DBUHGHL-SOP For Document Control PDF

Debre Birhan University Hakim Gizaw
Hospital Laboratory
Standard Operating Procedure for Document

Control
Compiler: ______ Signature:

Approver: Signature:
Effective Date: Jan 01, 2023 Version No.:1
Document No: DBUHGHL-QOO-SOP/4.3-01 Copy No _____
Debre Birhan University Hakim Gizaw Hospital Effective Date: Nov. 01/2023
Laboratory
Standard operating procedure for document control Version No:1
Document Number: - DBUHGHL-QOO-SOP/4.3-01 Page No: 2 of 17
Revision and Amendment
A. Annual Review of Document

Version Reviewed by Approved by
Review Date
Number Name Signature Name Sign
B. Revision Change History/Description

Version Effective Description of Version Change Name & Name &
number Date Signature of Signature of
Reviser approval
C. Amendment
Version Page Description of Amendment Amendment Effective Name & Signature of
number No Date Date approval
Compiled by: __ Authority: DBUHGHL

Any document appearing in a paper form with a stamp of `CONTROLED BY DBUHGHL is a controlled
document for internal use only.
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Abbreviations and acronyms:
ALS All Laboratory Section
CCD Chief Clinical Director
CD Compact Disc
CHA Charts
CKL Check List
DBUHGHL Debre Birhan University Hakim Gizaw Hospital Laboratory
LM Laboratory Manager
JA Job Aid
JD Job Description
N/A Not applicable
QMS Quality Management System
QO Quality Officer
QOO Quality Officer Office
SOP Standard Operating Procedure
T Table

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Purpose: This procedure gives instructions on how to control documents from creation through its
entire life in the system to final destruction i.e. development, review, authorization, control, and
distribution of controlled documents.
Scope: This procedure applies to all documents that constitute DBUHGHL Quality Management
System.
Responsibility:
Laboratory manager:
 Reviews and approves policies and procedures in their area of responsibility and verifies the
technical accuracy
Quality Manager
 It is the responsibility of the quality officer to ensure effective implementation and
maintenance of this procedure and review/revise as required
Staff members:
 Verifies the official version of the document is used by checking QMS requirements every
time
 Review document content for clarity and accuracy to determine need for new procedures or
modification to procedures.
 Initiates Document Change Requests.
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.

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1. Procedure
a. Document Format
i. Front page for SOPs and Manuals
When creating or developing manuals and procedures, the front page for these documents shall
follow the following format as indicated below
NB: Document copy number can be written in hand by blue or black ink for easy printing and
distribution.
Formats, job descriptions and job aids do not have cover page

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ii. Document Header Information (which appears on all pages except on the cover page):
The headers for all internally prepared documents shall follow the following format
Debre Birhan University Hakim Gizaw Hospital Effective date:
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Document title….. Version No:
Document Number: - DBUHGHL-
Page No: -of -
iii. Footer
The footer for all internally prepared manuals shall follow the following outlined format:
The footer for all internally prepared SOPS, F, JA, JD, CKL, CHA, and T is outlined as follow:
Compiled by: ___________ Authority: DBUHGHL
Any document appearing in a paper form with a stamp of `CONTROLLED BY DBUHGHL’ is a controlled
iv. The internally prepared documents shall follow the following Formatting Elements:
S. No Elements to be standardized Font type Font size Line spacing Attribute
1 Name of laboratory Times New Roman 24 1.5 Bold
2 Document title in the cover page “ 22 1.5 Bold
3 Headings within body of document “ 12 1.5 Bold
4 Body of document “ 12 1.5 Normal
5 Numbering of instructions “ 12 1.5 Normal
6 Header “ 12 1.0 Normal
7 Section Areas Labeling Arial 36 1.5 Bold
8 Equipment and furniture labeling Times New Roman 14 1.0 Bold

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v. Content of Declaration
All Manuals (Quality Policy Manual, Laboratory Hand Book, Specimen Management Guideline and
Laboratory Safety Manual), Processes, Managerial and Technical procedures have the following
declaration form at their last page.
vi. Declaration
I, the undersigned laboratory personnel, certify that I am conducting every steps of the procedures
incorporated in this QPM/Manual/Guideline/SOP after a prior reading.
S/N Full Name Signature Date Remark
Checklists, Formats and Job Aids will not have attached declaration form rather it will be taken as
declared by getting signature of users during training when they are newly introduced.
vii. Contents of Technical Procedures
1. Purpose – This should answer the question ‘Why does this procedure exist?’
2. Scope – These 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. Definitions-defines new terminologies to be used in the preparation of Technical
Procedures.
6. Principle – the scientific background of the procedure
7. Reagents and Supplies - supplies or reagents to be used in carrying out the process should
be listed here.
8. Equipment - All the equipment to be used in carrying out the process should be listed
here.

