alf Healthcare Quality Management System

Procedure
Document Control Procedue

Issue Date : 2023-03-06 Issue : 0 Rev. No : 0 Ref. No : MS.05.00.PR

About this Document

Document Type Procedure

Ref. No MS.05.00.PR

Issue Date 2023-03-06

Issue 0

Rev. No 0

Status Approve

Compatibility

Refrence Document Type

ISO 9001:2015 Quality Management System 7.5. Documented information

ISO 13485:2016 Medical devices | Quality Management System 4.2. Documentation requirements

ISO 50001:2018 Energy management systems 7.5. Documented information

ISO 17025:2017 General requirements for the competence of testing and calibration laboratories 8.2. Management system documentation (Option A)

ISO 13485:2016 Medical devices | Quality Management System 4.2.4. Control of documents

ISO 13485:2016 Medical devices | Quality Management System 5.5.3. Internal communication

ISO 9001:2015 Quality Management System 6.3. Planning of changes

Prepration & Approval

This document and information it contains are the sole property of alfanar, shall not be disclosed nor reproduced outside alfanar without prior written approval of the originator.
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 alf Healthcare Quality Management System

Procedure
Document Control Procedue

Issue Date : 2023-03-06 Issue : 0 Rev. No : 0 Ref. No : MS.05.00.PR

Mr. Mohammed Alsudaes

Prepared by
ENGINEER BIOMEDICAL
2022-02-15

Mr. Mohammed Al-ghamdi

Prepared by
Specialist Public Relations
2022-02-15

Dr. Khaled Hassan Makhlouf

Prepared by
DEPUTY MEDICAL OFFICER
2022-02-15

Engr. Waqar Ahmad Malik

Prepared by
Manager QA
2022-02-15

Miss. Marwa Fathy Eltawil

Prepared by
Quality Director
2022-02-15

Mr. Yasser AlJafar

Prepared by
Sr. QA/QC Engineer
2022-02-15

Engr. Nabil Youssef

Reviewed by
SR.MANAGER TECHNICAL HEALTHCARE
2022-02-22

Engr. Kalim Ullah Khan

Recommended by
TQM Manager
2022-02-26

Dr. Osama AlShayeb

Approved by
EXE. MANAGER DEVELOPMENT HEALTHCARE
2022-02-28

This document and information it contains are the sole property of alfanar, shall not be disclosed nor reproduced outside alfanar without prior written approval of the originator.
This is Approved document generated on Monday October 2, 2023, its validity needs to be checked before use from alfanar refrence system by scanning QR Code.
 alf Healthcare Quality Management System

Procedure
Document Control Procedue

Issue Date : 2023-03-06 Issue : 0 Rev. No : 0 Ref. No : MS.05.00.PR

Table of Contents

1 PURPOSE & SCOPE

2 TERMS & DEFINITION
3 References
4 Roles & Responsibilities
5 Key Performance Indicator (KPI)
6 Risk
7 Procedure
8 Records
9 Process Flows
10 Appendix

This document and information it contains are the sole property of alfanar, shall not be disclosed nor reproduced outside alfanar without prior written approval of the originator.
This is Approved document generated on Monday October 2, 2023, its validity needs to be checked before use from alfanar refrence system by scanning QR Code.
 alf Healthcare Quality Management System

Procedure
Document Control Procedue

Issue Date : 2023-03-06 Issue : 0 Rev. No : 0 Ref. No : MS.05.00.PR

1. PURPOSE & SCOPE

1. This procedure describes the methods used to ensure the approval, review, authorization and controlling the issues of all Quality System documentations and the
control of reference documents.
2. To ensure that changes & current revision status is available, legible and readily identifiable at the point of use.
3. To prevent the unintended use of obsolete documents and to apply suitable identification if they are retained for any purpose.
4. This procedure is applicabe on Quality Procedures, Work Instructions, forms and other Quality Documents.

2. TERMS & DEFINITION

2.1. VP : Vice President

2.2. MR : Management Representative

2.3. GM : General Manager

2.4. BUM : Business Unit Manager

2.5. DPM : Department Manager

2.6. PM : Project Manager

2.7. EPC : Engineering, Procurement & Construction

2.8. ISO : International Organization for Standardization

2.9. QMS : Quality Management System

2.10. TQM : Total Quality Management

2.11. QA : Quality Assurance

2.12. QC : Quality Control

2.13. External Documents : Customer Provided “Confidential” documents which cannot be used or distributed without prior permission.

