HARAMAYA UUNIVERSITY HIWET FANA

Comprehensive Specialized Hospital

Policy, Process and Procedures for

Document Control

Compiled By: Eyoel Abebe ( CG and QI Signature:

department )

Approved By: Dr Ahmed Mohammed Signature:

Effective Date: June 01, 2025 GC Version No. 1.0

Document No: HUHCSH/PSI/MSOP-001 Copy No. ___O1

 HARAMAYA UUNIVERSITY HIWET Document No: HUHFCSH/PSI/MSOP-001
FANA Comprehensive Specialized Version No: 1.0
Hospital
Policy, Process and Procedures for Page: 1 of 14
Document Control Effective Date: March 01, 2025 GC

Review, Version Change and Amendment History

A. Document Review History

Review Review Reviewed by: Approved by:
No. Date Name Sign. Name Sign.
02 Dr Mohammednur Abdulahi
(CCD)
Mr Nedir Zeki
Mr Dawit Gezahenge
May 20, Dr Ahmed Mohammed
Mr Bedhasa Ahmed
2025 (CCD)
Mr Kitesa Tariku
Dr Shalo
Mr Damte Adunga
Mr Ahmed Seid

B. Version Change History

Version. Effective Date Reason of Version Change Approved by:
No. Name Sign.
June

C. Amendment History
Review. Page No. Reason of Amendment Amendment Approved by:

‘This is a control document for internal use only’

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FANA Comprehensive Specialized Version No: 1.0
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Document Control Effective Date: March 01, 2025 GC

No. Date Name Sign.

Discontinuation Date: _____________________________

1. Purpose: This procedure gives instructions on how to control documents from creation through
its entire life in the system to destruction.
2. Scope: This procedure applies to all documents that constitute HARAMAYA UUNIVERSITY
HIWET FANA Comprehensive Specialized Hospital.
3. Abbreviations: This describes shorten version of a word, phrase, or text.

HUHFCSH – HARAMAYA UUNIVERSITY HIWET FANA Comprehensive Specialized

Hospital
PSI – Patient Safety Initiative
SOP – Standard Operating Procedure
NA– Not Applicable
4. Responsibility: It is the responsibility of the Quality Director/Manager to ensure effective
implementation and maintenance of this procedure.

5. Definitions:
 Document review - is done when one or more people formally assess documents with an
intention of initiating change if necessary.
 Document revision - improving, amending already existing documents.
 Quality Management System – composed of policies, processes, procedures, and forms
developed to manage an organization or hospital.
6. Policies
 HUHFCSH controls documents of both internal and external origin.
 HUHFCSH reviews all documents found in the hospital at least every two years to check
their continual suitability.

‘This is a control document for internal use only’

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 HUHFCSH prohibits amendment of documents by both hand written and using collection
fluid system.
 HUHFCSH writes page numbers in all internal documents like page 1 to total number of
pages, i.e. page 1 of 5 if the total number of pages of the document are 5.
 HUHFCSH provides a unique document identification number for all documents circulating
in the hospital.
 HUHFCSH maintains master file index of all internal and external documents. In addition,
the hospital has mini master file indexes at least in the main departments of the hospital.
 HUHFCSH maintains at least one copy of obsolete document when it is total discontinued
from the hospital system.

7. Processes

‘This is a control document for internal use only’

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8. Activity Description

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FANA Comprehensive Specialized Version No: 1.0
Hospital
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1. Document Format:
All Manuals/Guidelines (Hospital Manual, IPC Manual, Patient Safety Manual, etc.), Protocols,
Processes, Managerial and Technical procedures, Checklists, Job Descriptions, Formats and Job Aids
are identified with the following information as a standard format:
i. Document Cover Page Information (which appears on the cover page only)
 Hospital Name and Logo
 Document Title
 Compiler (Name & Signature of Compiler)
 Approver (Name & Signature of Approver)
 Document No:
 Copy No: _____
 Version No:
 Effective Date:
Note: 1. Document copy number can be written in blue or black ink for easy printing and
distribution.
2. Formats, job descriptions and job aids do not have cover page information.
3. Formats will not have copy numbers since it is very difficult to control blank formats.
ii. Document Header Information (which appears on all pages except on the cover page):
1. Hospital Name and Logo
2. Document Title
3. Document No:
4. Version No:
5. Effective Date:
6. Page number to the total number of pages
iii. Document Footer Information (which appears on all pages except on the cover page):
1. A statement which says ‘This is a control document for internal use only’.
iv. Document Format Elements
S. No Elements to be standardized Font type Font size Line Attribute
spacing
1 Hospital Name Times New 26 1.5 Bold
Roman
2 Document title in the cover page “ 16 1.5 Bold
2 Heading’s within body of document “ 12 1.5 Bold