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9. 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.
10. 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.
11. Calibration – All the required calibrations and the frequency of performing them must be
stated here
12. Quality Control – Quality control materials to be used and the frequency of analyzing
them must be stated here
13. Detailed Procedure - Step by step instructions of performing the procedure.
14. Calculations – If calculations are done in the procedure, they are detailed here. If
calculations are done by the machine automatically, state it that way.
15. Performance Characteristics- Method was verified for intended use.
16. Uncertainty of Measurement- Uncertainty of measurement values if applicable.
17. Interferences/Limitations – These states the limitations of the test.
18. Critical Values – Alert values that must be communicated to the clinicians immediately.
19. Result Reporting – State exactly how results must be reported to clinicians.
20. Result Interpretation – State interpretation of tests or final results where it is applicable.
21. Biological Reference Interval – If a reference range is applicable, it is stated here.
22. Supporting Documents - This section is to be used for associated procedures, forms,
figures, tables, or diagrams referenced in the document.
23. References – All guidance documents, cross-references, higher-level procedures or
publications that have contributed to the generation of the procedure should be listed here.
24. Reportable Range

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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.
b. Creating, Reviewing and Approving Documents
i. Creating New Documents
1. 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 Officer.
2. The quality officer will consult with the Laboratory Manager and respective
technical staffs to assess if the proposed document is really necessary.
3. If the proposal is approved, the quality officer will give the go-ahead to the person
who identified the need of that document.
4. The document is then developed and submitted to quality officer or assigned expert
who reviews for technical accuracy, completeness, reviewing of format and assigns
document number and update master list of documents.
5. Quality officer then send the document for approval to Laboratory Manager for
Technical or Managerial documents.
6. Once approved, quality officer ensures that all expected staffs to use the document
are given training and are asked to sign on the document declaration form attached
on the last page of each document.

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ii. Document review and approval

 Quality policy manual, safety manual, sample collection manual and laboratory hand book
issued to the DBUHGHL as part of QMS are reviewed after creation and annually by QO
in addition to LM and approved by hospital CCD. The remaining documents issued to
DBUHGHL as part of QMS are reviewed after creation and annually by quality officer,
safety officer and any other technical expertise as needed, and approved by LM.
Documents which are compiled by the LM will be approved by the QO. However, forms
are not signed to show approval. After annual review of documents, if there are any
amendments made to the documents shall be handled in the same manner as in section iii
below 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.
iii. 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 manuals and procedures are done only through the quality officer 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 officer.
 The quality officer follows the same procedure as in section i (2- 6) above.
 Quality officer ensures that amendments to documents are affected on all copies of
that document.
 All amendments made to documents are identified on the amendment sheet, which is
found on the first page of all documents next to the cover page.
iv. Document Changes/Revision
 All personnel are responsible for quality and have the responsibility to identify areas where
revisions needed to be made.
 Where a need for document revision is identified by staff or where a need is identified
through audit or management review, the relevant personnel should initiate such revision

