Standard Operating Procedure
Prof. Dr. Diler Aslan
It has become a habit to conduct business without learning about it.
The inspector is familiar with the kit manual and the standard operating procedure (SOP). So is the laboratory manager…
“Operation” refers to how you conduct your work at your workplace or wherever you are located. The laboratory prepares a Stable Operation (SOP) according to the kit guide. This explains how it applies the recommendations in the test kit within its laboratory.
If SOP had been translated as "Laboratory Operating Procedure," it wouldn't have been so misunderstood...
The manual prepared by the kit manufacturer for the test kit, in accordance with legal regulations, cannot be used as a Standard Operating Procedure (SOP) for the laboratory.
The differences between the kit manual and the SOP are as follows:
| Feature/
Difference |
Kit Guide | Standard Operating Procedure (SOP) |
| Definition | This document, provided by the manufacturer, contains information on the use, storage, operating principles, and results evaluation of the components that make up the kit. | A written procedure prepared by a laboratory in accordance with its own operations and conditions, containing step-by-step instructions for conducting a specific test. |
| Preparer | Kit manufacturer | Laboratory's expert staff |
| Scope | It is generally limited to the specific use of the kit. | It covers the entire process, from biological sample collection to results reporting. |
| Contents | This includes the content of the reagents, storage conditions, test principle, operating procedure, sources of error, reference ranges, etc. | Sample acceptance and rejection criteria, equipment preparation, calibration, quality control, safety precautions, and software usage are all included in the laboratory process. |
| Specificity to the Testing Environment | Suitable for general use, not specific to laboratory conditions. | The laboratory's equipment, personnel, workflow, and local conditions are specific to the environment. |
| Update Authority | The manufacturer does it. | Laboratory management and quality control are handled by the responsible person. |
| The Relationship Between Quality and Accreditation | It may have a quality certificate, but the laboratory... It is not integrated into the accreditation system. | It must comply with accreditation standards such as ISO 15189. |
| Risk and Security Approach | It contains general warnings regarding product safety. | It describes in detail the specific risks and safety precautions in a laboratory setting. |
| Calibration and Inspection | Provides general information about the use of calibrators and control materials. | Calibration frequency details the laboratory's defined processes associated with internal quality control and external quality assessments. |
| Application Flexibility | This is a standard procedure; no changes can be made during implementation. | The laboratory may revise the SOP by making changes to the process if needed. |
| Results Reporting | It provides general information regarding the evaluation of the results. | The reporting format for results includes specific practices defined by the laboratory, such as the reporting of critical values. |
Kit guideThis document contains standard information provided by the manufacturer and is general. It belongs to the External Resources Document category.
SOP: It is prepared according to the laboratory's own working procedures; it is specialized.
Wishing you a life filled with health, love, and respect…
19.02.2025
The author's work in this field includes: Clinical laboratory management at SSK hospital, management, presidency, and directorship positions at the university, Director of Pamukkale University Quality Management and Data Evaluation (KAVDEM) Application and Research Center. TÜRKAK ISO 15189 Auditor. External Evaluator for Higher Education.
Useful Book: “Risk, Quality and Process-Based Management Model in Medical Laboratories”. Nobel Academic Publishing, 2024. Ankara.
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