The document provides guidance on writing standard operating procedures (SOPs) for clinical laboratories. It discusses the importance of SOPs for ensuring consistency, accuracy, and quality in laboratory testing. The document outlines different types of SOPs that could be written for various areas of the clinical laboratory, including procedures for sample handling, equipment use, reagents, and safety. It emphasizes that SOPs should be concise, detailed, clear, and easily understood. The document also provides a roadmap for writing, revising, approving, and implementing SOPs in the clinical laboratory.
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
Good morning Sir
Omar, The New Technologist
has just assigned to the job recently
He doesn’t know what his tasks are !
Sorry Sir,
Mrs Nadia is on Vacation and No one
could do her Job
Sorry Doc,
The new chemistry machine
is troubleshooting
How to manage?
Sorry Sir,
Tarek is very sick
and No one could perform
his work
Doctor,
The blood cell counter always
gives Low hemoglobin values
Sorry Doctor
I can’t remember…
in that Centrifugation step
3000 rpm for 5 minutes
OR 5000 rpm for 3 minutes
3. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
Why there are No SOPs?
Sorry … Sir
5. Documents that include a set of step–by–step instructions
that laboratory staff should meticulously follow
when performing a procedure
These SOPs are complied to laboratory management system
to help lab staff to carry out complex routine operations
A set of written instructions
that document a routine or repetitive activity
Followed by an organization
اءاترــــجإ
ـيةسالقيا
ـيلــغالتش
Standard
Operating
Procedures
General definition
Laboratory definition
By US Environmental Protection Agency
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
6. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
Following well-written SOPs would ensure :
Consistency
تطابق
Accuracy
1
2
• Everyone should perform the tests exactly the same way
• So that the same result can be expected from all staff.
• Consistency enables people who use laboratory results
to observe changes in a particular patient’s results over time.
• Following written procedures
helps laboratory staff produce more accurate results.
• They not relying on memory alone
so they will not forget steps in the process.
7. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
Consistent (reliable) + Accurate results
are primary goals of the laboratory
Following well-written SOPs would ensure :
Consistency
تطابق
Accuracy
Quality
1
2
3
and could be considered as
the definition of quality in the laboratory.
8. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
A GOOD SOP should be :
Concise, Detailed and Clear
So that staff not normally performing the procedure
will be able to do so by following the SOP
All necessary details should be included
(e.g. ambient temperature requirements and precise timing instructions)
Easily understood by new personnel or students in training
Reviewed and Approved by the laboratory management
Approval is indicated by a signature and a date
(this is important to ensure that the procedures being used for testing in the laboratory
are those that are up to date and appropriate)
Updated on a regular basis
9. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
Dealing with
Laboratory
Safety Precautions
Equipment
Instruments and Machines
Test
Samples
Method
Receiving and
Describing
Quality
Assurance
Master
SOPs
Analysis
and Template
Prepare
Reagents
Archiving
Complaints
Registration
SOPs inside the Clinical laboratory?
A number of SOPs could be written:
10. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
SOPs inside the Clinical laboratory?
A number of SOPs could be written:
Laboratory
Method
Describing
Dealing with
Safety Precautions
Equipment
Instruments and Machines
Test
Samples
Receiving and
Quality
Assurance
Master
SOPs
Analysis
and Template
Prepare
Reagents
Archiving
Complaints
Registration
11. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
SOPs inside the Clinical laboratory?
A number of SOPs could be written:
Samples
Receiving and
Registration
Dealing with
Laboratory
Safety Precautions
Equipment
Instruments and Machines
Test
Method
Describing
Quality
Assurance
Master
SOPs
Analysis
and Template
Prepare
Reagents
Archiving
Complaints
12. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
SOPs inside the Clinical laboratory?
A number of SOPs could be written:
Prepare
Reagents
Dealing with
Laboratory
Safety Precautions
Equipment
Instruments and Machines
Test
Samples
Method
Receiving and
Describing
Quality
Assurance
Master
SOPs
Analysis
and Template
Archiving
Complaints
Registration
13. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
SOPs inside the Clinical laboratory?