Laboratory
by means of form, indicating the recommended changes to the relevant document, to the
QO. The validity of the recommendation is decided by the LM and QO.
 It is advisable that the compiler circulates a draft of the revised document to ensure that
staff members to whom the matter is of concern, are given an opportunity to make
comments. The compiler must process such comments and implement feasible/valid
comments in the final document.
 All Quality Management System documents are reviewed annually and revised as needed
by quality officer or senior staffs.
 All previous versions of documents become obsolete and destroyed by fire or shredding
when new versions have been put in use.
 The quality officer removes all obsolete documents from workstations and retains one copy
of obsolete document stamped with the word “OBSOLETE” and dated on the first page in
archival area for the time period specified on the document retention.
c. Document identification
The Laboratory has adopted the approach of aligning its documentation with the numbering of the
relevant clauses of ISO 15189. The system ensures contextualization of all documentations within the
quality management system that are associated with any clause of ISO15189. Documents are identified
by an alphanumeric system where the document type is identified by a descriptor together with the
relevant clause number from ISO 15189. The document is then pre-fixed by an abbreviation
(DBUHGHL) to indicate that it is DBUHGHL’s document and followed by two or more letters. e.g.,
/HEM/ showing the location of the document within the laboratory, next followed by one or more
alphabets and number, e.g. -F/4.3-; the alphabet is indicating the type of the document and the number
is indicating the relevant ISO 15189 clause/policy number and finally it will be suffixed by serial
number /-01/to indicate its serial number. By assembling the alphanumeric code, it will be read as the
following; DBUHGHL- HEM -F/4.3-01. If the document is related with all policies, no need to add
ISO clause/policy number e.g., DBUHGHL-HEM-MN-01. Concerning ALS, it describes the location
of all documents with the same heading but the internal content might vary among laboratories. If the
laboratory wants to expand its service area, the location of the document is prefixed by the first letter

Laboratory
of the branch laboratory. Eg. If the laboratory has emergency laboratory, the document number
becomes DBUHGHL-EHEM-F/4.3-01
Type descriptor Section Description
ALS All Laboratory Sections
CHEM Clinical Chemistry section
EMS Equipment Mini- store
HEM Hematology section
LMO Laboratory Manager office
MIC Microbiology section
PARA Parasitology Section
QOO Quality Officer Office
SER Serology Section
SR Sample reception/collection section
The document categories are listed as follows:
Type Descriptor Document Description Examples

CHA Charts DBUHGHL-SMH-CHA/5.5-01
CKL Checklist DBUHGHL-SMH-CKL/5.1-01
ED External Document DBUHGHL-SMH-ED/4.3-01
F Forms DBUHGHL-ALS-F/4.1-01
G Guideline DBUHGHL-SMH-G/4.1-01
JA Job Aid DBUHGHL-SMH-JA/5.1-01
JD Job Description DBUHGHL-SMH-JD/4.1-01
MN Manuals DBUHGHL-SMH-MN/4.2-01
MS MSDS DBUHGHL-SMH-MS/5.2-01
RB Reference Book DBUHGHL-SMH-RB/5.5-01
S Standards DBUHGHL-SMH-S/4.1-01
SOP Standard Operating Procedures DBUHGHL-SMH-SOP/4.1-01
TKI Test Kit Inserts DBUHGHL-SER- TKI /5.5-01
TM Training Manual DBUHGHL-SMH-TM/5.1-01
UM User Manual DBUHGHL-SMH-UM/5.3-01
DBUHGHL documents are prepared in English language. If a document is prepared in Amharic, each
Amharic Version document should include “A” with the document Unique ID at the end of serial
number (Example DBUHGHL-SMH-SOP/5.3-01A) and an external document that is needed for
internal use must be controlled/internalized by posting the DBUHGHL’s alphanumeric document

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identification system containing “ED” followed by its type and suffixed with a serial number as a
document unique ID. (Example DBUHGHL–SO-ED-TM-01)
d. Document distribution
All DBUHGHL documents issued to the laboratory as part of the quality management system are
distributed in accordance with document distribution list (DBUHGHL-SMH-F/4.3-02)
Master list of documents
a) The quality officer compiles updates and maintains the master list of documents for active
documents and obsolete document master list.
b) The master list of documents include: Document Title and No., Version Number, Effective
Date, Copy Number and Location
c) The quality officer retrieves obsolete documents guided by the master list of documents to
ensure all are removed from sections and also to distribute new documents.
i. Document Status and Originality
Any document appearing in a paper form with a stamp of `CONTROLLED BY DBUHGHL ’in the
bottom of each page is original.
The current status of documentation is identified by
 The revision/version numbers indicated on the front page or header for all internally prepared
documents together with the effective date. The original document is issued as Rev No 1 and
subsequent revisions are marked in sequential numerical order, e.g. 2, 3 etc.
 All current DBUHGHL documentation (SOP-; JD-, F-; CHA; JA-; MN-; etc.) must be
identified by reference to Document Master Registers (DBUHGHL-SMH-F/4.3-01). Each
register should be formatted as a matrix which cross-references each document to its current
status, i.e. Version No., document No. or effective date.
Storing and Archiving Documents
 The quality officer maintains master copy of hard 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 with the following information by
the quality officer or any assigned senior staff/s

