This document discusses standard operating procedure (SOP) formats for clinical laboratories. It begins with an overview of SOP formats and common elements. Key points include: - SOPs should have a standardized format for easy recognition and navigation, including a title page with identification details, table of contents, and formatted text. - The title page includes the lab name, SOP title and identification code, and signatures of those who prepared, revised, approved, and reviewed the SOP. - Sections within the SOP text generally include the title, objectives, abbreviations, responsibilities, safety, procedure, related documents, references, and appendices. - SOPs are commonly coded according to

1. Dr. Tamer Soliman
Lecturer of Clinical Pathology
Sohag University Hospital
EGYPT
‫اءات‬‫ر‬‫إج‬‫التشغيل‬‫القياسية‬‫لمعامل‬‫التحاليل‬‫ـبية‬‫ط‬‫ال‬
Standard
Operating
Procedures Clinical Laboratories
Based on WHO Laboratory Quality Stepwise Implementation Tool
for the Episode

2. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
SOPRoadmap

3. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
2.1 Title Page
2.2 TOC
2.3 Text
INTRO
1.1 Overview
1.2 Purpose
1.3 Benefits
1.4 Writing Styles
SOP General
FORMAT PROCESS
SOP
1 42
TYPES
SOP
3.1 Master SOP
3.2 Administrative
3.3 Technical SOPs
3.3.1 Procedure
3.3.2 Equipment
3.3.3 Analysis
3
SOP Roadmap
4.1 Preparation
4.2 Revision and Approval
4.3 Frequency of Reviewing
4.4 Checklists
4.5 Document Control
4.6 Document
Tracking and Archival
4.7 How to Apply a SOP System?

4. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
INTRO
1.1 Overview
1.2 Purpose
1.3 Benefits
1.4 Writing Styles
SOP
PROCESS
SOP
1 4
TYPES
SOP
3.1 Master SOP
3.2 Administrative
3.3 Technical SOPs
3.3.1 Procedure
3.3.2 Equipment
3.3.3 Analysis
3
2.1 Title Page
2.2 TOC
2.3 Text
General
FORMAT
2
SOP Roadmap
4.1 Preparation
4.2 Revision and Approval
4.3 Frequency of Reviewing
4.4 Checklists
4.5 Document Control
4.6 Document
Tracking and Archival
4.7 How to Apply a SOP System?

5. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
INTRO
1.1 Overview
1.2 Purpose
1.3 Benefits
1.4 Writing Styles
SOP
PROCESS
SOP
1 4
TYPES
SOP
3.1 Master SOP
3.2 Administrative
3.3 Technical SOPs
3.3.1 Procedure
3.3.2 Equipment
3.3.3 Analysis
3General
FORMAT
2
2.1 Title Page
2.2 TOC
2.3 Text
SOP Roadmap
4.1 Preparation
4.2 Revision and Approval
4.3 Frequency of Reviewing
4.4 Checklists
4.5 Document Control
4.6 Document
Tracking and Archival
4.7 How to Apply a SOP System?

6. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
2. SOP Format
It is a good idea to standardize the formats of SOPs
and efficiently use them
so staff can easily recognize the flow of the information

7. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
2. SOP Format
the information of long paragraphs is broken into 
a series of logical steps
1
2
3
When writing SOPs,

8. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
2. SOP Format
Consider more details during SOP writing
• If the process is critical
• Large number of people who will use this SOP
• If training is not routinely available.

9. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
2. SOP Format
NO one “correct” format for SOP writing
Internal SOP formatting will vary between different laboratories

10. 2. SOP Format 2.1 Title Page | 1st Page | Cover Page
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
The SOP first page or cover page
should contain the following information:
| Lab Name and Lab unit
National Public Health Lab
Microbiology Unit

11. 2. SOP Format 2.1 Title Page | 1st Page | Cover Page
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
The SOP first page or cover page
should contain the following information:
| Lab Name and Lab unit
| Title That clearly identifies the activity or procedure Gram Staining
National Public Health Lab
Microbiology Unit