‘This is a control document for internal use only’

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3 Body of document “ 12 1.5 Normal

4 Numbering of instructions “ 12 1.5 Normal
5 Header “ 10 1 Bold
6 Footer “ 10 1 Normal

v. Content of Declaration
All Manuals/Guidelines (Hospital Manual, IPC Manual, Patient Safety Manual), Protocols,
Processes, Managerial and Technical procedures have the following declaration form at their last
page.

Declaration
I, the undersigned professional, certify that I am conducting every steps of the
procedure/manual/policy incorporated in this procedure/manual/policy after a prior reading.

[Link]. Name Sign. Date

Note: Checklists, Formats, Job Aids, etc. will not have attached declaration form rather it will be
taken as declared by getting signature of users at training during when they are newly introduced.

vi. Contents of Technical Procedures

1. Purpose – This should answer the question ‘Why does this procedure exist?’
2. Scope – This states the circumstances where and when the procedure is applicable
3. Abbreviation- This describes shorten version of a word, phrase, or text.
4. Responsibility – Defines the people responsible for ensuring effective
implementation and maintenance of the procedure.
5. Principle – the scientific background of the procedure
6. Reagents and Supplies - supplies or reagents to be used in carrying out the process
should be listed here.

‘This is a control document for internal use only’

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7. Equipment - All the equipment to be used in carrying out the process should be listed
here.
8. Sample and container type - All the samples that will be used in the procedure
should be listed here, including container types. Patient preparation before sample
collection should also be noted here.
9. Environmental and Safety control – monitoring of temperature must be noted here.
Any safety precautions applicable to a procedure must be defined here. E.g. universal
precautions must be used when handling patient samples.
10. Calibration – All the required calibrations and the frequency of performing them
must be stated here
11. Quality Control – Quality control materials to be used and the frequency of
analyzing them must be stated here
12. Detailed Procedure - Step by step instructions of performing the procedure.
13. Calculations – If calculations are done in the procedure, they are detailed here. If
calculations are done by the machine automatically, state it that way.
14. Performance Characteristics- Method was verified for intended use.
15. Uncertainty of Measurement- Uncertainty of measurement values if applicable.
16. Interferences/Limitations – This states the limitations of the test
17. Critical Values – Alert values that must be communicated to the clinicians
immediately
18. Result Reporting – State exactly how results must be reported to clinicians
19. Result Interpretation – State interpretation of tests or final results where it is
applicable
20. Biological Reference Interval – If a reference range is applicable, it is stated here.
21. Supporting Documents - This section is to be used for associated procedures, forms,
figures, tables, or diagrams referenced in the document.
22. References – All guidance documents, cross-references, higher-level procedures or
publications that have contributed to the generation of the procedure should be listed
here.
Note: The majority of hospital technical procedures will not have the contents stated
for technical procedures above. The Quality Director/Manager of the hospital can also
additionally add type 2 contents for technical procedure contents or they can use
similar contents with managerial procedures.

‘This is a control document for internal use only’

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Viii. Contents of Managerial Procedures

1. Purpose
2. Scope
3. Abbreviations
4. Responsibility
5. Definitions
6. Activity Description/Procedure
7. Supporting Documents
8. References
NB: Activity description is the same as detailed procedure as defined under technical
procedures above.