A number of SOPs could be written:
Equipment
Instruments and Machines
Dealing with
Laboratory
Safety Precautions
Test
Samples
Method
Receiving and
Describing
Quality
Assurance
Master
SOPs
Analysis
and Template
Prepare
Reagents
Archiving
Complaints
Registration
14. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
SOPs inside the Clinical laboratory?
A number of SOPs could be written:
Test
Analysis
Dealing with
Laboratory
Safety Precautions
Equipment
Instruments and Machines
Samples
Method
Receiving and
Describing
Quality
Assurance
Master
SOPs
and Template
Prepare
Reagents
Archiving
Complaints
Registration
15. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
SOPs inside the Clinical laboratory?
A number of SOPs could be written:
Dealing with
Laboratory
Equipment
Instruments and Machines
Test
Samples
Method
Receiving and
Describing
Quality
Assurance
Master
SOPs
Analysis
and Template
Prepare
Reagents
Archiving
Complaints
Registration
Safety Precautions
16. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
SOPs inside the Clinical laboratory?
A number of SOPs could be written:
Master
SOPs
and Template
Dealing with
Laboratory
Safety Precautions
Equipment
Instruments and Machines
Test
Samples
Method
Receiving and
Describing
Quality
Assurance
SOPs
Analysis
Prepare
Reagents
Archiving
Complaints
Registration
17. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
SOPs inside the Clinical laboratory?
A number of SOPs could be written:
Quality
Assurance
Dealing with
Laboratory
Safety Precautions
Equipment
Instruments and Machines
Test
Samples
Method
Receiving and
Describing
Master
SOPs
Analysis
and Template
Prepare
Reagents
Archiving
Complaints
Registration
18. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
SOPs inside the Clinical laboratory?
A number of SOPs could be written:
Archiving
Dealing with
Laboratory
Safety Precautions
Equipment
Instruments and Machines
Test
Samples
Method
Receiving and
Describing
Quality
Assurance
Master
SOPs
Analysis
and Template
Prepare
Reagents
Complaints
Registration
19. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
SOPs inside the Clinical laboratory?
A number of SOPs could be written:
Dealing with
Complaints
s
Laboratory
Safety Precautions
Equipment
Instruments and Machines
Test
Samples
Method
Receiving and
Describing
Quality
Assurance
Master
SOPs
Analysis
and Template
Prepare
Reagents
Archiving
Registration
20. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
Policies
Standards
Procedures
Guidelines
Term
سياسات
معايي
اءاترإج
إرشادات
= Advise Me !
= What Is Required?
= Why I Do This?
= How I Do This?
21. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
Policies
Standards
Procedures
Guidelines
Term
Teacher
Director
Manager
Quality
Operator
Who
سياسات
معايي
اءاترإج
إرشادات
1
2
3
4 Advice on how to act in a given situation
Recommended but Not Mandatory
Quantifiable measures to achieve
acceptable level of quality
A set of ideas or plans that is used as
a basis for making decisions
A series of detailed steps
to accomplish an end
Meaning Example
Company
Policy
Life
Standard
Licensing
Procedures
Diagnosis
Guidelines
Level
Makes Them
22. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
ProcessProcedure عمليةاءرإج
Working to accomplish a task Using inputs to create an output
People work through a process
to achieve an objective
A Broad conceptA Limited concept
People use procedure
to carry out a task
Actions Decisions + Actions
The Procedure is a part of the Process The Process includes many Procedures
23. Be careful when using Generic SOP template
to prepare your own SOP
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
Attention
• These generic SOPs always need to be checked and adapted to
the situation in your laboratory.
• Otherwise, the procedures performed in your laboratory are still not
standardized and quality is not assured.
• Your SOPs should be appropriate for your department. SOPs should
take into account the conditions in your locale and the capabilities
and limitations of your department.
24. Package inserts are NOT SOP’s
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
Attention
• Package inserts do NOT include specific information that pertains
to your laboratory.
• Do NOT rely solely on manufacturer’s package inserts for SOP’s.
• DO use information from the package insert to include in the SOP.
• DO use illustrations from package inserts.
يتناسب
25. Spreading the tasks of writing SOPs over different staff members
1. Prevents the overloading of one staff member with a huge amount
of work.