2.14. QP : Quality Procedure

2.15. QR : Quality Record

2.16. JI : Job Instructions

2.17. WI : Work Instructions

2.18. MDF : Medical Device File

2.19. ITP : Inspection & Test Plan

3. References

3.1. ISO 9001:2015 :

Quality Management System requirements

This document and information it contains are the sole property of alfanar, shall not be disclosed nor reproduced outside alfanar without prior written approval of the originator.
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 alf Healthcare Quality Management System

Procedure
Document Control Procedue

Issue Date : 2023-03-06 Issue : 0 Rev. No : 0 Ref. No : MS.05.00.PR

3.2. ISO 13485:2016 :

Medical devices — Quality management systems — Requirements for regulatory purposes

3.3. MS.05.00.PR :
Records Control Procedure

3.4. MS.19.00.PR :
Communication Procedure

4. Roles & Responsibilities

4.1. Business Unit Manager

Responsible to ensure availability of all pertinent and current issues of appropriate documents and prompt removal of obsolete or superseded documents in his business
unit.

4.2. Management Representative

Responsible to ensure that processes needed for the quality management system are documented.

4.3. Department Manager

Responsible to ensure availability of all pertinent and current issues of appropriate documents and prompt removal of obsolete or superseded documents in his business
unit.

4.4. Project Manager

Responsible to ensure availability of all pertinent and current issues of appropriate documents and prompt removal of obsolete or superseded documents in his project.

4.5. TQM Manager

Responsible to review QMS Documents in coordination with QA Manager and recommend to the business units manager for their review.

4.6. Quality Assurance Manager

Responsible for the development and implementation of Quality Management System.

4.7. Quality Coordinator/ Personnel

Responsible for coordination with TQM Department regarding development and implementation of Quality Management System documents for their business area. He is
also responsible to obtain latest version of QMS Documents periodically and circulate among the relevant teams to ensure implementation of Quality Management System.

5. Key Performance Indicator (KPI)

MS.05.01.KP. Document Change Request : Complete document change request within 4 weeks of its initiation.

MS.05.02.KP. Distribution of Documents : QMS documents should be distributed to concnerened within one week of its issuance.

6. Risk

MS.05.00.RK. Usage of Obsolete Documents :

MS.05.01.RK. Documents disposed before desired retention period. :

7. Procedure

7.1. Development of Quality Management System

1. QMS documents shall be prepared by TQM department in coordination with concerned BUM, DPM and or PM and quality coordinator.
2. QA Manager shall collect all information from concerned BUM, DPM and or PM and prepare draft document for review of TQM Manager.
3. QA Manager shall ensure compliance of document as per Management System Requirements; where applicable.
4. TQM Manager in coordination with QA Manager reviews all QMS documents and recommend to BUM, DPM and or PM for their review.
5. Once document is reviewed by TQM Manager & BUM, DPM and or PM same shall be forwarded to competent authority for their review and approval.

This document and information it contains are the sole property of alfanar, shall not be disclosed nor reproduced outside alfanar without prior written approval of the originator.
This is Approved document generated on Monday October 2, 2023, its validity needs to be checked before use from alfanar refrence system by scanning QR Code.
 alf Healthcare Quality Management System

Procedure
Document Control Procedue

Issue Date : 2023-03-06 Issue : 0 Rev. No : 0 Ref. No : MS.05.00.PR

7.2. QMS Dcouments Approval Authority

The documents signatory authorities are as follow:

Top Management (President / Vice President / General Manager) of organization is authorize to approve quality documents having significant impact on company
policy including quality policy, quality manual, JI, WI and managerial procedures.
BUM, DPM and or PM are authorize to approve operational procedures, JI, WI or any other departmental procedures having insignificant impact on company
policy in due consultation with TQM Manager.
For minor modifications / changes in QMS document which does not affect the Policy Statement(s) can be approved by BUM, DPM and or PM . All other
modifications affecting Policy shall be sent to Top Management for their review and approval.

QMS document approval authority matrix is described in appendix MS.05.02.AP.

7.3. Distribution of QMS Documents

QA Manager maintains list of quality documents applicable for each department and distribute control copy of relevant documents to concerned departments through
quality coordinators within one week of its issuance.