2. Creating and Approving New Documents

i. Creating New Documents
a) When a need for a new document is identified, the person who has identified that need
will fill-in a document development or amendment form and submits it to the Quality
Director/Manager.
b) The Quality Director/Manager will consult with the Hospital Medical Director and
respective technical staffs to assess if the proposed document is really necessary.
c) If the proposal is approved, the Quality Director/Manager will give the go-ahead to
the person who identified the need of that document.
d) The document is then developed and submitted to Quality Director/Manager or
assigned expert who reviews for technical accuracy, completeness, reviewing of
format and assigns document number and update master list of documents.
e) Quality Director/Manager then send the document for approval to the Hospital
Medical Director for Technical or Managerial documents.
f) Once approved, Quality Director/Manager ensures that all staff expected to use the
document are given orientation/training and are asked to sign on the document
declaration form attached on the last page of each document after prior reading.
ii. Approval of Documents

‘This is a control document for internal use only’

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Hospital/Quality Manual, Patient Safety Manual, IPC Manual, Protocols and Job Descriptions are
approved for use by Medical Director/CEO. Managerial and Technical procedures, Job aids,
Checklists and Forms are approved for use by the Quality Director/Manager/Department
Heads. However forms are not signed to show approval.

3. Amendments to Documents
 Hand-written amendments are not permitted in all documents.
 Correction fluid must never be used in any of the documents.
 All amendments to documents are done only through the Quality Director/Manager as
follows:
 The person who identifies the need to amendment a document fills-in the document
development/amendment form and submits it to the Quality Director/Manager.
 The Quality Director/Manager follows the same procedure as in section 2 (b- f)
above.
 Quality Director/Manager ensures that amendments to documents are effected on all
copies of that document.
 All amendments made to documents are identified on the amendment history sheet,
which is found on the first page of documents.

4. Reviewing, Updating and Re-Approving Existing Documents

 As part of continuous improvement processes, all documents are reviewed every two
years.
 The Quality Director/Manager oversees this document review process.
 Assigned competent staffs perform the annual document reviews of procedures in their
respective sections.
 The Quality Director/Manager reviews the manuals in collaboration with the Medical
Director and CEO.
 Any amendment or updates to the documents resulting from the reviews are handled in the
same manner as in section 3 above on “Amendments to Documents”.
 If there are no amendments made in the reviews, it must be documented in the amendment
sheet that annual review done but no amendments were made.
 All previous versions of documents become obsolete when new versions have been put in
use.

‘This is a control document for internal use only’

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FANA Comprehensive Specialized Version No: 1.0
Hospital
Policy, Process and Procedures for Page: 10 of 14
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 The Quality Director/Manager removes all obsolete documents from section and replaces
them with new versions.
NB: All Manuals (Hospital/Quality Manual, Patient Safety Manual, IPC Manual, etc), Processes,
managerial and technical standard operating procedures must contain the A-C document revision and
amendment information on the second page that is next to the cover page.
A. Document Review History
Review Review Reviewed by: Approved by:
No. Date Name Sign. Name Sign.

B. Version Change History

Version. No. Effective Reason of Version Change Approved by:
Date Name Sign.

C. Amendment History
Review. Page No. Reason of Amendment Amendment Approved by:
No. Date Name Sign.

Discontinuation Date: ____________________________

5. Document Numbering System
A. Documents are numbered sequentially using alphanumeric system with
abbreviated form in the following order
1. HUHCSP for HARAMAYA UUNIVERSITY HIWET FANA Comprehensive
Specialized Hospital

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FANA Comprehensive Specialized Version No: 1.0
Hospital
Policy, Process and Procedures for Page: 11 of 14
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2. AHS for All Hospital Services

3. YY/YYY/YYYY for the type of document
4. 000 for three-digit serial number
Example: XCSP/AHS/MSOP-001
NB: Each type of document will start with a serial number 001.
B. Type of document are abbreviated as follows:
 MSOP – Managerial Standard Operating Procedures
 TSOP– Technical Standard Operating Procedures
 TF – Technical Forms
 MF– Managerial Forms
 PO–Policies
 PR–Protocols
 HN – Hospital Manuals
 SM–-Safety Manuals
 GL–Guidelines
 EMS–Emergency Medical Services
 OMS–Outpatient Medical Services
 IMS–Inpatient Medical Services
 MJA–Managerial Job Aids
 TJA–Technical Job Aids
 MCH–Managerial Charts
 TCH–Technical Charts
 HQM-Hospital Quality Manual
 JD-Job Descriptions
 RB – Reference Books
 TM- Training Modules
 MCL- Managerial Checklists
 TCL-Technical Checklists
 MSDS-Material Safety Data Sheet
 STD-Standards
 TKI-Test Kit Inserts
 JL-Journals, etc.
6. Master List of Documents