2. Increases the involvement and commitment of all staff members.
Writing SOPs is a Team Mission
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
Attention
26. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
Attention
SOP may not work well
if the work is related to Creativity
27. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
SOPRoadmap
28. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
SOP Roadmap
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
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?
29. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
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?
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
30. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
SOP Roadmap
2.1 Title Page
2.2 TOC
2.3 Text
General
FORMAT PROCESS
SOP
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
INTRO
1.1 Overview
1.2 Purpose
1.3 Benefits
1.4 Writing Styles
SOP
1
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?
31. 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
3
2.1 Title Page
2.2 TOC
2.3 Text
General
FORMAT
2
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
SOP Roadmap
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
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. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
SOP Roadmap
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?
34. 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?
35. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
SOP Roadmap
2.1 Title Page
2.2 TOC
2.3 Text
General
FORMAT PROCESS
SOP
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
INTRO
1.1 Overview
1.2 Purpose
1.3 Benefits
1.4 Writing Styles
SOP
1
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
General
FORMAT PROCESS
SOP
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
INTRO
SOP
1
1.1 Overview
1.2 Purpose
1.3 Benefits
1.4 Writing Styles
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. 1. SOP Intro
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
1.1 SOP OVERVIEW
SOPs are documents that include:
A set of step–by–step instructions
that laboratory staff should meticulously follow when performing a procedure
Laboratory Management System
Complex Routine Operations
These SOPs are complied to
To help lab staff to carry out
Definition
38. 1. SOP Intro 1.1 SOP OVERVIEW
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
• In quality management it is important that
You do what you say and say what you do
• By recording all the major processes in the laboratory in SOPs
You assure that these processes are carried out
In exactly the same way every time
Which means that you have standardized the process
• As the SOPs need to be reviewed and authorized by different persons
You also assure the quality of the procedures.
39. 1. SOP Intro 1.1 SOP OVERVIEW
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
WHO Laboratory Quality Stepwise Implementation Tool
3.1 Develop a Request Form for Laboratory Testing
3.2 Write a master SOP
3.3 Make a list of all tests performed in the laboratory
3.4 Make SOPs for all tests performed by the laboratory
https://extranet.who.int/lqsi/content/write-master-sop
https://extranet.who.int/lqsi/content/make-sops-all-tests-performed-laboratory
Phase I Phase II Phase III Phase IV
1. Create commitment for Quality Implementation
2. Ensure adequate and competent personnel
3. Make Procedures for all tests
4. Make procedures for all equipment
5. Start organizing an inventory system
6. Start organizing the biosafety
The 1st step in standardizing the primary process is :
The documentation of the procedures of all the tests currently performed in the laboratory in SOPs
SOPs is one of the components of the Laboratory Quality System
40. 1. SOP Intro 1.1 SOP OVERVIEW
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
WHO Laboratory Quality Stepwise Implementation Tool
Phase I Phase II Phase III Phase IV
SOPs is one of the components of the Laboratory Quality System
41. 1. SOP Intro 1.1 SOP OVERVIEW
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
WHO Laboratory Quality Stepwise Implementation Tool
Phase I Phase II Phase III Phase IV
Also, in quality management :
SOPs are subject to regular review and revision by setting up a document control system.