QMS Documents can be distributed digitally through emails or can be posted at organizational portal which should be accessible by all concerned end users.

Quality Coordinators manage to obtain latest version of QMS Documents periodically and circulate among the relevant teams to ensure implementation of Quality
Management System.

7.4. Document Classification

7.4.1. Controlled Documents

Various Documents, including Project Quality Plan / Program, Quality Control Plan / Inspection & Test Plan (ITP), Construction Design & Drawings, Calculations, Field
Inspection Checklists, MDF etc., are held under “Control” and listed by Quality Coordinator / QA/QC personnel in Reference Documents Index (MS.05.04.RD) and maintained
it throughout when required.

7.4.2. Uncontrolled Documents

When a version of QMS document is sent outside the company.

7.4.3. External Origin Documents

1. Any document, standard, drawing, specification or record provided by the client / supplier / agency not belongs to organization but can be used during any
organization process shall be marked / stamped as “External Origin Document”.
2. All external origin documents shall be received by the Document Controller / Quality Coordinator and distributed to concern after stamping and listing in Reference
Documents Index (MS.05.04.RD).
3. Concerned department / person shall maintain & control such documents till end of task or handing over / return back to its owner.

7.4.4. Reference Documents

1. Various support documents, including product / service standards, specifications & drawings are held for reference at the appropriate locations with the concerned
Manager(s). These are listed by the concerned department in Reference Documents Index (MS.05.04.RD).
2. The Reference Documents Index (MS.05.04.RD) is updated whenever support & reference documents are added, replaced or removed.
3. Concerned department contacts the client / suppliers of such references periodically to make sure that latest revision is obtained and are in use.

7.4.5. Obsolete Documents

When a new version of QMS document is approved or a new edition of an existing reference document (specification, drawings etc.) is added to the Reference Documents
Index (MS.05.04.RD), quality coordinator of concerned department ensures that the document holder receives the new version and that the old version is stamped with
“Obsolete”.

7.5. Document Seal

Each page of Quality Document should have a management seal comprissing of at least, the following information:

Company Name & Logo,

Title of Documents,
Document Reference No.,
Issue No. / Rev. No.,
Issuing date,
Page No.

This document and information it contains are the sole property of alfanar, shall not be disclosed nor reproduced outside alfanar without prior written approval of the originator.
This is Approved document generated on Monday October 2, 2023, its validity needs to be checked before use from alfanar refrence system by scanning QR Code.
 alf Healthcare Quality Management System

Procedure
Document Control Procedue

Issue Date : 2023-03-06 Issue : 0 Rev. No : 0 Ref. No : MS.05.00.PR

7.6. Stamping the QMS (Procedure, Checklists, WIs, & Forms etc.) Documents
Following five types of Stamps, for showing the status of the documents, are used:

Controlled Copy To be stamped only on the employees copies of Quality Procedures, checklists & WIs etc. It shows that document will be updated, in case of
any change(s). Also, it is not allowed to copy them without permission.

Uncontrolled Copy To be stamped on all documents which will be sent outside company e.g. customer copy. The stamp shows the document “Not subject to
update”.

Obsolete Documents To be stamped on Master & circulated copy (ies) of old “Controlled Copy” documents version.

Reference Documents To be stamped as “Reference Documents”.

External Origin To be stamped as "External Origin Documents"

Documents

For proper document handling & controlling, all projects & departments shall have “Controlled Copy, uncontrolled copy, Received / Faxed and Obsolete stamps” while
project sites should keep, in addition to these, “Distribution, Issued for Construction & Issued for Information” stamps. For details of “Quality Stamps” see Appendix-B of this
procedure.

7.7. Changing of Documents

1. Any staff member can propose any change(s) in Quality Management System (QMS) by initiating document change request manually in (MS.05.01.RD) format or
digitaly through portal or information system and obtaining approval & recommendation of his immediate Manager.
2. The Document Change Request (MS.05.01.RD), after review & approval of QA Manager, is forwarded or discussed with TQM Manager for review and approval.
3. Based on the feedback of TQM Manager / QA Manager will amend the document accordingly & change the Revision No. & Issue Date accordingly.
4. QA Manager shall retrieve “Old Copies” from all document holders and provides them the new ones.
5. QA Manager maintains and update Documents Change Log (MS.05.05.RD) after each change, modification, amendment, addition or deletion of Quality Document
in QMS.

