04/12/2025
How to prepare an SOP according as ISO 15189:2022 by t.me/laboratory_2025
First
Standard Operating Procedure is a written document that explains exactly how a task must be done in the laboratory so that everyone performs it the same way, every time.
simple terms, it’s a step-by-step guide for a lab process.
Steps
1. Identify the need for the SOP
Decide which process, test, or activity needs to be formalized. ISO 15189 expects all critical activities to be documented—anything tied to quality, safety, accuracy, or traceability.
2. Collect information
Talk to the people who actually perform the work, review instrument manuals, method sheets, manufacturer instructions, and any regulatory requirements.
3. Draft the SOP using a standardized format
ISO doesn’t force a template, but it requires clarity, traceability, and controlled documentation. Use the same structure across all SOPs so staff can follow them easily.
4. Perform risk-based thinking
ISO 15189:2022 stresses risk management. As you write the SOP, note anything that could introduce errors and clarify how the process minimizes them.
5. Verify the procedure
Before approval, the SOP should be tested in practice to confirm the steps make sense and produce consistent results.
6. Approve and authorize
The lab director or quality manager signs off. The SOP becomes a controlled document with a unique ID, version number, and effective date.
7. Train staff
Everyone who performs the task must be trained and competency-assessed. Training records must be kept.
8. Implement and monitor
Put the SOP into daily use and periodically review it for effectiveness and compliance with ISO requirements.
9. Update and revise
Whenever there’s a change in method, equipment, reagents, risks, or regulations, revise the SOP and document the changes.
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