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FANA Comprehensive Specialized Version No: 1.0
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a) The Quality Director/Manager compiles, updates and maintains the master list of documents.
b) The master list of document include: Document Title and No, Version Number, Effective
Date, Copy Number and Location
c) The Quality Director/Manager retrieves obsolete documents guided by the master list of
documents to ensure all are removed from sections and also to distribute new documents.
7. Storing and Archiving Documents
 The Quality Director/Manager maintains master copy of hard copy documents and/or a
folder with electronic copies of all documents that are part of the quality management
system.
 All the identified obsolete documents will be stamped or labeled with the following
information.
 Name of the organization
 Obsolete document
 Document No: _______,
 Date:__________/_____/____
 Name :__________Signature ______ (The person who gathers the document)
i. Hard Copies:
 The Quality Director/Manager maintains all master copy of all the documents.
 All obsolete versions of documents are retained for a period as defined in the document and
record retention times.
 All documents are stored securely in the archival room shelves.
ii. Electronic Copies:
 The Quality Director/Manager maintains folders of both current and obsolete documents on
his office computer which is protected by password
 The Quality Director/Manager also takes a back-up of 2 CDs or external hard disk of all
these documents. One CD or external hard disc will be kept at the Quality
Director/Manager and the other CD or external hard disc will be kept at the Medical
Director/CEO office in reserved lockable shelf. The back-up is done annually or whenever
major changes have been done to the documents. The CD or the external hard disc is
labeled with the date on which back-up was done and the type of document.
 Electronic word documents are only used by the Quality Director/Manager, while other
members of staff use hard copies and controlled pdf documents.
8. Managing External Documents

‘This is a control document for internal use only’

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i. Acquiring and Cataloging

 The Quality Director/Manager acquires all relevant external documents for the
implementation of quality management system.
 External documents may be downloaded from the website, purchased or received from
donors.
 The Quality Director/Manager maintains a list of all external documents on the master list
of documents.
 The Quality Director/Manager gives numbers to all external documents and/or
stamps/labeled them “External document”
 The Quality Director/Manager keeps the external documents and staffs are made aware of
their availability. External documents with technical information are kept in relevant
section.
ii. Updating and Distributing
a. The Quality Director/Manager ensures that the most current version of the external
documents are available in a timely manner and being aware of current versions may
include regular visits to the source website.
b. When a new version is available, the Quality Director/Manager acquires it either by
download, purchase or receipt from donor.
c. The Quality Director/Manager updates the version number of external documents on the
master list of documents.
d. The Quality Director/Manager distributes the new version, retrieves the old version and
retains one copy of old version for specified retention time.
9. Retention time for Documents
 Refer to Hospital/Quality Manual
10. Disposal of Documents
 Following the defined retention time, documents are destroyed via incineration by the
team established in the hospital that is coordinated by Quality Director/Manager.
 The Quality Director/Manager keeps records of all documents that have been
destroyed on the document disposal form.
11. Supporting Documents

[Link]. Document Title Document No.

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FANA Comprehensive Specialized Version No: 1.0
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1 Document Development/Amendment Form HUHFCSH/AHS/MF-001

2 Document Master List/Master File Index HUHFCSH/AHS/MF-002

3 Document Distribution Form HUHFCSH/AHS/MF-003

4 Document Borrowing and Returning Form HUHFCSH/AHS/MF-004

5 Document Disposal Form HUHFCSH/AHS/MF-005

6 Obsolete Document Registering Form HUHFCSH/AHS/MF-006

7 Master File Index of External Documents HUHFCSH/AHS/MF-007

12. References
a) ISO 15189:2022– Medical Laboratories-Requirements for quality and competence.
b) Clinical and Laboratory Standards Institute – The Key to Quality - 2006
c) Clinical and Laboratory Standards Institute: Quality management system; development
and management of laboratory documents; Approved guideline 6 th Edition. February,
2013.

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Declaration
I, the undersigned personnel, certify that I am conducting every step of the procedure incorporated in
this SOP after a prior reading.
[Link]. Name Sign. Date

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‘This is a control document for internal use only’