7.8. Documents Identification Scheme

7.8.1.
All Departments and projects shall follow Documents Identification Scheme (Appendix-A) for their documents handling & recording.

7.9. Document Archiving (Medical Devices)

The QMS documents are archived based on the projected useful life of the medical device or according to national regulatory requirements – whichever is the longest.
Document related to the manufacture or testing of a medical device must be retained for the lifetime of the device, but not less than two years after distribution of the
device. The retention period must also meet the requirements of the regulatory authorities of the countries in which the device is distributed.

8. Records

MS.05.01.RD. Document Change Request :

MS.05.02.RD. Document Distribution List :

MS.05.03.RD. Document’s Master List :

MS.05.04.RD. Reference Documents Index :

MS.05.05.RD. Documents Change Log :

9. Process Flows

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This is Approved document generated on Monday October 2, 2023, its validity needs to be checked before use from alfanar refrence system by scanning QR Code.
 alf Healthcare Quality Management System

Procedure
Document Control Procedue

Issue Date : 2023-03-06 Issue : 0 Rev. No : 0 Ref. No : MS.05.00.PR

MS.05.01.PF Control of Document

10. Appendix

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 alf Healthcare Quality Management System

Procedure
Document Control Procedue

Issue Date : 2023-03-06 Issue : 0 Rev. No : 0 Ref. No : MS.05.00.PR

MS.05.01.AP Documents Identification Scheme

All Departments and projects shall follow Documents Identification Scheme (Appendix-A) for their documents handling & recording.

This document and information it contains are the sole property of alfanar, shall not be disclosed nor reproduced outside alfanar without prior written approval of the originator.
This is Approved document generated on Monday October 2, 2023, its validity needs to be checked before use from alfanar refrence system by scanning QR Code.
 alf Healthcare Quality Management System

Procedure
Document Control Procedue

Issue Date : 2023-03-06 Issue : 0 Rev. No : 0 Ref. No : MS.05.00.PR

MS.05.02.AP QMS Documents Approval Authority

Document Propose Review Recommend Approve

Quality Policy Manager QA TQM Manager Vice President President

Business Unit Manager

Quality Manual Manager QA TQM Manager Business Unit Manager Vice President

Department Manager

Quality Procedure Manager QA Business Unit Manager Vice President

TQM Manager

Department Manager

This document and information it contains are the sole property of alfanar, shall not be disclosed nor reproduced outside alfanar without prior written approval of the originator.
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 alf Healthcare Quality Management System

Procedure
Document Control Procedue

Issue Date : 2023-03-06 Issue : 0 Rev. No : 0 Ref. No : MS.05.00.PR

MS.05.03.AP Quality Stamps

MS.05.01.ST. Controlled Copy :

MS.05.02.ST. Uncontrolled Copy :

MS.05.03.ST. Obsolete :

MS.05.04.ST. Received :

This document and information it contains are the sole property of alfanar, shall not be disclosed nor reproduced outside alfanar without prior written approval of the originator.
This is Approved document generated on Monday October 2, 2023, its validity needs to be checked before use from alfanar refrence system by scanning QR Code.
 alf Healthcare Quality Management System

Procedure
Document Control Procedue

Issue Date : 2023-03-06 Issue : 0 Rev. No : 0 Ref. No : MS.05.00.PR

MS.05.05.ST. Reviewed :

MS.05.06.ST. External Origin Document :

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This is Approved document generated on Monday October 2, 2023, its validity needs to be checked before use from alfanar refrence system by scanning QR Code.
 alf Healthcare Quality Management System

Procedure
Document Control Procedue

Issue Date : 2023-03-06 Issue : 0 Rev. No : 0 Ref. No : MS.05.00.PR

MS.05.09.ST. Project Distribution Stamp :

MS.05.07.ST. Issued For Construction (IFC) :

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 alf Healthcare Quality Management System

Procedure
Document Control Procedue

Issue Date : 2023-03-06 Issue : 0 Rev. No : 0 Ref. No : MS.05.00.PR

MS.05.08.ST. Issued For Information :

This document and information it contains are the sole property of alfanar, shall not be disclosed nor reproduced outside alfanar without prior written approval of the originator.
This is Approved document generated on Monday October 2, 2023, its validity needs to be checked before use from alfanar refrence system by scanning QR Code.