This document provides guidance on writing standard operating procedures (SOPs) for clinical laboratories. It discusses establishing a SOP system, including preparing SOPs, reviewing and approving SOPs, determining review frequency, using checklists, implementing document control, tracking documents, and applying an overall SOP system. The target audience is laboratory staff who will write and follow SOPs. Key points covered include determining who writes SOPs, how they are written, obtaining management approval, reviewing SOPs regularly, numbering SOPs for control and tracking, and applying SOPs to standardize laboratory operations.

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
Last 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
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
1 2
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
4.1 Preparation
4.2 Revision and Approval
4.3 Frequency of Reviews
4.4 Checklists
4.5 Document Control
4.6 Document
Tracking and Archival
4.7 How to Apply a SOP System?
PROCESS
SOP
4
SOP Roadmap

5. 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
1 2
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
PROCESS
SOP
4
SOP Roadmap
4.1 Preparation
4.2 Revision and Approval
4.3 Frequency of Reviews
4.4 Checklists
4.5 Document Control
4.6 Document
Tracking and Archival
4.7 How to Apply a SOP System?

6. 4. SOP Process
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
4.1 SOP Preparation
Who should prepare (write) the SOP :
Individuals who are knowledgeable with • The SOP activity
• The Laboratory internal structure
SOP PROCESS
A team approach can be followed, especially for multi–tasked processes
where the experiences of a number of individuals are critical.
Who know best all the small details
that make the tests perform optimally
and can describe these in the SOPs
Who are most often perform the test
Start

7. 4. SOP Process 4.1 SOP Preparation
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
To Whom SOP would be written :
Lab staff who are essentially subject-matter experts
• Who actually perform the work or
• Use the process
SOP PROCESS
Start

8. 4. SOP Process 4.1 SOP Preparation
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
SOP PROCESS
Making a list of all the tests performed in the laboratory
so you know which SOPs you have to write.
Who is responsible for this 1st step :
in cooperation with the Laboratory Manager
Quality Project Team
1st Step
Start
List

9. 4. SOP Process 4.1 SOP Preparation
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
SOP PROCESS
1st Step
Start
List

10. 4. SOP Process 4.1 SOP Preparation
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
SOP PROCESS
Start
List

11. 4. SOP Process 4.1 SOP Preparation
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
SOP PROCESS
So that someone
HOW SOP should be written?
The experience requirement for performing an activity should be noted in the section on personnel qualifications
• with limited experience
• without knowledge of the procedure
• but with a basic understanding
Can successfully perform the procedure
when unsupervised
Start
List
SOPs should be written with sufficient detail

12. 4. SOP Process 4.1 SOP Preparation
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
SOP PROCESS
• Prevents the overloading of one staff member with a huge amount of work
• Increases the involvement and commitment of all staff members.
Start
List
HOW SOP should be written?
Spreading the tasks of writing SOPs over different staff members

13. 4. SOP Process 4.1 SOP Preparation
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
SOP PROCESS
An example of an Analysis SOP is linked below
This can be used to get an impression of
Start
List
HOW SOP should be written?
• The writing style
• The level of detail

14. 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
1 2
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
PROCESS
SOP
4
SOP Roadmap
4.1 Preparation
4.2 Revision and Approval
4.3 Frequency of Reviews
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
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
1 2
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
PROCESS
SOP
4
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?
SOP Roadmap

16. 4. SOP Process
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
It is helpful if draft SOPs are actually tested by
individuals other than the original writer before
the SOPs are finalized.
4.2 SOP Review and Approval
Revision +
Approval
Start
SOP PROCESS
Who would review and approve the finalized SOPs?
Unit Director
(Immediate Supervisor)
QA Officer
1 2 SOPs should be reviewed (validated) by one or
more individuals with appropriate training and
experience with the process.
List

17. 4. SOP Process 4.2 SOP Review and Approval
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
Signature approval indicates that an SOP
has been both reviewed and approved by
management.
Use of electronic signatures, is an acceptable
substitution for paper, when practical.
Revision +
Approval
Start
SOP PROCESS
Who would review and approve the finalized SOPs?
Unit Director
(Immediate Supervisor)
QA Officer
1 2
List

18. 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
1 2
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
PROCESS
SOP
4
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?
SOP Roadmap

19. 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
1 2
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
PROCESS
SOP
4
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. 4. SOP Process
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
4.3 SOP Frequency of Reviewing
Start
SOP PROCESS
Reviewing
SOPs need to be updated to be useful
The review date should be added to each SOP that has been reviewed
If an SOP describes a process that is no longer followed,
it should be withdrawn from the current file and archived

21. SOP PROCESS
Reviewing
4. SOP Process 4.3 SOP Frequency of Reviewing
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
Start
The review process should be simple and not cumbersome
to encourage a timely review
The frequency of review should be indicated by management
in the Laboratory Quality Management Plan
The plan should also indicate the individual(s)
responsible for ensuring that SOPs are current and updated

22. 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
1 2
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
PROCESS
SOP
4
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?