12. 2. SOP Format 2.1 Title Page | 1st Page | Cover Page
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
National Public Health Lab
Microbiology Unit
The SOP first page or cover page
should contain the following information:
| Lab Name and Lab unit
| Title That clearly identifies the activity or procedure
| Code SOP identification (ID) number
Gram Staining
CODE : P05v04

13. 2. SOP Format 2.1 Title Page | 1st Page | Cover Page
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
The SOP first page or cover page
should contain the following information:
| Lab Name and Lab unit
| Title That clearly identifies the activity or procedure
| Code SOP identification (ID) number
| Signatures and signature dates
1. Person who Prepared the SOP Lab Staff
2. Person who Revised the SOP Unit Director
3. Person who Approved the SOP Lab Manager
4. Person who made the Review
5. Person who made the Annual Review
Gram Staining
Prepared By
Name Signature Date
Revised By
Approved By
Review
Annual Review
XXXXX XXXXX
CODE : P05v04
Review
Review
Revision
National Public Health Lab
Microbiology Unit

14. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
SOP Roadmap
INTRO
1.1 Overview
1.2 Purpose
1.3 Benefits
1.4 Writing Styles
SOP
PROCESS
SOP
1 4
TYPES
SOP
3.1 Master SOP
3.2 Administrative
3.3 Technical SOPs
3.3.1 Procedure
3.3.2 Equipment
3.3.3 Analysis
3General
FORMAT
2
2.1 Title Page
2.2 TOC
2.3 Text
4.1 Preparation
4.2 Revision and Approval
4.3 Frequency of Reviewing
4.4 Checklists
4.5 Document Control
4.6 Document
Tracking and Archival
4.7 How to Apply a SOP System?

15. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
INTRO
1.1 Overview
1.2 Purpose
1.3 Benefits
1.4 Writing Styles
SOP
PROCESS
SOP
1 4
TYPES
SOP
3.1 Master SOP
3.2 Administrative
3.3 Technical SOPs
3.3.1 Procedure
3.3.2 Equipment
3.3.3 Analysis
3General
FORMAT
2
2.1 Title Page
2.2 TOC
2.3 Text
SOP Roadmap
4.1 Preparation
4.2 Revision and Approval
4.3 Frequency of Reviewing
4.4 Checklists
4.5 Document Control
4.6 Document
Tracking and Archival
4.7 How to Apply a SOP System?

16. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
2. SOP Format 2.2 Table of Contents
A Table of Contents may be needed for
• Locating information, especially if the SOP is long
• Indicating changes or revisions made to SOP sections
A Table of Contents may come in different styles
Example
ISO Style

17. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
2. SOP Format 2.2 Table of Contents
A Table of Contents may be needed for
• Locating information, especially if the SOP is long
• Indicating changes or revisions made to SOP sections
A Table of Contents may come in different styles
Example
CLSI Style

18. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
INTRO
1.1 Overview
1.2 Purpose
1.3 Benefits
1.4 Writing Styles
SOP
PROCESS
SOP
1 4
TYPES
SOP
3.1 Master SOP
3.2 Administrative
3.3 Technical SOPs
3.3.1 Procedure
3.3.2 Equipment
3.3.3 Analysis
3General
FORMAT
2
2.1 Title Page
2.2 TOC
2.3 Text
SOP Roadmap
4.1 Preparation
4.2 Revision and Approval
4.3 Frequency of Reviewing
4.4 Checklists
4.5 Document Control
4.6 Document
Tracking and Archival
4.7 How to Apply a SOP System?

19. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
INTRO
1.1 Overview
1.2 Purpose
1.3 Benefits
1.4 Writing Styles
SOP
PROCESS
SOP
1 4
TYPES
SOP
3.1 Master SOP
3.2 Administrative
3.3 Technical SOPs
3.3.1 Procedure
3.3.2 Equipment
3.3.3 Analysis
3General
FORMAT
2
2.1 Title Page
2.2 TOC
2.3 Text
SOP Roadmap
4.1 Preparation
4.2 Revision and Approval
4.3 Frequency of Reviewing
4.4 Checklists
4.5 Document Control
4.6 Document
Tracking and Archival
4.7 How to Apply a SOP System?

20. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
2. SOP Format 2.3 SOP Text (Items)
Items may vary according to the PURPOSE of writing the SOP

21. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
2. SOP Format 2.3 SOP Text (Items)
General Items for Clinical Laboratory SOPs
• Header
1. Title
2. Objectives and Scope
3. Abbreviations, Definitions, and Terms used
4. Tasks, Responsibilities and Accountabilities
5. Safety and Environment
6. Procedure
7. Documents related
8. Forms related
9. References
10.Appendixes
• Log changes

22. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
2. SOP Format 2.3 SOP Text (Items)
General Items for Clinical Laboratory SOPs
• Header
1. Title
2. Objectives and Scope
3. Abbreviations, Definitions, and Terms used
4. Tasks, Responsibilities and Accountabilities
5. Safety and Environment
6. Procedure
7. Documents related
8. Forms related
9. References
10.Appendixes
• Log changes

23. • Header
1. Title
2. Objectives and Scope
3. Abbreviations, Definitions, and Terms used
4. Tasks, Responsibilities and Accountabilities
5. Safety and Environment
6. Procedure
7. Documents related
8. Forms related
9. References
10.Appendixes
• Log changes
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
2. SOP Format 2.3 SOP Text (Items)
General Items for Clinical Laboratory SOPs
• Headers are a very important part of the format
• Two different types of headers that could be used in SOP writing :
1. Complete header — on the first (cover) page of each SOP
Name of Lab | Hospital | Institute
SOP Title
Department | Unit Page 1 of 5
CODE
Name DateSignature
Prepared By
Revised By
Approved By
Review
Annual Review

24. • Header
1. Title
2. Objectives and Scope
3. Abbreviations, Definitions, and Terms used
4. Tasks, Responsibilities and Accountabilities
5. Safety and Environment
6. Procedure
7. Documents related
8. Forms related
9. References
10.Appendixes
• Log changes
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
2. SOP Format 2.3 SOP Text (Items)
General Items for Clinical Laboratory SOPs
• Headers are a very important part of the format
• Two different types of headers that could be used in SOP writing :
2. Reduced header — a smaller version that would appear on
all pages other than the first
Name of Lab | Hospital | Institute
SOP Title
Department | Unit Page 2 of 5
CODE

25. • Header
1. Title
2. Objectives and Scope
3. Abbreviations, Definitions, and Terms used
4. Tasks, Responsibilities and Accountabilities
5. Safety and Environment
6. Procedure
7. Documents related
8. Forms related
9. References
10.Appendixes
• Log changes
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
2. SOP Format 2.3 SOP Text (Items)
General Items for Clinical Laboratory SOPs
• Headers are a very important part of the format
• Two different types of headers that could be used in SOP writing :
2. Reduced header — a smaller version that would appear on
all pages other than the first
Name of Lab | Hospital | Institute
SOP Title
Department | Unit Page 2 of 5
CODE
SOP Coding
• To keep oversight, all SOPs need to be coded
• SOP coding is suitable for LDM systems.
• SOP coding may be done by different ways

26. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
2. SOP Format 2.3 SOP Text (Items)
General Items for Clinical Laboratory SOPs
• Header
1. Title
2. Objectives and Scope
3. Abbreviations, Definitions, and Terms used
4. Tasks, Responsibilities and Accountabilities
5. Safety and Environment
6. Procedure
7. Documents related
8. Forms related
9. References
10.Appendixes
• Log changes
• Headers are a very important part of the format
• Two different types of headers that could be used in SOP writing :
2. Reduced header — a smaller version that would appear on
all pages other than the first
Name of Lab | Hospital | Institute
SOP Title
Department | Unit Page 2 of 5
CODE
SOP Coding
Example : Coding according to SOP Purpose
The code of the Malaria Microscopy SOP is A04v03

27. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
2. SOP Format 2.3 SOP Text (Items)
General Items for Clinical Laboratory SOPs
• Header
1. Title
2. Objectives and Scope
3. Abbreviations, Definitions, and Terms used
4. Tasks, Responsibilities and Accountabilities
5. Safety and Environment
6. Procedure
7. Documents related
8. Forms related
9. References
10.Appendixes
• Log Changes
• Headers are a very important part of the format
• Two different types of headers that could be used in SOP writing :
2. Reduced header — a smaller version that would appear on
all pages other than the first
Name of Lab | Hospital | Institute
SOP Title
Department | Unit Page 2 of 5
CODE
SOP Coding
Example : Coding according to SOP Purpose
The code of the Malaria Microscopy SOP is A04v03
The first letter of SOP type
(Procedure, Analysis, Equipment and Administrative)

28. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
2. SOP Format 2.3 SOP Text (Items)
General Items for Clinical Laboratory SOPs
• Header
1. Title
2. Objectives and Scope
3. Abbreviations, Definitions, and Terms used
4. Tasks, Responsibilities and Accountabilities
5. Safety and Environment
6. Procedure
7. Documents related
8. Forms related
9. References
10.Appendixes
• Log Changes
• Headers are a very important part of the format
• Two different types of headers that could be used in SOP writing :
2. Reduced header — a smaller version that would appear on
all pages other than the first
Name of Lab | Hospital | Institute
SOP Title
Department | Unit Page 2 of 5
CODE
SOP Coding
Example : Coding according to SOP Purpose
The code of the Malaria Microscopy SOP is A04v03
The number of the SOP in this group

29. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
2. SOP Format 2.3 SOP Text (Items)
General Items for Clinical Laboratory SOPs
• Header
1. Title
2. Objectives and Scope
3. Abbreviations, Definitions, and Terms used
4. Tasks, Responsibilities and Accountabilities
5. Safety and Environment
6. Procedure
7. Documents related
8. Forms related
9. References
10.Appendixes
• Log Changes
• Headers are a very important part of the format
• Two different types of headers that could be used in SOP writing :
2. Reduced header — a smaller version that would appear on
all pages other than the first
Name of Lab | Hospital | Institute
SOP Title
Department | Unit Page 2 of 5
CODE
SOP Coding
Example : Coding according to SOP Purpose
The code of the Malaria Microscopy SOP is A04v03
The version number of the document

30. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
2. SOP Format 2.3 SOP Text (Items)
General Items for Clinical Laboratory SOPs
• Header
1. Title
2. Objectives and Scope
3. Abbreviations, Definitions, and Terms used
4. Tasks, Responsibilities and Accountabilities
5. Safety and Environment
6. Procedure
7. Documents related
8. Forms related
9. References
10.Appendixes
That clearly identifies the activity or procedure

31. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
2. SOP Format 2.3 SOP Text (Items)
General Items for Clinical Laboratory SOPs
• Header
1. Title
2. Objectives and Scope
3. Abbreviations, Definitions, and Terms used
4. Tasks, Responsibilities and Accountabilities
5. Safety and Environment
6. Procedure
7. Documents related
8. Forms related
9. References
10.Appendixes
‫الهدف‬ ‫العام‬‫اإلطار‬
Describe briefly
• The Objectives (Purpose)
• The Scope [ briefly describe the processes from the beginning to the end ]
• To whom this SOP is applicable

32. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
2. SOP Format 2.3 SOP Text (Items)
General Items for Clinical Laboratory SOPs
• Header
1. Title
2. Objectives and Scope
3. Abbreviations, Definitions, and Terms used
4. Tasks, Responsibilities
5. Safety and Environment
6. Procedure
7. Documents related
8. Forms related
9. References
10.Appendixes
3. Abbreviations, Definitions, and Terms used
• List the abbreviations and terms that are present in the
written SOP and give their definition
• For abbreviations that are general and used in all the
quality documents, refer to the first chapter of the quality
manual that lists all the frequently used abbreviations

33. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
2. SOP Format 2.3 SOP Text (Items)
General Items for Clinical Laboratory SOPs
• Header
1. Title
2. Objectives and Scope
3. Abbreviations, Definitions, and Terms used
4. Tasks, Responsibilities
5. Safety and Environment
6. Procedure
7. Documents related
8. Forms related
9. References
10.Appendixes
• Describe The tasks
• For each task, mention who is responsible for
Tasks Responsible
1.
2.
3.

34. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
2. SOP Format 2.3 SOP Text (Items)
General Items for Clinical Laboratory SOPs
• Header
1. Title
2. Objectives and Scope
3. Abbreviations, Definitions, and Terms used
4. Tasks, Responsibilities
5. Safety and Environment
6. Procedure
7. Documents related
8. Forms related
9. References
10.Appendixes
• Describe the possible risks for safety and the
laboratory environment related to performing the
this procedure or working on this equipment.
• Only describe the specific dangers related to
this procedure.
• As regarding the general safety rules, Refer to
the biosafety manual.

35. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
2. SOP Format 2.3 SOP Text (Items)
General Items for Clinical Laboratory SOPs
• Header
1. Title
2. Objectives and Scope
3. Abbreviations, Definitions, and Terms used
4. Tasks, Responsibilities
5. Safety and Environment
6. Procedure
7. Documents related
8. Forms related
9. References
10.Appendixes
Differs according to the SOP purpose
… Will be discussed later

36. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
2. SOP Format 2.3 SOP Text (Items)
General Items for Clinical Laboratory SOPs
• Header
1. Title
2. Objectives and Scope
3. Abbreviations, Definitions, and Terms used
4. Tasks, Responsibilities
5. Safety and Environment
6. Procedure
7. Documents related
8. Forms related
9. References
10.Appendixes
Provide a list of related document such as:
• Related SOPs,
• QM chapters,
• Log sheets,
• Package inserts,
• Evaluation/assessment reports,
• Equipment manuals,
• Software manuals, etc.

37. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
2. SOP Format 2.3 SOP Text (Items)
General Items for Clinical Laboratory SOPs
• Header
1. Title
2. Objectives and Scope
3. Abbreviations, Definitions, and Terms used
4. Tasks, Responsibilities
5. Safety and Environment
6. Procedure
7. Documents related
8. Forms related
9. References
10.Appendixes
When the documents are not coded according to
the quality management system: provide for each
document the location where it can be found.
For example:
• QM1 “General”
• Biosafety Manual, in every laboratory room and
the administration office
• Logbook < title > , room name / number

38. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
2. SOP Format 2.3 SOP Text (Items)
General Items for Clinical Laboratory SOPs
• Header
1. Title
2. Objectives and Scope
3. Abbreviations, Definitions, and Terms used
4. Tasks, Responsibilities
5. Safety and Environment
6. Procedure
7. Documents related
8. Forms related
9. References
10.Appendixes
Provide a list of forms that are relevant to this SOP:
• Request forms,
• Work-forms,
• Batch forms … etc.
If it is not coded, provide for each document
the location according to the Q management system

39. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
2. SOP Format 2.3 SOP Text (Items)
General Items for Clinical Laboratory SOPs
• Header
1. Title
2. Objectives and Scope
3. Abbreviations, Definitions, and Terms used
4. Tasks, Responsibilities
5. Safety and Environment
6. Procedure
7. Documents related
8. Forms related
9. References
10.Appendixes
Journal name, year + volume + issue,
title of article, author(s),
first page – last page
Refer to literature used for writing this SOP
Books Title, edition, author(s), publisher, year, city,
first page – last page
Journals

40. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
2. SOP Format 2.3 SOP Text (Items)
General Items for Clinical Laboratory SOPs
• Header
1. Title
2. Objectives and Scope
3. Abbreviations, Definitions, and Terms used
4. Tasks, Responsibilities
5. Safety and Environment
6. Procedure
7. Documents related
8. Forms related
9. References
10.Appendixes
• Provide a list of annexes (according to their codes).
• For documents without code: provide the location where
they can be found.
‫المرفقات‬

41. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
2. SOP Format 2.3 SOP Text (Items)
General Items for Clinical Laboratory SOPs
• Header
1. Title
2. Objectives and Scope
3. Abbreviations, Definitions, and Terms used
4. Tasks, Responsibilities
5. Safety and Environment
6. Procedure
7. Documents related
8. Forms related
9. References
10.Appendixes
• Log Changes
SOP CHANGE RECORDS
Section CHANGEDate Page Approved By
02.05.2018 21 Appendix 3 Added ____________
07.07.2018 5 Reagents Updated __________

42. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
To be Continued …
Episode 3