must be completed within
this timeframe, ensuring it is done before the document becomes
effective.
• The new or updated document is raised from a process owner who
identifies the need for a new or updated document.
• Training and distribution shall be documented using form # F-01-03.
• Distributed copies shall be a copy of the master one (which has been
reviewed and approved by QA) and shall be stamped with
(CONTROLLED COPY) stamp.
• For records that intended to be prepared by relevant departments as hard
copies, QA shall stamp the template of these forms by (CONTROLLED
COPY) stamp before their distribution (Refer to SOP-02).
• Each copy shall be coded by QA according to the following (This code
allows traceability during receiving and retrieval when the document will
be cancelled)

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 Procedures

• Code shall be according to the following structure: Department Code – XX

(where the XX is the serial no. of copy in the same department) and Department
1 Code shall be according to the following table:
Department Department Code
Quality Assurance QA
Information Technology IT
Human Resource HR
Top Management TM
Purchasing PU
production PR
Sales SA
Finance FN
Other -
• Also, soft copies can be distributed instead of hard ones in this case, QA should apply
the following:
- QA shall take one hard copy of the master one and stamp the copy with
(CONTROLLED COPY) stamp.
- After that QA should scan the copy stamped by (CONTROLLED COPY) stamp.
- Then QA can distribute the scanned copy on relevant personnel and retain the
controlled hard copy.
• During documents distribution, QA shall withdraw any cancelled documents from
relevant personnel to ensure that obsolete documents won’t be used.
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 Procedures

Documents Archiving:
4
• QA shall write the issue date, effective date (it is recommended generally
maximum one month from Issue Date) and review date (Re-issuance date)
of the document electronically, also issue no. that indicates the number of
changes/ updates for each document.
• QA shall track and document all changes in the IMS documents including
records.
• Then distribute the document for signature from the concerned personnel,
then stamp the approved signed hard copy by “MASTER COPY” stamp, all
current SOPs, POLs & WIs shall be tracked by QA using form # F-01-02.
• Form # F-01-02 shall be updated as soon as possible after updating any
document.
• For external documents:
- Documented information of external origin is information created by a
party outside of the company but kept by the company for its use. This
can include, for example, customer drawings, regulatory requirements,
and standards.
- The final documents received from external parties shall be reviewed by
QA and relevant departments and if they have been approved, they can
be stamped by company stamp.
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 Procedures

- Approved external documents shall be tracked by QA using form # F-01-06.

1 - Their distribution should be according to this procedure.
• At the time of distribution of updated documents, earlier versions “cancelled
documents” shall be stamped with “Cancelled”, all cancelled documents shall be
tracked by QA using form # F-01-05.
• Hard copies of documents shall be archived in a dedicated, identified, and secured
area and QA department shall be the only department that has permission to
access this area.
• The archiving area shall be suitable for documents archiving (e.g. away from heat
sources) to prevent their deterioration or loss.
• During documents archiving, current documents shall be separated from
cancelled documents and each one of them shall be externally identified.
• For soft files:
- All controlled documents (including internal and external documents) shall be
located in a directory called "COMPANY DOCUMENTS" on the documentation
center computer protected via secured password.

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 Procedures

- Each main folder shall be well identified e.g. for archiving of SOPs (the main
folder can be titled as “Internal Documents” which includes a sub folder titled
1 “SOPs” and inside this folder all SOPs shall be archived and identified with
their code no. and title).
- The hard-signed copies of SOPs, Policies, WIs and IMS manual shall be
scanned and archived in their soft folder.
- Cancelled documents shall be stored in a separated main folder in the
computer.
- For executed records (e.g. change requests, list of main SOPs) they should be
stored in separated main folder titled “Executed Records”.
- QA shall arrange with IT department for backup of contents of soft IMS files on
monthly basis.

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 Procedures

Controlled Documents Periodic Review:

5
• Documents shall be in compliance with the latest versions of the
standards and adequacy of the documents shall be reviewed.
• Documents shall be assessed and checked by the users for continued
suitability.
• A DCR is required to cancel or revise the document in accordance with
Periodic review form.
• DCR shall be submitted to QA for approval (then, follow the same
documentation cycle).
• Changes to documents shall be identified and tracked using the revision
history table in each procedure.

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 Procedures

6 Uncontrolled Copies:
• For customer off-site usage and other external distribution of documents;
such distributed documents should be clearly identified and stamped as
uncontrolled copies.

7 Retention Period of Obsolete Documents:

• At least one copy of obsolete documents shall be retained.
• The document retention period shall be two years after the completion of
service provision.
8 Disposal of Documents :
• After the end of the retention period QA can dispose of all obsolete
documents by any suitable means (e.g., by shredder machines or
manually, etc.)
• Ensure that the complete identity of document is destroyed, and the
document or part of document can no longer be used for any purpose.
• Maintain documents destruction record Form No. F-01-07.

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 Procedures

Stamps List

1 Stamp Use
1.
Master Copy For signed and approved SOPs & records to be
(Blue Color) archived by QA
1. For site use (documents to be distributed by QA on
Controlled Copy relevant departments).
(Green Color)

Uncontrolled Copy For documents to be distributed by QA for external

1.

(Red Color) parties. Will not be Updated”.

1. Cancelled For obsolete documents retained by QA.
(Red Color)

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 Relevant
Procedures/Forms

Forms/SOPs No Title
F-01-01 List of Individuals Authorized to Prepare Documents
F-01-02 Main List of Current Documents
F-01-03 Document Training & Receipt Form
F-01-04 Document Change Request (DCR)
F-01-05 List of Canceled Documents
F-01-06 External Documents List
F-01-07 List of Disposed Documents
SOP-02 Control of Records Procedure
SOP-11 Change Control Procedure

26 SOP-01
 SOP APPROVAL CYCLE

1st Issuance Date 06/04/2025

Effective Date 06/05/2025
Next Review Date 06/04/2028

Approval Position Name Sign/Date

Prepared by

Reviewed by

Approved by

Copy no.

STAMP

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