23. 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
1 2
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
PROCESS
SOP
4
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?
SOP Roadmap

24. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
Many activities use checklists:
• To ensure that steps are followed in order
• To document completed actions.
Any checklists included as part of an activity
• Should be referenced at the points in the procedure
where they are to be used
• Should be attached to the SOP.
Checklists
4. SOP Process 4.4 SOP Checklists
SOP PROCESS
Start Reviewing

25. 4. SOP Process 4.4 SOP Checklists
SOP PROCESS
ReviewingStart
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
Checklists
• The SOP should describe how the checklist is to be prepared,
or on what it is to be based.
• Copies of specific checklists should be then maintained in the
file with the activity results and/or with the SOP.
In those cases:
In some cases, detailed checklists are prepared
specifically for a given activity.

26. 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
1 2
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
PROCESS
SOP
4
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?
SOP Roadmap

27. 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
1 2
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
PROCESS
SOP
4
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?

28. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
Each laboratory should develop a numbering system
to systematically identify and label their SOPs
This document control should be described in its Quality Management Plan
4. SOP Process 4.5 SOP Document Control
Reviewing
SOP PROCESS
Start
Document
Control

29. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
Generally, each page of an SOP
should have control documentation notation
A short title and identification (ID) number
can serve as a reference designation
When the number of pages is indicated (e.g. 3 of 6),
the user can quickly check if the SOP is complete
Gram Staining
P05v03
Page 3 of 6
Location: in the upper right-hand corner of each document
page following the title page.
Reviewing
SOP PROCESS
Start
4. SOP Process 4.5 SOP Document Control Document
Control

30. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
The revision number (e.g. v03 in the left example) and date
are very useful in:
• Identifying the SOP in use when reviewing historical data.
• Critical when the need for evidentiary records is involved.
• When the activity is being reviewed.
4. SOP Process 4.5 SOP Document Control
Reviewing
SOP PROCESS
Start
Document
Control
Gram Staining
P05v03
Page 3 of 6

31. 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
1 2
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
PROCESS
SOP
4
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?

32. 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
1 2
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
PROCESS
SOP
4
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?

33. The plan should refer to the individual(s) responsible for
assuring that only the current version is used
The quality management plan should also designate
where, and how, outdated versions are to be archived
• In a manner to prevent their continued use,
• As well as to be available for historical data review.
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
4. SOP Process 4.6 Document Tracking and Archival
Reviewing
SOP PROCESS
Start
Document
Control
SOPs Archiving

34. The organization should maintain a master list of all SOPs
This file or database should refer to:
SOPs Archiving
• SOP number
• Version number
• Date of issuance
• Title
• Author
• Status (in-use or out-dated)
• Lab unit, branch or division
• Any historical information regarding past versions
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
4. SOP Process
Reviewing
SOP PROCESS
Start
Document
Control
4.6 Document Tracking and Archival
The QA Manager (or designee) is generally the individual responsible for maintaining
a file listing of all current, quality-related SOPs used within the laboratory.

35. 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
1 2
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
PROCESS
SOP
4
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?

36. 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
1 2
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
PROCESS
SOP
4
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?

37. Quality Project Team
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
Start
LM
+
All
Lab
Tests
4.7 How to Apply a SOP System?
1
Choosing
Who will write
the SOPs
Heroes
Assign
Them
Define
Tasks
When to
Finish
Archiving
Revise +
Approve
SOPFinished
in a weekly staff meeting
to all the staff members.
SOPs
Readand
UnderstandList
PresentSOPs
Monitor
SOPsReading
Listing
PeriodicReviewing
2 3 4 5
9
6 7 8
Making a list of all the tests performed in the laboratory
so you know which SOPs you have to write.

38. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
Start
All
Lab
Tests
4.7 How to Apply a SOP System?
1
Choosing
Who will write
the SOPs
Heroes
Assign
Them
Define
Tasks
When to
Finish
Archiving
Revise +
Approve
SOP
Ready
SOPFinished
SOPs
Readand
UnderstandList
PresentSOPs
Monitor
SOPsReading
Listing
PeriodicReviewing
2 3 4
9
6 7 85
Quality Project Team
+
LM

39. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
Start
4.7 How to Apply a SOP System?
Heroes
Make a list of all the tests performed in the laboratory
to know which SOPs would be written.
All
Lab
Tests
Listing
Quality Project Team
+
LM

40. 1
Choosing
Who will write
the SOPs
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
Start
4.7 How to Apply a SOP System?
Heroes
All
Lab
Tests
Listing
For each of the SOP,
Determine which of staff members are most suitable to write
Quality Project Team
+
LM
[ Previously described ]