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 Name of the organization

 Title of obsolete document
 Document No: _______,
 Date: __________/_____/____
 Name: __________Signature ______ (The person who gathers the Document)
i. Hard Copies:
 The quality officer 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 by the quality officer.
 All documents are stored securely in the archival room shelves.
ii. Electronic Copies
 The quality officer maintains folders of both current and obsolete documents on his office
computer which is protected by password.
 The quality officer 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 officer and the other
CD or external hard disc will be kept at the Laboratory manager reserved lockable shelf.
The back-up is done every two years 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 documents are only used by the quality officer, while other members of staff use
hard copies.
Managing external documents
i. Acquiring and Cataloging
 The quality officer 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 officer maintains a list of all external documents on the master list of external
documents.

Laboratory
 The quality officer gives numbers to all external documents

 The quality officer 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 officer ensures that the most current version of the external documents is
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 officer acquires it either by download,
purchase or receipt from donor.
c. The quality officer updates the version number of external documents on the master list of
documents.
d. The quality officer distributes the new version, retrieves the old version and retains one
copy of old version for specified retention time.
iii. Retention time for Documents
All copies of obsolete documents are archived and the retention time is defined based on the nature of
the documents as follows
S. N Name of Quality and Technical Records Retention Time

1. Procedure (SOPs) 5 years if methods not changed
2. Manuals/ Policies 5 years
3. Forms/Charts 5 years
3. Job aids 1 years, if methods not changed
5. Job description 3 years
6. Guideline Indefinite
7. Standards/Reference Books Indefinite
iv. Disposal of Documents

 Following the defined retention time, documents are destroyed via incineration by the
team established in the laboratory or organization that is coordinated by quality
officer and laboratory manager

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 The quality officer keeps records of all documents that have been destroyed on the
document disposal form.
Supporting Documents:
S.No. Document Title Document No.
2. Document Master List DBUHGHL- SO- F/4.3-01
3. Document Distribution Form DBUHGHL- SO- F/4.3-02
4. Document Development/Amendment Form DBUHGHL- SO- F/4.3-03
5. Document Index Form DBUHGHL- SO- F/4.3-04
6. Obsolete Document Disposal Form DBUHGHL- SO- F/4.3-05
References
a) ISO 15189:2012– Medical Laboratories-Requirements for quality and competence.

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Declaration
I, the undersigned laboratory personnel, certify that I am conducting every steps of the procedures
incorporated in this SOP after a prior reading.
S/N Full Name Signature Date Remark


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Debre Birhan University Hakim Gizaw

Standard Operating Procedure for Document

Compiler: ______ Signature:

Revision and Amendment

A. Annual Review of Document

B. Revision Change History/Description

Compiled by: __ Authority: DBUHGHL

Abbreviations and acronyms:

ALS All Laboratory Section

CCD Chief Clinical Director

CKL Check List

DBUHGHL Debre Birhan University Hakim Gizaw Hospital Laboratory

N/A Not applicable

QMS Quality Management System

QOO Quality Officer Office

SOP Standard Operating Procedure

Compiled by: __ Authority: DBUHGHL

Compiled by: __ Authority: DBUHGHL

Compiled by: __ Authority: DBUHGHL

Compiled by: __ Authority: DBUHGHL

Compiled by: __ Authority: DBUHGHL

Compiled by: __ Authority: DBUHGHL

viii. Contents of Managerial Procedures

Compiled by: __ Authority: DBUHGHL

ii. Document review and approval

Compiled by: __ Authority: DBUHGHL

Compiled by: __ Authority: DBUHGHL

The document categories are listed as follows:

Type Descriptor Document Description Examples

Compiled by: __ Authority: DBUHGHL

Compiled by: __ Authority: DBUHGHL

 Name of the organization

Compiled by: __ Authority: DBUHGHL

 The quality officer gives numbers to all external documents

S. N Name of Quality and Technical Records Retention Time

iv. Disposal of Documents

Compiled by: __ Authority: DBUHGHL

Compiled by: __ Authority: DBUHGHL

Compiled by: __ Authority: DBUHGHL

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