SOP’s

A standard operating procedure (SOP) is a set of written instructions that describe, in detail, how to perform a laboratory process or experiment safely and effectively. Laboratories must have written SOPs when the work in laboratory.

General Definition of SOPs:

A Set of Written Instructions, That documents a routine and Repetitive activity followed by Organization.

Laboratory SOPs Definition:

Document that include a set of Step-by-step Instructions instructions that laboratory staff should Meticulously follow when performing a procedure.

These SOPs are complies to Laboratory managment system to help lab staff to carry out complex routine operations.

Follow well written SOPs would ensure :

• Consistency:
  • Everyone should perform the test 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.
• Accuracy:
  • Follow written procedures, help laboratory staff produce more accurate results.
  • They not relying on memory alone, so they will not forget steps in the process.
• Quality: Consistency (Reliable) + Accurate Results are primary goals of the laboratory and could be considered as the definition of quality in the laboratory.

SOPs inside the clinical laboratory :

A Number of SOPs could be written.

1. Describing Laboratory Methods:
2. Sample Receiving and Registration:
3. Equipments:
4. Test Analysis:
5. Safety Precautions:
6. Master and Templates:
7. Quality Assurance:
8. Archiving:
9. Dealing with Complaints:

SOPs Road Map

1. Sop Introduction:
   1. Overview
   1. Purpose
   2. Benifits
   3. Writing Styles
2. General Formates:
   1. Title Page
   2. TOC
   3. Text
3. SOPs Types:
   1. Master SOPs
   2. Administrative SOps
   3. Technical SOPs
      1. Procedure
      2. Equipments
      3. Analysis
4. SOPs Process:
   1. Preparation
   2. Revision and Approval
   3. Frequency of Reviewing
   4. Checklists
   5. Document Controls
   6. Document Tracking and Archival
   7. How to apply a SOP system ?

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