14. Set up a document control system
[ will be discussed later ]
SOPs is one of the components of the Laboratory Quality System
42. 1. SOP Intro 1.1 SOP OVERVIEW
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
7
SOPs
for
NEED
WE
Reasons
43. 1. SOP Intro 1.1 SOP OVERVIEW
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
7
SOPs
for
NEED
WE
Reasons
Communications1 SOPs facilitate
Well-written SOPs
clearly communicate responsibilities
to Laboratory Staff
بالمسئولياتالتعريف
Lab
Staff
Written
Responsibility
44. 1. SOP Intro 1.1 SOP OVERVIEW
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
7
SOPs
for
NEED
WE
Reasons
Communications1 SOPs facilitate
They don’t have to rely on their memories
45. 1. SOP Intro 1.1 SOP OVERVIEW
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
7
SOPs
for
NEED
WE
Reasons
Total Quality System2 SOPs provide a
Quality Item How SOPs provide this item
Quality Policy Mission Statements
Quality Plan Implementation of Policies
Quality Manual Application of Standards
46. 1. SOP Intro 1.1 SOP OVERVIEW
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
7
SOPs
for
NEED
WE
Reasons
Total Quality System2 SOPs provide a
Procedure Implementation of SOPs
Training Using SOPs for self-training
Auditing Documenting Errors and Failures
Quality Improvement Corrective Actions
Quality Item How SOPs provide this item
47. 1. SOP Intro 1.1 SOP OVERVIEW
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
7
SOPs
for
NEED
WE
Reasons
Productivity3 SOPs Help to Increase
More likely to achieve Peak Performance
Also Manager by saving their time
Not have to remind them
of what needs to be done
Productivity Not have to
re-train Lab staff
48. 1. SOP Intro 1.1 SOP OVERVIEW
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
7
SOPs
for
NEED
WE
Reasons
Cross-training4 SOPs Facilitate
SOPs allow other lab staff
To fill in and complete tasks they don’t normally perform
if those key players are on vacation or out sick.
49. 1. SOP Intro 1.1 SOP OVERVIEW
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
7
SOPs
for
NEED
WE
Reasons
The Lab Staff5 SOPs are essential to
EvaluationProcess
Performance
How can you hold laboratory staff
responsible for tasks and processes
that aren’t documented?
50. 1. SOP Intro 1.1 SOP OVERVIEW
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
7
SOPs
for
NEED
WE
Reasons
The Lab Staff5 SOPs are essential to
EvaluationProcess
Performance
Without SOPs,
job performance
often becomes
a matterof opinion
51. 1. SOP Intro 1.1 SOP OVERVIEW
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
7
SOPs
for
NEED
WE
Reasons
The Lab Staff5 SOPs are essential to
EvaluationProcess
Performance
With SOPs, Manager can: Clearly identify
Successes
52. 1. SOP Intro 1.1 SOP OVERVIEW
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
7
SOPs
for
NEED
WE
Reasons
The Lab Staff5 SOPs are essential to
EvaluationProcess
Performance
With SOPs, Manager can: Communicate
Deficiencies
53. 1. SOP Intro 1.1 SOP OVERVIEW
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
7
SOPs
for
NEED
WE
Reasons
The Lab Staff5 SOPs are essential to
EvaluationProcess
Performance
With SOPs, Manager can be able to justify his:
Disciplinary Termination
actions Get OUT !! actions
عقاب الخدمةإنهاء
54. 1. SOP Intro 1.1 SOP OVERVIEW
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
7
SOPs
for
NEED
WE
Reasons
Support Each Other6 SOPs help Lab Staff to
When learning new processes,
Lab staff can help and train each other,
rather than relying on a manager to do so.
55. 1. SOP Intro 1.1 SOP OVERVIEW
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
7
SOPs
for
NEED
WE
Reasons
Support Each Other6 SOPs help Lab Staff to
Also, lab staff have theopportunity
to correct / redirect each other
when tasks are not being performed correctly.
56. 1. SOP Intro 1.1 SOP OVERVIEW
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
7
SOPs
for
NEED
WE
Reasons
Safer Work Environment7 SOPs help to Create a
Clearly written SOPs … Along with proper training
Reduce the odds of
Accidentsor Injuries
57. 1. SOP Intro 1.1 SOP OVERVIEW
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
7
SOPs
for
NEED
WE
Reasons
Safer Work Environment7 SOPs help to Create a
Clearly written SOPs … Along with proper training
Reduce legal liability
when an incident occur
58. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
2.1 Title Page
2.2 TOC
2.3 Text
General
FORMAT PROCESS
SOP
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
INTRO
SOP
1
1.1 Overview
1.2 Purpose
1.3 Benefits
1.4 Writing Styles
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?
59. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
4.1 Preparation
4.2 Review and Approval
4.3 Frequency of
Revisions and Reviews
4.4 Checklists
4.5 Document Control
4.6 Document
Tracking and Archival
2.1 Title Page
2.2 TOC
2.3 Text
General
FORMAT PROCESS
SOP
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
INTRO
SOP
1
1.1 Overview
1.2 Purpose
1.3 Benefits
1.4 Writing Styles
SOP Roadmap
60. 1. SOP Intro 1.2 SOP Purpose (Types of SOP)
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
Administrative
SOPs
إداري Technical
SOPs
تقنA B
61. 1. SOP Intro 1.2 SOP Purpose (Types of SOP)
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
Administrative
SOPs
إداري Technical
SOPs
تقنA B
Can be written for a wide variety of activities:
• Reviewing documentation such as contracts
• Quality Assurance and Management Plans
• Inspecting (auditing) the work of others
• Determining organizational training needs
• Developing information on records and maintenance
• Validating data packages
• Describing office correspondence procedures.
عقود
اقبةرم
المكتبية اسالترالم
62. 1. SOP Intro 1.2 SOP Purpose (Types of SOP)
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
Administrative
SOPs
إداري Technical
SOPs
تقنA B
SOPs for
Equipment
• Calibration
• Operation
• Maintenance
SOPs for
Analysis (Tests)
SOPs for
Procedures
Written for any procedure inside the Lab
• Range from collecting the patient sample
and cleaning of laboratory rooms
• Prepare Reagents
• Prepare Sample
• Perform Test analysis
• Perform Quality controls
2 3
[ The majority of Lab SOPs ]
Measurement of certain AnalyteFor Work on Lab Machines
1
63. 1. SOP Intro 1.2 SOP Purpose (Types of SOP)
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
Administrative
SOPs
إداري Technical
SOPs
تقنA B
Master
SOPs
[ SOP of SOPs ]
C
• Used to explain exactly HOW an SOP must be written
• To make sure that all the SOPs in the laboratory are
written in the same way and written complete
64. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
2.1 Title Page
2.2 TOC
2.3 Text
General
FORMAT PROCESS
SOP
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
INTRO
SOP
1
1.1 Overview
1.2 Purpose
1.3 Benefits
1.4 Writing Styles
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?
65. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
2.1 Title Page
2.2 TOC
2.3 Text
General
FORMAT PROCESS
SOP
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
INTRO
SOP
1
1.1 Overview
1.2 Purpose
1.3 Benefits
1.4 Writing Styles
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?
66. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
safety
checklists for
Reduce workSaving
Provide
Effort
minimize
Variations
address
concernsQuality
promote
Time Requirements
Governmental
Allow Following
Health and
miscommunication
minimize
Project
activities
valuable for
used as
auditing detailed instructions
Self–Training
as they provide
1 2 3 4 5 6
Legal
defensibility
7 8 9 10 11
1. SOP Intro 1.3 Benefits of using SOPs
67. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
2.1 Title Page
2.2 TOC
2.3 Text
General
FORMAT PROCESS
SOP
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
INTRO
SOP
1
1.1 Overview
1.2 Purpose
1.3 Benefits
1.4 Writing Styles
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?
68. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
2.1 Title Page
2.2 TOC
2.3 Text
General
FORMAT PROCESS
SOP
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
INTRO
SOP
1
1.1 Overview
1.2 Purpose
1.3 Benefits
1.4 Writing Styles
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?
69. 1. SOP Intro 1.4 Writing Style
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
Easy-To-ReadSimple+ Concise 2 Abbreviated
Step-by-step
Instructions
3
Available in
1
4 Information
Clear (Unambiguous)
Explicit
Detailed
Not complicated
The active voice
Use Present verb tense (Add … Mix … Incubate … etc.)
The Term “you” should Not be used, but implied
6
5
Local language
You should now add 1.0 ml and then you should vortex
Examples
Add 1.0 ml and vortex
70. 1. SOP Intro 1.4 Writing Style
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
Easy-To-ReadSimple+ Concise 2 Abbreviated
Step-by-step
Instructions
3
Available in
1
4 Information
Clear (Unambiguous)
Explicit
Detailed
Not complicated
The active voice
Use Present verb tense (Add … Mix … Incubate … etc.)
The Term “you” should Not be used, but implied
Concern using
illustrations
e.g. flowcharts
Following the style guide
used by the laboratory
e.g. Font size and margins
6
5
7
Local language
8
71. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
To be Continued …
Episode 2