41. Assign
Them
2
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
Start
All
Lab
Tests
4.7 How to Apply a SOP System?
Heroes
Listing
1
Choosing
Who will write
the SOPs
Quality Project Team
+
LM
Assign the selected staff members to write the SOPs
▪ Explain the procedure of writing SOPs
▪ Tell them to familiarize themselves with the Master SOP
▪ To use the protocol for writing Analysis SOPs in the Master SOP
▪ To Use the template for an Analysis SOP attached to the Master SOP
▪ If they have questions they can go to a member of the Quality Project TeamLab Manager

42. Assign
Them
Define
Tasks
2
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
Start
All
Lab
Tests
4.7 How to Apply a SOP System?
Heroes
Listing
1
Choosing
Who will write
the SOPs
Quality Project Team
+
LM
Lab Manager
Clearly Define:
• The tasks of the staff member
(Creating the SOP content: writing the procedure and other paragraphs)
• The tasks of the Quality Project Team
(Optimizing the SOP to make it matching with the Master SOP guidelines)

43. Assign
Them
Define
Tasks
When to
Finish
2
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
Start
All
Lab
Tests
4.7 How to Apply a SOP System?
Heroes
Listing
1
Choosing
Who will write
the SOPs
Quality Project Team
+
LM
Lab Manager
Make SMART appointments with the different staff members
when to finish their tasks to keep this process going

44. Revise +
Approve
3
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
Start
All
Lab
Tests
4.7 How to Apply a SOP System?
1
Choosing
Who will write
the SOPs
Heroes
Assign
Them
Define
Tasks
When to
Finish
Listing
2
Quality Project Team
+
LM
Unit Director QA Officer
1 2
[ Previously described ]

45. SOPFinished
4
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
Start
All
Lab
Tests
4.7 How to Apply a SOP System?
1
Choosing
Who will write
the SOPs
Heroes
Assign
Them
Define
Tasks
When to
Finish
Revise +
Approve
Listing
2 3
Quality Project Team
+
LM

46. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
Start
All
Lab
Tests
4.7 How to Apply a SOP System?
1
Choosing
Who will write
the SOPs
Heroes
Assign
Them
Define
Tasks
When to
Finish
Revise +
Approve
SOPFinished
Listing
2 3 4
Quality Project Team
+
LM

47. Archiving
5
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
Start
All
Lab
Tests
4.7 How to Apply a SOP System?
1
Choosing
Who will write
the SOPs
Heroes
Assign
Them
Define
Tasks
When to
Finish
Revise +
Approve
SOPFinished
Listing
2 3 4
Quality Project Team
+
LM
When SOPs are ready (i.e. written, reviewed, and authorized)
• Determine at which location copies of the SOPs must be available
• Refer to these locations in the SOP
• Refer the location where to replace old copies when the SOPs are revised

48. SOPs
Readand
UnderstandList
6
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
Start
All
Lab
Tests
4.7 How to Apply a SOP System?
1
Choosing
Who will write
the SOPs
Heroes
Assign
Them
Define
Tasks
When to
Finish
Archiving
Revise +
Approve
SOPFinished
Listing
2 3 4 5
Quality Project Team
+
LM
Include the SOPs in a Read and Understand List
• Indicate which staff members must read and understand
the SOPs (those for whom the SOPs are relevant).
• A template for a Read and Understand List should be provided.

49. PresentSOPs
7
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
Start
All
Lab
Tests
4.7 How to Apply a SOP System?
1
Choosing
Who will write
the SOPs
Heroes
Assign
Them
Define
Tasks
When to
Finish
Archiving
Revise +
Approve
SOPFinished
SOPs
Readand
UnderstandList
Listing
2 3 4 65
Quality Project Team
+
LM
In a weekly staff meeting to all the staff members,
• Present the SOPs and where to find them
• Explain which staff members have to read the SOPs
• Explain about the Read and Understand List
and that they must sign the list when they have read an SOP.

50. Monitor
SOPsReading
8
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
Start
All
Lab
Tests
4.7 How to Apply a SOP System?
1
Choosing
Who will write
the SOPs
Heroes
Assign
Them
Define
Tasks
When to
Finish
Archiving
Revise +
Approve
SOPFinished
SOPs
Readand
UnderstandList
PresentSOPs
Listing
2 3 4 6 75
Quality Project Team
+
LM
• Monitor that all the staff members have read the SOPs
assigned to them.
• If not, remind them that they still have to do this.

51. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
Start
All
Lab
Tests
4.7 How to Apply a SOP System?
1
Choosing
Who will write
the SOPs
Heroes
Assign
Them
Define
Tasks
When to
Finish
Archiving
Revise +
Approve
SOPFinished
SOPs
Readand
UnderstandList
PresentSOPs
Monitor
SOPsReading
Listing
2 3 4 6 7 85
PeriodicReviewing
9
Quality Project Team
+
LM

52. Many
Thanks
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman